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)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Juvenile Idiopathic Arthritis
• Intervention / Treatment: Drug: Tofacitinib; Drug: Tofacitinib

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): 275
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• Argentina
  • Caba, Argentina, C1280AEB
    • Hospital Britanico de Buenos Aires
  • Santa FE
    • Rosario, Santa FE, Argentina, S2000PBJ
      • Instituto CAICI SRL
  • Tucuman
    • San Miguel de Tucuman, Tucuman, 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
  • Brussels, Belgium, 1020
    • Queen Fabiola Children's University Hospital
  • Gent, 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)
  • Sao Paulo, Brazil, 05409-011
    • Instituto da Crianca do Hospital das Clinicas da FMUSP
  • Sao Paulo, Brazil, 04037-002
    • SPDM - Associacao Paulista para o Desenvolvimento da Medicina
  • Bahia
    • Salvador, 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
  • Parana
    • Curitiba, Parana, Brazil, 80250-060
      • Hospital Pequeno Príncipe Clinical Research Office
    • Curitiba, Parana, Brazil, 80250-060
      • Hospital Pequeno Príncipe/
  • RIO Grande DO SUL
    • Porto Alegre, RIO Grande DO SUL, Brazil, 90035-903
      • Hospital de Clinicas de Porto Alegre
  • SAO Paulo
    • Botucatu, SAO Paulo, Brazil, 18618-686
      • Faculdade de Medicina da UNESP
    • Campinas, SAO Paulo, Brazil, 13083-888
      • Hospital de Clínicas da Unicamp
    • Campinas, SAO Paulo, Brazil, 13083-881
      • Hospital de Clinicas da UNICAMP-Laboratorio de Reumatologia-L06
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3B 6A8
      • Alberta Children's Hospital
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 3V4
      • British Columbia Children's Hospital
    • Vancouver, British Columbia, Canada, V5Z2H6
      • Teck Acute Care Centre
    • Vancouver, British Columbia, Canada, V6H 3N1
      • C & W Health Centre of BC
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • McGill University Health Center, Glen Site
    • Montreal, Quebec, Canada, H4A 3J1
      • McGill University Health Center, Glen Site, Central Pharmacy
• China
  • Beijing, China, 100045
    • Beijing Children's Hospital, Capital Medical University/Rheumatology Department
  • Shanghai, China, 201102
    • Children's Hospital of Fudan University
  • Chongqing
    • Chongqing, Chongqing, China, 401122
      • Children's Hospital of Chongqing Medical University
  • Guangdong
    • Guangzhou, Guangdong, China, 510623
      • Guangzhou women and children's medical center
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
  • Hunan
    • Changsha, Hunan, China, 410011
      • The Second Xiangya Hospital of Central South University
  • Jiangsu
    • Suzhou, Jiangsu, China, 215003
      • Children's Hospital of Soochow University
  • Shaanxi
    • Xi'an, Shaanxi, China, 710003
      • Xi'an Children's Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610073
      • Chengdu Women's and Children's Central Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310057
      • The Children's Hospital Zhejiang University School Of Medicine
• Costa Rica
  • San Jose, Costa Rica, 10103
    • Hospital Metropolitano
• Germany
  • Bad Bramstedt, Germany, 24576
    • PRI - Pediatric Rheumatology Research Institute GmbH
  • Berlin, Germany, 13125
    • Helios Klinikum Berlin-Buch
  • Berlin, Germany, 13353
    • Universitaets-Kinderklinik Charite SPZ Kinderrheumatologie
  • Bremen, Germany, 28177
    • Klinikum Bremen-Mitte
  • Bremen, Germany, 28177
    • Klinikum Bremen-Mitte, Prof. Hess-Kinderklinik
  • Dresden, Germany, 01307
    • Universitaetsklinikum Carl Gustav Carus Dresden Klinik und Poliklinik fur Kinder-und Jugendmedizin
  • Garmisch-partenkirchen, Germany, 82467
    • Deutsches Zentrum für Kinder- und Jugendrheumatologie
  • 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
  • Bayern
    • Erlangen, Bayern, Germany, 91054
      • Universitaetsklinikum Erlangen Kinder- und Jugendklinik
• Hungary
  • Budapest, Hungary, 1094
    • Semmelweis Egyetem
• India
  • New Delhi, India, 110060
    • Sir Ganga Ram Hospital
  • Gujarat
    • Surat, Gujarat, India, 395002
      • Nirmal Hospital Pvt Ltd.
  • WEST Bengal
    • Kolkata, WEST Bengal, India, 700020
      • Institute of Post Graduate Medical Education and Research & SSKM Hospital
    • Kolkata, WEST Bengal, India, 700017
      • Institute of Child Health
• Israel
  • Haifa, Israel, 3109601
    • Rambam Health Care
  • Haifa, Israel, 31096 01
    • Rambam Health Care Campus
  • Kfar Saba, Israel, 4428164
    • Meir Medical Center
  • Kfar Saba, Israel, 4428164
    • Meir Medical Center - Pediatric Clinic
  • Ramat Gan, Israel, 52621
    • Chaim Sheba M.C Tel hashomer
• Italy
  • Genova, Italy, 16147
    • IRCCS Giannina Gaslini Department/Division
  • Milan
    • Milano, Milan, Italy, 20122
      • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
• Mexico
  • San Luis De Potosí, Mexico, 78213
    • Centro de Alta Especialidad de Reumatología e Investigación del Potosí, S.C.
  • San Luis Potosi, Mexico, 78290
    • Hospital Central "Dr. Ignacio Morones Prieto"
  • San Luis Potosi, Mexico, 78290
    • Unidad de Investigaciones Reumatologicas A.C.
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44650
      • Clínica de Investigacion en Reumatologia y Obesidad, S.C.
  • Nuevo LEON
    • Monterrey, Nuevo LEON, 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 Dziecięcy im. św. Ludwika w Krakowie
  • Lodz, Poland, 91-738
    • Klinika Kardiologii i Reumatologii Dzieciecej
  • Sosnowiec, Poland, 41-218
    • Centrum Pediatrii im. Jana Pawla II w Sosnowcu Sp. z o.o.
  • Warszawa, Poland, 00-728
    • WIP Warsaw IBD Point Profesor Kierkus
  • Warszawa, Poland, 02-637
    • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
• Russian Federation
  • Moscow, Russian Federation, 119435
    • FSAEI HE I.M. Sechenov First MSMU of Minzdrav of Russia (Sechenovskiy University)
  • Moscow, Russian Federation, 115522
    • Federal State Budgetary Scientific Institution
  • Moscow, Russian Federation, 119991
    • FSAEI HE I.M. Sechenov First MSMU of Minzdrav of Russia (Sechenovskiy University),
  • Moscow, Russian Federation, 119991
    • FSAI "NMRCCH" of MOH Russia
  • Saint-Petersburg, Russian Federation, 194100
    • FSBEI HE "St. Petersburg State Pediatric Medical University" of the Ministry of Healthcare
  • Tolyatti, Russian Federation, 445039
    • State Budgetary Healthcare Institution of Samara Region "Tolyatti City Clinical Hospital #5"
  • Republic OF Bashkortostan
    • Ufa, Republic OF Bashkortostan, Russian Federation, 450083
      • Clinic of FSBEI HE BSMU MoH RF
    • Ufa, Republic OF Bashkortostan, Russian Federation, 450008
      • FSBEI HE BSMU MoH RF
• Slovakia
  • Bratislava, Slovakia, 83340
    • Narodny ustav detskych chorob, Detska klinika LF UK a NUDCH
  • Kosice, Slovakia, 04011
    • Detska Fakultna nemocnica Kosice
  • Piestany, 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
  • Kwazulu-natal
    • Durban, Kwazulu-natal, South Africa, 4302
      • Enhancing Care Foundation
• Spain
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Valencia, Spain, 46026
    • Hospital Universitario y Politecnico La Fe
• Turkey
  • Ankara, Turkey, 06100
    • Hacettepe University Medical Faculty
  • Istanbul, Turkey, 34098
    • Istanbul University Cerrahpasa Medical Faculty
  • Istanbul, Turkey, 34764
    • Umraniye Training and Research Hospital
  • Istanbul, Turkey, 35767
    • Umraniye Training and Research Hospital
  • Kadikoy / Istanbul, Turkey, 34722
    • Istanbul Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi Cocuk Romatoloji Bolumu
  • Kayseri, Turkey, 38039
    • Erciyes University Medical Faculty
• 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
  • Glasgow, United Kingdom, G51 4TF
    • NHS Greater Glasgow and Clyde Royal Hospital for Children
  • WEST Midlands
    • Birmingham, WEST Midlands, United Kingdom, B4 6NH
      • Birmingham Woman's and Children's NHS Foundation Trust
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Phoenix Children's Hospital
    • Phoenix, Arizona, United States, 85016
      • Phoenix Children's Hospital- Inpatient Pharmacy
  • 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 Education and Office Building
    • San Diego, California, United States, 92123
      • Rady Children's Hospital Research Pharmacy
    • 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, District of Columbia, United States, 20010
      • Children's National Medical Center
    • Washington, District of Columbia, United States, 20010
      • IDS Pharmacy
  • Florida
    • Miami, Florida, United States, 33155
      • Nicklaus Children's Hospital
    • Orlando, Florida, United States, 32803
      • AdventHealth
    • Orlando, Florida, United States, 32804
      • AdventHealth Pediatric Outpatient Procedures and Sedation
    • Orlando, Florida, United States, 32804
      • AHMG Pediatric Rheumatology and Immunology
    • Orlando, Florida, United States, 32804
      • AdventHealth Investigational Drug Services
    • Saint Pertersburg, Florida, United States, 33701
      • Johns Hopkins All Children's Hospital
    • Saint Petersburg, Florida, United States, 33701
      • All Children's Hospital Speciality Physicians
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Center for Advanced Pediatrics
    • Augusta, Georgia, United States, 30912
      • Augusta University
    • Augusta, Georgia, United States, 30912
      • Augusta University Health Pharmacy
    • 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
    • Chicago, Illinois, United States, 60611
      • Lurie Rheumatology Offices
  • 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
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • Lake Success, New York, United States, 11042
      • Cohen Children's Medical Center of New York
    • New York, New York, United States, 10021
      • Hospital for Special Surgery
    • New York, New York, United States, 10032
      • Columbia University Medical Center-Herbert Irving Pavillion
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • UNC Children's Hospital
    • Chapel Hill, North Carolina, United States, 27599
      • UNC Clinical & Translational Research Unit
    • 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
    • Raleigh, North Carolina, United States, 27607
      • UNC Children's Raleigh
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences 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

