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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01096069
Recruitment Status : Unknown
Verified March 2010 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Not yet recruiting
First Posted : March 30, 2010
Last Update Posted : March 30, 2010
Information provided by:
Hospital de Clinicas de Porto Alegre

Brief 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.

Condition or disease
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
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Expressão de Cregs e a Resposta clínica em Pacientes AR Tratada Com Rituximabe
Study Start Date : June 2010
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab
U.S. FDA Resources

Rheumatoid arthritis patients undergoing treatment with rituximab.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01096069

Contact: Ricardo M Xavier, PhD 3359-8315
Contact: Ana P Alegretti, Master 3359-8316

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

Responsible Party: Ricardo Machado Xavier, Hospital de Clinicas de Porto Alegre Identifier: NCT01096069     History of Changes
Other Study ID Numbers: 09/585
First Posted: March 30, 2010    Key Record Dates
Last Update Posted: March 30, 2010
Last Verified: March 2010

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

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