A Study of LY2127399 in Rheumatoid Arthritis

Study Overview
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Brief Summary
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This study will investigate how LY2127399 works in participants with rheumatoid arthritis (RA) who are not adequately responding to methotrexate. Participants will receive LY2127399 via an injection(s) under the skin at 4 week intervals for up to 52 weeks. Key study procedures include biopsies of the lining of an inflamed joint and blood tests to measure RA activity.

Official Title
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An Exploratory Open-Label Biomarker Study of LY2127399 in Patients With Moderate to Severe Rheumatoid Arthritis Receiving Synovial Biopsies

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: LY2127399


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of adult onset RA disease according to revised 1987 American Rheumatism Association (ARA) criteria and currently have a documented history of positive for rheumatoid factor (RF) and/or anti-cyclic citrullinated peptide antibody (anti-CCP Ab) and have moderately to severely active RA despite ongoing methotrexate (MTX) therapy Have active RA defined as the presence of at least 8/68 tender and at least 8/66 swollen joints, as determined by the tender joint count and swollen joint count assessment forms Have a screening C-reactive protein (CRP) measurement greater than 1.2 times upper limit of normal or erythrocyte sedimentation rate (ESR) greater than 28 millimeters/hour (mm/hr) Have a clinically inflamed joint suitable for synovial biopsy procedure Exclusion Criteria: Have used an unstable dose of non-steroidal anti-inflammatory drugs (NSAIDs) within 6 weeks prior to baseline Have used oral corticosteroids at average daily doses of >10 milligrams/day (mg/day) of prednisone or its equivalent within 6 weeks prior to baseline Have received any parenteral corticosteroid injection within 6 weeks of baseline Have used other disease-modifying anti-rheumatic drugs (DMARDs) other than MTX, hydroxychloroquine, and/or sulfasalazine in the 8 weeks prior to baseline

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY2127399<br>LY2127399 given subcutaneously (SC) at 240 milligrams (mg) as a loading dose in the first week followed by 120 mg SC every 4 weeks for up to 52 weeks. | Drug: LY2127399<br>* Administered subcutaneously<br>* Other names: tabalumab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Synovitis Scores From Baseline up to Week 16 | Primary and secondary analyses were not conducted given insufficient data due to termination of the trial. | Baseline up to Week 16 | 
| Percent Change in Synovial B Cell Mass From Baseline up to Week 16 | Primary and secondary analyses were not conducted given insufficient data due to termination of the trial. | Baseline up to Week 16 | 
| Percent Change in Synovial Immunoglobulin (Ig) Synthesis From Baseline up to Week 16 | Primary and secondary analyses were not conducted given insufficient data due to termination of the trial. | Baseline up to Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Various Cell Types in the Blood From Baseline up to Week 24 | Primary and secondary analyses were not conducted given insufficient data due to termination of the trial. | Baseline up to Week 24 |