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



Status:Terminated
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:5/10/2018
Start Date:December 2010
End Date:January 2014

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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 Methotrexate Therapy (FLEX M)

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


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
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