A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T)
- Conditions
- rheumarheumatoid arthritis1000381610023213
- Registration Number
- NL-OMON40162
- Lead Sponsor
- Janssen-Cilag
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 7
1. Have completed the final study agent administrations in the primary study (Week 104 injection in CNTO136ARA3002 or Week 52 injection in CNTO136ARA3003) including all other assessments required for these visits. The subject will then be deemed to have completed participation in those studies and will be eligible to enroll in this long-term extension study.;2. Sign 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.;3. Sign an informed consent form (ICF) for pharmacogenetics research in order to participate in the optional pharmacogenetics component of this study, where local regulations permit. Refusal to give consent for this component does not exclude a subject from participation in this clinical study.
1. Withdraws consent and/or discontinues participation in study CNTO136ARA3002 or CNTO136ARA3003 ;2. Is pregnant ;3. Has active diverticulitis ;4. 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To evaluate the long-term safety of sirukumab in subjects with RA, who are<br /><br>refractory to disease modifying antirheumatic drugs (DMARD) or anti-TNF*<br /><br>agents.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary objectives are to observe the following long-term effects of<br /><br>sirukumab in subjects with RA who are refractory to DMARDs or anti-TNF* agents<br /><br>on:<br /><br>* Efficacy<br /><br>* Pharmacokinetics<br /><br>* Immunogenicity<br /><br>* Pharmacodynamics<br /><br>* Pharmacogenetics<br /><br>* PFS-AI usability (as defined in a separate substudy protocol)</p><br>