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

Conditions

• Rheumatoid Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• rituximab — DRUG
  1000 mg in 250 mL intravenous infusion
• methotrexate — DRUG
  10 to 25 mg/week (oral or parenteral)
• methylprednisolone — DRUG
  100 mg methylprednisolone administered by slow intravenous infusion at least 30 minutes prior to the start of each study drug infusion
• acetaminophen — DRUG
  1 gram acetaminophen administered orally 30 to 60 minutes prior to the start of each study drug infusion
• antihistamine — DRUG
  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

Study Details

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.

Key Dates

Start date

Jul 26, 2011

Status verified

Jul 2017

Primary completion

Jan 6, 2013

Completion

Jan 6, 2013

Study Design

Enrollment

351 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Rituximab
  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.

Primary Outcome Measure

Percentage of Participants Experiencing Any Infusion-related Reaction (IRR) Associated With the Second Rituximab Infusion [ Time Frame: Within 24 hours of beginning infusion on Day 15 ]

Locations (86)

Find similar trials in Birmingham, AL

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