A Study on The Safety of Administering Rituximab at A More Rapid Rate in Patients With Rheumatoid Arthritis (RATE-RA)

Roche

Status and phase: Completed; Phase 4

Conditions: Rheumatoid Arthritis

Treatments: Drug: acetaminophen; Drug: methotrexate; Drug: rituximab; Drug: antihistamine; Drug: methylprednisolone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01382940

ML25641

Details and patient eligibility

About

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.

Enrollment: 351 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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351 participants in 1 patient group

Rituximab

Experimental group

Description:

Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.

Treatment:

Drug: acetaminophen

Drug: rituximab

Drug: antihistamine

Drug: methylprednisolone

Drug: methotrexate