Safety and Tolerability of Rituxan With Methotrexate and Etanercept or Methotrexate and Adalimumab in Patients With Active Rheumatoid Arthritis

Phase 2 Terminated 54 enrolled Biogen Genentech, Inc. · collab Hoffmann-La Roche · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

The primary objective of this study was to evaluate the tolerability and safety of rituximab in combination with methotrexate (MTX) and etanercept or adalimumab in participants with active rheumatoid arthritis (RA). The secondary objective was to explore the efficacy of rituximab in combination with MTX and etanercept or adalimumab in participants with active RA.

Timeline

Start: 2006-05
Primary completion: 2009-04
Completion: 2011-07

Publications

Results Greenwald MW, Shergy WJ, Kaine JL, Sweetser MT, Gilder K, Linnik MD. Evaluation of the safety of rituximab in combination with a tumor necrosis factor inhibitor and methotrexate in patients with active rheumatoid arthritis: results from a randomized controlled trial. Arthritis Rheum. 2011 Mar;63(3):622-32. doi: 10.1002/art.30194.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rituximab	Monoclonal antibody	500 mg	Intravenous
Background	Adalimumab	Monoclonal antibody	40 mg	Subcutaneous
Background	Etanercept	Protein / enzyme biologic	25 mg	Subcutaneous
Background	Etanercept	Protein / enzyme biologic	50 mg	Subcutaneous
Background	Methotrexate	Small molecule	15 mg	Oral
Background	Methotrexate	Small molecule	25 mg	Oral
Background	Methylprednisolone	Other / unclassified	100 mg	Intravenous

Safety and Tolerability of Rituxan With Methotrexate and Etanercept or Methotrexate and Adalimumab in Patients With Active Rheumatoid Arthritis

Summary

Timeline

Publications

Drugs

Indications