ong-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003

Phase 1

• Conditions: Rheumatoid Arthritis; MedDRA version: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2012-001176-10-ES
• Lead Sponsor: Janssen-Cilag International N.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-05
• Last Update Posted: 28 May 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2165

Inclusion Criteria

Each potential subject must satisfy all of the following criteria to be enrolled in the study. Each subject must:
Inclusion Criteria:
- Completed participation in Studies CNTO136ARA3002 or CNTO136ARA3003
- Signed an informed consent form (ICF) indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
- Signed an informed consent form (ICF) for pharmacogenetics research (how a person?s genes may affect a drug?s effects) in order to participate in the optional pharmacogenetics component of this study.

Refusal to give consent for this component does not exclude a participant from participation in this clinical study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1890
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 275

Exclusion Criteria

Exclusion Criteria:
- Withdraws consent and/or discontinues participation in study CNTO136ARA3002 or CNTO136ARA3003
- Is pregnant - Has active diverticulitis
- Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (eg, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The purpose of this study is to evaluate the long-term safety and efficacy of CNTO 136 (sirukumab) in participants with rheumatoid arthritis (RA) who are unresponsive to treatment with modifying<br>antirheumatic drugs (DMARDs) or anti-TNF alpha agents;Secondary Objective: The secondary objectives are to observe the following long-term effects of sirukumab in subjects with RA who are refractory to DMARDs or anti-TNF alpha agents on: <br>? Efficacy<br>? Pharmacokinetics <br>? Immunogenicity<br>? Pharmacodynamics<br>? Pharmacogenetics<br>? PFS-AI usability (as defined in a separate substudy protocol);Primary end point(s): 1) The number of participants with cardiovascular serious adverse events (SAEs)<br>2) The number of participants with malignancies<br>3) The number of participants with serious infections<br>4) The number of participants with gastrointestinal perforations;Timepoint(s) of evaluation of this end point: 1-4) Up to 224 weeks