NCT00808210

A Study to Evaluate Ocrelizumab in Combination With Methotrexate Compared With Infliximab Plus Methotrexate in Patients With Active Rheumatoid Arthritis Currently Responding Inadequately to Etanercept or Adalimumab

A PHASE II RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCRELIZUMAB IN COMBINATION WITH METHOTREXATE, COMPARED TO INFLIXIMAB PLUS METHOTREXATE IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS CURRENTLY RESPONDING INADEQUATELY TO ETANERCEPT OR ADALIMUMAB

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II, randomized, active-controlled, double-blind, double-dummy, parallel-group, multicenter study in the United States enrolling patients with active RA. The study will enroll approximately 290 patients at approximately 130 sites.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Infliximab	Intravenous repeating dose
DRUG	Methotrexate	Oral or parenteral repeating dose
DRUG	Methylprednisolone	Intravenous repeating dose
DRUG	Ocrelizumab	Intravenous repeating dose
DRUG	Placebo	Intravenous repeating dose

Timeline

• Start date: 2009-03-05
• Primary completion: 2012-11-14
• Completion: 2012-11-14
• First posted: 2008-12-15
• Last updated: 2020-11-06
• Results posted: 2020-11-06

Locations

53 sites across 1 country: United States