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Efficacy Study Of Tofacitinib In Pediatric JIA Population

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ClinicalTrials.gov Identifier: NCT02592434
Recruitment Status : Recruiting
First Posted : October 30, 2015
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
Evaluate efficacy, safety and tolerability of tofacitinib in pediatric JIA patients.

Condition or disease Intervention/treatment Phase
Juvenile Idiopathic Arthritis Drug: CP-690,550 (tofacitinib) Other: placebo Phase 3

Detailed Description:

This is a randomized withdrawal, double blind, placebo controlled study of pediatric subjects (2 to <18 years of age) with JIA. The primary objective is to compare the efficacy of tofacitinib versus placebo for the treatment of signs and symptoms of JIA at Week 26 of the double blind phase as measured by the percentage of subjects with disease flare (according to PRCSG/PRINTO Disease Flare criteria) after Week 18 of the open label run in phase.All eligible subjects enrolled in the study will initially receive open label tofacitinib for 18 weeks (run in phase). At the end of the 18 week run in phase, only subjects who achieve at least a JIA ACR 30 response will be randomized to the 26 week double blind, placebo controlled phase. Subjects who do not achieve a JIA ACR 30 response at this time point will be discontinued from the study. In addition, subjects who experience a single episode of disease flare at any time during the study (including the open label run in and double blind phase) will also be discontinued from the study. All subjects participating in this study, including those discontinued from the study, will have the option, if eligible (based on inclusion and exclusion criteria), of enrolling in the tofacitinib JIA long term extension study (A3921145).

Subjects who are eligible for the 26 week double blind phase will be randomized (1:1 ratio) to either active tofacitinib or placebo. For subjects with polyarticular course JIA (ie, extended oligoarthritis, polyarthritis RF+, polyarthritis RF , systemic JIA with active arthritis but without active systemic features), randomization will be stratified by JIA category and baseline CRP (normal, above normal). For subjects with psoriatic and enthesitis related arthritis, randomization will be stratified by JIA category.

Approximately 210 subjects will be enrolled in the open label run in phase. Among subjects with polyarticular course JIA, stratification will target at least 50% with a baseline CRP above the upper limit of normal. The first cohort (ie, polyarticular course JIA) will have at least 170 subjects enrolled in the run in phase with the minimum number of JIA categories as follows: 24 with extended oligoarthritis, 20 with polyarthritis RF+, 62 with polyarthritis RF-, and no minimum for subjects with systemic JIA with active arthritis but without active systemic features. Additional cohorts (ie, psoriatic and enthesitis related arthritis) will include a minimum of 20 subjects with psoriatic arthritis, and 20 subjects with enthesitis related arthritis. The overall target minimum number of subjects to be enrolled in the study by age is as follows: 20 subjects 2 to <6 years, 20 subjects 6 to <12 years, and 20 subjects 12 to <18 years. The duration of subject participation among those who complete the study (without discontinuation) is expected to be approximately 44 weeks.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy, Safety And Tolerability Of Tofacitinib For Treatment Of Polyarticular Course Juvenile Idiopathic Arthritis (Jia) In Children And Adolescent Subjects
Actual Study Start Date : June 10, 2016
Estimated Primary Completion Date : May 21, 2019
Estimated Study Completion Date : May 21, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CP-690,550
Treatment arm: Tofacitinib tablets or solution, according to subjects' body weights
Drug: CP-690,550 (tofacitinib)

During the open label run in phase, all subjects will receive active tofacitinib oral tablets or oral solution twice daily (BID) orally, at a dosage based on the subject's body weight as specified below.

During the double blind, placebo controlled phase, subjects will receive either active tofacitinib oral tablets/oral solution or matching placebo oral tablets/oral solution, twice daily (BID), at a dosage specified below.

Body Weight (Dosage in tablet [BID] or solution [BID]):

5<7kg (2mg or 2mL); 7<10kg(2.5mg or 2. mL); 10 <15kg (3mg or 3mL); 15<25kg (3.5mg or 3.5mL); 25<40kg (4mg or 4mL); 40kg (5 mg or 5 ml).

Oral solution (1 mg/mL) is used for subjects <40 kg. Oral tablets (5 mg) are used for subjects >=40 kg.

Other Name: Matching placebo to tofacitinib (same tablet or solution as the active arm).

