Status:
COMPLETED
Safety, Efficacy and Pharmacokinetics Study of ALD518 in Patients With Active Rheumatoid Arthritis
Lead Sponsor:
CSL Behring
Conditions:
Arthritis, Rheumatoid
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the safety and efficacy of ALD518 in three different doses in patients who have not had an adequate response to methotrexate.
Detailed Description
This will be a phase II, parallel-group, double-blind, randomized, placebo-controlled study of ALD518 in patients with active RA with an inadequate response to methotrexate. Enrolled patients will be...
Eligibility Criteria
Inclusion
- Active Rheumatoid Arthritis for at least 16 weeks duration
- Have a C-reactive protein (CRP) of ≥ 10mg/L
- Have a stable dose of methotrexate (≥ 10mg/week) for at least 3 months
Exclusion
- Arthritis onset prior to 16 years old
- Received any biologic therapy in the previous 12 months
- A history of or currently have active tuberculosis
- Any clinically significant concurrent medical condition
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT00867516
Start Date
October 1 2008
End Date
December 1 2009
Last Update
July 9 2020
Active Locations (26)
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1
K-W Musculoskeletal Research, Inc.
Kitchener, Ontario, Canada, N2M 5N6
2
Rheumatology Research Associates
Ottawa, Ontario, Canada, KIH IA2
3
V. Tsitlanadze Scientific Practical Centre of Rheumatology
Tbilisi, Georgia, 0102
4
Medulla Chemotherapy and Immunotherapy Clinic
Tbilisi, Georgia, 0186