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Clinical Follow-up of Anti-Carbamylated Antibody Status in Rheumatoid Arthritis

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.
 
ClinicalTrials.gov Identifier: NCT02958319
Recruitment Status : Unknown
Verified May 2017 by David Vega Morales, Universidad Autonoma de Nuevo Leon.
Recruitment status was:  Recruiting
First Posted : November 8, 2016
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
David Vega Morales, Universidad Autonoma de Nuevo Leon

Brief Summary:
Patients with rheumatoid arthritis (RA) with positive antibodies against carbamylated proteins (anti-CarP) have a more severe clinical course. The primary objective of this study in adult subject with RA is as follows: To explore the clinical differences in activity indexes (Disease Activity Score of 28 joints with Erythro Sedimentaion Rate (DAS28-ESR)) at 6, 12 and 18 months of follow up according the anti-CarP antibodies status.

Condition or disease
RheumatoId Arthritis

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Study Type : Observational
Estimated Enrollment : 262 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Follow-up of Anti-Carbamylated Antibody Status in Rheumatoid Arthritis Patients at 6, 12 and 18 Months
Study Start Date : June 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Group/Cohort
Anti P Carb negative RA patients
RA patients negative for antibodies against the carbamylated proteins
Anti P Carb positive RA patients
RA patients positive for antibodies against the carbamylated proteins



Primary Outcome Measures :
  1. DAS28 ESR [ Time Frame: 6, 12 and 18 Months ]
    To explore the clinical differences in activity indexes (DAS28-ESR) at 6, 12 and 18 months of follow up according the anti-CarP status



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  • Patients older than 18 years old, both gender, with RA diagnosis according to ACR EULAR 2010 classification that accepted and signed informed consent that were seen at the Rheumatology Clinic in Hospital Universitario "Dr. José Eleuterio González", Monterrey, NL. México.
  • Exclusion: Chronic kidney disease and pregnant patients
Criteria

Inclusion Criteria:

  • Rheumatoid arthritis patients according to ACR EULAR 2010 classification that accepted and signed informed consent

Exclusion Criteria:

  • Chronic kidney disease and pregnant patients

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 ClinicalTrials.gov identifier (NCT number): NCT02958319


Contacts
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Contact: David V Vega-Morales, MsSc 52 81 80485210 ext 143 drdavidvega@yahoo.com.mx

Locations
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Mexico
Servicio de Reumatología, Departamento de Medicina Interna, Facultad de Medicina y Hospital Universitario, Universidad Autonoma de Nuevo León Recruiting
Monterrey, Nuevo León, Mexico, 64460
Contact: David Vega-Morales, MsSc    52 81 80485210 ext 143    drdavidvega@yahoo.com.mx   
Sponsors and Collaborators
Universidad Autonoma de Nuevo Leon
Investigators
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Study Chair: Jose Gerardo Garza Leal, PhD Comité de Ética en Investigación, Facultad de Medicina y Hospital Universitario, Universidad Autónoma de Nuevo León

Publications:
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Responsible Party: David Vega Morales, MD, MsSc, Doctorate, Universidad Autonoma de Nuevo Leon
ClinicalTrials.gov Identifier: NCT02958319    
Other Study ID Numbers: RE16-00001
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: via email request
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs