Behcet's DiseasePhase 3ITACNCT03371095
Induction Therapy With Anti-TNFα vs Cyclophosphamide in Severe Behçet Disease
A Phase 3 study testing Infliximab and Cyclophosphamide in people with Behcet's Disease and Vasculitis, run by Assistance Publique - Hôpitaux de Paris at 27 sites in France.
Trial summary
Behçet's disease (BD) is a systemic vasculitis of arterial and venous vessels of any size, involving young patients (from 15 to 45 years). BD significantly increases morbidity and mortality. Therapeutic management of BD depends on the clinical presentation and organ involved. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Behcet's Disease, Vasculitis
- What is being tested?
- Infliximab and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 27 sitesFrance
- Study dates
- 25 May 2018to 11 Apr 2022
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 12 years old
- Written inform consent (Informed Consent should be obtained from the legal guardian in accordance with regional laws or regulations for patients 12 to 17 years of age)
- Diagnosis of BD according to international criteria for BD (ICBD) (see Appendix 1).
- Life threatening active BD defined as 1 of the following disease categories and according to the validated international definition:
- Major vessel disease: arterial aneurysms or arterial stenosis, myocarditis and/or major deep vein thrombosis (i.e. inferior vena cava, superior vena cava, cardiac cavity thrombosis, pulmonary embolism, supra-hepatic vessels, renal and mesenteric vessels). Diagnosis of major vessel involvement will be done using vascular doppler sonography, echocardiography, angio-CT scan and/or cardiac magnetic resonance imaging (MRI).
- Central nervous system involvement: encephalitis or meningoencephalitis or myelitis. The diagnosis of neuro-Behçet's (CNS involvement) will be based on objective neurological symptoms that were associated with neuroimaging (CNS and/or medullar MRI) findings suggestive of BD-related CNS involvement. Cerebrospinal fluid (CSF) findings showing aseptic inflammation may be associated.
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- Chest X-ray results (postero-anterior and lateral) within 12 weeks prior to inclusion with no evidence of active Tuberculosis, active infection, or malignancy
- For female subjects of child-bearing age, a negative pregnancy test
- For subjects with reproductive potential, a willingness to use contraceptive measures adequate to prevent the subject or the subject's partner from becoming pregnant during the study and 6 months after stopping therapy. Adequate contraceptive measures include hormonal methods used for two or more cycles prior to Inclusion (e.g., oral contraceptive pills, contraceptive patch, or contraceptive vaginal ring), barrier methods (e.g., contraceptive sponge, diaphragm used in conjunction with contraceptive foam or jelly, or condom used in conjunction with contraceptive foam or jelly), intrauterine methods (IUD), sterilization (e.g., tubal ligation or a monogamous relationship with a vasectomized partner), and abstinence.
- A potential subject with a positive interferon-gamma release assay (IGRA) (e.g., QuantiFERON®-TB Gold or T-spot TB® Test) or a positive tuberculin skin test (≤6 months) is eligible if her/his chest X-ray does not show evidence suggestive of active tuberculosis (TB) disease and there are no clinical signs and symptoms of pulmonary and/or extra-pulmonary TB disease. These subjects with a latent TB infection who have not already received a prophylactic TB treatment must agree in advance to complete such a treatment course.
- HIV negative serology and negative HBs Ag test (≤1 month)
Who cannot join
- Evidence of active Tuberculosis
- HIV or active HBV infection (HBs Ag+).
- Pregnancy or lactation
- Have been taking an oral daily dose of a glucocorticoid of more than 20 mg prednisone equivalent for more than 6 weeks continuously prior to the inclusion visit or taking more than 3000 mg methylprednisolone 4 weeks prior to the inclusion visit
- Alcohol or drug dependance
- Severe renal (creatinine clearance <30ml/min/1,73m2) or pre-existing hemorrhagic cystitis or liver insufficiency (hepatic encephalopathy) or urinary obstruction
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- Heart failure ≥ stage III / IV NYHA,
- History of malignancy within 5 years prior to Inclusion other than carcinoma in situ of the cervix or excised basal cell or squamous cell carcinoma of the skin.
- History of multiple sclerosis and/or demyelinating disorder
- History of severe allergic or anaphylactic reactions to cyclophosphamide or infliximab
- Infectious disease:
- Infection requiring treatment with intravenous antibiotics within 2 weeks prior to Inclusion
- History of recurrent infection
- Laboratory values assessed during Inclusion:
- Hemoglobin < 8 g/dL
- WBC < 2.0 x 103/mm3
- Platelet count < 70 x 103/mm3
- Use of the following systemic treatments during the specified periods:
- Treatment with systemic biologic therapy or with cyclophosphamide within 3 months prior to Inclusion
- if on azathioprine, mycophenolate mofetil, or methotrexate at the time of inclusion, these drugs must be withdrawn prior to receiving the cyclophosphamide or infliximab dose on Day 1
- Any live (attenuated) vaccine within 4 weeks prior inclusion; recombinant or killed virus vaccines are permitted.
- Lack of affiliation to a social security benefit plan (as a beneficiary or assignee), patients affiliated to universal medical coverage (CMU) are eligible for the study
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
France27 sites
CHRU Amiens
Amiens
Hôpital Avicenne
Bobigny
CHU Bordeaux
Bordeaux
Hôpital Saint André
Bordeaux
CH Ambroise Paré
Boulogne-Billancourt
CHU Caen
Caen
Henri Mondor Hospital
Créteil
CHU Dijon
Dijon
CHU Grenoble
Grenoble
CHU Bicêtre
Le Kremlin-Bicêtre
CHRU Lille
Lille
Hôpital de la Croix Rousse
Lyon
Hôpital Edouard Herriot
Lyon
Hôpital de La Timone
Marseille
CH Metz
Metz
CHU Bichat
Paris
CHU Tenon
Paris
Hôpital de La Pitié Salpetriere
Paris
Hôpital Foch
Paris
Hôpital Lariboisière
Paris
Hôpital Saint Antoine
Paris
Hôpital Saint Louis
Paris
CHU Poitiers
Poitiers
Hôpital Bois Guillaume
Rouen
CH Saint-Denis
Saint-Denis
CHU Purpan
Toulouse
CH Valenciennes
Valenciennes
About this study
Official title: Multicenter, Randomized, Prospective Trial Comparing the Efficacy and Safety of Infliximab to That of Cyclophosphamide in Severe Behçet's Disease. ITAC : Induction Therapy With Anti-TNFα vs Cyclophosphamide in Severe Behçet Disease
Behçet's disease (BD) is a systemic vasculitis of arterial and venous vessels of any size, involving young patients (from 15 to 45 years). BD significantly increases morbidity and mortality. Therapeutic management of BD depends on the clinical presentation and organ involved. Although colchicine, nonsteroidal antiinflammatory agents and topical treatments are often sufficient for mucocutaneous and joint involvement, more aggressive approach with immunosuppressive agents is warranted for severe manifestations. Early recognition and vigorous use of immunosuppressives with high dose steroids have changed the prognosis of patients with severe BD. BD is a severe systemic vasculitis leading to blindness in up to 20% at 4 years and a 5-year mortality rate of 15% in patients with major vessel or neurological involvement. Cyclophosphamide has been used for life-threatening BD for 40 years. However, the outcome of severe complications of BD is poor. The European League Against Rheumatism (EULAR) recommendation for the management of BD advocated cyclophosphamide plus glucocorticoids for life-threatening manifestations (i.e neurological and/or major vessel involvement). TNFa antagonists have been used with success in severe and/or resistant cases. In addition, the incidence of blindness in BD has been dramatically reduced in the recent years with the use of anti-TNF. However, there is no firm evidence or randomized controlled trials directly addressing the best induction immunosuppressive therapy in severe BD manifestations. The investigators therefore aimed to assess the best induction therapy in severe and difficult to treat BD patients. The investigators hypothesize that up to 70% of the patients with life-threatening manifestations of BD receiving these compounds [anti-TNFa or cyclophosphamide] will achieve a complete remission of BD at 6 months and with less than 0.1 mg/kg/day of prednisone.
ITAC, is the first randomized prospective, head to head study, comparing infliximab, to cyclophosphamide in severe manifestations of BD. There is no firm evidence or randomized controlled trials directly addressing the best induction immunosuppressive therapy in severe BD. Cyclophosphamide failed to demonstrate sustainable remission over 70 % of life threatening BD cases. There is little published information on use of immunosuppressants other than cyclophosphamide for severe BD. TNFa antagonists have been used with success in severe and/or resistant cases. TNFa expression correlates with BD activity and other immunological data provide a strong rationale for targeting BD with biologics. Despite a strong rationale, these compounds are not yet approved in BD, which guarantees the innovative nature of this study that aims selecting or dropping any arm when evidence of efficacy already exists.
- Conditions
- Behcet's Disease, Vasculitis
- Being tested
- Infliximab, Cyclophosphamide
- Keywords
- Behcet's Disease, Vasculitis, Biotherapy, immunosuppressant, Infliximab
- Medical subject headings
- Behcet Syndrome, Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfliximabDrug
Use of infliximab instead of cyclophosphamide
CyclophosphamideDrug
Use of cyclophosphamide
| Study group | Role | What they receive |
|---|---|---|
| Infliximab | Experimental | Infliximab 5mg/kg intravenously at week 0, 2, 6, 12, and 18 Receives: Drug: Infliximab |
| Cyclophosphamide | Active comparator | Cyclophosphamide 0.7g/m2 up to 1.2g/m2 intravenously at week 0, 4, 8, 12, 16 and 20 Receives: Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete clinical response
The complete clinical response is defined by the remission of all affected organs involved at baseline with a prednisone ≤ 0.1mg/kg per day
Measured: At week 22 after randomization
Secondary outcomes (36)
Complete clinical response
The complete clinical response is defined by the remission of all affected organs involved at baseline with a prednisone ≤ 0.1mg/kg per day
Measured: At week 12 after randomization
Complete clinical response
The complete clinical response is defined by the remission of all affected organs involved at baseline with a prednisone ≤ 0.1mg/kg per day
Measured: At week 48 after randomization
Remission of CNS and/or cardiovascular involvement
Measured: At week 12 after randomization
Remission of CNS and/or cardiovascular involvement
Measured: At week 22 after randomization
Remission of CNS and/or cardiovascular involvement
Measured: At week 48 after randomization
Percent meeting the target of ≤ 0.1 mg/day/kg of prednisone
Measured: At week 22 after randomization
Percent meeting the target of ≤ 0.1 mg/day/kg of prednisone
Measured: At week 48 after randomization
Mean dose of prednisone
Measured: At week 12 after randomization
Mean dose of prednisone
Measured: At week 22 after randomization
Mean dose of prednisone
Measured: At week 48 after randomization
Cumulative dose of prednisone
Measured: At week 12 after randomization
Cumulative dose of prednisone
Measured: At week 22 after randomization
Cumulative dose of prednisone
Measured: At week 48 after randomization
Time to response onset
Measured: At week 48 after randomization
C-reactive protein
CRP in blood sample
Measured: Every 4 weeks
Time to relapse
Relapse will be defined as the reappearance of clinical and/or paraclinical features of active disease or by the occurrence of new lesions at week 48
Measured: At week 48 after randomization
Rate of relapse
Measured: At week 48 after randomization
Time to occurrence of worsening
Worsening will be defined as the progression of preexisting lesions) at week 22 and 48
Measured: At week 48 after randomization
Rate of worsening
Measured: At week 48 after randomization
Overall survival
Measured: At week 22 after randomization
Overall survival
Measured: At week 48 after randomization
Event Free Survival
Measured: At week 22 after randomization
Event Free Survival
Measured: At week 48 after randomization
Frequency of adverse clinical events
Incidence of Treatment related Adverse Events
Measured: At week 22 after randomization
Severity of adverse clinical events
Measured: At week 22 after randomization
Change in quality of life
Change in quality of life (QOL) (SF-36V2TM Health Survey)
Measured: At week 12 after randomization
Change in quality of life
Change in quality of life (QOL) (SF-36V2TM Health Survey)
Measured: At week 22 after randomization
Changes in CNS involvement
Changes in CNS involvement on physical exam, and cerebral and/or medullar MRI.
Measured: At week 12 after randomization
Changes in CNS involvement
Changes in CNS involvement on physical exam, and cerebral and/or medullar MRI.
Measured: At week 22 after randomization
Changes in vascular involvement
Changes in vascular involvement on physical exam, vascular Doppler US, and angio-CT imaging and biologically (normalization of C reactive protein)
Measured: At week 12 after randomization
Changes in vascular involvement
Changes in vascular involvement on physical exam, vascular Doppler US, and angio-CT imaging and biologically (normalization of C reactive protein)
Measured: At week 22 after randomization
Changes in cardiological involvement
Changes in cardiological involvement on physical exam, echocardiography (normalization of left ventricular function and/or disappearance of cardiac thrombosis), and cardiac magnetic resonance imaging (disappearance of gadolinium enhancement and normalization of left ventricular function) and biologically (normalization of troponin and of C reactive protein)
Measured: At week 12 after randomization
Changes in cardiological involvement
Changes in cardiological involvement on physical exam, echocardiography (normalization of left ventricular function and/or disappearance of cardiac thrombosis), and cardiac magnetic resonance imaging (disappearance of gadolinium enhancement and normalization of left ventricular function) and biologically (normalization of troponin and of C reactive protein)
Measured: At week 22 after randomization
Serum concentration measurement of TNFa inhibitor at week 22
Measured: At week 12 after randomization
Change in Behcet's Disease Current Activity Form
Measured: At week 12 after randomization
Change in Behcet's Disease Current Activity Form
Measured: At week 22 after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start25 May 2018
- Primary completion24 Dec 2021
- Study completion11 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behcet's DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03371095
- Sponsor's protocol ID
- P160932J
- Acronym
- ITAC
- Status last verified
- Dec 2017
- First submitted
- 7 Dec 2017
- Last updated
- 3 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Prospective Trial Comparing the Efficacy and Safety of Infliximab to That of Cyclophosphamide in Severe Behçet's Disease. ITAC : Induction Therapy With Anti-TNFα vs Cyclophosphamide in Severe Behçet Disease
- ClinicalTrials.gov ID
- NCT03371095
- Acronym / sponsor ID
- ITAC / P160932J
- Conditions
- Behcet's Disease, Vasculitis
- Keywords
- Behcet's Disease, Vasculitis, Biotherapy, immunosuppressant, Infliximab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 25 May 2018 (actual)
- Primary completion
- 24 Dec 2021 (actual)
- Study completion
- 11 Apr 2022 (actual)
- First posted
- 13 Dec 2017 (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.
Behçet's disease (BD) is a systemic vasculitis of arterial and venous vessels of any size, involving young patients (from 15 to 45 years). BD significantly increases morbidity and mortality. Therapeutic management of BD depends on the clinical presentation and organ involved. Although colchicine, nonsteroidal antiinflammatory agents and topical treatments are often sufficient for mucocutaneous and joint involvement, more aggressive approach with immunosuppressive agents is warranted for severe manifestations. Early recognition and vigorous use of immunosuppressives with high dose steroids have changed the prognosis of patients with severe BD. BD is a severe systemic vasculitis leading to blindness in up to 20% at 4 years and a 5-year mortality rate of 15% in patients with major vessel or neurological involvement. Cyclophosphamide has been used for life-threatening BD for 40 years. However, the outcome of severe complications of BD is poor. The European League Against Rheumatism (EULAR) recommendation for the management of BD advocated cyclophosphamide plus glucocorticoids for life-threatening manifestations (i.e neurological and/or major vessel involvement). TNFa antagonists have been used with success in severe and/or resistant cases. In addition, the incidence of blindness in BD has been dramatically reduced in the recent years with the use of anti-TNF. However, there is no firm evidence or randomized controlled trials directly addressing the best induction immunosuppressive therapy in severe BD manifestations. The investigators therefore aimed to assess the best induction therapy in severe and difficult to treat BD patients. The investigators hypothesize that up to 70% of the patients with life-threatening manifestations of BD receiving these compounds [anti-TNFa or cyclophosphamide] will achieve a complete remission of BD at 6 months and with less than 0.1 mg/kg/day of prednisone.
ITAC, is the first randomized prospective, head to head study, comparing infliximab, to cyclophosphamide in severe manifestations of BD. There is no firm evidence or randomized controlled trials directly addressing the best induction immunosuppressive therapy in severe BD. Cyclophosphamide failed to demonstrate sustainable remission over 70 % of life threatening BD cases. There is little published information on use of immunosuppressants other than cyclophosphamide for severe BD. TNFa antagonists have been used with success in severe and/or resistant cases. TNFa expression correlates with BD activity and other immunological data provide a strong rationale for targeting BD with biologics. Despite a strong rationale, these compounds are not yet approved in BD, which guarantees the innovative nature of this study that aims selecting or dropping any arm when evidence of efficacy already exists.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infliximab | Experimental | Drug: InfliximabInfliximab 5mg/kg intravenously at week 0, 2, 6, 12, and 18 |
| Cyclophosphamide | Active comparator | Drug: CyclophosphamideCyclophosphamide 0.7g/m2 up to 1.2g/m2 intravenously at week 0, 4, 8, 12, 16 and 20 |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 12 years old
- Written inform consent (Informed Consent should be obtained from the legal guardian in accordance with regional laws or regulations for patients 12 to 17 years of age)
- Diagnosis of BD according to international criteria for BD (ICBD) (see Appendix 1).
- Life threatening active BD defined as 1 of the following disease categories and according to the validated international definition:
- Chest X-ray results (postero-anterior and lateral) within 12 weeks prior to inclusion with no evidence of active Tuberculosis, active infection, or malignancy
Key exclusion criteria (22 listed)
- Evidence of active Tuberculosis
- HIV or active HBV infection (HBs Ag+).
- Pregnancy or lactation
- Have been taking an oral daily dose of a glucocorticoid of more than 20 mg prednisone equivalent for more than 6 weeks continuously prior to the inclusion visit or taking more than 3000 mg methylprednisolone 4 weeks prior to the inclusion visit
- Alcohol or drug dependance
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 |
|---|---|---|
| InfliximabUse of infliximab instead of cyclophosphamide | Drug | Infliximab |
| CyclophosphamideUse of cyclophosphamide | Drug | Cyclophosphamide |
Primary outcome
Complete clinical response
Time frame: At week 22 after randomization
The complete clinical response is defined by the remission of all affected organs involved at baseline with a prednisone ≤ 0.1mg/kg per day
36 secondary outcomes
Complete clinical response
Time frame: At week 12 after randomization
Complete clinical response
Time frame: At week 48 after randomization
Remission of CNS and/or cardiovascular involvement
Time frame: At week 12 after randomization
Remission of CNS and/or cardiovascular involvement
Time frame: At week 22 after randomization
Remission of CNS and/or cardiovascular involvement
Time frame: At week 48 after randomization
Percent meeting the target of ≤ 0.1 mg/day/kg of prednisone
Time frame: At week 22 after randomization
Percent meeting the target of ≤ 0.1 mg/day/kg of prednisone
Time frame: At week 48 after randomization
Mean dose of prednisone
Time frame: At week 12 after randomization
Mean dose of prednisone
Time frame: At week 22 after randomization
Mean dose of prednisone
Time frame: At week 48 after randomization
Cumulative dose of prednisone
Time frame: At week 12 after randomization
Cumulative dose of prednisone
Time frame: At week 22 after randomization
Cumulative dose of prednisone
Time frame: At week 48 after randomization
Time to response onset
Time frame: At week 48 after randomization
C-reactive protein
Time frame: Every 4 weeks
Time to relapse
Time frame: At week 48 after randomization
Rate of relapse
Time frame: At week 48 after randomization
Time to occurrence of worsening
Time frame: At week 48 after randomization
Rate of worsening
Time frame: At week 48 after randomization
Overall survival
Time frame: At week 22 after randomization
Overall survival
Time frame: At week 48 after randomization
Event Free Survival
Time frame: At week 22 after randomization
Event Free Survival
Time frame: At week 48 after randomization
Frequency of adverse clinical events
Time frame: At week 22 after randomization
Severity of adverse clinical events
Time frame: At week 22 after randomization
Change in quality of life
Time frame: At week 12 after randomization
Change in quality of life
Time frame: At week 22 after randomization
Changes in CNS involvement
Time frame: At week 12 after randomization
Changes in CNS involvement
Time frame: At week 22 after randomization
Changes in vascular involvement
Time frame: At week 12 after randomization
Changes in vascular involvement
Time frame: At week 22 after randomization
Changes in cardiological involvement
Time frame: At week 12 after randomization
Changes in cardiological involvement
Time frame: At week 22 after randomization
Serum concentration measurement of TNFa inhibitor at week 22
Time frame: At week 12 after randomization
Change in Behcet's Disease Current Activity Form
Time frame: At week 12 after randomization
Change in Behcet's Disease Current Activity Form
Time frame: At week 22 after randomization
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 3 Jul 2023.
- Individual participant dataSharing planned: Undecided
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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.
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Infliximab and Cyclophosphamide in people with Behcet's Disease and Vasculitis, run by Assistance Publique - Hôpitaux de Paris at 27 sites in France.
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 11 inclusion and 22 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 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in France. 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?
Complete clinical response (time frame: At week 22 after randomization). 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 3 Jul 2023.