Long-term Safety and Efficacy of Sirukumab in Participants With RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003
Status: | Completed |
---|---|
Conditions: | Arthritis, Rheumatoid Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 9/28/2018 |
Start Date: | August 7, 2013 |
End Date: | April 30, 2018 |
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)
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 antirheumatic drugs (DMARDs) or anti-TNF alpha agents.
(sirukumab) in participants with rheumatoid arthritis (RA) who are unresponsive to treatment
with modifying antirheumatic drugs (DMARDs) or anti-TNF alpha agents.
This is a multicenter, long-term study of sirukumab (CNTO 136) that will be conducted in two
groups of participants at the same time (parallel-group study). The maximum duration of
participation in this study is 208 weeks, followed by approximately 16 weeks of safety and
efficacy follow-up after the administration of the final study agent injection of sirukumab.
Participant safety will be monitored throughout the study.
groups of participants at the same time (parallel-group study). The maximum duration of
participation in this study is 208 weeks, followed by approximately 16 weeks of safety and
efficacy follow-up after the administration of the final study agent injection of sirukumab.
Participant safety will be monitored throughout the study.
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
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
We found this trial at
67
sites
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