Overview

A Study for Patients With Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy

Status:
Completed
Trial end date:
2010-12-01
Target enrollment:
0
Participant gender:
All
Summary
To assess the efficacy of LY2127399 versus placebo using American College of Rheumatology (ACR)50 response scale at 24 weeks
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eli Lilly and Company
Treatments:
Antibodies, Monoclonal
Methotrexate
Criteria
Inclusion Criteria:

- Have given written informed consent

- Women must not be at risk to become pregnant during study participation

- Diagnosis of Rheumatoid Arthritis (RA)

- Current, regular use of Methotrexate, at a stable dose

- Other criteria to be reviewed by study doctor

Exclusion Criteria:

- Use of excluded medications(reviewed by study doctor)

- Have not failed biologic tumor necrosis factor-alpha (TNF-α) inhibitor therapy

- Have had recent or ongoing infection which, in the opinion of the study doctor put
patient at an unacceptable risk for participation in the study

- Evidence of tuberculosis

- Have systemic inflammatory condition other than RA, such as juvenile RA, Crohn's
disease, ulcerative colitis, psoriatic arthritis or seronegative spondyloarthropathy

- Other criteria to be reviewed by study doctor