Rheumatoid ArthritisNCT04022525
Assessment of Leflunomide Efficacy and Hepatotoxicity in Patients With Rheumatoid Arthritis Through Pharmacokinetic and Genetic Approaches
An observational study of Rheumatoid Arthritis, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Leflunomide 20Mg Tab
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2018to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Rheumatoid arthritis patients from both sexes with different disease activity status receiving solely leflunomide with or without hydroxychloroquine
Who may be able to join
- Rheumatoid arthritis patients already receiving leflunomide with or without Hydroxychloroquine but without other Disease modifying agents
Who cannot join
- Those diagnosed with other rheumatic diseases or Rheumatoid patients receiving disease modifying agents other than leflunomide
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Leflunomide 20Mg Tab
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leflunomide 20Mg TabDrug
blood samples of rheumatoid patients will be collected for SNPs detection and drug assay
| Study group | Role | What they receive |
|---|---|---|
| leflunomide responsive vs non-responsive | Not described Receives: Drug: Leflunomide 20Mg Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one -two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start1 Feb 2018
- Primary completion31 Aug 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Abdelkhalik Ahmed Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04022525
- Sponsor's protocol ID
- 2016/12/28-006
- Status last verified
- Sep 2020
- First submitted
- 15 Jul 2019
- Last updated
- 9 Sep 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Leflunomide Efficacy and Hepatotoxicity in Patients With Rheumatoid Arthritis Through Pharmacokinetic and Genetic Approaches
- ClinicalTrials.gov ID
- NCT04022525
- Acronym / sponsor ID
- 2016/12/28-006
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 17 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| leflunomide responsive vs non-responsive | – | Drug: Leflunomide 20Mg Tab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Rheumatoid arthritis patients from both sexes with different disease activity status receiving solely leflunomide with or without hydroxychloroquine
Key inclusion criteria (1 listed)
- Rheumatoid arthritis patients already receiving leflunomide with or without Hydroxychloroquine but without other Disease modifying agents
Key exclusion criteria (1 listed)
- Those diagnosed with other rheumatic diseases or Rheumatoid patients receiving disease modifying agents other than leflunomide
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leflunomide 20Mg Tabblood samples of rheumatoid patients will be collected for SNPs detection and drug assay | Drug | leflunomide responsive vs non-responsive |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of single nucleotide polymorphisms associated with response to the drug (time frame: one -two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.