Placebo Comparator: Placebo
Control arm: matching placebo tablets or solution for tofacitinib
Other: placebo
matching placebo tablet or solution for tofacitinib
Other Name: Placebo for tofacitinib




Primary Outcome Measures :
  1. Occurrence of disease flare (according to PRCSG/PRINTO Disease Flare criteria) at Week 26 of the double blind phase (ie, week 44 of the study period) [ Time Frame: week 44 ]

Secondary Outcome Measures :
  1. Occurrence of disease flare (according to PRCSG/PRINTO Disease Flare criteria) [ Time Frame: 26- week double blind phase ]
  2. Time to disease flare [ Time Frame: 26-week double blind phase ]
  3. JIA ACR 30 50 70 90 100 response [ Time Frame: 18-week open label run in and 26-week double blind phase ]
  4. Change from baseline in JADAS 27 CRP [ Time Frame: 18-week open label run in and 26-week double blind phase ]
  5. Presence of JIA ACR inactive disease and clinical remission [ Time Frame: 26-week double blind phase ]
  6. Change from baseline in each JIA ACR core set variable [ Time Frame: 18-week open label run in and 26-week double blind phase ]
  7. Change from baseline in CHQ responses [ Time Frame: 18-week open label run in and 26-week double blind phase ]
  8. Change from baseline in CHAQ responses [ Time Frame: 18-week open label run in and 26-week double blind phase ]
  9. Occurrence of active uveitis (according to SUN criteria) [ Time Frame: 18- week open label run in and 26-week double blind phase ]
  10. In subjects with ERA: Change from baseline in the Tender Entheseal Assessment [ Time Frame: 26-week double blind phase ]
  11. Taste acceptability of tofacitinib oral solution [ Time Frame: on Day 14 of the open label run in phase ]
    patients who receive oral solution will choose one of the following: Like very much, Like a little, Not sure, Dislike a little, Dislike very much.

  12. Safety during the study, with focus on serious infections, cytopenias, malignancies, cardiovascular diseases, and validated assessments of growth and pubertal development [ Time Frame: 44-week study period ]
  13. In subjects with ERA: change from baseline in Schober's test response [ Time Frame: 26-week double blind phase ]
  14. In subjects with ERA: change from baseline in overall Back Pain [ Time Frame: 26-week double blind phase ]
    Using a numeric rating scale

  15. In subjects with ERA: change from baseline in Nocturnal Back Pain responses [ Time Frame: 26-week double blind phase ]
    Using a numeric rating scale

  16. PK parameter in first 40 Subjects Enrolled (Excluding Subjects with Systemic JIA) [ Time Frame: day 1 ]
    Clearance

  17. PK parameter in all subjects [ Time Frame: Day 84 ]
    Clearance

  18. PK parameter after first 40 Subjects Enrolled (excluding Subjects with Systemic JIA), and all subjects with systemic JIA [ Time Frame: Day 14 ]
    Clearance

  19. PK parameter in first 40 Subjects Enrolled (Excluding Subjects with Systemic JIA) [ Time Frame: Day 1 ]
    Volume of Distribution

  20. PK parameter in all subjects [ Time Frame: Day 84 ]
    Volume of Distribution

  21. PK parameter after first 40 Subjects Enrolled (excluding Subjects with Systemic JIA), and all subjects with systemic JIA [ Time Frame: Day 14 ]
    Volume of Distribution

  22. In subjects with PsA, change from baseline in body surface area (BSA) affected by psoriasis [ Time Frame: 18-week open label run in and 26-week double blind phase ]
  23. Change from baseline in JADAS 27 ESR [ Time Frame: 18-week open label run in and 26-week double blind phase ]
  24. Change from baseline in occurence of JADAS minimum disease activity [ Time Frame: 18-week open label run in and 26-week double blind phase ]
  25. Change from baseline in JADAS inactive disease status [ Time Frame: 18-week open label run in and 26-week double blind phase ]
  26. In subjects with PsA, change from baseline in physician's global assessment (PGA) of psoriasis [ Time Frame: 18-week open label run in and 26-week double blind phase ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female aged 2 to <18 years.
  2. Must meet International League Against Rheumatism (ILAR) JIA diagnostic criteria for one of the following categories with active disease for at least 6 weeks:

    • Extended oligoarthritis;
    • Polyarthritis (RF+);
    • Polyarthritis (RF-);
    • Systemic JIA with active arthritis but without active systemic features in the prior 6 months and at the time of enrollment;
    • Psoriatic arthritis;
    • Enthesitis related arthritis. Subjects with polyarticular course JIA (ie, extended oligoarthritis, polyarthritis RF+, polyarthritis RF , systemic JIA with active arthritis but without active systemic features) must have a minimum of 5 active joints (an active joint is defined as a joint with swelling or, in the absence of swelling, limited range of motion accompanied by either pain on motion or tenderness) at screening and baseline to be eligible for study entry.

    Subjects with psoriatic or enthesitis related arthritis must have a minimum of 3 active joints (an active joint is defined as a joint with swelling or, in the absence of swelling, limited range of motion accompanied by either pain on motion or tenderness) at screening and baseline to be eligible for study entry.

    Treatment with stable doses of a Non Steroidal Anti inflammatory Drug (NSAID) and/or a stable dose of an oral glucocorticoid, and/or a stable dose of methotrexate is permitted.

    For subjects receiving an oral glucocorticoid: Glucocorticoids may be administered at a maximum dose of 0.2 mg of prednisone equivalent per kilogram per day or 10 mg per day for ≥ 2 weeks before baseline, whichever is lower.

    For subjects receiving methotrexate (MTX) treatment: MTX may be administered either orally or parenterally at doses not to exceed 25 mg/wk or 20 mg/m2/week (whichever is lower); participants must have taken MTX for 3 months and be at a stable dose for at least 6 weeks before baseline. Subjects taking MTX must be taking folic acid or folinic acid in accordance with local standards.

    For subjects with psoriatic arthritis, the following topical treatments for psoriasis are allowed: non medicated emollients for use over the whole body; topical steroids including hydrocortisone and hydrocortisone acetate ≤1% for the palms, soles, face, and intertriginous areas only; tar, salicylic acid preparations, and shampoos free of corticosteroids are permitted only for the scalp

  3. Inadequate response or intolerance to at least one Disease Modifying Anti Rheumatic Drug (DMARD), which may include MTX or biologic agents; in the case of ERA and psoriatic arthritis, inadequate response to Non Steroidal Anti Inflammatory Drugs (NSAIDs).
  4. No evidence or history of untreated or inadequately treated active or latent tuberculosis (TB) infection as evidenced by the following:

    1. A negative QuantiFERON ®TB Gold In Tube test performed within the 3 months prior to screening. A negative purified protein derivative (PPD) test can be substituted for the QuantiFERON® TB Gold In Tube test only if the central laboratory is unable to perform the test or cannot determine the results to be positive or negative and the Pfizer medical monitor is informed and agrees on a case by case basis.
    2. Chest radiograph without changes suggestive of active tuberculosis (TB) infection within 3 months prior to screening is recommended and should be performed according to local standards of care or country-specific guidelines.
    3. No history of either untreated or inadequately treated latent or active TB infection.

    If a subject has previously received an adequate course of therapy for either latent (9 months of isoniazid in a locale where rates of primary multi drug resistant TB infection are <5% or an acceptable alternative regimen) or active (acceptable multi drug regimen) TB infection, neither a PPD test nor a QuantiFERON-Gold®TM test need be obtained. A chest radiograph should be obtained if not done within the 3 months prior to screening. To be considered eligible for the study, the chest radiograph must be negative for active tuberculosis infection.

    A subject who is currently being treated for latent TB infection can only be enrolled with confirmation of current incidence rates of multi-drug resistant TB infection, documentation of an adequate treatment regimen, and prior approval of the Sponsor.

  5. Fertile males and females who are, in the opinion of the investigator, sexually active and at risk for pregnancy with their partner(s) must be willing and able to use a highly effective method of contraception as outlined in this protocol during the study and for at least 28 days after the last dose of study medication.

6 Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

7. Evidence of a personally signed and dated Informed Consent document and Assent document (as appropriate) indicating that the subject and a legally acceptable representative/parent(s)/legal guardian has been informed of all pertinent aspects of the study.

