A Study of Mavrilimumab in Subjects with Moderate-to-Severe Rheumatoid Arthritis
Study identifier:CD-IA-CAM-3001-1071
ClinicalTrials.gov identifier:NCT01706926
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase 2b Study to Evaluate the Efficacy and Safety of Mavrilimumab in Subjects with Moderate-to-Severe Rheumatoid Arthritis
Medical condition
Rheumatoid Arthritis
Phase
Phase 2
Healthy volunteers
No
Study drug
-
Sex
All
Actual Enrollment
420
Study type
Interventional
Age
18 Years - 80 Years
Date
Study Start Date: 01 Aug 2012
Primary Completion Date: 01 Dec 2013
Study Completion Date: 01 Jan 2014
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Aug 2016 by MedImmune, LLC
Sponsors
MedImmune, LLC
Collaborators
MedImmune Ltd.
Inclusion and exclusion criteria
Loading...
No locations available
| 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 |
Contacts
Contact Backup
null MedImmune
-
-
Investigators
Principal Investigator
Marius Albulescu
MedImmune Ltd.
