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

A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (as)

This is the first study of oral tofacitinib in adults with active ankylosing spondylitis. It is designed to obtain information on the efficacy and safety of 3 different doses of tofacitinib.

Study Overview

• Status: Completed
• Conditions: Ankylosing Spondylitis
• Intervention / Treatment: Drug: Tofacitinib 2 mg; Drug: Tofacitinib 5 mg; Drug: Tofacitinib 10 mg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 208
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1V 3M7
    • G.R.M.O. Inc
  • Quebec
    • Montreal, Quebec, Canada, H2L 1S6
      • Institut de Rhumatologie de Montreal
• Czech Republic
  • Ostrava, Czech Republic, 722 00
    • Artroscan s.r.o.
  • Praha 11- Chodov, Czech Republic, 14800
    • Mediscan Group s.r.o.
  • Praha 2, Czech Republic, 128 50
    • Revmatologicky ustav
  • Praha 4, Czech Republic, 140 00
    • Revmatologicka ambulance
  • Uherske Hradiste, Czech Republic, 68601
    • Medical Plus
• Germany
  • Berlin, Germany, 12203
    • Charite Universitaetsmedizin Berlin
  • Hamburg, Germany, 22415
    • Praxis fuer klinische Studien
  • Hildesheim, Germany, 31134
    • Gemeinschaftspraxis Dres. von Hinueber / Demary
  • Vogelsang-Gommern, Germany, 39245
    • Immunologisches Zentrum Vogelsang-Gommern GmbH
• Hungary
  • Budapest, Hungary, 1036
    • Qualiclinic Kft
  • Budapest, Hungary, 1023
    • Orszagos Reumatologiai es Fiziotherapias Intezet II. Reumatologiai Osztaly
  • Budapest, Hungary, 1036
    • Synexus Magyarorszag Kft. - Synexus Hungary Clinical Research Centre
  • Békéscsaba, Hungary, 5600
    • Dr. Rethy Pál Korhaz es Rendelointezet, Reumatologia
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
  • Szikszó, Hungary, 3800
    • CRU Hungary Kft.
  • Veszprem, Hungary, H-8200
    • Csolnoky Ferenc Korhaz Reumatologiai Osztaly
• Korea, Republic of
  • Gwangju, Korea, Republic of, 501-757
    • Chonnam National University Hospital
  • Incheon, Korea, Republic of, 400-711
    • Inha University Hospital
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital
  • Suwon, Korea, Republic of, 443-721
    • Ajou University Hospital
• Poland
  • Bialystok, Poland, 15- 879
    • Niepubliczny Zaklad Opieki Zdrowotnej Centrum Osteoporozy i Chorob Kostno-Stawowych
  • Bydgoszcz, Poland, 85-168
    • Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy
  • Elblag, Poland, 82-300
    • Centrum Kliniczno-Badawcze J. Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka Partnerska
  • Katowice, Poland, 40-954
    • Medica Pro Familia Sp. z o.o. S.K.A. Oddzial Katowice
  • Krakow, Poland, 30-510
    • Malopolskie Centrum Medyczne s.c.
  • Lublin, Poland, 20-582
    • Zespol Poradni Specjalistycznych Reumed Filia Onyksowa
  • Nowa Sol, Poland, 67-100
    • Twoja Przychodnia - Centrum Medyczne Nowa Sol
  • Torun, Poland, 87-100
    • NZOZ Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna w Toruniu
  • Mazowieckie
    • Nadarzyn, Mazowieckie, Poland, 05-830
      • NZOZ Lecznica MAK-MED s.c.
• Russian Federation
  • Ekaterinburg, Russian Federation, 620149
    • SBEI HPE Ural State Medical University of MoH of RF based on Municipal Budgetary Institution
  • Moscow, Russian Federation, 115522
    • Federal State Budgetary Institution
  • Saint-Petersburg, Russian Federation, 191014
    • OOO AVA-PETER "Scandinavia clinic"
  • Sestroretsk, Russian Federation, 197706
    • Saint-Petersburg State Budgetary Healthcare Institution
• Spain
  • A Coruna, Spain, 15006
    • Complexo Hospitalario Universitario A Coruña
  • Cordoba, Spain, 14004
    • Hospital Universitario Reina Sofia
  • Madrid, Spain, 28046
    • Hospital Universitario de La Paz
  • Sabadell, Spain, 08208
    • Corporació Sanitària Parc Taulí
  • A Coruna
    • Santiago de Compostela, A Coruna, Spain, 15706
      • Hospital Clinico Universitario Santiago de Compostela
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
      • Hospital Universitari de Bellvitge
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Hospital Universitario Marques de Valdecilla
• Taiwan
  • Kaohsiung, Taiwan, 80756
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Taichung, Taiwan, 40447
    • China Medical University Hospital
  • Taichung, Taiwan, 40201
    • Chung Shan Medical University Hospital
• United States
  • California
    • Indian Wells, California, United States, 92210
      • Desert Medical Imaging
    • Palm Desert, California, United States, 92260
      • Desert Medical Advances
  • Florida
    • Clearwater, Florida, United States, 33756
      • Arthritis & Rheumatology Associates
    • Ormond Beach, Florida, United States, 32174
      • Millennium Research
    • Tampa, Florida, United States, 33609
      • Southwest Florida Clinical Research Center
  • Indiana
    • Indianapolis, Indiana, United States, 46214
      • Covance Central Laboratory Services,Inc
  • Maryland
    • Hagerstown, Maryland, United States, 21740
      • Klein & Associates, M.D., P.A.
    • Hagerstown, Maryland, United States, 21740
      • Progressive Radiology
  • Nebraska
    • Lincoln, Nebraska, United States, 68516
      • Physician Research Collaboration, LLC
    • Lincoln, Nebraska, United States, 68506
      • Advanced Medical Imaging (MRI center)
    • Lincoln, Nebraska, United States, 68516
      • Arthritis Center of Nebraska (X-ray center)
  • North Carolina
    • Ballantyne, North Carolina, United States, 28277
      • Charlotte Radiology/ Carolina Imaging Services
    • Charlotte, North Carolina, United States, 28204
      • Joint and Muscle Research Institute
    • Charlotte, North Carolina, United States, 28207
      • Presbyterian Imaging
  • Ohio
    • Middleburg Heights, Ohio, United States, 44130
      • Paramount Medical Research & Consulting, LLC
    • Westlake, Ohio, United States, 44145
      • Premier Physicians Centers
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center For Clinical Research
    • Wyomissing, Pennsylvania, United States, 19610
      • Clinical Research Center of Reading, LLC
  • Washington
    • Seatle, Washington, United States, 98122
      • Investigational Drug Service
    • Seattle, Washington, United States, 98122
      • Seattle Rheumatology Associates
    • Spokane, Washington, United States, 99204
      • Arthritis Northwest, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Documented diagnosis of Ankylosing Spondylitis
• Has active disease despite concurrent nonsteroidal anti-inflammatory drugs (NSAIDs) treatment or is intolerant to NSAIDs