Exclusion Criteria

Subjects with any of the following characteristics/conditions will not be included in the study:

  1. Previous JIA treatment with tofacitinib.
  2. Systemic JIA (sJIA) with active systemic features (including subjects with characteristic sJIA fever and rash or serositis within 6 months of enrollment).
  3. Persistent oligoarthritis.
  4. Undifferentiated JIA.
  5. Infections:

    1. Chronic infections;
    2. Any infection requiring hospitalization, parenteral antimicrobial therapy or judged to be opportunistic by the investigator within the 6 months prior to the first dose of study drug;
    3. Any treated infections within 2 weeks of Baseline visit;
    4. A subject know to be infected with Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C;
    5. History of infected joint prosthesis with prosthesis still in situ.
  6. History of recurrent (more than one episode) herpes zoster or disseminated (at least one episode) herpes zoster, or disseminated (at least one episode) herpes simplex.
  7. Active uveitis (according to SUN criteria) within 3 months of enrollment.
  8. Blood dyscrasias, including:

    1. Hemoglobin <10 g/dL or Hematocrit <33%;
    2. White Blood Cell count <3.0 x 109/L;
    3. Neutrophil count <1.2 x 109/L;
    4. Platelet count <100 x 109/L;
    5. Lymphocyte count <0.75 x 109/L.
  9. Estimated glomerular filtration rate [GFR] <40 mL/min/1.73 m2 at Screening. GFR will be calculated by the central lab using the bedside Schwartz formula.
  10. Current or recent history of uncontrolled clinically significant renal, hepatic, hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurologic disease.
  11. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥1.5 times the upper limit of normal.
  12. History of any other rheumatologic disease, other than Sjogren's syndrome..
  13. History or current symptoms suggestive of lymphoproliferative disorders (eg, Epstein Barr Virus [EBV] related lymphoproliferative disorder, lymphoma, leukemia, or signs and symptoms of current lymphatic disease).
  14. Vaccinated or exposed to a live or attenuated vaccine within the 6 weeks prior to the first dose of study drug, or is expected to be vaccinated or to have household exposure to these vaccines during treatment or during the 6 weeks following discontinuation of study drug.
  15. Subjects without documented evidence of having received at least one dose of the varicella vaccine in countries where the vaccine is approved and standard of care or those who do not have evidence of prior exposure to varicella zoster virus (VZV) based on serological testing (ie, VZV IgG Ab).
  16. Current malignancy or history of any malignancy with the exception of adequate treated or excised basal cell or squamous cell or cervical cancer in situ.
  17. Subjects who have previously failed more than 3 biologic therapies (with different mechanisms of action) for JIA.
  18. Subjects with a first degree relative with a hereditary immunodeficiency; IgA deficiency not exclusionary.
  19. Recent (within 28 days prior to first dose of study drug) significant trauma or major surgery.
  20. Subjects receiving potent and moderate CYP3A4 inhibitors or inducers.
  21. Prior treatment with non B cell specific lymphocyte depleting agents/therapies (eg, almetuzumab [CAMPATH], alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation, etc.). Subjects who have received rituximab or other selective B lymphocyte depleting agents (including experimental agents) are eligible if they have not received such therapy for at least 1 year prior to study baseline and have normal CD 19/20+ counts by FACS analysis.
  22. Use of prohibited prescription or non prescription drugs and dietary supplements listed in Appendix 1 and Appendix 4 within the specified time frame prior to the first dose of study medication.
  23. Herbal supplements must be discontinued at least 28 days prior to the first dose of study medication.
  24. Use of certain biologic and non biologic DMARDs are disallowed at any time during this study (Appendix 1).
  25. For subjects with PsA, oral and topical medications and alternative treatments that could affect psoriasis are prohibited (see Inclusion Criterion 2 for exceptions). This includes topical corticosteroids, tars, keratolytics, anthralin, vitamin D analogs, and retinoids which must be discontinued at least 2 weeks prior to first dose of study drug. Also prohibited is ultraviolet B (UVB) (narrowband or broadband) phototherapy that must be discontinued at least 2 weeks prior to first dose of study drug. Psoralens + ultraviolet A (UVA) phototherapy (PUVA) must be discontinued at least 4 weeks prior to first dose of study drug.
  26. Subjects who are children of or related to investigational site staff members, site staff members otherwise supervised by the investigator, or Pfizer employees directly involved in the conduct of the study.
  27. Participation in other studies involving investigational drug(s) within 4 weeks or 5 half lives (whichever is longer) prior to study entry and/or during study participation. Exposure to investigational biologics should be discussed with the Sponsor.
  28. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
  29. Pregnant or nursing females are excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02592434


Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

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Locations
United States, Arkansas
Arkansas Children's Hospital - Attention: Jill Hernandez Active, not recruiting
Little Rock, Arkansas, United States, 72202
Arkansas Children's Hospital Active, not recruiting
Little Rock, Arkansas, United States, 72202
United States, California
Loma Linda University Children's Hospital Active, not recruiting
Loma Linda, California, United States, 92354
Loma Linda University Clinical Trial Center Active, not recruiting
Loma Linda, California, United States, 92354
Loma Linda University Eye Institute Active, not recruiting
Loma Linda, California, United States, 92354
Loma Linda University General Pediatric Clinic - Meridian Active, not recruiting
Loma Linda, California, United States, 92354
Pediatric Specialty Team Centers of LLU Children's Hospital Active, not recruiting
Loma Linda, California, United States, 92408
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Pediatric Specialty Team Centers of LU Children's Hospital Active, not recruiting
San Bernardino, California, United States, 92408
Rady Children's Hospital - San Diego Active, not recruiting
San Diego, California, United States, 92123
Rady Children's Hospital Center for Pediatric Clinical Research Active, not recruiting
San Diego, California, United States, 92123
Rady Children's Hospital Research Pharmacy Active, not recruiting
San Diego, California, United States, 92123
Rady Children's Hospital Rheumatology Clinic Active, not recruiting
San Diego, California, United States, 92123
United States, Connecticut
Connecticut Children's Medical Center -Pharmacy Active, not recruiting
Hartford, Connecticut, United States, 06106
Connecticut Children's Medical Center Active, not recruiting
Hartford, Connecticut, United States, 06106
United States, District of Columbia
Children's National Medical Center Active, not recruiting
Washington, District of Columbia, United States, 20010
IDS Pharmacy Children's National Medical Center Active, not recruiting
Washington, District of Columbia, United States, 20010
United States, Florida
Nicklaus Children's Hospital Active, not recruiting
Miami, Florida, United States, 33155
United States, Georgia
Children's Healthcare of Atlanta-Pediatric Research Center Active, not recruiting
Atlanta, Georgia, United States, 30322
Children's Healthcare of Atlanta Active, not recruiting
Atlanta, Georgia, United States, 30322
Children's Specialty Services Active, not recruiting
Atlanta, Georgia, United States, 30322
Georgia Regents University Active, not recruiting
Augusta, Georgia, United States, 30912
United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago Active, not recruiting
Chicago, Illinois, United States, 60611
Lurie Children's Investigational Drug Pharmacy Active, not recruiting
Chicago, Illinois, United States, 60611
The University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
United States, Indiana
IU Health Investigational Drug Services Active, not recruiting
Indianapolis, Indiana, United States, 46202
Riley Hospital for Children at IU Health Active, not recruiting
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Tufts Medical Center Floating Hospital for Children Active, not recruiting
Boston, Massachusetts, United States, 02111
United States, Minnesota
Journey Clinic: Center for Children with Cancer and Blood Diseases, Uni. of Minnesota Medical Centre Active, not recruiting
Minneapolis, Minnesota, United States, 55454
Pediatric Specialty Care Explorer Clinic, University of Minnesota Medical Center Active, not recruiting
Minneapolis, Minnesota, United States, 55454
University of Minnesota Medical Center, Fairview IDS Pharmacy Active, not recruiting
Minneapolis, Minnesota, United States, 55455
United States, New Jersey
Hackensack University Medical Center Active, not recruiting
Hackensack, New Jersey, United States, 07601
United States, New York
Montefiore Medical Center Active, not recruiting
Bronx, New York, United States, 10467
Pharmacy Department Active, not recruiting
Bronx, New York, United States, 10467
Cohen Children's Medical Center of NY Active, not recruiting
Lake Success, New York, United States, 11042
