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)
18 Years
N/A
Both
Rheumatoid Arthritis
Trial Information
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)
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
The number of participants with cardiovascular serious adverse events (SAEs)
Outcome Time Frame:
Up to 224 weeks
Safety Issue:
No
Principal Investigator
Janssen Research & Development, LLC Clinical Trial
Investigator Role:
Study Director
Investigator Affiliation:
Janssen Research & Development, LLC
Authority:
United States: Food and Drug Administration
Study ID:
CR102023
NCT ID:
NCT01856309
Start Date:
July 2013
Completion Date:
November 2019
Related Keywords:
- Rheumatoid Arthritis
- Rheumatoid Arthritis
- Sirukumab
- CNTO 136
- CNTO136ARA3002
- SIRROUND-D
- CNTO136ARA3003
- SIRROUND-T
- SIRROUND-LTE
- Arthritis
- Arthritis, Rheumatoid
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