RecruitingNCT07388407

Pharmacogenetics of Leflunomide in the Management of Rheumatoid Arthritis

Pharmacogenetics of Leflunomide in the RA Management


Sponsor

Foundation University Islamabad

Enrollment

110 participants

Start Date

Sep 1, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 20 YearsMax Age: 65 Years

Inclusion Criteria4

  • 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

Exclusion Criteria9

  • Patients not willing to participate/ consent not given
  • Patients below the age of 20
  • Non- Pakistani origin
  • Taking another DMARD simultaneously
  • Compromised renal and hepatic functions
  • Cognitive impairment, neurological disease
  • Pregnant/ lactating patients
  • Patients having inflammatory bowel disease/ Irritable bowel syndrome
  • Patients with active infective diseases -Patients who fail to complete 3 months of leflunomide therapy-

Interventions

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

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


Locations(2)

Shifa International Hospital

Islamabad, Punjab Province, Pakistan

Fauji Foundation Hospital, Rawalpindi

Rawalpindi, Punjab Province, Pakistan

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NCT07388407