Phase 2
Completed N=136
A Multi-Site Study to Evaluate the Safety and Effect of Study Drug on Participants With Rheumatoid Arthritis
Arthritis, Rheumatoid
Source: ClinicalTrials.gov NCT00308282 ↗
Enrolled (actual)
136
Serious AEs
5.9%
Results posted
Mar 2019
Primary outcomePrimary: Percentage of Participants Achieving American College of Rheumatology 20% Response (ACR20) (Effectiveness of LY2127399 in Treating Rheumatoid Arthritis Using the ACR20 Scale) — 29.4; 57.6; 67.6; 51.5 percentage of participants
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 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving American College of Rheumatology 20% Response (ACR20) (Effectiveness of LY2127399 in Treating Rheumatoid Arthritis Using the ACR20 Scale) |
29.4; 57.6; 67.6; 51.5 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAE) (Safety of Repeat Doses (3) of LY2127399 Through Evaluation of Laboratory Tests, Vital Signs and Electrocardiograms) |
15; 14; 15; 15 | — |
| SECONDARY Evaluation of the Pharmacokinetics of LY2127399: Clearance |
0.0079; 0.0062; 0.0054 | — |
| SECONDARY Percentage of Participants Achieving ACR 50 and ACR70 |
20.6; 57.6; 55.9; 42.4; 2.9; 24.2 | — |
| SECONDARY Change From Baseline in the Disease Activity Score 28 Joint Count (DAS28-CRP) |
-0.78; -1.68; -1.62; -1.46 | — |
| SECONDARY European League Against Rheumatism (EULAR28) Response: Percentage of Participants With Combined Good and Moderate Responses |
52.9; 90.9; 88.2; 81.8 | — |
| SECONDARY Change From Baseline (CFB) in Serum Immunoglobulins IgG, IgA and IgM |
6.2; -26.7; -97.2; -72.0; -18.9; -11.1 | — |
| SECONDARY Change From Baseline in CD20+ B Cell Number Count |
-46.9; -56.3; -135.9; -59.2 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00308282). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.