Arthritis, RheumatoidPhase 4NCT00280644
Leflunomide in Rheumatoid Arthritis
A Phase 4 study testing Leflunomide in people with Arthritis, Rheumatoid, run by Sanofi at 1 site in Turkey (Türkiye).
Trial summary
Study objectives: To provide more insight on the modulation of inflammation and matrix degrading factors in serum and urine by leflunomide in early , active patients with RA and to validate the sensitivity of DEMRI (Dynamic Enhanced Magnetic Resonance Imaging) in detecting inflammatory changes in active RA in response… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- Leflunomide
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2004to not given
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who has diagnosis of rheumatoid arthritis based upon the ACR (American College of Rheumatology) diagnostic criteria
- Patient who has not ARA functional class IV (ACR 1991 revised criteria). Active disease defined as > 6 swollen or tender joints, by physician and as well as by patient global assessment of disease activity as moderate or worse
- Patient who has active disease defined by a modified Disease Activity Score (DAS)>3.2
- At least one wrist joint with active disease, defined by clinically detectable synovitis at that site due to technical facility of using wrist joint for DEMRI (Dynamic Enhanced Magnetic Resonance Imaging)
- Patient who has received unchanged doses of oral corticosteroids (with a maximum dose of 10 mg prednisone daily or steroid equivalent orally administered ) and concomitant stable doses of nonsteroidal anti-inflammatory drugs for at least 4 weeks before entering the study
- Woman of childbearing potential,who is demonstrated not to be pregnant (by serum pregnancy test) or breast feeding at screening visit, and who is agree to undergo urine pregnancy testing monthly during the study, and serum pregnancy test at the end of the treatment
- Woman of childbearing potential, who agrees to maintain an adequate mean of contraception and not to get pregnant through the study and for 24 months after the discontinuation of the treatment.Man wishing to father a child, who has a consent to discontinue the treatment with study medication, will undergo a drug elimination procedure
Who cannot join
- The patient who has ARA functional class IV
- The patient who has a history of other inflammatory joint disease, e.g. mixed connective tissue disease, seronegative spondylarthropathy, psoriatic arthritis, Reiter's syndrome, systemic lupus erythematosus, sarcoidosis, history of Felty's syndrome, or any arthritis with onset prior to 16 years of age
- The patient who has a congenital or acquired severe immunodeficiency, a history of cancer or lymphoproliferative disease, or he/she has received total lymphoid irradiation
- The patient who is in known HIV positive status defined by either a positive blood test or clinical diagnosis
- The patient who has been sick with persistent infection or severe infection within 3 months of enrollment
- Known Glucose 6 Phosphate Dehydrogenase (G6PD) deficiency
Show all 16Show fewer
- The patient who has acute intermittent porphyria
- The patient who has hematopoietic disorder (haemoglobin < 9 g/dl, White Blood Cells < 3500/mm3, platelet count < 120.000/mm3)
- The patient who has impaired coagulation, on treatment with oral anti-coagulants
- The patient who has uncontrolled diabetes, unstable ischaemic heart disease, active inflammatory bowel disease, active peptic ulcer disease or history of active peptic ulcer disease during the previous 4 months (documented by gastroscopy or clinically diagnosed by a physician), recent or history of major traumatic injury, history of malignancy.
- The patient who has clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult
- Patients body weight is < 45 kg
- The patient who has received therapy within the previous 3 months with any investigational drug, alkylating agents (e.g. cyclophosphamide, chlorambucil), biological agents (e.g. interferon, monoclonal antibodies, growth factor, cytokines).