Cohen Children's Medical Center of New York Active, not recruiting
New Hyde Park, New York, United States, 11040
Columbia University Medical Center - Herbert Irving Pavillion Active, not recruiting
New York, New York, United States, 10032
CUMC Research Pharmacy Active, not recruiting
New York, New York, United States, 10032
United States, North Carolina
Children's Specialty Center Active, not recruiting
Charlotte, North Carolina, United States, 28203
Carolinas HealthCare System IDS Pharmacy Active, not recruiting
Charlotte, North Carolina, United States, 28204
Pediatric Research Active, not recruiting
Charlotte, North Carolina, United States, 28207
United States, Ohio
Cincinnati Childrens Hospital Medical Center Active, not recruiting
Cincinnati, Ohio, United States, 45229-3039
United States, Oregon
Legacy Emanuel Medical Center - Inpatient Pharmacy Active, not recruiting
Portland, Oregon, United States, 97227
Randall Children's Hospital at Legacy Emanuel Active, not recruiting
Portland, Oregon, United States, 97227
United States, Pennsylvania
The Children's Hospital of Philadelphia Active, not recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Dell Children's Medical Center of Central Texas Active, not recruiting
Austin, Texas, United States, 78723
Specially for Children, Dell Children's Medical Center of Central Texas Active, not recruiting
Austin, Texas, United States, 78723
Texas Children's Hospital - Clinical Care center Active, not recruiting
Houston, Texas, United States, 77030
Texas Children's Hospital - Clinical Research Center Active, not recruiting
Houston, Texas, United States, 77030
Texas Children's Hospital - Investigational Pharmacy Active, not recruiting
Houston, Texas, United States, 77030
Texas Children's Hospital - Main Hospital Active, not recruiting
Houston, Texas, United States, 77030
Texas Children's Hospital/Baylor College of Medicine - Feigin Center Active, not recruiting
Houston, Texas, United States, 77030
United States, Utah
PCH Pharmacy - Primary Children's Hospital - Pharmacy Active, not recruiting
Salt Lake City, Utah, United States, 84113
Primary Children's Hospital Active, not recruiting
Salt Lake City, Utah, United States, 84113
United States, Washington
Seattle Children's Hospital Active, not recruiting
Seattle, Washington, United States, 98105
Argentina
Instituto CAICI SRL Active, not recruiting
Rosario, Santa FE, Argentina, S2000PBJ
Centro Medico Privado de Reumatologia Active, not recruiting
San Miguel de Tucuman, Tucuman, Argentina, T4000AXL
Hospital Britanico de Buenos Aires Active, not recruiting
Caba, Argentina, C1280AEB
Australia, New South Wales
The Sydney Children's Hospital Network Westmead Active, not recruiting
Westmead, New South Wales, Australia, 2145
Australia, Victoria
The Royal Children's Hospital Active, not recruiting
Parkville, Victoria, Australia, 3052
Belgium
UZ Leuven-Gasthuisberg Active, not recruiting
Leuven, Belgium, 3000
Brazil
SER - Servircos Especializados em Reumatologia Active, not recruiting
Salvador, Bahia, Brazil, 40150-150
CMIP -Centro Mineiro de Pesquisa Ltda / Reumatocenter Active, not recruiting
Juiz de Fora, MG, Brazil, 36010-570
Santa Casa de Misericordia de Belo Horizonte Terminated
Belo Horizonte, Minas Gerais, Brazil, 30150-220
Santa Casa de Misericordia de Belo Horizonte Terminated
Belo Horizonte, Minas Gerais, Brazil, 30150-320
Hospital Pequeno Principe / A ssociacao Hospitalar de Protecao a Infancia Active, not recruiting
Curitiba, Parana, Brazil, 80250-060
Instituto de Pesquisa Pele Pequeno Principe Active, not recruiting
Curitiba, Parana, Brazil, 80250-060
Instituto de Puericultura e Pediatria Martagao Gesteira Active, not recruiting
Rio de Janeiro, RJ, Brazil, 21941-912
Instituto da Crianca do Hospital das Clinicas da FMUSP Active, not recruiting
Sao Paulo, SAN Paulo, Brazil, 05409-011
Faculdade de Medicina da UNESP Active, not recruiting
Botucatu, SAO Paulo, Brazil, 18618-686
SPDM- Associacao Paulista para o Desenvolvimento da Medicina-Hospital Sao Paulo Active, not recruiting
Sao Paulo, Brazil, 04037-002
Canada, Alberta
Alberta Children's Hospital - Inpatient Pharmacy Active, not recruiting
Calgary, Alberta, Canada, T3B 6A8
Alberta Children's Hospital/University of Calgary Active, not recruiting
