Long-Term Safety Study Of Tofacitinib In Patients With Juvenile Idiopathic Arthritis

March 2, 2026 updated by: Pfizer

A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA)

Evaluate long-term safety and tolerability of tofacitinib in patients with JIA, who have previously participated in tofacitinib JIA studies.

Study Overview

Status

Completed

Conditions

Juvenile Idiopathic Arthritis

Intervention / Treatment

Detailed Description

This is a Phase 2/3, long term, open-label, follow-up study. Subjects will have previously participated in qualifying/index JIA studies of tofacitinib. Those who have already completed such participation and enroll outside the 14 day window following completion of the End of Study (EOS) Visit of the qualifying/index study will participate in a screening Visit to determine eligibility. A Baseline Visit will then occur within 28 days after the Screening Visit. For subjects who are completing participation in a qualifying study of tofacitinib and enrolling on the same day of the EOS Visit of the qualifying/index study, the EOS Visit of the qualifying/index study can be combined with the Screening and Baseline Visits for this study. The subjects who enroll within the 14 day window following completion of the EOS Visit of the qualifying/index study will participate in a combined Screening and Baseline Visit for this study. After the Baseline Visit, visits will occur at 1 month (1 month=30 days) and 3 months, then every 3 months thereafter as long as the subject remains in the study.

Approximately 340 participants are projected to enroll into this open label extension study after completing a qualifying/index study in the JIA program.

For subjects who entered this study from the A3921103 and A3921104 qualifying/index studies, their participation in this study ends after the first marketing approval of tofacitinib for the treatment of polyarticular course Juvenile Idiopathic Arthritis (pJIA) in any country. This study will end once the last subject, and all other subjects, who entered from index study A3921165 have completed approximately 1 year in this study, or after the first marketing approval of tofacitinib for the treatment of systemic JIA, whichever comes first.

The total duration of an individual subject's participation may vary depending upon when they enter the trial.

Study Type

Interventional

Enrollment (Actual)

302

Phase

Phase 2
Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - CABA, Argentina, C1280AEB
    - Hospital Britanico de Buenos Aires
- Santa Fe Province
  - Rosario, Santa Fe Province, Argentina, S2000PBJ
    - Instituto CAICI SRL
- Tucumán Province
  - San Miguel de Tucumán, Tucumán Province, Argentina, T4000AXL
    - Centro Medico Privado de Reumatologia
Australia
- New South Wales
  - Westmead, New South Wales, Australia, 2145
    - The Children's Hospital at Westmead
- Victoria
  - Parkville, Victoria, Australia, 3052
    - The Royal Children's Hospital
Belgium
- - Ghent, Belgium, 9000
    - UZ Gent
  - Leuven, Belgium, 3000
    - UZ Leuven - Gasthuisberg
Brazil
- - Rio de Janeiro, Brazil, 21941-912
    - Instituto de Puericultura e Pediatria Martagao Gesteira (IPPMG)
  - São Paulo, Brazil, 04037-002
    - SPDM - Associacao Paulista para o Desenvolvimento da Medicina
  - São Paulo, Brazil, 05409-011
    - Instituto da Crianca do Hospital das Clinicas da FMUSP
- Estado de Bahia
  - Salvador, Estado de Bahia, Brazil, 40150-150
    - SER - Serviços Especializados em Reumatologia
- Minas Gerais
  - Juiz de Fora, Minas Gerais, Brazil, 36010-570
    - CMIP - Centro Mineiro de Pesquisa Ltda
- Paraná
  - Curitiba, Paraná, Brazil, 80250-060
    - Hospital Pequeno Príncipe Clinical Research Office
- São Paulo
  - Botucatu, São Paulo, Brazil, 18618-686
    - Faculdade de Medicina da UNESP
Canada
- Alberta
  - Calgary, Alberta, Canada, T3B 6A8
    - Alberta Children's Hospital
- British Columbia
  - Vancouver, British Columbia, Canada, V6H 3V4
    - British Columbia Children's Hospital
- Quebec
  - Montreal, Quebec, Canada, H4A 3J1
    - McGill University Health Center, Glen Site
China
- - Beijing, China, 100045
    - Beijing Children's Hospital, Capital Medical University/Rheumatology Department
- Jiangsu
  - Suzhou, Jiangsu, China, 215003
    - Children's Hospital of Soochow University
- Zhejiang
  - Hangzhou, Zhejiang, China, 310057
    - The Children's Hospital Zhejiang University School of Medicine
Germany
- - Bad Bramstedt, Germany, 24576
    - PRI - Pediatric Rheumatology Research Institute GmbH
  - Hamburg, Germany, 22081
    - Hamburger Zentrum fur Kinder und Jugendrheumatologie
  - Sankt Augustin, Germany, 53757
    - Asklepios Klinik Sankt Augustin GmbH
  - Sendenhorst, Germany, 48324
    - St. Josef-Stift Sendenhorst
India
- - New Delhi, India, 110060
    - Sir Ganga Ram Hospital
- Gujarat
  - Surat, Gujarat, India, 395002
    - Nirmal Hospital Pvt Ltd.
- West Bengal
  - Kolkata, West Bengal, India, 700017
    - Institute of Child Health
  - Kolkata, West Bengal, India, 700020
    - Institute of Post Graduate Medical Education and Research & SSKM Hospital
Israel
- - Haifa, Israel, 31096 01
    - Rambam Health Care Campus
  - Kfar Saba, Israel, 4428164
    - Meir Medical Center - Pediatric Clinic
  - Ramat Gan, Israel, 52621
    - Chaim Sheba M.C Tel hashomer
Mexico
- - San Luis Potosí City, Mexico, 78290
    - Unidad de Investigaciones Reumatologicas A.C.
  - San Luis Potosí City, Mexico, 78290
    - Hospital Central "Dr. Ignacio Morones Prieto"
  - San Luis de Potosí, Mexico, 78213
    - Centro de Alta Especialidad de Reumatología e Investigación del Potosí, S.C.
- Jalisco
  - Guadalajara, Jalisco, Mexico, 44650
    - Clínica de Investigacion en Reumatologia y Obesidad, S.C.
- Nuevo León
  - Monterrey, Nuevo León, Mexico, 64460
    - Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Poland
- - Bydgoszcz, Poland, 85-667
    - Wojewodzki Szpital Dzieciecy im. J. Brudzinskiego
  - Krakow, Poland, 31-503
    - Wojewódzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie
  - Lodz, Poland, 91-738
    - Klinika Kardiologii i Reumatologii Dzieciecej
  - Warsaw, Poland, 02-637
    - Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
Russia
- - Moscow, Russia, 115522
    - Federal State Budgetary Scientific Institution
  - Moscow, Russia, 119435
    - FSAEI HE I.M. Sechenov First MSMU of Minzdrav of Russia (Sechenovskiy University)
  - Moscow, Russia, 119991
    - FSAEI HE I.M. Sechenov First MSMU of Minzdrav of Russia (Sechenovskiy University),
  - Moscow, Russia, 119991
    - FSAI "NMRCCH" of MOH Russia
  - Saint Petersburg, Russia, 194100
    - FSBEI HE "St. Petersburg State Pediatric Medical University" of the Ministry of Healthcare
  - Tolyatti, Russia, 445039
    - State Budgetary Healthcare Institution of Samara Region "Tolyatti City Clinical Hospital #5"
- Bashkortostan Republic
  - Ufa, Bashkortostan Republic, Russia, 450008
    - FSBEI HE BSMU MoH RF
  - Ufa, Bashkortostan Republic, Russia, 450083
    - Clinic of FSBEI HE BSMU MoH RF
Slovakia
- - Piešťany, Slovakia, 921 12
    - Narodny Ustav Reumatickych Chorob
South Africa
- - Durban, South Africa, 4301
    - Durban International Clinical Research Site, Enhancing Care Foundation
- CAPE TOWN
  - Panorama, CAPE TOWN, South Africa, 7500
    - Panorama Medical Centre
Spain
- - Madrid, Spain, 28034
    - Hospital Universitario Ramón y Cajal
  - Madrid, Spain, 28046
    - Hospital Universitario La Paz
  - Valencia, Spain, 46026
    - Hospital Universitario y Politécnico La Fe
Turkey (Türkiye)
- - Ankara, Turkey (Türkiye), 06100
    - Hacettepe University Medical Faculty
  - Istanbul, Turkey (Türkiye), 34764
    - Umraniye Training and Research Hospital
  - Kadikoy / Istanbul, Turkey (Türkiye), 34722
    - Istanbul Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi Cocuk Romatoloji Bolumu
Ukraine
- - Dnipro, Ukraine, 49006
    - Communal Institution "Dnipropetrovsk Specialized Clinical Medical Center of Mother and Child n.a.
  - Ivano-Frankivsk, Ukraine, 76014
    - Ivano-Frankivsk Regional Children's Clinical Hospital
  - Vinnytsia, Ukraine, 21000
    - Communal Non-profit Enterprise
United Kingdom
- WEST Midlands
  - Birmingham, WEST Midlands, United Kingdom, B4 6NH
    - Birmingham Woman's and Children's NHS Foundation Trust
United States
- Arkansas
  - Little Rock, Arkansas, United States, 72202
    - Arkansas Children's Hospital
- California
  - Loma Linda, California, United States, 92354
    - Loma Linda University Children's Hospital
  - Loma Linda, California, United States, 92354
    - Loma Linda University Eye Institute
  - Loma Linda, California, United States, 92354
    - Loma Linda University General Pediatric Clinic - Meridian
  - Loma Linda, California, United States, 92354
    - Loma Linda University Clinical Trials Center
  - Loma Linda, California, United States, 92408
    - Pediatric Speciality Team Centers of LLU Children's Hospital (Rheumatology)
  - Los Angeles, California, United States, 90027
    - Children's Hospital Los Angeles
  - San Bernardino, California, United States, 92408
    - Pediatric Speciality Team Centers of LLU Children's Hospital (Rheumatology)
  - San Diego, California, United States, 92123
    - Rady Children's Hospital San Diego
  - San Diego, California, United States, 92123
    - Rady Children's Hospital Center for Pediatric Clinical Research
  - San Diego, California, United States, 92123
    - Rady Children's Hospital Rheumatology Clinic
  - San Diego, California, United States, 92123
    - Rady Children's Hospital San Diego- Education and Office Building
  - San Diego, California, United States, 92123
    - Rady Children's Research Pharmacy
- Connecticut
  - Hartford, Connecticut, United States, 06106
    - Connecticut Children's Medical Center
- District of Columbia
  - Washington D.C., District of Columbia, United States, 20010
    - Children's National Medical Center
  - Washington D.C., District of Columbia, United States, 20010
    - IDS Pharmacy
- Florida
  - Miami, Florida, United States, 33155
    - Nicklaus Children's Hospital
- Georgia
  - Atlanta, Georgia, United States, 30329
    - Center for Advanced Pediatrics
  - Augusta, Georgia, United States, 30912
    - Augusta University
  - Augusta, Georgia, United States, 30912
    - AU Medical Center
- Illinois
  - Chicago, Illinois, United States, 60611
    - Ann & Robert H. Lurie Children's Hospital of Chicago
  - Chicago, Illinois, United States, 60637
    - The University of Chicago Medical Center
- Indiana
  - Indianapolis, Indiana, United States, 46202
    - Riley Hospital for Children at IU Health
- Massachusetts
  - Boston, Massachusetts, United States, 02111
    - Tufts Medical Center - Floating Hospital for Children
- Minnesota
  - Minneapolis, Minnesota, United States, 55454
    - Explorer Clinic, University of Minnesota Children's Hospital
- New Jersey
  - Hackensack, New Jersey, United States, 07601
    - Hackensack University Medical Center
- New York
  - Lake Success, New York, United States, 11042
    - Cohen Children's Medical Center of New York
  - New York, New York, United States, 10032
    - Columbia University Medical Center-Herbert Irving Pavillion
  - The Bronx, New York, United States, 10467
    - Montefiore Medical Center
- North Carolina
  - Charlotte, North Carolina, United States, 20207
    - Pediatric Research
  - Charlotte, North Carolina, United States, 28203
    - Levine Children's Specialty Center
  - Charlotte, North Carolina, United States, 28207
    - Atrium Health- Investigational Drug Services
- Ohio
  - Cincinnati, Ohio, United States, 45229
    - Cincinnati Children's Hospital Medical Center
- Oregon
  - Portland, Oregon, United States, 97227
    - Randall Children's Hospital at Legacy Emanuel
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19104
    - The Children's Hospital of Philadelphia
- Texas
  - Austin, Texas, United States, 78723
    - Dell Children's Medical Group, Dell Children's Medical Center
  - Houston, Texas, United States, 77030
    - Texas Children's Hospital- Clinical Care Center
  - Houston, Texas, United States, 77030
    - Texas Children's Hospital- Clinical Research Center
  - Houston, Texas, United States, 77030
    - Texas Children's Hospital- Investigational Pharmacy
  - Houston, Texas, United States, 77030
    - Texas Children's Hospital- Main Hospital
  - Houston, Texas, United States, 77030
    - Texas Children's Hospital/Baylor College of Medicine- Feigin Center
- Utah
  - Salt Lake City, Utah, United States, 84113
    - Intermountain - Primary Children's Hospital
- Washington
  - Seattle, Washington, United States, 98105
    - Seattle Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Pediatric subjects with JIA aged from 2 to less than 18 years who met entry criteria for the qualifying/index study and in the opinion of the investigator have sufficient evidence of JIA disease activity to warrant use of tofacitinib as a DMARD. Subjects turning 18 years of age during participation in the qualifying/index study or subsequently will be eligible for participation in this study.
The subject has discontinued disallowed concomitant medications for the required time prior to the first dose of study drug, as defined in Appendix 1, and is taking only those concomitant medications in doses and frequency allowed by the protocol.
Fertile male subjects and female subjects of childbearing potential who are, in the opinion of the investigator, sexually active and at risk for pregnancy with their partner(s) must be using a highly effective method of contraception as outlined in this protocol throughout the study and for at least 28 days after the last dose of study medication.
Subjects must have previously completed participation in a qualifying study of tofacitinib for the treatment of JIA. Subjects who have required earlier discontinuation of treatment in a qualifying study for reasons other than tofacitinib related serious adverse events may be eligible.

Exclusion Criteria:

persistent oligoarthritis, and undifferentiated JIA.
Infections:
1. Chronic infections.
2. Any infection requiring hospitalization, parenteral antimicrobial therapy or judged to be opportunistic by the investigator within the 3 months prior to the first dose of study drug.
3. Any treated infections within 2 weeks of baseline visit.
4. A subject known to be infected with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus.
5. History of infected joint prosthesis with prosthesis still in situ.
History of recurrent (more than one episode) herpes zoster or disseminated (a single episode) herpes zoster or disseminated (a single episode) herpes simplex.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tofacitinib All patients will be in tofacitinib treatment group.	Drug: Tofacitinib Tofacitinib will be administered orally BID (twice daily) approximately 12 hours (±2 hours) apart, once in the morning and once in the evening, based on body weight for all subjects for all three index studies (A3921103, A3921104, and A3921165) 5 mg BID Dose Level: Body Weight (Dose in tablet [mg BID] or solution [ml BID]) 5 - < 7 kg (2 mg or 2 ml) 7 - < 10 kg (2.5 mg or 2.5 ml) 10 - <15 kg (3 mg or 3 ml) 15 - <25 kg (3.5 mg or 3.5 ml) 25 - <40 kg (4 mg or 4 ml) >=40 kg (5 mg or 5 ml) Oral solution (1 mg/mL concentration) will be used for subjects weighing <40 kg. Oral tablets (5 mg) will be used for subjects weighing >=40 kg; subjects who are unable to swallow tablets will have the option of taking oral solution. Subjects will swallow study tablets whole and will not manipulate or chew tablets prior to swallowing. Other Names: CP 690,550, Xeljanz Drug: Tofacitinib For subjects rolling over from study A3921103 and actively participating in this study at the time of Protocol Amendment 6 and receiving a dosage of tofacitinib in accordance with the dosing scheme specified in Protocol Amendment 5, investigators will have the option of maintaining the subject's current dosage regimen from index study A3921103 (if the desired clinical response has been attained with no safety concern) or adjusting the dosage regimen in accordance with the dosing scheme specified in this section. Other Names: CP-690,550, Xeljanz

Participant Group / Arm

Intervention / Treatment

Experimental: Tofacitinib

All patients will be in tofacitinib treatment group.

Drug: Tofacitinib

Tofacitinib will be administered orally BID (twice daily) approximately 12 hours (±2 hours) apart, once in the morning and once in the evening, based on body weight for all subjects for all three index studies (A3921103, A3921104, and A3921165)

5 mg BID Dose Level:

Body Weight (Dose in tablet [mg BID] or solution [ml BID]) 5 - < 7 kg (2 mg or 2 ml) 7 - < 10 kg (2.5 mg or 2.5 ml) 10 - <15 kg (3 mg or 3 ml) 15 - <25 kg (3.5 mg or 3.5 ml) 25 - <40 kg (4 mg or 4 ml) >=40 kg (5 mg or 5 ml)

Oral solution (1 mg/mL concentration) will be used for subjects weighing <40 kg. Oral tablets (5 mg) will be used for subjects weighing >=40 kg; subjects who are unable to swallow tablets will have the option of taking oral solution.

Subjects will swallow study tablets whole and will not manipulate or chew tablets prior to swallowing.

Other Names:

CP 690,550, Xeljanz

Drug: Tofacitinib

For subjects rolling over from study A3921103 and actively participating in this study at the time of Protocol Amendment 6 and receiving a dosage of tofacitinib in accordance with the dosing scheme specified in Protocol Amendment 5, investigators will have the option of maintaining the subject's current dosage regimen from index study A3921103 (if the desired clinical response has been attained with no safety concern) or adjusting the dosage regimen in accordance with the dosing scheme specified in this section.

Other Names:

CP-690,550, Xeljanz

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Laboratory Test Abnormalities Time Frame: During study treatment (maximum up to 118 months)	Parameters: Hematology (hemoglobin, hematocrit, erythrocytes, platelets, leukocytes, lymphocytes, lymphocytes/leukocytes, neutrophils, neutrophils/leukocytes, basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes, monocytes, monocytes/leukocytes, prothrombin international normalized ratio, erythrocyte sedimentation rate), clinical chemistry (bilirubin, direct/indirect bilirubin, aspartate/alanine aminotransferase, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase, protein, albumin, blood urea nitrogen, creatinine, cholesterol, high and low density lipoprotein cholesterol, Friedewald estimation, triglycerides, sodium, potassium, chloride, calcium, bicarbonate, glucose, creatine kinase, C reactive protein), urinalysis (specific gravity, potential of hydrogen (pH), glucose/ protein/ hemoglobin/ erythrocytes/ leukocytes, ketones, leukocyte esterase, hyaline casts, bacteria). Number of participants with at least 1 laboratory abnormality are reported.	During study treatment (maximum up to 118 months)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Time Frame: From start of the study intervention up to 28 days after last dose of the study intervention or until study completion or withdrawal, whichever is longer (maximum up to 118 months from start of study intervention)	An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily had a causal relationship with the treatment or usage. A serious AE (SAE) was defined as any untoward medical occurrence at any dose that met one or more of the following criteria: resulted in death, was life-threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. An TEAE was any AE that occurred following the start of study treatment in this study or increased in severity following the start of study treatment in this study. AE included both SAEs and all non-SAEs.	From start of the study intervention up to 28 days after last dose of the study intervention or until study completion or withdrawal, whichever is longer (maximum up to 118 months from start of study intervention)
Absolute Values of Body Weight at Baseline Time Frame: At Baseline	Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).	At Baseline
Absolute Value of Body Weight at Month 12 and Its Change From Baseline at Month 12 Time Frame: Baseline, Month 12	Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).	Baseline, Month 12
Absolute Value of Body Weight at Month 24 and Its Change From Baseline at Month 24 Time Frame: Baseline, Month 24	Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).	Baseline, Month 24
Absolute Value of Body Weight at Month 36 and Its Change From Baseline at Month 36 Time Frame: Baseline, Month 36	Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).	Baseline, Month 36
Absolute Value of Body Weight at Month 48 and Its Change From Baseline at Month 48 Time Frame: Baseline, Month 48	Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).	Baseline, Month 48
Absolute Value of Body Weight at Month 60 and Its Change From Baseline at Month 60 Time Frame: Baseline, Month 60	Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).	Baseline, Month 60
Absolute Value of Body Weight at Month 72 and Its Change From Baseline at Month 72 Time Frame: Baseline, Month 72	Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).	Baseline, Month 72
Absolute Value of Body Weight at Month 84 and Its Change From Baseline at Month 84 Time Frame: Baseline, Month 84	Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).	Baseline, Month 84
Absolute Value of Height at Baseline Time Frame: At Baseline	Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).	At Baseline
Absolute Value of Height at Month 12 and Its Change From Baseline at Month 12 Time Frame: Baseline, Month 12	Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).	Baseline, Month 12
Absolute Value of Height at Month 24 and Its Change From Baseline at Month 24 Time Frame: Baseline, Month 24	Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).	Baseline, Month 24
Absolute Value of Height at Month 36 and Its Change From Baseline at Month 36 Time Frame: Baseline, Month 36	Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).	Baseline, Month 36
Absolute Value of Height at Month 48 and Its Change From Baseline at Month 48 Time Frame: Baseline, Month 48	Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).	Baseline, Month 48
Absolute Value of Height at Month 60 and Its Change From Baseline at Month 60 Time Frame: Baseline, Month 60	Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).	Baseline, Month 60
Absolute Value of Height at Month 72 and Its Change From Baseline at Month 72 Time Frame: Baseline, Month 72	Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).	Baseline, Month 72
Absolute Value of Height at Month 84 and Its Change From Baseline at Month 84 Time Frame: Baseline, Month 84	Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).	Baseline, Month 84
Number of Participants According to Tanner Stage at Baseline Time Frame: At Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap)	Pubertal development was measured using Tanner stage, by age group (2 to <6 years, 6 to <12 years, and 12 years or older) for males and females separately. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (fully developed breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes continue to enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size).	At Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap)
Number of Participants With Shift in Tanner Stage From Baseline to Month 12 Time Frame: Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 12	Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 12. Only rows with non-zero values were reported in this outcome measure.	Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 12
Number of Participants With Shift in Tanner Stage From Baseline to Month 24 Time Frame: Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 24	Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 24. Only rows with non-zero values were reported in this outcome measure.	Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 24
Number of Participants With Shift in Tanner Stage From Baseline to Month 36 Time Frame: Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 36	Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 36. Only rows with non-zero values were reported in this outcome measure.	Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 36
Number of Participants With Shift in Tanner Stage From Baseline to Month 48 Time Frame: Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 48	Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 48. Only rows with non-zero values were reported in this outcome measure.	Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 48
Number of Participants With Shift in Tanner Stage From Baseline to Month 60 Time Frame: Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 60	Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 60. Only rows with non-zero values were reported in this outcome measure.	Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 60
Number of Participants With Shift in Tanner Stage From Baseline to Month 72 Time Frame: Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 72	Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 72. Only rows with non-zero values were reported in this outcome measure.	Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 72
Number of Participants With Shift in Tanner Stage From Baseline to Month 84 Time Frame: Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 84	Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 84. Only rows with non-zero values were reported in this outcome measure.	Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 84