- The patient who has received other DMARD (Disease Modifying Antirheumatic Drugs) therapy (D-penicillamine, oral or injectable gold, chloroquine, hydroxychloroquine, cyclosporine,MTX) who hasn't been followed by a washout period of 28 days
- Patients who had a therapy of oral corticosteroids exceeding a prednisone equivalent of 10 mg/day, parenteral or intra-articular corticoid injection, within the previous 4 weeks
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Leflunomide on Joint Inflammation and Destruction of Joint Integrity in Active Rheumatoid Arthritis (RA) Patients
Study objectives:
- To provide more insight on the modulation of inflammation and matrix degrading factors in serum and urine by leflunomide in early , active patients with RA and to validate the sensitivity of DEMRI (Dynamic Enhanced Magnetic Resonance Imaging) in detecting inflammatory changes in active RA in response to treatment with leflunomide
- Effect of leflunomide therapy on physical function improvement and Quality of life
- Conditions
- Arthritis, Rheumatoid
- Being tested
- Leflunomide
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeflunomideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients responding according to "28-Joint Disease Activity Score" (DAS28) criteria (a 1.2 point increase compared with pretreatment values), C-Reactive Protein (CRP)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2006 (estimated)
- Study startApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Edibe Taylan, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00280644
- Sponsor's protocol ID
- HWA486_4022
- Status last verified
- Jan 2011
- First submitted
- 19 Jan 2006
- Last updated
- 11 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Leflunomide on Joint Inflammation and Destruction of Joint Integrity in Active Rheumatoid Arthritis (RA) Patients
- ClinicalTrials.gov ID
- NCT00280644
- Acronym / sponsor ID
- HWA486_4022
- Conditions
- Arthritis, Rheumatoid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- First posted
- 23 Jan 2006 (estimated)
- 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.
Study objectives:
- To provide more insight on the modulation of inflammation and matrix degrading factors in serum and urine by leflunomide in early , active patients with RA and to validate the sensitivity of DEMRI (Dynamic Enhanced Magnetic Resonance Imaging) in detecting inflammatory changes in active RA in response to treatment with leflunomide
- Effect of leflunomide therapy on physical function improvement and Quality of life
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient who has diagnosis of rheumatoid arthritis based upon the ACR (American College of Rheumatology) diagnostic criteria
- Patient who has not ARA functional class IV (ACR 1991 revised criteria). Active disease defined as > 6 swollen or tender joints, by physician and as well as by patient global assessment of disease activity as moderate or worse
- Patient who has active disease defined by a modified Disease Activity Score (DAS)>3.2
- At least one wrist joint with active disease, defined by clinically detectable synovitis at that site due to technical facility of using wrist joint for DEMRI (Dynamic Enhanced Magnetic Resonance Imaging)
- Patient who has received unchanged doses of oral corticosteroids (with a maximum dose of 10 mg prednisone daily or steroid equivalent orally administered ) and concomitant stable doses of nonsteroidal anti-inflammatory drugs for at least 4 weeks before entering the study
Key exclusion criteria (16 listed)
- The patient who has ARA functional class IV
- The patient who has a history of other inflammatory joint disease, e.g. mixed connective tissue disease, seronegative spondylarthropathy, psoriatic arthritis, Reiter's syndrome, systemic lupus erythematosus, sarcoidosis, history of Felty's syndrome, or any arthritis with onset prior to 16 years of age
- The patient who has a congenital or acquired severe immunodeficiency, a history of cancer or lymphoproliferative disease, or he/she has received total lymphoid irradiation
- The patient who is in known HIV positive status defined by either a positive blood test or clinical diagnosis
- The patient who has been sick with persistent infection or severe infection within 3 months of enrollment
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 | Drug | – |
Primary outcome
The proportion of patients responding according to "28-Joint Disease Activity Score" (DAS28) criteria (a 1.2 point increase compared with pretreatment values), C-Reactive Protein (CRP)
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 11 Jan 2011.
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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.
Edibe Taylan study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Leflunomide in people with Arthritis, Rheumatoid, run by Sanofi at 1 site in Turkey (Türkiye).
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 7 inclusion and 16 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 11 Jan 2011. 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 Turkey (Türkiye). 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The proportion of patients responding according to "28-Joint Disease Activity Score" (DAS28) criteria (a 1.2 point increase compared with pretreatment values), C-Reactive Protein (CRP). 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 11 Jan 2011.