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A Study to Evaluate the Effects of Rituximab on Immune Responses in Subjects With Active Rheumatoid Arthritis Receiving Background Methotrexate

NCT00282308 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2017-08-10

Study results available
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Summary

This was a Phase II, randomized, open-label, multicenter study designed to evaluate the immune response to vaccines after administration of 1000 mg of rituximab in subjects with active rheumatoid arthritis (RA) who were receiving background methotrexate (MTX).

Conditions

Interventions

DRUG

Rituximab

Rituximab was supplied in single-use vials.

DRUG

Methotrexate

DRUG

Methylprednisone

Patients received methylprednisolone 100 mg intravenously before each infusion of rituximab.

BIOLOGICAL

C. albicans

Patients received an intradermal injection of C. albicans (0.1 mL) on the volar surface of the forearm.

BIOLOGICAL

Tetanus toxoid adsorbed booster vaccine

Patients received an intramuscular injection of the tetanus toxoid adsorbed booster vaccine (1 mg in 0.5 mL) in the deltoid muscle.

BIOLOGICAL

23-valent pneumococcal polysaccharide vaccine

Patients received an intramuscular injection of the 23-valent pneumococcal polysaccharide vaccine (0.5 mL) in the deltoid muscle.

BIOLOGICAL

Keyhole limpet hemocyanin

Patients received a subcutaneous injection of keyhole limpet hemocyanin (1 mg)

Sponsors & Collaborators

  • Genentech, Inc.

    lead INDUSTRY

Principal Investigators

  • Ariella Kelman, M.D. · Genentech, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-23
Primary Completion
2008-01-31
Completion
2012-05-28

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT00282308 on ClinicalTrials.gov