NCT01050998

A Study to Evaluate the Efficacy and Safety of CAM-3001 (Drug) in Subjects With Rheumatoid Arthritis

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 516 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
BIOLOGICAL	Mavrilimumab 10 mg	Mavrilimumab (CAM-3001) 10 mg injection subcutaneously every other week for 12 weeks.
BIOLOGICAL	Mavrilimumab 30 mg	Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks.
BIOLOGICAL	Mavrilimumab 50 mg	Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks.
BIOLOGICAL	Mavrilimumab 100 mg	Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks.
OTHER	Placebo	Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks.

Timeline

• Start date: 2010-01-05
• Primary completion: 2011-06-09
• Completion: 2012-07-27
• First posted: 2010-01-18
• Last updated: 2018-06-25
• Results posted: 2017-02-16

Locations

55 sites across 11 countries: Bulgaria, Czechia, Estonia, Hungary, Japan, Latvia, Lithuania, Poland, Romania, Russia, Ukraine