A Rheumatoid Arthritis Study in Participants on a Background Treatment of Methotrexate

• Status: Terminated
• Trial end date: 2014-01-01
• 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 while on a background treatment of methotrexate.

This study is comprised of 3 periods:

Period 1: 52-week blinded treatment

Period 2: additional 48-week unblinded treatment

Period 3: 48-week post-treatment follow-up

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

Details

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

Criteria

Inclusion Criteria:

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

• Regular use of methotrexate (MTX) in the past 12 weeks, with the dose being stable during the past 8 weeks

• At least 8 tender and swollen joints

• At least one erosion of a hand or foot joint observed on an X-ray

• 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

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

Exclusion Criteria:

• Use of unstable doses of non-steroidal anti-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/day (mg/day) of oral steroids in the last 6 weeks

• History of an inadequate response to a biologic disease-modifying anti-rheumatic drug (DMARD)

• History of a serious reaction to other biological DMARDs

• History of the use of rituximab or other B cell therapy

• Use of DMARDS other than MTX, hydroxychloroquine, or sulfasalazine within the last 8 weeks

• Use of leflunomide within the last 12 weeks (unless cholestyramine was used to speed up the elimination of leflunomide)

• 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

• History of the use of rituximab, any other B cell targeted biotherapy, or denosumab