Assessment of Leflunomide Efficacy and Hepatotoxicity in Patients With Rheumatoid Arthritis Through Pharmacokinetic and Genetic Approaches

Assiut University80 enrolled

Overview

The RA patients receiving leflunomide for more than one month, and not receiving other DMARDs (except hydroxychloroquine), will be enrolled to assess their disease activity. Blood samples will be collected for genetic studies and pharmacokinetic assay of the blood levels of the drug and its active metabolite.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Rheumatoid Arthritis

Interventions

Leflunomide 20Mg TabDRUG

blood samples of rheumatoid patients will be collected for SNPs detection and drug assay

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Rheumatoid arthritis patients already receiving leflunomide with or without Hydroxychloroquine but without other Disease modifying agents Exclusion Criteria: * Those diagnosed with other rheumatic diseases or Rheumatoid patients receiving disease modifying agents other than leflunomide

Locations (1)

Assiut University Hospital

Asyut, Egypt

Outcomes

Primary Outcomes

Detection of single nucleotide polymorphisms associated with response to the drug

SNPs associated with the response or adverse drug reactions will be detected and correlated with the ratio of leflunomide to its active metabolite

Time frame: one -two years

Data from ClinicalTrials.gov

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