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Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Rituximab
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arthritis Centre, University of Manitoba

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rituximab

Arm Description

Outcomes

Primary Outcome Measures

To define the synovial effects of rituximab treatment in TNFa naive patients with early rheumatoid arthritis

Secondary Outcome Measures

To define the effects of rituximab treatment on the phenotype and function of peripheral blood T and B cells

Full Information

First Posted
August 20, 2009
Last Updated
March 19, 2012
Sponsor
University of Manitoba
Collaborators
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00963703
Brief Title
Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis
Official Title
Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis Using Rituximab: A Pilot Study Evaluating Synovial Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Manitoba
Collaborators
Hoffmann-La Roche

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rituximab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
Rituximab 1000 mg Intravenously day 1 and day 15
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Arthritis Centre, University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1M4
Country
Canada

12. IPD Sharing Statement

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Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis

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