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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04022525
Recruitment Status : Completed
First Posted : July 17, 2019
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
Alaa Abdelkhalik Ahmed Mohamed, Assiut University

Tracking Information
First Submitted Date July 15, 2019
First Posted Date July 17, 2019
Last Update Posted Date September 9, 2020
Actual Study Start Date February 1, 2018
Actual Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 15, 2019)
Detection of single nucleotide polymorphisms associated with response to the drug [ Time Frame: 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Assessment of Leflunomide Efficacy and Hepatotoxicity in Patients With Rheumatoid Arthritis Through Pharmacokinetic and Genetic Approaches
Official Title Assessment of Leflunomide Efficacy and Hepatotoxicity in Patients With Rheumatoid Arthritis Through Pharmacokinetic and Genetic Approaches
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Rheumatoid Arthritis
Intervention Drug: Leflunomide 20Mg Tab
blood samples of rheumatoid patients will be collected for SNPs detection and drug assay
Study Groups/Cohorts leflunomide responsive vs non-responsive
Intervention: Drug: Leflunomide 20Mg Tab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 15, 2019)
80
Original Actual Enrollment Same as current
Actual Study Completion Date December 31, 2019
Actual Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Egypt
Removed Location Countries  
 
Administrative Information
NCT Number NCT04022525
Other Study ID Numbers 2016/12/28-006
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement Not Provided
Responsible Party Alaa Abdelkhalik Ahmed Mohamed, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Investigators Not Provided
PRS Account Assiut University
Verification Date September 2020