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Clinical Trials/NCT02592434
NCT02592434CompletedPhase 3

EFFICACY, SAFETY AND TOLERABILITY OF TOFACITINIB FOR TREATMENT OF POLYARTICULAR COURSE JUVENILE IDIOPATHIC ARTHRITIS (JIA) IN CHILDREN AND ADOLESCENT SUBJECTS

Pfizer101 sites in 1 country225 target enrollmentStarted: June 10, 2016Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Pfizer
Enrollment
225
Locations
101
Primary Endpoint
Double Blind Phase: Percentage of Participants With Disease Flare According to Pediatric Rheumatology Collaborative Study Group/Pediatric Rheumatology International Trials Organization (PRCSG/PRINTO) Disease Flare Criteria at Week 44
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
2 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Male or female aged 2 to <18 years.
  • •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
  • •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).
  • •No evidence or history of untreated or inadequately treated active or latent tuberculosis (TB) infection as evidenced by the following:
  • •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.
  • •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.
  • •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.
  • •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.
  • •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:
  • •Previous JIA treatment with tofacitinib.
  • •Systemic JIA (sJIA) with active systemic features (including subjects with characteristic sJIA fever and rash or serositis within 6 months of enrollment).
  • •Persistent oligoarthritis.
  • •Undifferentiated JIA.
  • •Infections:
  • •Chronic infections;
  • •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;
  • •Any treated infections within 2 weeks of Baseline visit;
  • •A subject know to be infected with Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C;
  • •History of infected joint prosthesis with prosthesis still in situ.
  • •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.
  • •Active uveitis (according to SUN criteria) within 3 months of enrollment.
  • •Blood dyscrasias, including:
  • •Hemoglobin <10 g/dL or Hematocrit <33%;
  • •White Blood Cell count <3.0 x 109/L;
  • •Neutrophil count <1.2 x 109/L;
  • •Platelet count <100 x 109/L;
  • •Lymphocyte count <0.75 x 109/L.
  • •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.
  • •Current or recent history of uncontrolled clinically significant renal, hepatic, hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurologic disease.
  • •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥1.5 times the upper limit of normal.
  • •History of any other rheumatologic disease, other than Sjogren's syndrome..
  • •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).
  • •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.
  • •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).
  • +14 more not shown

Exclusion Criteria

  • Not provided

Arms & Interventions

CP-690,550

Experimental

Treatment arm: Tofacitinib tablets or solution, according to subjects' body weights

Intervention: CP-690,550 (tofacitinib) (Drug)

Placebo

Placebo Comparator

Control arm: matching placebo tablets or solution for tofacitinib

Intervention: placebo (Other)

Outcomes

Primary Outcomes

Double Blind Phase: Percentage of Participants With Disease Flare According to Pediatric Rheumatology Collaborative Study Group/Pediatric Rheumatology International Trials Organization (PRCSG/PRINTO) Disease Flare Criteria at Week 44

Time Frame: Week 44

According to PRCSG/PRINTO, disease flare defined as worsening of \>=30 percent(%) in \>=3 of 6 variables of JIA core set, with no more than 1 variable improving by \>=30%. Six core variables: 1) Number of joints with active arthritis (joint with swelling/in absence of swelling, limited range of motion accompanied by pain/tenderness), 2)Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a Visual Analog Scale\[VAS\] of 0\[no activity\] to 10\[maximum activity\]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on VAS of 0\[very well\] to 10\[very poor\], 5) Childhood Health Assessment Questionnaire- Disability Index (CHAQ-DI): 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score,which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction);6) Erythrocyte Sedimentation Rate(ESR).

