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

• Status: Completed
• Trial end date: 2013-01-06
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Acetaminophen; Histamine Antagonists; Histamine H1 Antagonists; Methotrexate; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Rituximab

Criteria

Key Inclusion Criteria:

• Adult patients, ≥ 18 years of age

• Rheumatoid arthritis of ≥ 6 months duration, diagnosed according to the revised 1987 American College of Rheumatology criteria

• Inadequate response to at least one approved anti-TNF agent (adalimumab, etanercept, infliximab, golimumab, or certolizumab)

• Patients who have received 1 to 2 prior courses of rituximab (RTX) may be enrolled, provided their most recent course of RTX occurred over 6 months but no more than 9 months prior to baseline. The RTX dosage must have been two 1000 mg infusions per course administered at the standard approved rate

• Methotrexate treatment between 10 and 25 mg/week (oral or parenteral) for at least 8 weeks immediately prior to baseline

Key Exclusion Criteria:

• Major surgery (including joint surgery) within 8 weeks prior to screening or planned surgery within 6 months following baseline

• Rheumatic autoimmune disease other than rheumatoid arthritis

• Functional class IV as defined by American College of Rheumatology (ACR) criteria

• Prior history of or current inflammatory joint disease other than rheumatoid arthritis

• History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies

• Previous serious infusion reaction to any prior biologic therapy

• Known active current or history of recurrent infection

• Evidence of chronic hepatitis B or C infection

• Pregnant or lactating women

• Body weight of > 150 kg