A Study of LY2127399 in Rheumatoid Arthritis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-05-31

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.

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Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LY2127399

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.

Group Type EXPERIMENTAL

LY2127399

Intervention Type DRUG

Administered subcutaneously

Interventions

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LY2127399

Administered subcutaneously

Intervention Type DRUG

Other Intervention Names

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tabalumab

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No