Secondary Outcomes

  • Open-Label Phase: Percentage of Participants With Disease Flare According to Pediatric Rheumatology Collaborative Study Group/Pediatric Rheumatology International Trials Organization (PRCSG/PRINTO) Disease Flare Criteria at Week 2, 4, 8, 12 and 18(Weeks 2, 4, 8, 12 and 18)
  • Double Blind Phase: Time to Disease Flare(Day 1 of Week 19 up to week 44)
  • Open-Label Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 Response at Weeks 2, 4, 8, 12 and 18(Weeks 2, 4, 8, 12 and 18)
  • Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 50 Response at Week 44(Week 44)
  • Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 Response at Week 44(Week 44)
  • Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 70 Response at Week 44(Week 44)
  • Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Childhood Health Assessment Questionnaire- Disability Index (CHAQ-DI) Total Score at Week 44(Baseline, Week 44)
  • Double Blind Phase: Change From Double-Blind Baseline in JADAS-27 Erythrocyte Sedimentation Rate (ESR) Score at Weeks 20, 24, 28, 32, 36, 40 and 44(Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44)
  • Open-Label Phase: Percentage of Participants With JADAS-27 CRP Minimum Disease Activity at Weeks 2, 4, 8, 12 and 18(Weeks 2, 4, 8, 12 and 18)
  • Double Blind Phase: Percentage of Participants With JADAS-27 CRP Minimum Disease Activity at Double Blind Baseline (Week 18), Week 20, 24, 28, 32, 36, 40 and 44(Double Blind Baseline (Week 18), Week 20, 24, 28, 32, 36, 40 and 44)
  • Open-Label Phase: Percentage of Participants With JADAS-27 CRP Inactive Disease Activity at Week 2, 4, 8, 12 and 18(Weeks 2, 4, 8, 12 and 18)
  • Double Blind Phase: Percentage of Participants With JADAS-27 CRP Inactive Disease Activity at Double Blind Baseline (Week 18), Week 20, 24, 28, 32, 36, 40 and 44(Double Blind Baseline (Week 18), Week 20, 24, 28, 32, 36, 40 and 44)
  • Double Blind Phase: Percentage of Participants With Disease Flare According to PRCSG/PRINTO Disease Flare Criteria at Week 20, 24, 28, 32, 36 and 40(Weeks 20, 24, 28, 32, 36 and 40)
  • Open-Label Phase: Time to Disease Flare(Day 1 up to week 18)
  • Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 Response at Double Blind Baseline, Weeks 20, 24, 28, 32, 36 and 40(Double Blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36 and 40)
  • Open-Label Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 50 Response at Weeks 2, 4, 8, 12 and 18(Weeks 2, 4, 8, 12 and 18)
  • Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 50 Response at Double Blind Baseline, Weeks 20, 24, 28, 32, 36 and 40(Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36 and 40)
  • Open-Label Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 70 Response at Weeks 2, 4, 8, 12 and 18(Weeks 2, 4, 8, 12 and 18)
  • Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 70 Response at Double Blind Baseline (Week 18),Week 20, 24, 28, 32, 36 and 40(Double Blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36 and 40)
  • Open-Label Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 90 Response at Week 2, 4, 8, 12 and 18(Weeks 2, 4, 8, 12 and 18)
  • Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Number of Joints With Limited Range of Motion at Double Blind Baseline (Week 18), Week 20, 24, 28, 32, 36, 40 and 44(Double Blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44)
  • Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 90 Response at Double Blind Baseline (Week 18), Week 20, 24, 28, 32, 36, 40 and 44(Double Blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44)
  • Open-Label Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 100 Response at Week 2, 4, 8, 12 and 18(Weeks 2, 4, 8, 12 and 18)
  • Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 100 Response at Double Blind Baseline (Week 18), Week 20, 24, 28, 32, 36, 40 and 44(Double Blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44)