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

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

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

1

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Standard laboratory safety data and adverse event (AE) reports. Body weight, height and Tanner Stages will collected to assess growth and physical development.	up to 8 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Physician global evaluation of disease activity at each visit.	up to 8 years
Number of joints with active arthritis at each visit.	up to 8 years
Number of joints with limitation of motion at each visit.	up to 8 years
Index of inflammation (C-reactive protein [CRP] and Erythrocyte Sedimentation Rate [ESR]) at each visit.	up to 8 years
Parent's Assessment of Physical Function (Childhood Health Assessment Questionnaire [CHAQ]Disability Index)at each visit.	up to 8 years
Parent's Assessment of Child's Arthritis Pain (Childhood Health Assessment Questionnaire [CHAQ] Discomfort Index, Visual Analog Scale [VAS])at each visit.	up to 8 years
Parent's Global Assessment of Overall Wellbeing (Childhood Health Assessment Questionnaire [CHAQ] subsection, Visual Analog Scale [VAS])at each visit.	up to 8 years
JIA American College of Rheumatology (ACR) response and occurrence of JIA ACR disease flare at each visit.	up to 8 years
JIA ACR Clinical Inactive Disease status and Clinical Remission on Medication at each visit.	up to 8 years
Change from baseline in Juvenile Arthritis Disease Activity Score (JADAS) 27- CRP and JADAS 27-ESR, and occurrence of JADAS minimum disease activity and inactive disease at each visit.	up to 8 years
In subjects with Enthesitis Related Arthritis (ERA): Change from baseline in the Tender Entheseal Assessment, Modified Schober's Test, Overall Back Pain and Nocturnal Back Pain responses at various visits.	up to 8 years
In subjects with psoriatic arthritis (PsA): Change from baseline in body surface area (BSA) affected by psoriasis and Physician's Global Assessment (PGA) of psoriasis) at various visits.	up to 8 years
In subjects with sJIA: "Absence of Fever", defined as absence of fever due to sJIA in the week preceding the assessment at each visit.	up to 8 years
Eligibility of tapering defined per protocol for corticosteroids	up to 8 years
Eligibility of tapering defined per protocol for methotrexate	up to 8 years
Eligibility of tapering defined per protocol for leflunomide	Up to 8 years
Eligibility of tapering defined per protocol for tofacitinib	Up to 8 years

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2013
• Primary Completion (Estimated): March 22, 2025
• Study Completion (Estimated): March 22, 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): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Arthritis; Pediatric; JIA; tofacitinib; Xeljanz; CP-690,550; Long-term
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Juvenile; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Janus Kinase Inhibitors; Tofacitinib
• Other Study ID Numbers: A3921145; JIA (Other Identifier: Alias Study Number); 2011-004915-22 (EudraCT Number)

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.