Long-term Safety and Efficacy of Sirukumab in Participants With RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003

Completed · Phase 3 · Has a placebo group

Conditions studied: Arthritis, Rheumatoid

In brief

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.

Key facts

Study ID

NCT01856309

Run by

Janssen Research & Development, LLC

People needed

1820

Starts

2013-08-07

Expected to finish

2018-04-30

Last updated by the study team

2019-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Glendale, Arizona, United States
• Study site — Mesa, Arizona, United States
• Study site — Peoria, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Covina, California, United States
• Study site — El Cajon, California, United States
• Study site — Glendale, California, United States
• Study site — Hemet, California, United States
• Study site — Huntington Beach, California, United States
• Study site — La Jolla, California, United States
• Study site — La Palma, California, United States
• Study site — Placentia, California, United States
• Study site — Upland, California, United States
• Study site — Victorville, California, United States
• Study site — Whittier, California, United States
• Study site — Hamden, Connecticut, United States
• Study site — Aventura, Florida, United States
• Study site — Boca Raton, Florida, United States
• Study site — Brandon, Florida, United States
• Study site — Daytona Beach, Florida, United States
• Study site — DeBary, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Palm Harbor, Florida, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.