  • Open Label Phase: Change From Baseline in Juvenile Arthritis Disease Activity Score 27 (JADAS-27) C-Reactive Protein (CRP) Score at Weeks 2, 4, 8, 12 and 18(Baseline, Weeks 2, 4, 8, 12 and 18)
  • Double Blind Phase: Change From Double-Blind Baseline in Juvenile Arthritis Disease Activity Score (JADAS) 27 C-Reactive Protein (CRP) Score at Week 20, 24, 28, 32, 36, 40 and 44(Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44)
  • Open Label Phase: Change From Baseline in JADAS-27 Erythrocyte Sedimentation Rate (ESR) Score at Week 2, 4, 8, 12 and 18(Baseline, weeks 2, 4, 8, 12 and 18)
  • Double Blind Phase: Percentage of Participants With JIA ACR Inactive Disease at Double Blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44(Double Blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44)
  • Double Blind Phase: Percentage of Participants With Presence of JIA ACR Clinical Remission(From Week 18 in double blind phase up to Week 44)
  • Open Label Phase: JIA ACR Core Variable- Change From Baseline in Number of Joints With Active Arthritis at Week 2, 4, 8, 12 and 18(Baseline, Weeks 2, 4, 8, 12 and 18)
  • Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Number of Joints With Active Arthritis at Weeks 20, 24, 28, 32, 36, 40 and 44(Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44)
  • Open Label Phase: JIA ACR Core Variable- Change From Baseline in Number of Joints With Limited Range of Motion at Weeks 2, 4, 8, 12 and 18(Baseline, Weeks 2, 4, 8, 12 and 18)
  • Open Label Phase: JIA ACR Core Variable- Change From Baseline in Physician Global Evaluation of Disease Activity at Week 2, 4, 8, 12 and 18(Baseline, Weeks 2, 4, 8, 12 and 18)
  • Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Physician Global Evaluation of Disease Activity at Weeks 20, 24, 28, 32, 36, 40 and 44(Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44)
  • Open Label Phase: JIA ACR Core Variable- Change From Baseline in Parent/Legal Guardian/Participant Global Evaluation of Overall Well-Being at Weeks 2, 4, 8, 12 and 18(Baseline, Weeks 2, 4, 8, 12 and 18)
  • Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Parent/Legal Guardian/Participant Global Evaluation of Overall Well-Being at Weeks 20, 24, 28, 32, 36, 40 and 44(Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44)
  • Double Blind Phase: Number of Participants With Tanner Staging Evaluation (Genitalia)(Week 44)
  • Open-Label Phase: Number of Participants With Laboratory Abnormalities(From the first dose of study drug up to Week 18)
  • Open Label Phase: JIA ACR Core Variable- Change From Baseline in Childhood Health Assessment Questionnaire- Disability Index (CHAQ-DI) Total Scores at Weeks 2, 4, 8, 12 and 18(Baseline, Weeks 2, 4, 8, 12 and 18)
  • Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Childhood Health Assessment Questionnaire- Disability Index (CHAQ-DI) Total Scores at Weeks 20, 24, 28, 32, 36, and 40(Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, and 40)
  • Open-Label Phase: Change From Baseline in Child Health Questionnaire (CHQ) Responses at Week 4 and Week 18(Baseline, Week 4 and Week 18)
  • Double Blind Phase: Change From Double-Blind Baseline in Child Health Questionnaire (CHQ) Responses at Week 44(Double-Blind Baseline (Week 18), Week 44)
  • Open Label Phase: Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ)- Discomfort Index at Weeks 2, 4, 8, 12 and 18(Baseline, Weeks 2, 4, 8, 12 and 18)
  • Double Blind Phase:Change From Double-Blind Baseline in Childhood Health Assessment Questionnaire (CHAQ)- Discomfort Index at Weeks 20, 24, 28, 32, 36, 40 and 44(Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36,40 and 44)
  • Open-Label Phase: Percentage of Participants With Active Uveitis at Baseline(Baseline)
  • Double Blind Phase: Percentage of Participants With Active Uveitis at Week 24 and Week 44(Week 24 and Week 44)