Exclusion Criteria:

• Pregnant or lactating females
• Currently receiving or previous use of a Tumor Necrosis Factor (TNF) inhibitor or any biological agent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; 4 blinded tablets (two 1 mg and two 5 mg matching placebo tablets) will be administered orally twice a day (in the AM and PM) for 12 weeks
EXPERIMENTAL: Tofacitinib 2 mg	Drug: Tofacitinib 2 mg; 4 blinded tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) will be administered orally twice a day (in the AM and PM) for 12 weeks
EXPERIMENTAL: Tofacitinib 5 mg	Drug: Tofacitinib 5 mg; 4 blinded tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) will be administered orally twice a day (in the AM and PM) for 12 weeks
EXPERIMENTAL: Tofacitinib 10 mg	Drug: Tofacitinib 10 mg; 4 blinded tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) will be administered orally twice a day (in the AM and PM) for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving 20 Percent (%) Improvement in Assessment of SpondyloArthritis International Society (ASAS) Score (ASAS 20) at Week 12	The primary analysis of this outcome measure was performed using the Emax model. Clinical response to treatment was assessed according to ASAS20 criteria. ASAS20 responder had improvement of greater than or equal to (≥) 20% and ≥1 unit in at least 3 domains (on a scale of 0 [least] to 10 [worst]) and no worsening of ≥20% and less than or equal to (≤)1 unit in the remaining domain. The domains are: Patient's Global Assessment of Disease Activity, spinal pain, function and inflammation (from Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Missing data were handled by nonresponsive (NRI)/ last observation carried forward (LOCF). Missing values due to a subject dropping out from the study were handled by setting the ASAS20 value to NRI. The LOCF approach was applied to missing components, if just some of the components of the ASAS20 were missing.	Week 12
Percentage of Participants Achieving ASAS20 at Week 12	The supportive analysis of this outcome measure was performed using the normal approximation for two proportions. Clinical response to treatment was assessed according to ASAS20 criteria. ASAS20 responder had improvement of ≥ 20% and ≥1 unit in at least 3 domains (on a scale of 0 [least] to 10 [worst]) and no worsening of ≥20% and ≤1 unit in the remaining domain. The domains are: Patient's Global Assessment of Disease Activity, spinal pain, function and inflammation (from Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Missing data were handled by NRI/LOCF. Missing values due to a subject dropping out from the study were handled by setting the ASAS20 value to NRI. The LOCF approach was applied to missing components, if just some of the components of the ASAS20 were missing.	Baseline, Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving 20% Improvement in ASAS Score at Weeks 2, 4 and 8	Clinical response to treatment was assessed according to ASAS20 criteria. ASAS20 responder had improvement of ≥ 20% and ≥1 unit in at least 3 domains (on a scale of 0 [least] to 10 [worst]) and no worsening of ≥20% and ≤1 unit in the remaining domain. The domains are: Patient's Global Assessment of Disease Activity, spinal pain, function and inflammation (from Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Missing data were handled by NRI/LOCF. Missing values due to a subject dropping out from the study were handled by setting the ASAS20 value to NRI. The LOCF approach was applied to missing components, if just some of the components of the ASAS20 were missing.	Baseline, Week 2, Week 4, Week 8
Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Index of Disease Activity Score of the Sacroiliac (SI) Joints at Week 12	SPARCC scoring consists of assessing six SI joint MRI image coronal slices representing the largest proportion of the synovial compartment of the SI joints for edema. The maximum score per slice was 2 and 12 for all 6 slices. The total minimum and maximum score for all SI joints across 6 slices is 0 to 72 and higher scores indicate more inflammation. A negative change from baseline indicates improvement. Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available.	Baseline, Week 12
