A Study of LY2127399 in Rheumatoid Arthritis

Phase 2

Terminated

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: LY2127399

• Registration Number: NCT01576549
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-10
• Study First Submitted QC: 2012-04-11
• Study First Posted: 2012-04-12
• Study Start: 2012-05
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Disposition First Submitted: 2013-09-27
• Disposition First Submitted QC: 2013-09-27
• Disposition First Posted: 2013-10-28
• Status Verified: 2018-03
• Results First Submitted: 2018-03-24
• Results First Submitted QC: 2018-03-24
• Last Update Submitted: 2018-03-24
• Results First Posted: 2018-04-26
• Last Update Posted: 2018-04-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LY2127399	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Percent Change in Various Cell Types in the Blood From Baseline up to Week 24	Baseline up to Week 24	Primary and secondary analyses were not conducted given insufficient data due to termination of the trial.

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.; 🇺🇸 Mesquite, Texas, United States