Secondary Outcome Measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

To obtain contact information for a study center near you, click here.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2013

Primary Completion (Actual)

February 12, 2025

Study Completion (Actual)

February 12, 2025

Study Registration Dates

First Submitted

December 22, 2011

First Submitted That Met QC Criteria

December 27, 2011

First Posted (Estimated)

December 28, 2011

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

A3921145
JIA (Other Identifier: Alias Study Number)
2023-509651-14-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Juvenile Idiopathic Arthritis

University of Aarhus
Aarhus University Hospital

Completed

Ultrasonography in Juvenile Idiopathic Arthritis

Polyarticular Juvenile Rheumatoid Arthritis | Systemic Juvenile Idiopathic Arthritis | Juvenile Idiopathic Arthritis, Oligoarthritis

Denmark
Bangladesh Medical University

Completed

Comparative Study of Leflunomide Plus Methotrexate Versus Methotrexate Monotherapy in Refractory Polyarticular Juvenile Idiopathic Arthritis Patients (JIA)

Juvenile Idiopathic Arthritis | Polyarticular Juvenile Idiopathic Arthritis | Refractory Polyarticular Juvenile Idiopathic Arthritis

Bangladesh
Assiut University

Not yet recruiting

Tenosynovitis in Polyarticular and Oligoarticular Juvenile Idiopathic Arthritis

Juvenile Idiopathic Arthritis | Tenosynovitis | Polyarticular Juvenile Idiopathic Arthritis | Oligoarticular Juvenile Idiopathic Arthritis
Changchun GeneScience Pharmaceutical Co., Ltd.

Recruiting

To Evaluate the Efficacy and Safety of Genalumab for Injection in the Treatment of Active Systemic Juvenile Idiopathic Arthritis.

Active Systemic Juvenile Idiopathic Arthritis

China
Novartis Pharmaceuticals
Pediatric Rheumatology International Trials Organization

Completed

Flare Prevention Study of Canakinumab in Patients With Active Systemic Juvenile Idiopathic Arthritis (SJIA) (β-SPECIFIC 2)

Systemic Juvenile Idiopathic Arthritis With Active Flare

United States, Argentina, Canada, Switzerland, Germany, Israel, South Africa, Belgium, Italy, Spain, France, Brazil, Turkey, Hungary, Poland, Norway, Sweden, Netherlands, Peru
Novartis Pharmaceuticals

Completed

ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line Use of Canakinumab (ß-SPECIFIC 4)

Systemic Juvenile Idiopathic Arthritis (SJIA)

Italy, Russian Federation, Turkey, Belgium, Spain, Germany, France, Israel, Canada, United States, Hungary, Austria, Brazil, Sweden, Netherlands, Poland
Pfizer