Change From Baseline in SPARCC MRI Index of Disease Activity Score of the Spine at Week 12	SPARCC scoring of the magnetic resonance imaging (MRI) of the spine consists of assessing six disco-vertebral units (DVU) with 3 consecutive sagittal slices at each DVU. The minimum and maximum SPARCC score for all 6 DVUs is 0 to 108, with higher scores indicating more damage. A negative change from baseline indicates improvement. Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available.	Baseline, Week 12
Change From Baseline in Modified Berlin Ankylosing Spondylitis Spine Magnetic Resonance Imaging Activity Score (ASspiMRI) of the Spine at Week 12	Berlin modification of the ASspiMRI is a measure of acute lesion as determined by short-tau inversion recovery (STIR) sequences. All 23 disco-vertebral units (DVU) of the spine (from C2 to S1), defined as the region between 2 virtual lines through the middle of each vertebra, were scored in a single dimension, which is represented the highest level of inflammation in that particular DVU. Total spine ASspiMRI scores can range from 0-69 with higher scores indicating more disease activity. A negative change from baseline indicates improvement. Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available.	Baseline, Week 12
Percentage of Participants Achieving 40% Improvement in ASAS Score at Weeks 2, 4, 8 and 12	ASAS 40 is defined as ≥40% and absolute change of ≥2 units in at least 3 domains on a 0-10 scale (0=no disease activity, 10=high disease activity), and no worsening in the remaining domain. Missing data were handled by NRI/LOCF.	Baseline, Week 2, Week 4, Week 8, Week 12
Percentage of Participants Achieving ASAS5/6 Response at Weeks 2, 4, 8 and 12	ASAS5/6 consists of 6 domains: the 4 used in ASAS20 (Patient's Global Assessment of Disease Activity, spinal pain, function, inflammation plus spinal mobility and an acute phase reactant, C Reactive Protein (CRP). ASAS 5/6 is defined as ≥20% improvement in at least 5 domains and no worsening in the remaining domain. Missing data were handled by NRI/LOCF.	Baseline, Week 2, Week 4, Week 8, Week 12
Change From Baseline of Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein ASDAS(CRP) at Weeks 2, 4, 8 and 12	The ASDAS(CRP) is a derived score that uses back pain, duration of morning stiffness, Patient's Global Assessment of their disease and peripheral pain/swelling. The formula used for calculating the ASDAS (CRP)is: 0.12 x Back Pain + 0.06 x Duration of Morning Stiffness + 0.11 x Patient Global + 0.07 x Peripheral Pain/Swelling + 0.58 x Ln(CRP+1). The calculated score can be from 0 to no defined upper limit. A negative number indicates a reduction in the score which indicates decrease in disease activity.	Baseline, Week 2, Week 4, Week 8, Week 12
Percentage of Participants With ASDAS Clinically Important Improvement at Weeks 2, 4, 8 and 12	The ASDAS clinically important improvement was calculated from the ASDAS data. The ASDAS clinically important improvement is defined as change (decrease) from baseline of ≥1.1 units. Missing data were handled by NRI/LOCF.	Baseline, Week 2, Week 4, Week 8, Week 12
Percentage of Participants With ASDAS Major Improvement at Weeks 2, 4, 8 and 12	The ASDAS major improvement was calculated from the ASDAS data. The ASDAS major improvement was defined as change (decrease) from baseline of ≥2.0 units. Missing data were handled by NRI/LOCF.	Baseline, Week 2, Week 4, Week 8, Week 12
Percentage of Participants Achieving ASDAS Inactive Disease at Weeks 2, 4, 8 and 12	The ASDAS inactive disease was calculated from the ASDAS data. The ASDAS inactive disease was defined as ASDAS <1.3 units. Missing data were handled by NRI/LOCF.	Baseline, Week 2, Week 4, Week 8, Week 12
Change From Baseline in BASDAI Total Score at Week 2, 4, 8 and 12	BASDAI is a validated self-assessment tool used to determine disease activity in participant with Ankylosing Spondylitis. Utilizing a Numerical Rating Scale (NRS) of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q)1-4. This score is then divided by 5. BASDAI=Q1+Q2+Q3+Q4+[Q5+Q6/2]/5. The final BASDAI score averages the individual assessments for a final score range of 0-10. Negative values indicate improvement.	Baseline, Week 2, Week 4, Week 8, Week 12
Percentage of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)50 Response at Weeks 2, 4, 8 and 12	BASDAI is a validated self-assessment tool used to determine disease activity in participant with Ankylosing Spondylitis. Utilizing a Numerical Rating Scale (NRS) of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q)1-4. This score is then divided by 5. The final BASDAI score range from 0-10. A positive response was defined as a 50% improvement in the BASDAI from baseline.	Baseline, Week 2, Week 4, Week 8, Week 12
