A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to one or more TNF-a Inhibitors

• Conditions: Rheumatoid Arthritis; MedDRA version: 12.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis

• Registration Number: EUCTR2010-022207-22-GR
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-20
• Last Update Posted: 10 November 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 555

Inclusion Criteria

• Patients will be male and female aged =18 years of age with a diagnosis of moderately to severely active adult onset RA
• Diagnosis of Rheumatoid Arthritis (RA) of more than 6 months and less than 15 years
• At least 8 tender and swollen joints
• An abnormally high C-reactive protein (CRP) level or erythrocyte sedimentation rate (ESR)
• Positive for Rheumatoid Factor (RF) or Anti-cyclic citrullinated peptide (CCP) antibody
• Previously treated with biologic TNF-a inhibitor therapy (infliximab, certolizumab, golimumab, etanercept, adalimumab) and stopped treatment due to insufficient efficacy or intolerance
• Regular use of at least one conventional disease-modifying anti-rheumatic drug (DMARD), with a stable dose for at least 8 weeks prior to study start
• 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

• Use of unstable doses of non-steroidal inflammatory drugs (NSAIDS) in the past 6 weeks
• Steroid injection or intravenous (IV) infusion in the last 6 weeks
• Use of more than 10 mg/day of oral steroids in the last 6 weeks
• History of a serious reaction to other biological DMARDs
• Use of an oral calcineurin inhibitor (e.g., cyclosporin or tacrolimus) in the last 8 weeks
• Surgery on a joint or other major surgery less than 2 months ago, or plans to have joint surgery or major surgery during the study
• Active fibromyalgia, juvenile chronic arthritis, spondyloarthropathy, Crohn's disease, ulcerative colitis, psoriatic arthritis, or other systemic inflammatory condition except RA
• Cervical cancer or squamous skin cancer within the past 3 years, or other cancer within the past 5 years
• Received a live vaccine received within the past 12 weeks (for example, vaccines for measles, mumps, rubella, and chicken pox, and nasal-spray flu vaccines)
• Hepatitis or human immunodeficiency virus (HIV)
• A serious bacterial infection (for example, pneumonia or cellulitis) within 3 months or a serious bone or joint infection within 6 months
• Symptoms of herpes zoster or herpes simplex within the last month
• Active or latent tuberculosis (TB)
• Current symptoms of a serious disorder or illness
• Use of an investigational drug within the last month

Study & Design

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