Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis

Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis Using Rituximab: A Pilot Study Evaluating Synovial Outcomes

The purpose of this study is to determine how well Rituximab works in early stages of disease and the effects it has on an inflamed joint and blood cells.

This will allow the investigators to get a better understanding of how this treatment affects the inflamed joints of rheumatoid arthritis (RA) patients.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: Rituximab

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1M4
      • Arthritis Centre, University of Manitoba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with documented rheumatoid arthritis by ACR criteria
• Disease duration < 5 years
• May have previously been treated with methotrexate,hydroxychloroquine or sulfasalazine, either as a single DMARD or in combination
• Tender joint count >= 6, swollen joint count >= 6, and one must be a knee
• Corticosteroids <= 10 mg per day permitted on stable doses for at least 4 weeks
• Patients must consent to 2 arthroscopic synovial biopsy procedures

Exclusion Criteria:

• History of severe allergic or anaphylactic reactions to monoclonal antibodies
• Previous treatment with Rituximab
• Previous treatment with Arava
• Injected with steroids within 4 weeks of day 1 of study
• Treatment with any investigational agent within 4 weeks of day of study
• Any severe or significant medical condition or disease or known active infection
• Pregnancy or nursing at present

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rituximab	Drug: Rituximab; Rituximab 1000 mg Intravenously day 1 and day 15

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To define the synovial effects of rituximab treatment in TNFa naive patients with early rheumatoid arthritis	Biopsies of inflamed joint at beginning and at week 8 of study

Secondary Outcome Measures

Outcome Measure	Time Frame
To define the effects of rituximab treatment on the phenotype and function of peripheral blood T and B cells	Collected at beginning of study and week 8

Collaborators and Investigators

• Sponsor: University of Manitoba
• Collaborators: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: August 20, 2009
• First Submitted That Met QC Criteria: August 20, 2009
• First Posted (Estimate): August 21, 2009

Study Record Updates

• Last Update Posted (Estimate): March 20, 2012
• Last Update Submitted That Met QC Criteria: March 19, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Physiological Effects of Drugs; Antirheumatic Agents; Antineoplastic Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Rituximab
• Other Study ID Numbers: B2007:160