Pharmacological Action Clinical Trial
Official title:
Pharmacogenomic in Colombian Patients With Rheumatoid Arthritis
The pharmacogenomics of the Colombian population with rheumatoid arthritis (RA), understood
as the individual response to drugs depending on the genome of each patient, can be an
explanation for the problems of effectiveness and safety that appear during the
pharmacotherapeutic treatment of RA.
Currently, there are limited studies on the pharmacogenomics of the Colombian population;
Therefore, it is necessary to identify and classify the genetic polymorphisms characteristic
of Colombian patients with RA, which influence the response of methotrexate, infliximab,
etanercept, adalimumab and thus contribute to precision medicine and medical prescription
according to the Specificity of the genome of each patient.
This project aims to determine the association of genetic polymorphisms with the response to
inhibitors of tumor necrosis factor alpha (TNFα) and methotrexate. To do this, a prospective
study of cases and controls will be performed in patients in 3 hospital of Colombia with
pharmacotherapeutic treatment of methotrexate, infliximab, etanercept, adalimumab, in
monotherapy or combination therapy.
As a result, it is expected to contribute to the performance of specific genetic tests for RA
and the generation of a pharmacogenomic basis of the Colombian population with RA.
Status | Recruiting |
Enrollment | 372 |
Est. completion date | September 17, 2020 |
Est. primary completion date | October 17, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients with rheumatoid arthritis on treatment with Methotrexate, Adalimumab, Infliximab or Etanercept (monotherapy or combination therapy) - Over 18 years - With DAS 28 (Disease Activity Score in 28 Joints) greater than 3.2 - With SDAI (Simple Disease Activity Index) less than 3.3 - Use of medication> 3 months - Anti TNFa, used for the first time. - Subscribe to informed consent Exclusion Criteria: - Patients who after applying the tool to identify other causes of variability; Identify other causes that variability in response (non-adherence to travel, forgetfulness, etc.). - Previous use of anti TNFa drugs. - Inpatient Patients |
Country | Name | City | State |
---|---|---|---|
Colombia | Pablo Tobon Uribe Hospital | Medellin |
Lead Sponsor | Collaborator |
---|---|
Universidad de Antioquia | Hospital Pablo Tobón Uribe |
Colombia,
Bernzweig EP. Liability for malpractice...its role in nursing education. J Nurs Educ. 1969 Apr;8(2):33-41. — View Citation
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Muralidharan N, Antony PT, Jain VK, Mariaselvam CM, Negi VS. Multidrug resistance 1 (MDR1) 3435C>T gene polymorphism influences the clinical phenotype and methotrexate-induced adverse events in South Indian Tamil rheumatoid arthritis. Eur J Clin Pharmacol. 2015 Aug;71(8):959-65. doi: 10.1007/s00228-015-1885-0. Epub 2015 Jun 14. — View Citation
Salazar J, Moya P, Altés A, Díaz-Torné C, Casademont J, Cerdà-Gabaroi D, Corominas H, Baiget M. Polymorphisms in genes involved in the mechanism of action of methotrexate: are they associated with outcome in rheumatoid arthritis patients? Pharmacogenomics. 2014 Jun;15(8):1079-90. doi: 10.2217/pgs.14.67. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of exomes and genetic variants identified | The identification of polymorphisms will be carried out through the next generation sequencing technique | 1 year |
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