Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT00963703
First received: August 20, 2009
Last updated: March 19, 2012
Last verified: March 2012
  Purpose

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 Intervention
Rheumatoid Arthritis
Drug: Rituximab

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: December 2007
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rituximab Drug: Rituximab
Rituximab 1000 mg Intravenously day 1 and day 15

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Hani El-Gabalawy, Arthritis Centre, Unversity of Manitoba
ClinicalTrials.gov Identifier: NCT00963703     History of Changes
Other Study ID Numbers: B2007:160
Study First Received: August 20, 2009
Last Updated: March 19, 2012
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on July 23, 2014