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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Hospital de Clinicas de Porto Alegre.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT01096069
First received: February 23, 2010
Last updated: March 29, 2010
Last verified: March 2010
  Purpose

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.


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Expressão de Cregs e a Resposta clínica em Pacientes AR Tratada Com Rituximabe

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas de Porto Alegre:

Estimated Enrollment: 10
Study Start Date: June 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Rituximab
Rheumatoid arthritis patients undergoing treatment with rituximab.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01096069

Contacts
Contact: Ricardo M Xavier, PhD 3359-8315 rmxavier@hcpa.ufrgs.br
Contact: Ana P Alegretti, Master 3359-8316 anaalegretti@gmail.com

Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Study Director: Ricardo M Xavier, PhD HCPA
  More Information

No publications provided

Responsible Party: Ricardo Machado Xavier, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT01096069     History of Changes
Other Study ID Numbers: 09/585
Study First Received: February 23, 2010
Last Updated: March 29, 2010
Health Authority: Brazil: Ethics Committee

Keywords provided by Hospital de Clinicas de Porto Alegre:
Rituximab, rheumatoid arthritis, CD55, CD59

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Rituximab
Antineoplastic Agents
Antirheumatic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014