Status:
COMPLETED
A Study for Patients With Rheumatoid Arthritis on Methotrexate (MTX) With an Inadequate Response to TNFα Inhibitor Therapy
Lead Sponsor:
Eli Lilly and Company
Conditions:
Arthritis, Rheumatoid
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to explore whether LY2127399 is effective in relieving signs and symptoms of rheumatoid arthritis (RA) in patients with a history of inadequate response or intolerance to ...
Eligibility Criteria
Inclusion
- Have given written informed consent approval
- Women must not be at risk to become pregnant during study participation
- Diagnosis of Rheumatoid Arthritis
- Active Rheumatoid Arthritis
- Current, regular use of Methotrexate, at a stable dose
- Have been on at least 1 biologic tumor necrosis factor-alpha (TNFα) inhibitor therapy and either failed or were intolerant to treatment
- Other criteria to be reviewed by study doctor
Exclusion
- Use of excluded medications (reviewed by study doctor)
- Have medical findings which, in the opinion of the study doctor, put patient at an unacceptable risk for participation in the study
- Have had recent or ongoing infection which, in the opinion of the study doctor put patient at an unacceptable risk for participation
- Evidence of tuberculosis
- Have systemic inflammatory condition other than rheumatoid arthritis (RA), such as juvenile RA, seronegative spondyloarthropathy, Crohn's disease, ulcerative colitis, or psoriatic arthritis.
- Other criteria to be reviewed by study doctor
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00689728
Start Date
June 1 2008
End Date
May 1 2010
Last Update
December 6 2018
Active Locations (45)
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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.
Birmingham, Alabama, United States, 35205
2
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.
Mesa, Arizona, United States, 85208
3
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.
Palm Desert, California, United States, 92260
4
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.
Riverside, California, United States, 92501