Pediatric Arthritis Study of Certolizumab Pegol

Completed · Phase 3

Conditions studied: Polyarticular-course Juvenile Idiopathic Arthritis (JIA)

In brief

A Multicenter, Open-label Study to Assess the Pharmacokinetics, Safety and Efficacy of Certolizumab Pegol in Children and Adolescents With Moderately to Severely Active Polyarticular-course Juvenile Idiopathic Arthritis (JIA).

Key facts

Study ID

NCT01550003

Run by

UCB BIOSCIENCES GmbH

People needed

193

Starts

2012-03-08

Expected to finish

2024-04-08

Last updated by the study team

2024-10-23

Who can join

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

You may qualify if…

• Study participant is 2 to 17 years of age (inclusive) at Baseline (Visit 2)
• Study participants must weigh ≥10 kg (22lb) at Baseline (Visit 2)
• Study participants must have had onset of signs and symptoms consistent with a diagnosis of Juvenile Idiopathic Arthritis (JIA) (according to the International League of Associations for Rheumatology Classification of Juvenile Idiopathic Arthritis, 2001) and initiation of JIA treatment for at least 6 months prior to Baseline (Visit 2). Eligible JIA categories include: polyarthritis rheumatoid factor-positive, polyarthritis rheumatoid factor-negative, extended oligoarthritis, juvenile psoriatic arthritis, and enthesitis-related arthritis (ERA)
• Study participants must have active polyarticular-course disease, defined as ≥5 joints with active arthritis at Screening and at Baseline
• Study participants must have had an inadequate response to, or intolerance to, at least 1 disease-modifying antirheumatic drug (DMARD) (nonbiologic or biologic). For example, study participant had prior inadequate response to methotrexate (MTX) (based on the Investigator's clinical judgment)
• If the study participant is using MTX, then the study participant must have been on MTX for a minimum of 3 months at Screening. In addition, the dose must have been stable for at least 1 month before Screening at ≥10 to ≤15 mg/m\^2 per week. If the study participant is not using MTX, then the treatment must have been previously withdrawn for documented reasons of intolerability or inadequate response
• If the study participant is using oral corticosteroid therapy, the dose must have been stable for at least 7 days prior to the Baseline arthritis assessment at a maximum dose of 10 mg or 0.2 mg/kg prednisone (or equivalent) per day, whichever is the smaller dose

You may not qualify if…

• Study participant has previously been exposed to more than 2 biologic agents
• Study participant previously failed to respond to treatment with more than one tumor necrosis factor alpha (TNFα) antagonist drug
• Study participant is currently receiving or has received any experimental (biological or nonbiological) therapy (within or outside a clinical study) in the 3 months or 5 half-lives prior to Baseline (Visit 2), whichever is longer
• Study participant had previous treatment with a biological therapy for juvenile idiopathic arthritis (JIA) that resulted in a severe hypersensitivity reaction or an anaphylactic reaction
• Study participant previously participated in this study or has previously been treated with CZP (whether in a study or not)
• Study participant has a history of systemic JIA, with or without systemic features
• Study participant has a secondary, noninflammatory type of rheumatic disease or of joint pains (eg, fibromyalgia) that in the Investigator's opinion is symptomatic enough to interfere with evaluation of the effect of study medication
• Study participant has other inflammatory arthritis (eg, systemic lupus erythematosus, inflammatory bowel disease-related)
• Study participant has active uveitis or a history of active uveitis within the preceding 6 months
• Study participant has current, chronic or recurrent clinically significant infections
• Study participant has a current sign or symptom which may indicate infection (eg, fever, cough), a history of chronic or recurrent infections within the same organ system (more than 3 episodes requiring antibiotics/antivirals during the 12 months prior to Screening [Visit 1]), had a recent (within the 6 months prior to Screening [Visit 1]) serious or life-threatening infection (including herpes zoster), or is at a high risk of infection in the Investigator's opinion (eg, study participants with leg ulcers, indwelling urinary catheter, and persistent or recurrent chest infections or permanently bed-ridden or wheelchair bound)

Where it is running

• Ra0043 71 — Little Rock, Arkansas, United States
• Ra0043 79 — Los Angeles, California, United States
• Ra0043 84 — San Francisco, California, United States
• Ra0043 83 — Hartford, Connecticut, United States
• Ra0043 81 — Washington D.C., District of Columbia, United States
• Ra0043 82 — Chicago, Illinois, United States
• Ra0043 90 — Chicago, Illinois, United States
• Ra0043 75 — Indianapolis, Indiana, United States
• Ra0043 80 — Hackensack, New Jersey, United States
• Ra0043 77 — Livingston, New Jersey, United States
• Ra0043 85 — New Hyde Park, New York, United States
• Ra0043 87 — New York, New York, United States
• Ra0043 74 — Charlotte, North Carolina, United States
• Ra0043 76 — Durham, North Carolina, United States
• Ra0043 70 — Avon, Ohio, United States
• Ra0043 73 — Cincinnati, Ohio, United States
• Ra0043 78 — Cleveland, Ohio, United States
• Ra0043 95 — Cleveland, Ohio, United States
• Ra0043 86 — Columbus, Ohio, United States
• Ra0043 89 — Portland, Oregon, United States
• RA0043 2 — Buenos Aires, Argentina
• Ra0043 15 — Curitiba, Brazil
• Ra0043 14 — Porto Alegre, Brazil
• Ra0043 12 — São Paulo, Brazil
• Ra0043 21 — Calgary, Canada

Full record on ClinicalTrials.gov

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