ong-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Immune System Diseases [C20]; MedDRA version: 19.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Rheumatoid Arthritis

• Registration Number: EUCTR2012-001176-10-GB
• Lead Sponsor: Janssen-Cilag International N.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-12-20
• Study Completion: 2018-05-01
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 1820

Inclusion Criteria

Each potential subject must satisfy all of the following criteria to be enrolled in the study. Each subject must:
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1890
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 275

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified