Status:
COMPLETED
A Study for Japanese Participants With Rheumatoid Arthritis (RA)
Lead Sponsor:
Eli Lilly and Company
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
20-75 years
Phase:
PHASE1
Brief 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 wil...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01253226
Start Date
September 1 2009
End Date
August 1 2011
Last Update
October 23 2018
Active Locations (10)
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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.
Aichi, Japan
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.
Chiba, Japan
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.
Fukui, Japan
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.
Gunma, Japan