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Trial record 42 of 1104 for:    pharmacogenomics OR pharmacogenetics

Pharmacogenomic in Colombian Patients With 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03352622
Recruitment Status : Recruiting
First Posted : November 24, 2017
Last Update Posted : February 21, 2018
Hospital Pablo Tobón Uribe
Information provided by (Responsible Party):
Universidad de Antioquia

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.

Condition or disease Intervention/treatment Phase
Pharmacological Action Other: CASES Other: CONTROLS Not Applicable

Detailed Description:

Rheumatoid arthritis is an important public health problem; In recent years better health outcomes have been achieved with the incorporation of synthetic and biological disease modifying drugs. However, problems of variability in response are reported, leading to ineffectiveness and adverse reactions in 30-40% of patients. In this sense, Pharmacogenomics, through the study of genetic variants of proteins involved in the pharmacokinetics and pharmacodynamics of drugs, becomes a way to maximize the efficacy and safety of pharmacotherapy.

This work aims to give an overview of the pharmacogenomics of rheumatoid arthritis and the possibility of using genetic tools to support the pharmacotherapeutic decision in the clinical consultation, in order to improve the response to treatment of this disease.

The relevance of this study is to provide the possibility of applying the candidate genes selected for their biological importance, either in the kinetics or by their relation in the pharmacological action, in the identification of individuals at risk of adverse effects or With probability of being resistant to the treatment. Therefore, it is expected that the information generated will be able to be used in daily clinical practice, contributing to identify the best therapeutic option (greater effectiveness and safety) in patients with rheumatoid arthritis. In addition, it is expected that this type of information will contribute to optimize the costs of care in this disease, which is classified in Colombia as a high cost pathology, in which medicines can reach up to 86% of the total cost.

Overall, individuals respond differently to drug therapy and no medication is 100% effective in all patients, which may be due to an alteration in the pharmacokinetics and pharmacodynamics of drugs associated with conditions Genetic-environmental. In this context, the study of candidate pharmacogenomic genes has been most successful in identifying and explaining variation in pharmacological response, compared to candidate gene investigations of the disease. Therefore, this work should contribute to the choice of the best therapeutic option in patients with RA in Colombia and, thus, to strengthen the country's health sector.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 372 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: CASES AND CONTROLS
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Pharmacogenomic in Colombian Patients With Rheumatoid Arthritis
Actual Study Start Date : October 17, 2017
Estimated Primary Completion Date : October 17, 2018
Estimated Study Completion Date : September 17, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: CASES
Patients with RA with methotrexate therapy and inhibitors of tumor necrosis factor alpha (TNFα) infliximab, etanercept, adalimumab; That present problems of effectiveness
Other: CASES
Patients with RA with methotrexate therapy and inhibitors of tumor necrosis factor alpha (TNFα) infliximab, etanercept, adalimumab; That present problems of effectiveness.

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

Primary Outcome Measures :
  1. Number of exomes and genetic variants identified [ Time Frame: 1 year ]
    The identification of polymorphisms will be carried out through the next generation sequencing technique

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:   Yes

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 TNFα, 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 TNFα drugs.
  • Inpatient 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 identifier (NCT number): NCT03352622

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Contact: Yolima Puentes, Pharmacist +574-3135742922

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Pablo Tobon Uribe Hospital Recruiting
Medellin, Colombia
Sponsors and Collaborators
Universidad de Antioquia
Hospital Pablo Tobón Uribe
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Principal Investigator: Yolima Puentes, Pharmacist Universidad de Antioquia

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Responsible Party: Universidad de Antioquia Identifier: NCT03352622     History of Changes
Other Study ID Numbers: Pharmacogenomic
First Posted: November 24, 2017    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universidad de Antioquia:
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents
Gastrointestinal Agents
Anti-Inflammatory Agents, Non-Steroidal