A Study to Evaluate the Efficacy and Safety of CAM-3001 (Drug) in Subjects with Rheumatoid Arthritis
Study identifier:MI-CP219
ClinicalTrials.gov identifier:NCT01050998
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
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
Medical condition
Rheumatoid Arthritis
Phase
Phase 2
Healthy volunteers
No
Study drug
-
Sex
All
Actual Enrollment
516
Study type
Interventional
Age
18 Years - 80 Years
Date
Study Start Date: 05 Jan 2010
Primary Completion Date: 09 Jun 2011
Study Completion Date: 27 Jul 2012
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Mar 2018 by MedImmune, LLC
Sponsors
MedImmune, LLC
Collaborators
MedImmune Ltd.
Inclusion and exclusion criteria
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| 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. |
Contacts
Investigators
Principal Investigator
Marius Albulescu
MedImmune Ltd.
