Pharmacological ActionNCT03352622
Pharmacogenomic in Colombian Patients With Rheumatoid Arthritis
A study testing CASES in people with Pharmacological Action, run by Universidad de Antioquia at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pharmacological Action
- What is being tested?
- CASES
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 372 participants
- Where
- 1 siteColombia
- Study dates
- 17 Oct 2017to 17 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Pharmacological Action
- Being tested
- CASES, CONTROLS
- Keywords
- PHARMACOGENOMICS, POLYMORPHISM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CASESOther
Also called NO RESPONDERS
Patients with RA with methotrexate therapy and inhibitors of tumor necrosis factor alpha (TNFα) infliximab, etanercept, adalimumab; That present problems of effectiveness.
CONTROLSOther
Also called RESPONDERS
Patients with RA with methotrexate therapy inhibitors of tumor necrosis factor alpha (TNFα) infliximab, etanercept, adalimumab; No problems of effectiveness
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: CONTROLS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of exomes and genetic variants identified
The identification of polymorphisms will be carried out through the next generation sequencing technique
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start17 Oct 2017
- Primary completion17 Oct 2018 (estimated)
- Study completion17 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pharmacological ActionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- CASES AND CONTROLS
- Masking
- None (open label)
- Enrolment
- 372 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Antioquia
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Pablo Tobón Uribe
- Responsible party
- Sponsor
- Investigators
- Yolima Puentes, Pharmacist, Principal investigator, Universidad de Antioquia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03352622
- Sponsor's protocol ID
- Pharmacogenomic
- Status last verified
- Jun 2017
- First submitted
- 10 Nov 2017
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 25084201Muralidharan 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.
PubMed 26071279Dupont JA. Significance of operative cultures in total hip arthroplasty. Clin Orthop Relat Res. 1986 Oct;(211):122-7.
PubMed 3769251Bernzweig EP. Liability for malpractice...its role in nursing education. J Nurs Educ. 1969 Apr;8(2):33-41. No abstract available.
PubMed 4388501
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenomic in Colombian Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT03352622
- Acronym / sponsor ID
- Pharmacogenomic
- Conditions
- Pharmacological Action
- Keywords
- PHARMACOGENOMICS, POLYMORPHISM
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 372 participants (estimated)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Collaborators
- Hospital Pablo Tobón Uribe
- Study start
- 17 Oct 2017 (actual)
- Primary completion
- 17 Oct 2018 (estimated)
- Study completion
- 17 Sep 2020 (estimated)
- First posted
- 24 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- CASES AND CONTROLS
| Arm | Type | Receives |
|---|---|---|
| CASES | Active comparator | Other: CASESPatients with RA with methotrexate therapy and inhibitors of tumor necrosis factor alpha (TNFα) infliximab, etanercept, adalimumab; That present problems of effectiveness |
| CONTROLS | Active comparator | Other: CONTROLSPatients with RA with methotrexate therapy inhibitors of tumor necrosis factor alpha (TNFα) infliximab, etanercept, adalimumab; No problems of effectiveness |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CASESAlso: NO RESPONDERSPatients with RA with methotrexate therapy and inhibitors of tumor necrosis factor alpha (TNFα) infliximab, etanercept, adalimumab; That present problems of effectiveness. | Other | CASES |
| CONTROLSAlso: RESPONDERSPatients with RA with methotrexate therapy inhibitors of tumor necrosis factor alpha (TNFα) infliximab, etanercept, adalimumab; No problems of effectiveness | Other | CONTROLS |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
- Background: PubMed 25084201Salazar 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.
- Background: PubMed 26071279Muralidharan 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.
- Background: PubMed 3769251Dupont JA. Significance of operative cultures in total hip arthroplasty. Clin Orthop Relat Res. 1986 Oct;(211):122-7.
- Background: PubMed 4388501Bernzweig EP. Liability for malpractice...its role in nursing education. J Nurs Educ. 1969 Apr;8(2):33-41. No abstract available.
- Individual participant dataSharing planned: Undecided
Related trials for Pharmacological Action
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of NT 201 in Adults With Moderate to Severe Platysma Prominence in Europe (PLATINUM EU)
Neuromuscular Agents, Peripheral Nervous System Agents
RecruitingObservational study
Natural History of Depression, Bipolar Disorder and Suicide Risk
Behavioral Symptoms, Suicide
Recruiting
Efficacy and Safety of Ultrasound-Guided Pharmacopuncture as an Adjunctive Therapy in Inpatients With Post-Traffic Accident Tension-Type Headache
Pharmacologic Action
RecruitingPhase 3
A Non-inferiority Pharmacokinetic and Safety/Tolerability Study of Two Different Doses of Weekly SC Alpha1-PI 15% Compared With Corresponding Standard IV Alpha1-PI in Participants With Alpha1-Antitrypsin Deficiency (AATD)
Alpha 1 Antitrypsin Deficiency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yolima Puentes, Pharmacist principal investigator
Universidad de Antioquia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CASES in people with Pharmacological Action, run by Universidad de Antioquia at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yolima Puentes, Pharmacist (+574-3135742922, yolimap16@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of exomes and genetic variants identified (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03352622, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2018.