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

Not Applicable

• Conditions: -M080 Juvenile rheumatoid arthritis; Juvenile rheumatoid arthritis; M080

• Registration Number: PER-129-12
• Lead Sponsor: CB BIOSCIENCES GmbH,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-11-14
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 0

Inclusion Criteria

1. AN INSTITUTIONAL REVIEW BOARD (IRB)/INDEPENDENT ETHICS COMMITTEE (IEC) APPROVED WRITTEN INFORMED CONSENT FORM IS SIGNED AND DATED BY THE SUBJECT OR BY THE PARENT(S) OR LEGAL REPRESENTATIVE. THE CONSENT FORM OR A SPECIFIC ASSENT FORM, WHERE REQUIRED, WILL BE SIGNED AND DATED BY MINORS.
2. SUBJECT/LEGAL REPRESENTATIVE/PARENT IS CONSIDERED RELIABLE AND CAPABLE OF ADHERING TO THE PROTOCOL, VISIT SCHEDULE OR MEDICATION INTAKE ACCORDING TO THE JUDGMENT OF THE INVESTIGATOR.
3. SUBJECT MUST BE ABLE AND WILLING TO COMPLY WITH THE REQUIREMENTS OF THE STUDY.
4. SUBJECT IS 2 TO 17 YEARS OF AGE (INCLUSIVE) AT BASELINE (VISIT 2).
5. SUBJECTS MUST WEIGH >10KG (221B) AT BASELINE (VISIT 2).
6. SUBJECTS MUST HAVE HAD A DIAGNOSIS OF JIA (ACCORDING TO THE INTERNATIONAL LEAGUE OF ASSOCIATIONS FOR RHEUMATOLOGY CLASSIFICATION OF JUVENILE IDIOPATHIC ARTHRITIS, 2001) 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 ERA.
7. SUBJECTS MUST HAVE ACTIVE POLYARTICULAR-COURSE DISEASE, DEFINED AS >5 JOINTS WITH ACTIVE ARTHRITIS AT SCREENING AND AT BASELINE.

Exclusion Criteria

1. SUBJECT HAS PREVIOUSLY BEEN EXPOSED TO MORE THAN 2 BIOLOGIC AGENTS.
2. SUBJECT PREVIOUSLY FAILED TO RESPOND TO, TREATMENT WITH MORE THAN ONE TUMOR NECROSIS FACTOR ALPHA (TNFΑ) ANTAGONIST DRUG. LACK OF RESPONSE TO TREATMENT IS DEFINED AS NO CLINICAL DISEASE IMPROVEMENT WITHIN THE FIRST 12 WEEKS OF TREATMENT. (SUBJECTS WHO DEMONSTRATED CLINICAL RESPONSE WITHIN 12 WEEKS OF TREATMENT AND SUBSEQUENTLY LOST RESPONSE AFTER 12 WEEKS OF TREATMENT ARE ELIGIBLE.)
3. SUBJECT IS CURRENTLY RECEIVING OR HAS RECEIVED ANY EXPERIMENTAL (BIOLOGICAL OR NON-BIOLOGICAL) THERAPY (WITHIN OR OUTSIDE A CLINICAL STUDY) IN THE 3 MONTHS OR 5 HALF-LIVES PRIOR TO BASELINE (VISIT 2), WHICHEVER IS LONGER.
4. SUBJECT HAD PREVIOUS TREATMENT WITH A BIOLOGICAL THERAPY FOR JIA THAT RESULTED IN A SEVERE HYPERSENSITIVITY REACTION OR AN ANAPHYLACTIC REACTION.
5. SUBJECT PREVIOUSLY PARTICIPATED IN THIS STUDY OR HAS PREVIOUSLY BEEN TREATED WITH CZP (WHETHER IN A STUDY OR NOT).
6. SUBJECT HAS RECEIVED ANY PROHIBITED MEDICATION AS DETAILED IN TABLE 6-1.
7. SUBJECTS HAS A HISTORY OF SYSTEMIC JIA, WITH OR WITHOUT SYSTEMIC FATURES.
8. SUBJECT HAS A SECONDARY, NONINFLAMMATORY TYPE OF RHEUMATIC DIEASE OR OF JOINT PAINS (EG, FIBROMYALGIA) THAT IN THE INVESTIGATOR’S OPINION IS SYMPTOMATIC ENOUGH TO INTERFERE WITH EVALUATON OF THE EFFECT OF STUDY MEDICATION.

Study & Design

• Study Type: Interventional
• Study Design: Not specified