Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00963703
• Other study ID #: B2007:160
• Status: Completed
• Phase: N/A
• First received: August 20, 2009
• Last updated: March 19, 2012
• Start date: December 2007
• Est. completion date: March 2012

Study information

• Verified date: March 2012
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Rituximab
Rituximab 1000 mg Intravenously day 1 and day 15

Locations

Country	Name	City	State
Canada	Arthritis Centre, University of Manitoba	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	Hoffmann-La Roche

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No