Calgary, Alberta, Canada, T3B 6A8
Canada, British Columbia
Children's & Women's Health Centre of B.C. Active, not recruiting
Vancouver, British Columbia, Canada, V6H 3N1
British Columbia Children's Hospital Active, not recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Quebec
McGill University Health Canter, Glen site, Pharmacy Active, not recruiting
Montreal, Quebec, Canada, H4A 3J1
McGill University Health Center, Glen Site, Center for Innovative Medicine (CIM) Active, not recruiting
Montreal, Quebec, Canada, H4A 3J1
Israel
Rambam Health Care Active, not recruiting
Haifa, Israel, 3109601
Meir Medical Center Active, not recruiting
Kfar Saba, Israel, 4428164
Chaim Sheba M.C Tel hashomer Active, not recruiting
Ramat Gan, Israel, 52621
Mexico
Clinica de Investigacion en Reumatologia y Obesidad, S.C. Active, not recruiting
Guadalajara, Jalisco, Mexico, 44650
Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi S.C. Active, not recruiting
San Luis Potosi, Mexico, 78213
Sociedad de Beneficencia Espanola, A.C. Active, not recruiting
San Luis Potosi, Mexico, 78250
Hospital Central "Dr. Ignacio Morones Prieto" Active, not recruiting
San Luis Potosi, Mexico, 78290
Unidad de Investigaciones Reumatologicas A.C. Active, not recruiting
San Luis Potosi, Mexico, 78290
Poland
Wojewodzki Szpital Dzieciecy im. J. Brudzinskiego Active, not recruiting
Bydgoszcz, Poland, 85-667
Szpital Specjalistyczny im. A. Falkiewicza Oddzial Pediatryczno Not yet recruiting
Wroclaw, Poland, 52-114
Russian Federation
FSAEI HE I.M. Sechenov First MSMU of Minzdrav of Russia (Sechenovskiy University) Active, not recruiting
Moscow, Russian Federation, 119435
FSAEI HE I.M Sechenov First MSMU of Minzdrav of Russia (Sechenovskiy University) Active, not recruiting
Moscow, Russian Federation, 119991
FSAI "NMRCCH" of MOH Russia Active, not recruiting
Moscow, Russian Federation, 119991
FSBEI HE "St. Petersburg State Pediatric Medical Unversity"of the Ministry of the Russian Federation Active, not recruiting
Saint-Petersburg, Russian Federation, 194100
State Budgetary Healthcare Institution of Samara Region "Tolyatti City Clinical Hospital #5" Active, not recruiting
Tolyatti, Russian Federation, 445039
Spain
Hospital Universitario Ramon y Cajal Active, not recruiting
Madrid, Spain, 28034
Hospital Universitario y Politecnico La Fe Active, not recruiting
Valencia, Spain, 46026
Turkey
Hacettepe University Medical Faculty Active, not recruiting
Ankara, Turkey, 06100
Istanbul Medeniyet University Medical Faculty Active, not recruiting
Istanbul, Turkey, 34000
Istanbul University Cerrahpasa Medical Faculty Active, not recruiting
Istanbul, Turkey, 34098
Umraniye Training and Research Hospital Active, not recruiting
Istanbul, Turkey, 34764
Erciyes University Medical Faculty Active, not recruiting
Kayseri, Turkey, 38039
Ukraine
Ivano-Frankivsk Regional Children's Clinical Hospital Active, not recruiting
Ivano-Frankivsk, Ukraine, 76014
Vinnytsia Regional Children's Clinical Hospital Active, not recruiting
Vinnitsya, Ukraine, 21000
United Kingdom
University Hospital Southampton NHS Foundation Trust Active, not recruiting
Southampton, Hampshire, United Kingdom, SO14 0YG
University Hospital Southampton NHS Foundation Trust Active, not recruiting
Southampton, Hampshire, United Kingdom, SO16 6YD
Birmingham Woman's and Children's NHS Foundation Trust Active, not recruiting
Birmingham, WEST Midlands, United Kingdom, B4 6NH
University Hospitals Bristol NHS Foundation Trust Not yet recruiting
Bristol, United Kingdom, BS2 8BJ
University Hospitals Bristol NHS Foundation Trust Not yet recruiting
Bristol, United Kingdom, BS2 8HW
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02592434     History of Changes
Other Study ID Numbers: A3921104
2015-001438-46 ( EudraCT Number )
PROPEL STUDY ( Other Identifier: Alias Study Number )
PROPEL ( Other Identifier: Alias Study Number )
First Posted: October 30, 2015    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018

Keywords provided by Pfizer:
Arthritis
Pediatric
Long-term
JIA
polyarticular
CP-690,550
tofacitinib
Xeljanz

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pharmaceutical Solutions
Tofacitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action