Status:
COMPLETED
A Multi-Site Study to Evaluate the Safety and Effect of Study Drug on Participants With Rheumatoid Arthritis
Lead Sponsor:
Eli Lilly and Company
Conditions:
Arthritis, Rheumatoid
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study is a multicenter, double-blind, study to evaluate the safety and effectiveness of treatment with LY2127399 (in addition to the standard of care treatment, methotrexate) for participants wit...
Eligibility Criteria
Inclusion
- Male or female between the ages of 18 and 75 years
- Have given written informed consent approval
- Women must not be at risk to become pregnant during study participation
- Diagnosis of Rheumatoid Arthritis according to the 1987 revised American Rheumatism Association (ARA) criteria for the classification of RA
- Serum C-reactive protein (CRP) measurement greater than the upper limit of normal (ULN, 0.574 mg/dL), or erythrocyte sedimentation rate (ESR) ≥28 mm/hr
- Current, regular use of Methotrexate, at a stable dose
- Biologic DMARD naïve, and have had an insufficient response (in the opinion of the investigator) to an adequate therapeutic dose of at least 1 oral DMARD
Exclusion
- Use of excluded medications (reviewed by study doctor)
- Surgical treatment of a joint with 2 months of study enrollment that is to be assessed in the study
- Are unable to ambulate; that is, confined to bed or wheelchair bound
- Have medical findings which, in the opinion of the study doctor, put participant at an unacceptable risk for participation in the study
- Have had recent or ongoing infection which, in the opinion of the study doctor put participant at an unacceptable risk for participation.
Key Trial Info
Start Date :
March 28 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 18 2007
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT00308282
Start Date
March 28 2006
End Date
October 18 2007
Last Update
September 10 2019
Active Locations (14)
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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.
Bacau, Romania, 600114
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.
Baia Mare, Romania, 430031
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.
Brasov, Romania, 500365
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.
Brăila, Romania, 810217