drugset / Trial / NCT01382940

A Study on The Safety of Administering Rituximab at A More Rapid Rate in Patients With Rheumatoid Arthritis

NCT01382940

Phase 4 Completed 351 enrolled Hoffmann-La Roche
NaSingle-groupOpen-labelTreatment

Summary

This study was designed to evaluate the safety of administering rituximab at a more rapid infusion rate in patients with moderate to severe rheumatoid arthritis who have had an inadequate response to biopharmaceuticals that treat diseases by interfering with tumor necrosis factor (anti-TNF therapies), and were receiving methotrexate therapy for more than eight weeks.

Timeline

Start
2011-07-26
Primary completion
2013-01-06
Completion
2013-01-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Rituximab Monoclonal antibody 1000 mg Intravenous
Background Acetaminophen Small molecule 1 g Oral
Background Diphenhydramine Unknown 50 mg Oral
Background Methotrexate Small molecule 10 mg Oral
Background Methotrexate Small molecule 25 mg Oral
Background Methylprednisolone Other / unclassified 100 mg Intravenous

Indications