Conditions: Rheumatoid Arthritis
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 351
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: 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.

Interventions: intervention 1: rituximab intervention 2: methotrexate intervention 3: methylprednisolone intervention 4: acetaminophen intervention 5: antihistamine
Intervention descriptions: intervention 1: 1000 mg in 250 mL intravenous infusion intervention 2: 10 to 25 mg/week (oral or parenteral) intervention 3: 100 mg methylprednisolone administered by slow intravenous infusion at least 30 minutes prior to the start of each study drug infusion intervention 4: 1 gram acetaminophen administered orally 30 to 60 minutes prior to the start of each study drug infusion intervention 5: 50 mg diphenhydramine hydrochloride or equivalent dose of alternate antihistamine administered orally 30 to 60 minutes prior to the start of each study drug infusion

Protocol document: