NCT01225393

A Study to Evaluate the Efficacy and Safety of MLTA3698A in Combination With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Compared With Adalimumab in Combination With a DMARD in Patients With Active Rheumatoid Arthritis

A Phase II, Randomized, Double-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of MLTA3698A in Combination With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Compared With Adalimumab in Combination With a DMARD in Patient With Active Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 211 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II, randomized, double-blind, placebo-controlled, parallel-group, multicenter study enrolling patients with active rheumatoid arthritis (RA).

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	MLTA3698A	Subcutaneous repeating dose
DRUG	adalimumab	Subcutaneous repeating dose
DRUG	leflunomide	Stable dose if not on methotrexate
DRUG	methotrexate	Stable dose if not on leflunomide
DRUG	placebo	Subcutaneous repeating dose

Timeline

• Start date: 2010-11-01
• Primary completion: 2012-07-01
• First posted: 2010-10-21
• Last updated: 2016-11-02

Locations

67 sites across 10 countries: United States, Bulgaria, Chile, Germany, Hungary, Mexico, Peru, Poland, Romania, Spain