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Completed

NCT Number: NCT00963703

Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arthritis Centre, University of Manitoba

Winnipeg, Manitoba, R3A 1M4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rituximab

Drug

Rituximab 1000 mg Intravenously day 1 and day 15

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • Hoffmann-La Roche

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Aug 21, 2009
Registry last updated
Mar 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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