A Rheumatoid Arthritis Study in Participants

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to help answer if LY2127399 is safe and effective in the treatment of rheumatoid arthritis with or without background disease-modifying anti-rheumatic drug (DMARD) therapy.

This study is comprised of 2 periods:

Period 1 - 24-week blinded treatment

Period 2 - 48-week post-treatment follow-up

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Antibodies, Monoclonal; Antirheumatic Agents

Criteria

Inclusion Criteria:

• Diagnosis of Rheumatoid Arthritis (RA) of more than 6 months and less than 15 years

• Global Assessment of Disease Activity visual analog scale (VAS) greater than or equal to 20/100 millimeters (mm)

• If on one or more conventional disease-modifying anti-rheumatic Drugs (DMARDs) at randomization, must have been on a stable dose for at least 8 weeks prior to study start.

• Women must not be pregnant, breastfeeding, or become pregnant during the study

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 milligrams per day (mg/day) of oral steroids in the last 6 weeks

• Use of biologic DMARD concurrently or recently

• History of a serious reaction to other biological DMARDs

• Use of an oral calcineurin inhibitor (for example, cyclosporin or tacrolimus) in the last 8 weeks

• Surgery on a joint or other major surgery less than 2 months prior to study start, 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 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