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8 and 12	BASFI is a validated self-assessment tool that determines the degree of physical functional limitation in Ankylosing Spondylitis. Utilizing a Numerical Rating Scale (NRS) of 0-10 (0=easy, 10=impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions with lower scores indicating better physical function. The higher the negative value the better the improvement.	Baseline, Week 2, Week 4, Week 8, Week 12
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 2, 4, 8 and 12	BASMI is an objective measure of spinal mobility and was completed by a blinded assessor. The BASMI score is composed of 5 clinical measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. The derived score used the average of the 5 assessments on a scale of 0-10 scale with higher scores indicating more impairment of spinal mobility. BASMI was analyzed using the linear function method. The higher the negative value the better the improvement.	Baseline, Week 2, Week 4, Week 8, Week 12
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Weeks 4, 8 and 12	Assessment of enthesitis of 13 sites was performed in the following, 1st costochondral joint left and right, 7th costochondral joint left and right, posterior superior iliac spine left and right, anterior superior iliac spine left and right, iliac crest left and right, 5th lumbar spinous process and proximal insertion of Achilles tendon left and right. Each site was graded for the presence (1) and absence (0) of tenderness yielding total MASES ranging from 0 (no tenderness) to 13 (worst possible score; severe tenderness).	Baseline, Week 4, Week 8, Week 12
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History	Participants were assessed at Baseline, Week 12 and Week 16 (Follow-up) to determine if they had specific Ankylosing Spondylitis medical history or changes in specific Ankylosing Spondylitis medical history which included: Inflammatory Bowel Disease (IBD), Peripheral Articular Involvement (PAI; as assessed by swollen joint count), psoriasis (PSO) and uveitis (UVE).	Baseline, Week 12 and Follow-up
Change From Baseline of Total Swollen Joint Count at Weeks 2, 4 8 and 12	This assessment was performed by the blinded assessor using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints) for determination of the total number of swollen joints. Forty-four joints were assessed for swelling on left and right side and included the following: sternoclaviculars, acromioclaviculars, shoulders, elbows, wrists, metacarpophalangeals (I, II, III, IV, V), thumb interphalangeal, proximal interphalangeals (II, III, IV, V), knees, ankles, and metatarsophalangeals (I, II, III, IV, V). Artificial joints were not assessed. A negative change means improvement.	Baseline, Week 2, Week 4, Week 8, Week 12
Change From Baseline of Mean Spinal Mobility (Chest Expansion) at Week 2, 4, 8 and 12	Chest expansion, measured in centimeters (cm), is defined as the difference in the thoracic circumference during full expiration versus full inspiration. This was measured at the 4th intercostal space. The difference between maximal inspiration and expiration of the two attempts was recorded. The better of the two attempts was used to calculate chest expansion. Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available.	Baseline, Week 2, Week 4, Week 8, Week 12
Change From Baseline to Week 12 in Short-Form-36 Health Survey (SF-36) Physical and Mental Health Scores at Week 12	SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (0=no functioning, 100=highest level of functioning). Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available.	Baseline, Week 12
Change From Baseline in EuroQol EQ-5D Health State Profile (EQ-5D) Utility Score at Week 12	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of single utility score. Health state profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression; Scale range 1 to 3 (1=better health state [no problems], 3=worst health state [confined to bed]).	Baseline, Week 12
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Weeks 2, 4, 8 and 12	FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).	Baseline, Week 2, Week 4, Week 8, Week 12

