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

NCT01382940 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 351

Last updated 2017-08-01

Study results available
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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.

Conditions

Interventions

DRUG

rituximab

1000 mg in 250 mL intravenous infusion

DRUG

methotrexate

10 to 25 mg/week (oral or parenteral)

DRUG

methylprednisolone

100 mg methylprednisolone administered by slow intravenous infusion at least 30 minutes prior to the start of each study drug infusion

DRUG

acetaminophen

1 gram acetaminophen administered orally 30 to 60 minutes prior to the start of each study drug infusion

DRUG

antihistamine

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01382940 on ClinicalTrials.gov