A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis(RA) - ND

• Conditions: Rheumatoid Arthritis.; MedDRA version: 9.1Level: PTClassification code 10039073

• Registration Number: EUCTR2010-022208-36-IT
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-08
• Last Update Posted: 17 March 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1505

Inclusion Criteria

1. Patients who completed 24 weeks of participation in Study BCDO or Study BCDV, or who completed 100 weeks of participation in Study BCDM. 2. Woman must not be pregnant, breastfeeding, or become pregnant during the 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients will be excluded from the study if they meet any of the following criteria: 1. Presence of significant uncontrolled cerebro-cardiovascular (for example: myocardial infarction [MI], unstable angina, unstable arterial hypertension, severe heart failure or cerebrovascular accident), respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic or neuropsychiatric disorders or abnormal laboratory values at baseline that in the opinion of the Investigator pose an unacceptable risk to the patient if study drug would be administered. 2. Have any other condition that renders the patient unable to understand the nature, scope, and possible consequences of the study or precludes the patient from following and completing the protocol, in the opinion of the Investigator.

Study & Design

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