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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04022525

Enrollment

Registered

2019-07-17

Start date

2018-02-01

Completion date

2019-12-31

Last updated

2020-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Brief summary

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.

Interventions

DRUGLeflunomide 20Mg Tab

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

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Detection of single nucleotide polymorphisms associated with response to the drug	one -two years	SNPs associated with the response or adverse drug reactions will be detected and correlated with the ratio of leflunomide to its active metabolite

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026