Phase 2
Completed N=121
A Safety and Pharmacokinetics Study in Participants With Rheumatoid Arthritis
Arthritis, Rheumatoid
Source: ClinicalTrials.gov NCT00380744 ↗
Enrolled (actual)
121
Serious AEs
2.5%
Results posted
Feb 2019
Primary outcomePrimary: Number of Participants With Adverse Events (AEs) — 0; 0; 0; 0 Participants
Summary
The purpose of this study is to examine the safety and efficacy of this antibody in participants with rheumatoid arthritis.
Part A of the study is an initial dose escalation phase
Part B of the study is a randomized allocation of the entire dosing group to parallel treatment assignments
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) |
0; 0; 0; 0; 0; 1 | — |
| SECONDARY Pharmacokinetics (PK): Area Under the Concentration Time Curve at Steady State for One Dosing Interval Time 0 to 168 Hours (AUC0-168 hr,ss) of LY2189102 |
196; 902; 1150; 2810; 6650; 18200 | — |
| SECONDARY Change From Baseline in Simple Disease Activity Index Score (SDAI) |
-6.81; -7.41; -5.72; -22.59; -4.60; -7.87 | — |
| SECONDARY Change From Baseline in Disease Activity Score 28-Joint Count (DAS28) |
-0.71; -0.68; -0.50; -1.66; -0.48; -0.59 | — |
| SECONDARY Change From Baseline in C-Reactive Protein (CRP) |
-8.36; -19.73; -10.18; -19.59; -9.44; -10.14 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire (HAQ) Score |
-0.22; -0.09; -0.09; -0.22; -0.19; -0.71 | — |
Eligibility Criteria
Inclusion Criteria
- diagnosis of rheumatoid arthritis
- regular use of methotrexate
- active rheumatoid arthritis
Exclusion Criteria
- Juvenile Rheumatoid Arthritis
- evidence of tuberculosis
- women who are pregnant or become pregnant during study, or are breast-feeding
Data sourced from ClinicalTrials.gov (NCT00380744). 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.