Recruiting

Korea Xeljanz Post-marketing Surveillance for Juvenile Idiopathic Arthritis (KRXeljanzJIA)

Polyarticular Juvenile Idiopathic Arthritis | Psoriatic Arthritis, Juvenile

South Korea
Novartis

Completed

Safety, Efficacy and Pharmacokinetics of Subcutaneous ACZ885 in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA)

Arthritis, Juvenile Rheumatoid

Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna

Not yet recruiting

Role of Interleukin 18 (IL-18) and Interleukin 18 Binding Protein (IL-18BP) in the Diagnostic Work-up of Systemic Juvenile Idiopathic Arthritis and Autoinflammatory Diseases: Possible Biomarkers in the Differential Diagnosis of Other Febrile Diseases

Systemic Juvenile Idiopathic Arthritis (sJIA)

Italy
University of British Columbia
University of Manitoba; The Hospital for Sick Children; McGill University Health... and other collaborators

Recruiting

CAPRI National Juvenile Idiopathic Arthritis Registry

Juvenile Idiopathic Arthritis (JIA)

Canada

Clinical Trials on Tofacitinib

National Institute of Dental and Craniofacial Research...

Recruiting

Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren Disease

Sjogren's Syndrome

United States
The First Affiliated Hospital of Xiamen University

Recruiting

Tofacitinib for Glucocorticoid-Resistant Moderate-to-Severe Thyroid Eye Disease (TOFA-GO)

Graves Ophthalmopathy | Graves Orbitopathy | Thyroid Eye Disease, TED

China
Consorci Sanitari de l'Alt Penedès i Garraf

Not yet recruiting

Tofacitinib in Juvenile Idiopathic Arthritis

Juvenile Idiopathic Arthritis (JIA)

Spain
Hexsel Dermatology Clinic

Not yet recruiting

Topical Use of 2% Tofacitinib for Nail Psoriasis: an Exploratory Clinical Study

Nail Psoriasis
University of Colorado, Denver
GLOBAL Down Syndrome Foundation; Anschutz Acceleration Initiative

Recruiting

Modulation of the Immune System in Down Syndrome for Improved Outcomes and Neurodevelopment - 1 (MISSION-1)

Down Syndrome

United States
Pfizer

Completed

Dose-Ranging Study Of Tofacitinib In Adults With Active Ankylosing Spondylitis

Ankylosing Spondylitis

Korea, Republic of, United States, Spain, Taiwan, Canada, Czech Republic, Poland, Hungary, Germany, Russian Federation
Philippe ROUSSELOT

Not yet recruiting

A Precision Medicine Trial for Patients With Relapsed or Refractory T Cell ALL (ALL-TARGET)

LAL

France, Netherlands, Spain, Czechia, Poland, Germany
Chia Tai Tianqing Pharmaceutical Group Nanjing...

Not yet recruiting

A Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQH3906 Capsules in the Treatment of Active Psoriatic Arthritis

Psoriatic Arthritis

China
Pfizer

Completed

Tofacitinib Bioequivalence Study Comparing Tablets And Capsules

Healthy

Singapore
Pfizer

Completed

A Study to Demonstrate the Equivalence of the Tofacitinib Oral Solution to the Tablet Formulation in Healthy Participants.