  • Open-Label Phase: Change From Baseline in the Tender Entheseal Assessment at Weeks 2, 4, 8, 12 and 18(Baseline, weeks 2, 4, 8, 12 and 18)
  • Double Blind Phase: Change From Double-Blind Baseline in the Tender Entheseal Assessment at Weeks 20, 24, 28, 32, 36, 40 and 44(Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44)
  • Open-Label Phase: Change From Baseline in the Modified Schober's Test at Week 2, 4, 8, 12 and 18(Baseline, Weeks 2, 4, 8, 12 and 18)
  • Double Blind Phase: Change From Double Blind Baseline in the Modified Schober's Test at Week 20, 24, 28, 32, 36, 40 and 44(Double Blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44)
  • Open-Label Phase: Change From Baseline in the Overall Back Pain and Nocturnal Back Pain Responses at Week 2, 4, 8, 12 and 18(Baseline, Weeks 2, 4, 8, 12 and 18)
  • Double Blind Phase: Change From Double-Blind Baseline in the Overall Back Pain and Nocturnal Back Pain Responses at Week 20, 24, 28, 32, 36, 40 and 44(Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44)
  • Open-Label Phase: Changes From Baseline in Percentage of Body Surface Area (BSA) Affected With Psoriasis at Weeks 2, 4, 8, 12 and 18(Baseline, Weeks 2, 4, 8, 12 and 18)
  • Double Blind Phase: Changes From Double Blind Baseline in Body Surface Area (BSA) Affected With Psoriasis at Week 20, 24, 28, 32, 36, 40 and 44(Double Blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44)
  • Open-Label Phase: Changes From Baseline in Physician's Global Assessment (PGA) of Psoriasis Assessments at Weeks 2, 4, 8, 12 and 18(Baseline, Weeks 2, 4, 8, 12 and 18)
  • Double Blind Phase:Change From Double-Blind Baseline in Physician's Global Assessment (PGA) of Psoriasis Assessments at Weeks 20, 24, 28, 32, 36, 40 and 44(Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44)
  • Open-Label Phase: Taste Assessment of Tofacitinib Oral Solution on Day 14(Day 14)
  • Open-Label Phase: Number of Participants With Serious Infections, Cytopenia, Malignancies and Cardiovascular Diseases(From the first dose of study drug up to Week 18)
  • Double Blind Phase: Number of Participants With Serious Infections, Cytopenia, Malignancies and Cardiovascular Diseases(From the first dose of study drug in double blind up to week 44)
  • Open-Label Phase: Number of Participants With Tanner Staging Evaluation (Pubic Hair)(Day 1)
  • Double Blind Phase: Number of Participants With Tanner Staging Evaluation (Breast Exam)(Week 44)
  • Open-Label Phase: Number of Participants With Tanner Staging Evaluation (Genitalia)(Day 1)
  • Double Blind Phase: Number of Participants With Tanner Staging Evaluation (Pubic Hair)(Week 44)
  • Open-Label Phase: Number of Participants With Tanner Staging Evaluation (Breast Exam)(Day 1)
  • Double Blind Phase: Number of Participants With Physical Examination Abnormalities(Weeks 18, 20, 24, 28, 32, 36, 40 and 44)
  • Double Blind Phase: Number of Participants With Laboratory Abnormalities(From the first dose of study drug in double blind up to Week 44)
  • Open-Label Phase: Number of Participants With Physical Examination Abnormalities(Baseline, Weeks 2, 4, 8, 12 and 18)
  • Open-Label Phase: Number of Participants With Vital Sign Abnormalities(From the first dose of study drug up to Week 18)
  • Double Blind Phase: Number of Participants With Vital Sign Abnormalities(From the first dose of study drug in double blind up to week 44)
  • Open-Label Phase: Number of Participants With Change From Baseline in Vital Sign Measures(From the first dose of study drug up to Week 18)
  • Double Blind Phase: Number of Participants With Change From Baseline in Vital Sign Measures(From the first dose of study drug in double blind up to week 44)

Investigators

Sponsor
Pfizer
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (101)

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