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

Assiut University

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Drug: Leflunomide 20Mg Tab

Study type: Observational

Funder types: Other

Identifiers

NCT04022525

2016/12/28-006

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

80 participants in 1 patient group

leflunomide responsive vs non-responsive

Treatment:

Drug: Leflunomide 20Mg Tab