Healthy

United States

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Physician Global Evaluation of Disease Activity Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in Systemic Juvenile Idiopathic Arthritis (sJIA) 1 Analysis Set Time Frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36	Physician global evaluation of disease activity assessed overall arthritis appearance at specified time points. The evaluation was based on the participant's disease signs, functional capacity and physical examination. The investigator rated the overall level of disease activity by entering a number from 0 (no disease activity) to 10 (maximum disease activity) on a visual analogue scale (VAS). Higher scores signified more disease activity.	Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in Physician Global Evaluation of Disease Activity Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set Time Frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36	Physician global evaluation of disease activity assessed overall arthritis appearance at specified time points. The evaluation was based on the participant's disease signs, functional capacity and physical examination. The investigator rated the overall level of disease activity by entering a number from 0 (no disease activity) to 10 (maximum disease activity) on a VAS. Higher scores signified more disease activity.	Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in Physician Global Evaluation of Disease Activity Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set Time Frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78	Physician global evaluation of disease activity assessed overall arthritis appearance at specified time points. The evaluation was based on the participant's disease signs, functional capacity and physical examination. The investigator rated the overall level of disease activity by entering a number from 0 (no disease activity) to 10 (maximum disease activity) on a VAS. Higher scores signified more disease activity. In this outcome measure pJIA stands for polyarticular course juvenile idiopathic arthritis.	Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78
Change From Baseline in Physician Global Evaluation of Disease Activity Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in Enthesitis Related Arthritis (ERA) Analysis Set Time Frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36	Physician global evaluation of disease activity assessed overall arthritis appearance at specified time points. The evaluation was based on the participant's disease signs, functional capacity and physical examination. The investigator rated the overall level of disease activity by entering a number from 0 (no disease activity) to 10 (maximum disease activity) on a VAS. Higher scores signified more disease activity.	Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in Physician Global Evaluation of Disease Activity Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in Psoriatic Arthritis (PsA) Analysis Set Time Frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36	Physician global evaluation of disease activity assessed overall arthritis appearance at specified time points. The evaluation was based on the participant's disease signs, functional capacity and physical examination. The investigator rated the overall level of disease activity by entering a number from 0 (no disease activity) to 10 (maximum disease activity) on a VAS. Higher scores signified more disease activity.	Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in Number of Joints With Active Arthritis at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set Time Frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36	Active arthritis was defined as a joint with swelling or, in the absence of swelling, limitation of motion accompanied by either pain on motion, or tenderness not due to deformity.	Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in Number of Joints With Active Arthritis at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set Time Frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36	Active arthritis was defined as a joint with swelling or, in the absence of swelling, limitation of motion accompanied by either pain on motion, or tenderness not due to deformity.	Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in Number of Joints With Active Arthritis at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set Time Frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78	Active arthritis was defined as a joint with swelling or, in the absence of swelling, limitation of motion accompanied by either pain on motion, or tenderness not due to deformity.	Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78
Change From Baseline in Number of Joints With Active Arthritis at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set Time Frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36	Active arthritis was defined as a joint with swelling or, in the absence of swelling, limitation of motion accompanied by either pain on motion, or tenderness not due to deformity.	Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in Number of Joints With Active Arthritis at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set Time Frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36	Active arthritis was defined as a joint with swelling or, in the absence of swelling, limitation of motion accompanied by either pain on motion, or tenderness not due to deformity.	Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in Number of Joints With Limitation of Motion at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set Time Frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36		Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in Number of Joints With Limitation of Motion at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set Time Frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36		Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in Number of Joints With Limitation of Motion at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set Time Frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78		Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78
Change From Baseline in Number of Joints With Limitation of Motion at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set Time Frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36		Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in Number of Joints With Limitation of Motion at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set Time Frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36		Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in C-Reactive Protein (CRP) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set Time Frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36	CRP was a laboratory measurement test for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation.	Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in CRP at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set Time Frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36	CRP was a laboratory measurement test for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation.	Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in CRP at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set Time Frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78	CRP was a laboratory measurement test for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation.	Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78
Change From Baseline in CRP at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set Time Frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36	CRP was a laboratory measurement test for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation.	Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in CRP at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set Time Frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36	CRP was a laboratory measurement test for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation.	Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set Time Frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36	ESR was a laboratory test that provides a measure of inflammation. A higher rate is consistent with inflammation.	Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set Time Frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36	ESR was a laboratory test that provides a measure of inflammation. A higher rate is consistent with inflammation.	Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set Time Frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78	ESR was a laboratory test that provides a measure of inflammation. A higher rate is consistent with inflammation.	Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78
Change From Baseline in ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set Time Frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36	ESR was a laboratory test that provides a measure of inflammation. A higher rate is consistent with inflammation.	Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set Time Frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36	ESR was a laboratory test that provides a measure of inflammation. A higher rate is consistent with inflammation.	Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) - Parental Evaluation of Physical Function (Disability Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set Time Frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36	CHAQ comprised of: disability index and discomfort index, and parent global assessment of overall well-being. Disability index assessed function in 8 areas: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities-distributed among a total of 30 items. Each question was rated from Grade 0 to 3, 0= without any difficulty, 1= with some difficulty, 2= with much difficulty, 3= unable to do. If aids or devices were used or assistance was required, the minimum score for that functional area was 2. Parent/legal guardians were required to answer all questions. The disability index was calculated as the mean of the 8 functional areas and scores were averaged to calculate CHAQ disability index, which ranged from 0= no/minimal physical dysfunction to 3= very severe physical dysfunction; higher score indicated more disability.	Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in CHAQ - Parental Evaluation of Physical Function (Disability Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set Time Frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36	CHAQ comprised of: disability index and discomfort index, and parent global assessment of overall well-being. Disability index assessed function in 8 areas: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities-distributed among a total of 30 items. Each question was rated from Grade 0 to 3, 0= without any difficulty, 1= with some difficulty, 2= with much difficulty, 3= unable to do. If aids or devices were used or assistance was required, the minimum score for that functional area was 2. Parent/legal guardians were required to answer all questions. The disability index was calculated as the mean of the 8 functional areas and scores were averaged to calculate CHAQ disability index, which ranged from 0= no/minimal physical dysfunction to 3= very severe physical dysfunction; higher score indicated more disability.	Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in CHAQ - Parental Evaluation of Physical Function (Disability Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set Time Frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78	CHAQ comprised of: disability index and discomfort index, and parent global assessment of overall well-being. Disability index assessed function in 8 areas: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities-distributed among a total of 30 items. Each question was rated from Grade 0 to 3, 0= without any difficulty, 1= with some difficulty, 2= with much difficulty, 3= unable to do. If aids or devices were used or assistance was required, the minimum score for that functional area was 2. Parent/legal guardians were required to answer all questions. The disability index was calculated as the mean of the 8 functional areas and scores were averaged to calculate CHAQ disability index, which ranged from 0= no/minimal physical dysfunction to 3= very severe physical dysfunction; higher score indicated more disability.	Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78
Change From Baseline in CHAQ - Parental Evaluation of Physical Function (Disability Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set Time Frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36	CHAQ comprised of: disability index and discomfort index, and parent global assessment of overall well-being. Disability index assessed function in 8 areas: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities-distributed among a total of 30 items. Each question was rated from Grade 0 to 3, 0= without any difficulty, 1= with some difficulty, 2= with much difficulty, 3= unable to do. If aids or devices were used or assistance was required, the minimum score for that functional area was 2. Parent/legal guardians were required to answer all questions. The disability index was calculated as the mean of the 8 functional areas and scores were averaged to calculate CHAQ disability index, which ranged from 0= no/minimal physical dysfunction to 3= very severe physical dysfunction; higher score indicated more disability.	Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in CHAQ - Parental Evaluation of Physical Function (Disability Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set Time Frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36	CHAQ comprised of: disability index and discomfort index, and parent global assessment of overall well-being. Disability index assessed function in 8 areas: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities-distributed among a total of 30 items. Each question was rated from Grade 0 to 3, 0= without any difficulty, 1= with some difficulty, 2= with much difficulty, 3= unable to do. If aids or devices were used or assistance was required, the minimum score for that functional area was 2. Parent/legal guardians were required to answer all questions. The disability index was calculated as the mean of the 8 functional areas and scores were averaged to calculate CHAQ disability index, which ranged from 0= no/minimal physical dysfunction to 3= very severe physical dysfunction; higher score indicated more disability.	Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in CHAQ - Parental Evaluation of Child's Arthritis Pain (Discomfort Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set Time Frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36	CHAQ comprised of: disability index and discomfort index, and parent global assessment of overall well-being. For the assessment of discomfort index, the parent/legal guardian or adult caregiver who interacted daily with the participant were required to rate the overall arthritis pain of participant from 0 (no pain) to 10 (very severe pain), on a VAS, where higher scores indicated more severe pain.	Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in CHAQ - Parental Evaluation of Child's Arthritis Pain (Discomfort Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set Time Frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36	CHAQ comprised of: disability index and discomfort index, and parent global assessment of overall well-being. For the assessment of discomfort index, the parent/legal guardian or adult caregiver who interacted daily with the participant were required to rate the overall arthritis pain of participant from 0 (no pain) to 10 (very severe pain), on a VAS, where higher scores indicated more severe pain.	Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in CHAQ - Parental Evaluation of Child's Arthritis Pain (Discomfort Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set Time Frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78	CHAQ comprised of: disability index and discomfort index, and parent global assessment of overall well-being. For the assessment of discomfort index, the parent/legal guardian or adult caregiver who interacted daily with the participant were required to rate the overall arthritis pain of participant from 0 (no pain) to 10 (very severe pain), on a VAS, where higher scores indicated more severe pain.	Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78
Change From Baseline in CHAQ - Parental Evaluation of Child's Arthritis Pain (Discomfort Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set Time Frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36	CHAQ comprised of: disability index and discomfort index, and parent global assessment of overall well-being. For the assessment of discomfort index, the parent/legal guardian or adult caregiver who interacted daily with the participant were required to rate the overall arthritis pain of participant from 0 (no pain) to 10 (very severe pain), on a VAS, where higher scores indicated more severe pain.	Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in CHAQ - Parental Evaluation of Child's Arthritis Pain (Discomfort Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set Time Frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36	CHAQ comprised of: disability index and discomfort index, and parent global assessment of overall well-being. For the assessment of discomfort index, the parent/legal guardian or adult caregiver who interacted daily with the participant were required to rate the overall arthritis pain of participant from 0 (no pain) to 10 (very severe pain), on a VAS, where higher scores indicated more severe pain.	Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in CHAQ - Parental Evaluation of Overall Well-being at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set Time Frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36	CHAQ comprised of: disability index and discomfort index, and parent global assessment of overall well-being. For assessment of parent global assessment of overall well-being, the parent/legal guardian/participant were required to rate the overall well-being from 0 (very well) to 10 (very poor) on a VAS, where higher score indicated poor well-being.	Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in CHAQ - Parental Evaluation of Overall Well-being at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set Time Frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36	CHAQ comprised of: disability index and discomfort index, and parent global assessment of overall well-being. For assessment of parent global assessment of overall well-being, the parent/legal guardian/participant were required to rate the overall well-being from 0 (very well) to 10 (very poor) on a VAS, where higher score indicated poor well-being.	Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in CHAQ - Parental Evaluation of Overall Well-being at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set Time Frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78	CHAQ comprised of: disability index and discomfort index, and parent global assessment of overall well-being. For assessment of parent global assessment of overall well-being, the parent/legal guardian/participant were required to rate the overall well-being from 0 (very well) to 10 (very poor) on a VAS, where higher score indicated poor well-being.	Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78
Change From Baseline in CHAQ - Parental Evaluation of Overall Well-being at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set Time Frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36	CHAQ comprised of: disability index and discomfort index, and parent global assessment of overall well-being. For assessment of parent global assessment of overall well-being, the parent/legal guardian/participant were required to rate the overall well-being from 0 (very well) to 10 (very poor) on a VAS, where higher score indicated poor well-being.	Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in CHAQ - Parental Evaluation of Overall Well-being at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set Time Frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36	CHAQ comprised of: disability index and discomfort index, and parent global assessment of overall well-being. For assessment of parent global assessment of overall well-being, the parent/legal guardian/participant were required to rate the overall well-being from 0 (very well) to 10 (very poor) on a VAS, where higher score indicated poor well-being.	Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

Long-Term Safety Study Of Tofacitinib In Patients With Juvenile Idiopathic Arthritis

A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA)

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

General Publications

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimated)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Clinical Trials on Juvenile Idiopathic Arthritis

Clinical Trials on Tofacitinib

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Austria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations