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

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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.

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.

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
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