Pharmacogenetics of Leflunomide in the Management of Rheumatoid Arthritis

Recruiting now

Conditions studied: Rhematoid Arthritis

In brief

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.

Key facts

Study ID

NCT07388407

Run by

Foundation University Islamabad

People needed

110

Starts

2024-09-01

Expected to finish

2026-09-30

Last updated by the study team

2026-02-05

Who can join

Age: 20 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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-

Where it is running

• Fauji Foundation Hospital, Rawalpindi — Rawalpindi, Punjab Province, Pakistan (enrolling)
• Shifa International Hospital — Islamabad, Punjab Province, Pakistan

Full record on ClinicalTrials.gov

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