Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00963703

Enrollment

Registered

2009-08-21

Start date

2007-12-31

Completion date

2012-03-31

Last updated

2012-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

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.

Interventions

DRUGRituximab

Rituximab 1000 mg Intravenously day 1 and day 15

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Secondary

Measure	Time frame
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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026