A Multi-Site Study to Evaluate the Safety and Effect of Study Drug on Participants With Rheumatoid Arthritis

Lilly

Status and phase: Completed; Phase 2

Conditions: Arthritis, Rheumatoid

Treatments: Drug: Placebo; Drug: LY2127399

Study type: Interventional

Funder types: Industry

Identifiers

NCT00308282

11055 (Registry Identifier)

H9B-MC-BCDF (Other Identifier)

Details and patient eligibility

About

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 with Rheumatoid Arthritis. Participants will receive three intravenous doses of LY2127399 or placebo. Participants will participate in 10 or more visits to the study site, over 6 months. Evaluation of safety and efficacy will be conducted throughout the study.

Enrollment: 136 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

136 participants in 2 patient groups, including a placebo group

A

Experimental group

Treatment:

Drug: LY2127399

B

Placebo Comparator group

Treatment:

Drug: Placebo