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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 3

Conditions: Arthritis, Rheumatoid

Treatments: Drug: Placebo; Drug: Sirukumab 50 mg; Drug: Sirukumab 100 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01856309

CNTO136ARA3004 (Other Identifier)

2012-001176-10 (EudraCT Number)

CR102023

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,820 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

1,820 participants in 2 patient groups

Sirukumab 100 mg

Experimental group

Treatment:

Drug: Sirukumab 100 mg

Sirukumab 50 mg / placebo

Experimental group

Treatment:

Drug: Placebo

Drug: Sirukumab 50 mg