Overview

A Study for Japanese Participants With Rheumatoid Arthritis (RA)

Status:
Completed
Trial end date:
2011-08-01
Target enrollment:
0
Participant gender:
All
Summary
This study will evaluate the safety and tolerability of multiple doses of LY2127399 (tabalumab) in Japanese participants with RA. The study consists of a 20-week treatment period. All participants will be followed for up to 12 weeks after the last study drug administration.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eli Lilly and Company
Treatments:
Antibodies, Monoclonal
Criteria
Inclusion Criteria:

- Have given written informed consent

- Women must not be pregnant, breastfeeding or be at risk to become pregnant during
study participation

- Diagnosis of RA

- Active RA

- Current, regular use of Methotrexate, at a stable dose

- Body weight between 40 and 105 kilograms (kg), inclusive

Exclusion Criteria:

- Use of excluded medications (reviewed by study doctor)

- 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

- Evidence of tuberculosis

- Have systemic inflammatory condition other than RA