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Pharmacogenetics of Leflunomide in the Management of Rheumatoid Arthritis

ConditionRhematoid Arthritis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-65
SponsorFoundation University Islamabad

About this trial

1. Patients taking leflunomide as the only disease-modifying anti-rheumatic drug (DMARD) will be recruited after consent. 2. Blood sample for DNA extraction will be taken The patient will be followed up till two visits 3 months apart, and efficacy and toxicity will be checked using DAS28, ultrasonography, and blood tests for ESR, CRP, anti-CCP, liver function tests, etc. The data form for toxicity will be filled. 3. DNA will be extracted in the laboratory, and SNP will be identified. 4. The efficacy and toxicity data will be studied against the SNPs found 5. An algorithm will be constructed for Pakistani RA patients taking leflunomide.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

At baseline, all patients should fulfill the revised ACR/EULAR criteria for RA10

Pakistani individuals

between ages of 20-75 years

New cases started on Leflunomide/ those already taking for less than a month and their biochemical and clinical data is available

Disqualifiers

Patients not willing to participate/ consent not given

Patients below the age of 20

Non- Pakistani origin

Taking another DMARD simultaneously

Trial population

Patient of RA taking Leflunomide

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Study for the correlation of SNPs with efficacy and toxicity of Leflunomide in RA patients

    Drug

    Study for the correlation of SNPs with efficacy and toxicity of Leflunomide in RA patients

Treatment groups

110 Participants
are divided into 1 treatment group
Group A: RA patients taking Leflunomide1 intervention

Trial outcomes

Primary outcomes

1

DAS Score Measurement

The Disease Activity Score (DAS28) is calculated by assessing 28 tender/swollen joints, blood inflammatory markers (ESR or CRP), and patient global health (VAS), with scores \<2.6 indicating remission and \>5.1 indicating high disease activity. It is primarily computed using specialised calculators for Rheumatoid Arthritis. We will take this score at the start of leflunomide therapy, at three-month intervals and at 6 months. The significant outcome will be a 10% decrease from the baseline and will be correlated with the SNP identified.

Time frame
2 years

Secondary outcomes

1

SNP identification in DHOD gene

SNPs detected from the Sanger sequencing will be tabulated against the efficacy, which is the DAS score and visual pain analogue. A 10% decrease in the baseline score will be considered significant improvement. An increase in the adverse effects like deranged LFTs, an increase in vomiting, and alopecia will be measured using ANOVA.

Time frame
2 years
2

Measurement of Hepatotoxicity of Leflunomide

Baseline liver function tests will be recorded and then repeated at 3- and 6-month intervals to correlate with the genetic basis.

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Foundation University Islamabad

Lead sponsor

Shifa Tameer-e-Millat University

Collaborator

Source ClinicalTrials.gov
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