A Study of AK106-001616 in Patients With Rheumatoid Arthritis (RA)
ClinicalTrials.gov ID
NCT00902369
Lead Sponsor
Asahi Kasei Therapeutics CorporationINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 2
Enrollment
130Estimated
Last Update Posted
Jul 25, 2016Estimated
Start Date
May 2009
Primary Completion Date
Oct 2009Actual
Completion Date
Jul 2010Actual
Brief Summary
This will be a Phase II, multi-centre study consisting of 2 parts. Part 1: Clinical Pharmacology Study (drug-drug interaction between AK106-001616 and methotrexate) Part 2: Proof of Concept Study
Rheumatoid Arthritis
AK106-001616
Placebo
Active comparator
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of RA (class I to III)
Stable dose of methotrexate (at least 12 weeks)
Exclusion Criteria:
Pregnant or breastfeeding
Abnormal screening laboratory test values considered to be clinically significant