Pharmacogenomic in Colombian Patients With Rheumatoid Arthritis

NCT03352622 | Unknown

• 1 other identifier: Pharmacogenomic
• Study Type: interventional
• Target: 372
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pharmacological Action

Keywords

PHARMACOGENOMICS; POLYMORPHISM

Outcome Measures

Primary Outcomes (1)

• Number of exomes and genetic variants identified

  The identification of polymorphisms will be carried out through the next generation sequencing technique

  1 year

Study Arms (2)

CASES

ACTIVE COMPARATOR

Patients with RA with methotrexate therapy and inhibitors of tumor necrosis factor alpha (TNFα) infliximab, etanercept, adalimumab; That present problems of effectiveness

Other: CASES

CONTROLS

ACTIVE COMPARATOR

Patients with RA with methotrexate therapy inhibitors of tumor necrosis factor alpha (TNFα) infliximab, etanercept, adalimumab; No problems of effectiveness

Other: CONTROLS

Interventions

CASES OTHER

Patients with RA with methotrexate therapy and inhibitors of tumor necrosis factor alpha (TNFα) infliximab, etanercept, adalimumab; That present problems of effectiveness.

Also known as: NO RESPONDERS

CASES

CONTROLS OTHER

Patients with RA with methotrexate therapy inhibitors of tumor necrosis factor alpha (TNFα) infliximab, etanercept, adalimumab; No problems of effectiveness

Also known as: RESPONDERS

CONTROLS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 TNFα, used for the first time.
• Subscribe to informed consent

You may not qualify if:

• 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 TNFα drugs.
• Inpatient Patients

Sponsors & Collaborators

• Universidad de Antioquia: lead
• Hospital Pablo Tobón Uribe: collaborator

Study Sites (1)

Pablo Tobon Uribe Hospital

Medellín, Colombia

RECRUITING

Related Publications (4)

• Salazar J, Moya P, Altes A, Diaz-Torne C, Casademont J, Cerda-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.

  PMID: 25084201 BACKGROUND

• 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.

  PMID: 26071279 BACKGROUND

• Dupont JA. Significance of operative cultures in total hip arthroplasty. Clin Orthop Relat Res. 1986 Oct;(211):122-7.

  PMID: 3769251 BACKGROUND

• Bernzweig EP. Liability for malpractice...its role in nursing education. J Nurs Educ. 1969 Apr;8(2):33-41. No abstract available.

  PMID: 4388501 BACKGROUND

Study Officials

• Yolima Puentes, Pharmacist

  Universidad de Antioquia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yolima Puentes, Pharmacist

CONTACT

+574-3135742922; yolimap16@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: CASES AND CONTROLS

Study Record Dates

• First Submitted: November 10, 2017
• First Posted: November 24, 2017
• Study Start: October 17, 2017
• Primary Completion: October 17, 2018
• Study Completion: September 17, 2020
• Last Updated: February 22, 2018

Record last verified: 2017-06

Locations

CO (1)