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Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00963703
Recruitment Status : Completed
First Posted : August 21, 2009
Last Update Posted : March 20, 2012
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment
Rheumatoid Arthritis Drug: Rituximab

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis Using Rituximab: A Pilot Study Evaluating Synovial Outcomes
Study Start Date : December 2007
Primary Completion Date : March 2012
Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Rituximab Drug: Rituximab
Rituximab 1000 mg Intravenously day 1 and day 15


Outcome Measures

Primary Outcome Measures :
  1. To define the synovial effects of rituximab treatment in TNFa naive patients with early rheumatoid arthritis [ Time Frame: Biopsies of inflamed joint at beginning and at week 8 of study ]

Secondary Outcome Measures :
  1. To define the effects of rituximab treatment on the phenotype and function of peripheral blood T and B cells [ Time Frame: Collected at beginning of study and week 8 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00963703


Locations
Canada, Manitoba
Arthritis Centre, University of Manitoba
Winnipeg, Manitoba, Canada, R3A 1M4
Sponsors and Collaborators
University of Manitoba
Hoffmann-La Roche
More Information

Responsible Party: Dr. Hani El-Gabalawy, Arthritis Centre, Unversity of Manitoba
ClinicalTrials.gov Identifier: NCT00963703     History of Changes
Other Study ID Numbers: B2007:160
First Posted: August 21, 2009    Key Record Dates
Last Update Posted: March 20, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents