Arthritis, RheumatoidPhase 3LEADERNCT00596206
Leflunomide EfficAcy Response Related to Dosing Regimen in Early Rheumatoid Arthritis
A Phase 3 study testing leflunomide in people with Arthritis, Rheumatoid, run by Sanofi at 5 sites in 5 countries.
Trial summary
To assess the efficacy response rate at 3-months of two dosing regimen of leflunomide in DMARDs-naive patients presenting an early-RA using American College of Rheumatology 20% response rate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- leflunomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 5 sitesin 5 countries
- Study dates
- Dec 2007to Oct 2009
- Phase
- Phase 3
- 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
Who may be able to join
- Diagnosis of active rheumatoid arthritis in the previous 6 months (according to the ACR guidelines)
- Must have active disease to be initiated by DMARDs (Disease Modifying Anti-Rheumatic Drugs)
Who cannot join
- Patient presenting or having a history of other inflammatory joint disease
- Patient with ongoing or previous Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme
- Patient with significantly impaired bone marrow function or significant anaemia, leucopenia or thrombocytopenia due to causes or other than active rheumatoid arthritis
- Persistent infection or severe infection within 3 months before enrollment,
- Uncontrolled hypertension, uncontrolled diabetes, unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, terminal illness or other medical condition which, in the opinion of the investigator, would put the patient at risk to participate in the study,
- Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult
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- Severe hypoproteinemia (e.g., in case of severe liver disease or nephrotic syndrome) with serum albumin < 3.0 g/dl
- Moderate or severe impairment of renal function, as known by serum creatinine > 133 mcmol/L (or 1.5 mg/dl)
- Patient with history of recent and clinically significant drug or alcohol abuse
- Impairment of liver function or persisting ALT (SGPT) elevations of more than 2-fold the upper limit of normal
- Pregnancy
- Breastfeeding
- Women of childbearing potential, except if they fulfill specific conditions,
- Men wishing to father children during the course of the study or within the 24 months thereafter (or 3 month with the washout procedure)
- Patient with a congenital or acquired severe immuno-deficiency, a history of cancer or lymphoproliferative disease, or any patient who has received total lymphoid irradiation
- Known HIV positive status
- Known positive serology for hepatitis B or C
- Patient with hypersensitivity to any of the excipients in the tablets of leflunomide
- Previous therapy at any time with:
- any DMARD including methotrexate, oral or injectable gold salts, chloroquine, hydroxychloroquine, ciclosporin, azathioprine, methotrexate, sulfasalazine
- D penicillamine
- alkylating agents, e.g., cyclophosphamide, chlorambucil, biological agents, e.g., interferon, monoclonal antibodies, growth factor, cytokines
- any investigational drug
- any antimetabolites
- any opiates
- Therapy within the previous 4 weeks with:
- oral corticosteroids exceeding a prednisolone equivalent of 10 mg/day
- parenteral or intra-articular corticoid injection
- 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
5 sites in 5 countries.
5 sites in 5 countries
About this study
Official title: Assessment of the Early Efficacy Response Rate of Leflunomide According to the Initial Dosing Regimen in the Treatment of Naive-DMARD (Disease Modifying Anti-Rheumatic Drug) Early RA (Rheumatoid Arthritis)-Patients
To assess the efficacy response rate at 3-months of two dosing regimen of leflunomide in DMARDs-naive patients presenting an early-RA using American College of Rheumatology 20% response rate.
To assess the clinical efficacy at 1-month and 3-month using complementary efficacy criteria (ACR 50, ACR 70, DAS 28) in each group of treatment, To assess the clinical and biological safety using standard blood monitoring, TEAED and SAE in each group of treatment, To evaluate treatment modifications; particularity leflunomide and concomitant use of AINS and corticoids.
- 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
20 or 100 mg per os, Film coated tablet, for 3 days + matching placebo, then 20 mg once daily for 3 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 100 mg of leflunomide Receives: Drug: leflunomide |
| 2 | Active comparator | 20 mg of leflunomide Receives: Drug: leflunomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical efficacy response rate using ACR 20 criteria in each initial dosing regimen group
Measured: at 3 month
Secondary outcomes (5)
Clinical efficacy response rate using ACR 50, ACR 70, DAS 28 efficacy criteria in each group of treatment
Measured: at 1 and 3 months
Clinical and biological safety using standard blood monitoring, TEAED and SAE in each group of treatment
Measured: From the Informed Consent Form (ICF) signature to the end of the study
Measure of acute phase response (ESR, CRP)
Measured: At 1 and 3 months
Patient and physician global assessment
Measured: At 1 and 3 months
SF-36 questionnaire
Measured: At 1 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gilles Perdriset, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00596206
- Sponsor's protocol ID
- LEFLU_R_01143
- Other IDs
- Eudract#: 2007-000886-40
- Acronym
- LEADER
- Status last verified
- Oct 2010
- First submitted
- 4 Jan 2008
- Last updated
- 13 Oct 2010
- Results posted
- No
Publications
Cutolo M, Bolosiu H, Perdriset G; LEADER Study Group. Efficacy and safety of leflunomide in DMARD-naive patients with early rheumatoid arthritis: comparison of a loading and a fixed-dose regimen. Rheumatology (Oxford). 2013 Jun;52(6):1132-40. doi: 10.1093/rheumatology/kes321. Epub 2013 Feb 11.
PubMed 23401601
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Early Efficacy Response Rate of Leflunomide According to the Initial Dosing Regimen in the Treatment of Naive-DMARD (Disease Modifying Anti-Rheumatic Drug) Early RA (Rheumatoid Arthritis)-Patients
- ClinicalTrials.gov ID
- NCT00596206
- Acronym / sponsor ID
- LEADER / LEFLU_R_01143
- Conditions
- Arthritis, Rheumatoid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 16 Jan 2008 (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.
To assess the efficacy response rate at 3-months of two dosing regimen of leflunomide in DMARDs-naive patients presenting an early-RA using American College of Rheumatology 20% response rate.
To assess the clinical efficacy at 1-month and 3-month using complementary efficacy criteria (ACR 50, ACR 70, DAS 28) in each group of treatment, To assess the clinical and biological safety using standard blood monitoring, TEAED and SAE in each group of treatment, To evaluate treatment modifications; particularity leflunomide and concomitant use of AINS and corticoids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: leflunomide100 mg of leflunomide |
| 2 | Active comparator | Drug: leflunomide20 mg of leflunomide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of active rheumatoid arthritis in the previous 6 months (according to the ACR guidelines)
- Must have active disease to be initiated by DMARDs (Disease Modifying Anti-Rheumatic Drugs)
Key exclusion criteria (29 listed)
- Patient presenting or having a history of other inflammatory joint disease
- Patient with ongoing or previous Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme
- Patient with significantly impaired bone marrow function or significant anaemia, leucopenia or thrombocytopenia due to causes or other than active rheumatoid arthritis
- Persistent infection or severe infection within 3 months before enrollment,
- Uncontrolled hypertension, uncontrolled diabetes, unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, terminal illness or other medical condition which, in the opinion of the investigator, would put the patient at risk to participate in the study,
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 |
|---|---|---|
| leflunomide20 or 100 mg per os, Film coated tablet, for 3 days + matching placebo, then 20 mg once daily for 3 months | Drug | 1, 2 |
Primary outcome
Clinical efficacy response rate using ACR 20 criteria in each initial dosing regimen group
Time frame: at 3 month
5 secondary outcomes
Clinical efficacy response rate using ACR 50, ACR 70, DAS 28 efficacy criteria in each group of treatment
Time frame: at 1 and 3 months
Clinical and biological safety using standard blood monitoring, TEAED and SAE in each group of treatment
Time frame: From the Informed Consent Form (ICF) signature to the end of the study
Measure of acute phase response (ESR, CRP)
Time frame: At 1 and 3 months
Patient and physician global assessment
Time frame: At 1 and 3 months
SF-36 questionnaire
Time frame: At 1 and 3 months
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 13 Oct 2010.
- Derived from this study: PubMed 23401601Cutolo M, Bolosiu H, Perdriset G; LEADER Study Group. Efficacy and safety of leflunomide in DMARD-naive patients with early rheumatoid arthritis: comparison of a loading and a fixed-dose regimen. Rheumatology (Oxford). 2013 Jun;52(6):1132-40. doi: 10.1093/rheumatology/kes321. Epub 2013 Feb 11.
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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.
Gilles Perdriset study director
Sanofi
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing leflunomide in people with Arthritis, Rheumatoid, run by Sanofi at 5 sites in 5 countries.
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 2 inclusion and 29 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 13 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Czechia, Italy, Portugal, Romania, South Korea. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Clinical efficacy response rate using ACR 20 criteria in each initial dosing regimen group (time frame: at 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00596206, which also lists 1 linked publication.
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 13 Oct 2010.