Study identifier:CD-IA-CAM-3001-1071
ClinicalTrials.gov identifier:NCT01706926
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase 2b Study to Evaluate the Efficacy and Safety of Mavrilimumab in Subjects with Moderate-to-Severe Rheumatoid Arthritis
Rheumatoid Arthritis
Phase 2
No
-
All
420
Interventional
18 Years - 80 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Aug 2016 by MedImmune, LLC
MedImmune, LLC
MedImmune Ltd.
The primary objective of this study is to evaluate the efficacy of 3 subcutaneous doses of mavrilimumab compared with placebo in combination with methotrexate (MTX) in subjects with moderate-to-severe adult onset Rheumatoid Arthritis (RA).
Despite the therapeutic improvements with recent biologic agents approved for rheumatoid arthritis, there is still significant unmet medical need for the treatment of subjects with this chronic disease to achieve a faster, more complete response, and higher rates of remission. The aim of the study is to explore the optimum dose of mavrilimumab for further clinical development and more fully investigate the efficacy and safety profile of mavrilimumab after longer drug exposure (that is, 24 weeks). The results of this study will form the basis for future clinical studies with mavrilimumab.
Location
Location
Tallinn, Estonia
Location
Debrecen, Hungary
Location
Ostrava - Trebovice, Czech Republic
Location
Zlin, Czech Republic
Location
Bruntal, Czech Republic
Location
Praha 4, Czech Republic
Location
Barranquilla, Colombia
Location
Plovdiv, Bulgaria
Arms | Assigned Interventions |
---|---|
Placebo Comparator: Placebo Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route. | Other: Placebo Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks. |
Experimental: Mavrilimumab 30 mg Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. | Biological/Vaccine: Mavrilimumab 30 mg Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks Other Name: CAM-3001 |
Experimental: Mavrilimumab 100 mg Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. | Biological/Vaccine: Mavrilimumab 100 mg Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks. Other Name: CAM-3001 |
Experimental: Mavrilimumab 150 mg Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. | Biological/Vaccine: Mavrilimumab 150 mg Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks. Other Name: CAM-3001 |
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