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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01096069
• Other study ID #: 09/585
• Status: Not yet recruiting
• Phase: N/A
• First received: February 23, 2010
• Last updated: March 29, 2010
• Start date: June 2010
• Est. completion date: December 2011

Study information

• Verified date: March 2010
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Ricardo M Xavier, PhD
• Phone: 3359-8315
• Email: rmxavier[@]hcpa.ufrgs.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Patients of both gender, aged greater than or equal to 18 years; and lower than 70 years.

2. 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.

3. 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.

4. DAS28 score greater than or equal to 3.2.

5. Use of adequate contraception, as judged from the attending physician.

6. Desire to participate voluntarily, the ability to understand the protocol, documented by signing the consent form (attached).

Exclusion Criteria:

1. overlapping rheumatic disease, autoimmune lymphoproliferative and neoplastic.

2. active infection, patients with the use of cytotoxic drugs, presence of positive serology for HCV, HBV and HIV, active or latent tuberculosis.

3. allergy or hypersensitivity to rituximab.

4. pregnant woman or performing breastfeeding.

5. participating in another clinical study with intervention.

6. with functional class IV defined based on the criteria of Steinbrocker functional classification for RA.

7. prior therapy with Rituximab.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre