A Study of LY2127399 in Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01576549
• Other study ID #: 14319
• Secondary ID: H9B-MC-BCEE
• Status: Terminated
• Phase: Phase 2
• First received: April 10, 2012
• Last updated: March 24, 2018
• Start date: May 2012
• Est. completion date: May 2013

Study information

• Verified date: March 2018
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• LY2127399
Administered subcutaneously

Locations

Country	Name	City	State
United States	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.	Battle Creek	Michigan
United States	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.	Frederick	Maryland
United States	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.	Mayfield	Ohio
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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