Study identifier:MI-CP219
ClinicalTrials.gov identifier:NCT01050998
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Efficacy and Safety of CAM-3001 in Subjects with Rheumatoid Arthritis
Rheumatoid Arthritis
Phase 2
No
-
All
516
Interventional
18 Years - 80 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Mar 2018 by MedImmune, LLC
MedImmune, LLC
MedImmune Ltd.
The primary objectives of this study is to assess the safety, tolerability and efficacy of multiple doses of the mavrilimumab (CAM-3001) administered subcutaneously in subjects with moderately active Rheumatoid Arthritis (RA).
This is a Phase 2, randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate the efficacy and safety of multiple doses of the mavrilimumab (CAM-3001) (10 milligram [mg], 30 mg, 50 mg, and 100 mg) administered subcutaneously in adult subjects with moderately active RA.
Location
Location
Praha 2, Czech Republic
Location
Plovdiv, Bulgaria
Location
Varna, Bulgaria
Location
Sofia, Bulgaria
Location
Ostrava - Trebovice, Czech Republic
Location
Uherske Hradiste, Czech Republic
Location
Zlin, Czech Republic
Location
Bruntal, Czech Republic
Arms | Assigned Interventions |
---|---|
Experimental: Mavrilimumab 10 mg Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally. | Biological/Vaccine: Mavrilimumab 10 mg Mavrilimumab (CAM-3001) 10 mg injection subcutaneously every other week for 12 weeks. Other Name: CAM-3001 |
Experimental: Mavrilimumab 30 mg Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally. | Biological/Vaccine: Mavrilimumab 30 mg Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks. Other Name: CAM-3001 |
Experimental: Mavrilimumab 50 mg Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally. | Biological/Vaccine: Mavrilimumab 50 mg Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks. Other Name: CAM-3001 |
Experimental: Mavrilimumab 100 mg Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally. | Biological/Vaccine: Mavrilimumab 100 mg Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks. Other Name: CAM-3001 |
Placebo Comparator: Placebo Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally. | Other: Placebo Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks. |
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