Efficacy Study Of Tofacitinib In Pediatric JIA Population

Completed · Phase 3 · Has a placebo group

Conditions studied: Juvenile Idiopathic Arthritis

In brief

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

Key facts

Study ID

NCT02592434

Run by

Pfizer

People needed

225

Starts

2016-06-10

Expected to finish

2019-05-16

Last updated by the study team

2020-04-13

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• Loma Linda University Children's Hospital — Loma Linda, California, United States
• Loma Linda University Clinical Trial Center — Loma Linda, California, United States
• Loma Linda University Eye Institute — Loma Linda, California, United States
• Loma Linda University General Pediatric Clinic - Meridian — Loma Linda, California, United States
• Pediatric Specialty Team Centers of LLU Children's Hospital — Loma Linda, California, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Pediatric Specialty Team Centers of LU Children's Hospital — San Bernardino, California, United States
• Rady Children's Hospital - San Diego — San Diego, California, United States
• Rady Children's Hospital Center for Pediatric Clinical Research — San Diego, California, United States
• Rady Children's Hospital Education and Office Building — San Diego, California, United States
• Rady Children's Hospital Research Pharmacy — San Diego, California, United States
• Rady Children's Hospital Rheumatology Clinic — San Diego, California, United States
• Connecticut Children's Medical Center -Pharmacy — Hartford, Connecticut, United States
• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• IDS Pharmacy Children's National Medical Center — Washington D.C., District of Columbia, United States
• Nicklaus Children's Hospital — Miami, Florida, United States
• Children's Healthcare of Atlanta-Pediatric Research Center — Atlanta, Georgia, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Children's Specialty Services — Atlanta, Georgia, United States
• Augusta University Health Pharmacy — Augusta, Georgia, United States
• Augusta University — Augusta, Georgia, United States
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Arkansas Children's Hospital - Attention: Jill Hernandez — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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