A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY OF CNTO 136 (SIRUKUMAB) A HUMAN ANTI-IL-6 MONOCLONAL ANTIBODY, ADMINISTERED SUBCUTANEOUSLY, IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS DESPITE DMARD THERAPY

Not Applicable

• Registration Number: PER-108-12
• Lead Sponsor: Janssen Research & Develoment, LLC,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-21
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. BE A MAN OR A WOMAN OF 18 YEARS OF AGE (OR THE LEGAL AGE OF CONSENT IN THE JURISDICTION IN WHICH THE STUDY IS TAKING PLACE) OR OLDER.
2. HAVE A DIAGNOSIS OF RA (ACCORDING TO THE REVISED 1987 CRITERIA OF THE ARA²) FOR AT LEAST 3 MONTHS BEFORE SCREENING.
3. HAVE MODERATELY TO SEVERELY ACTIVE RA WITH AT LEAST 6 OF 68 TENDER JOINTS AND 6 OF 66 SWOLLEN JOINTS, AT SCREENING AND AT BASELINE.
4. HAVE BEEN REFRACTORY TO SINGLE-AGENT OR COMBINATION DMARD THERAPY THAT INCLUDES MTX OR SSZ DUE TO:
. LACK OF BENEFIT AFTER AT LEAST 12 WEEKS OF DMARD, AS ASSESSED BY THE TREATING PHYSICIAN.
. DOCUMENTED LACK OF BENEFIT MAY INCLUDE INADEQUATE IMPROVEMENT IN JOINT COUNTS, PHYSICAL FINCTION, OR OVERALL DISEASE ACTIVITY. IT IS RECOMMENDED THAT SUBJECTS SHOULD HAVE BEEN EXPOSED TO THE HIGHEST TOLERATED DOSE OF MTX OF UP TO 25 MG PER WEEK.
5. IF USING ORAL CORTICOSTEROIDS, MUST BE ON A STABLE DOSE EQUIVALENT TO ≤ 10 MG/DAY OF PREDNISONE FOR AT LEAST 2 WEEKS PRIOR TO THE FIRST ADMINISTRATION OF STUDY AGENT. iF CURRENTLY NOT USING CORTICOSTEROIDS, THE SUBJECT MUST NOT HAVE RECIEVED ORAL CORTICOSTEROIDS FOR AT LEAST 2 WEEKS PRIOR TO THE FIRST ADMINISTRATION OF STUDY AGENT
6. IF USING NSAIDs OR OTHER ANALGESICS FOR RA, MUST BE ON A STABLE DOSE FOR AT LEAST 2 WEEKS PRIOR TO THE FIRST ADMINISTRATION OF STUDY AGENT.

Exclusion Criteria

1. A. HAS A HISTORY OF INTOLERANCE TO AT LEAST 2 OR INADEQUATE RESPONSE TO AT LEAST 1 ANTI-TNF α AGENT AFTER 3 MONTHS OF THERAPY.
B. HAS RECEIVED INFLIXIMAB, GOLIMUMAB, ADALIMUMAB, CERTOLIZUMAB PEGOL, ETANERCEPT, OR YISAIPU WITHIN 3 MONTHS OF THE FIRST STUDY AGENT ADMINISTRATION.
2. A. HAS A HISTORY OF INTOLERANCE TO TOCILIZUMAB THAT PRECLUDED FURTHER TREATMENT WITH IT, OR INADEQUATE RESPONSE TO 3 MONTHS OF TOCILIZUMAB (ANTI-IL-6 RECEPTOR) THERAPY.
B. HAS USED B-CELL DEPLETING THERAPY (EG, RITUXIMAB) WITHIN 7 MONTHS OF FIRST STUDY AGENT ADMINISTRATION OR HAVE EVIDENCE DURING SCREENING OF ABNORMALLY LOW B CELL LEVEL CAUSED BY PREVIOUS B-CELL DEPLETION THERAPY.
C. HAS USED ANAKINRA WITHIN 4 WEEKS OF FIRST STUDY AGENT ADMINISTRATION.
D. HAS USED ANY OTHER BIOLOGIC THERAPY FOR THE TREATMENT OF RA WITHIN 3 MONTHS OF THE FIRST STUDY AGENT ADMINISTRATION.
3. HAS RECEIVED INTRA-ARTICULAR (IA), INTRAMUSCULAR (IM), OR IV CORTICIOSTEROIDS FOR RA, INCLUDING ADRENOCORTICOTROPHIC HORMONE DURING THE 4 WEEKS PRIOR TO FIRST STUDY AGENT ADMINISTRATION.
4. HAS RECEIVED LEFLUNOMIDE WITHIN 24 MONTHS BEFORE THE FIRST STUDY AGENT ADMINISTRATION AND HAVE NOT UNDERGONE A DRUG ELIMINATION PROCEDURE, UNLESS THE M1 METABOLITE IS MEASURED AND IS UNDTECTABLE. DRUG ELIMINATION PROCEDURE MUST BE COMPLETED PRIOR TO OBTAINING INFORMED CONSENT.

Study & Design

• Study Type: Interventional
• Study Design: Not specified