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• Cella D, Lenderking WR, Chongpinitchai P, Bushmakin AG, Dina O, Wang L, Cappelleri JC, Navarro-Compan V. Functional Assessment of Chronic Illness Therapy-Fatigue is a reliable and valid measure in patients with active ankylosing spondylitis. J Patient Rep Outcomes. 2022 Sep 23;6(1):100. doi: 10.1186/s41687-022-00508-0.
• van der Heijde D, Deodhar A, Wei JC, Drescher E, Fleishaker D, Hendrikx T, Li D, Menon S, Kanik KS. Tofacitinib in patients with ankylosing spondylitis: a phase II, 16-week, randomised, placebo-controlled, dose-ranging study. Ann Rheum Dis. 2017 Aug;76(8):1340-1347. doi: 10.1136/annrheumdis-2016-210322. Epub 2017 Jan 27.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (ACTUAL): March 1, 2015
• Study Completion (ACTUAL): March 1, 2015

Study Registration Dates

• First Submitted: February 6, 2013
• First Submitted That Met QC Criteria: February 6, 2013
• First Posted (ESTIMATE): February 8, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): June 10, 2016
• Last Update Submitted That Met QC Criteria: May 4, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Spondyloarthritis; Ankylosing Spondylitis; Spondyloarthropathy; Spondylitis; Oral preparation; Ankylosing
• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Spondylarthropathies; Bone Diseases, Infectious; Ankylosis; Spondylitis; Spondylarthritis; Spondylitis, Ankylosing; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Tofacitinib
• Other Study ID Numbers: A3921119; 2011-005689-39 (EUDRACT_NUMBER)