Complement Regulatory Proteins Expression and Clinical Response in Rheumatoid Arthritis (RA) Patients Treated With Rituximab

March 29, 2010 updated by: Hospital de Clinicas de Porto Alegre

Expressão de Cregs e a Resposta clínica em Pacientes AR Tratada Com Rituximabe

There is a correlation between the CD55, CD59, CD35 and CD46 expression on B lymphocytes of patients before and after treatment with rituximab and the level of depletion and repopulation time for these cells. The theoretical rationale of the study assumes that the correlation, if any, will be a negative correlation. However, the hypothesis of positive correlation (two-tailed test) will also be tested.

Study Overview

Status

Unknown

Conditions

Rheumatoid Arthritis

Detailed Description

Rituximab, an anti-CD20 monoclonal antibody, is a new alternative treatment for patients with severe immune diseases and resistance to conventional treatment. One of the mechanisms of action of this drug is the complement-mediated lysis. Most RA patients respond well to rituximab treatment, however, some are refractory and mechanism of this non-response is still unclear. The role of CD55 and CD59 protein and its overexpression as a mechanism of resistance to rituximab treatment in lymphoma patients have been investigated. However, there has not been studied a correlation between the intensity of expression of these regulatory molecules on B cells of RA patients and resistance to treatment with Rituximab.

Study Type

Observational

Enrollment (Anticipated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients diagnosed with RA and clinical indication for treatment with rituximab and who have obtained access to medication (private purchase, delivery by a private health plan, lawsuit or donation by the laboratory Roche) will be invited to participate in the study during the physician appointment.

Description

Inclusion Criteria:

Patients of both gender, aged greater than or equal to 18 years; and lower than 70 years.
Patients diagnosed with RA for at least 6 months according to the criteria of the American College of Rheumatology (ACR) in 1987 for classification of AR.
Patients with a medical indication for therapy with rituximab, with prescription of this therapy for the first time and have not yet received the first dose.
DAS28 score greater than or equal to 3.2.
Use of adequate contraception, as judged from the attending physician.
Desire to participate voluntarily, the ability to understand the protocol, documented by signing the consent form (attached).

Exclusion Criteria:

overlapping rheumatic disease, autoimmune lymphoproliferative and neoplastic.
active infection, patients with the use of cytotoxic drugs, presence of positive serology for HCV, HBV and HIV, active or latent tuberculosis.
allergy or hypersensitivity to rituximab.
pregnant woman or performing breastfeeding.
participating in another clinical study with intervention.
with functional class IV defined based on the criteria of Steinbrocker functional classification for RA.
prior therapy with Rituximab.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Rituximab Rheumatoid arthritis patients undergoing treatment with rituximab.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

Study Director: Ricardo M Xavier, PhD, HCPA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Anticipated)

December 1, 2010

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

February 23, 2010

First Submitted That Met QC Criteria

March 29, 2010

First Posted (Estimate)

March 30, 2010

Study Record Updates

Last Update Posted (Estimate)