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

NCT04022525 | Completed FDA Drug

• 1 other identifier: 2016/12/28-006
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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

  one -two years

Study Arms (1)

leflunomide responsive vs non-responsive

Drug: Leflunomide 20Mg Tab

Interventions

Leflunomide 20Mg Tab DRUG

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

leflunomide responsive vs non-responsive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Rheumatoid arthritis patients from both sexes with different disease activity status receiving solely leflunomide with or without hydroxychloroquine

You may qualify if:

• Rheumatoid arthritis patients already receiving leflunomide with or without Hydroxychloroquine but without other Disease modifying agents

You may not qualify if:

• Those diagnosed with other rheumatic diseases or Rheumatoid patients receiving disease modifying agents other than leflunomide

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital

Asyut, Egypt

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Leflunomide

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: July 17, 2019
• Study Start: February 1, 2018
• Primary Completion: August 31, 2019
• Study Completion: December 31, 2019
• Last Updated: September 9, 2020

Record last verified: 2020-09

Locations

EG (1)