Eosinophilic Granulomatosis With PolyangiitisPhase 3MAINRITSEGNCT03164473
Maintenance of Remission With Rituximab Versus Azathioprine for Newly-diagnosed or Relapsing Eosinophilic Granulomatosis With Polyangiitis.
A Phase 3 study testing Rituximab and Azathioprine in people with Eosinophilic Granulomatosis With Polyangiitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to investigate, after achievement of remission, the efficacy of rituximab compared with azathioprine maintenance therapy on duration of remission, in patients with relapsing or newly-diagnosed Eosinophilic granulomatosis with polyangiitis EPGA receiving standard of care therapy including… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eosinophilic Granulomatosis With Polyangiitis
- What is being tested?
- Rituximab and Azathioprine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteFrance
- Study dates
- 7 Mar 2018to 23 Sep 2024
- 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
- patients with a diagnosis of EGPA according to Lanham and/or ACR 1990 criteria and/or Revised Chapel Hill Nomenclature and/or MIRRA study inclusion criteria
- 18 years of age or more
- with newly-diagnosed EGPA or after a vasculitis flare and remission achieved within the past year
- independently of ANCA status
- within 30-360 days following achievement of vasculitis remission (corresponding to a Birmingham Vasculitis Activity Score (BVAS)=0) achieved with an induction regimen including the one used in the REOVAS trial: either CS alone or in association with CYC (total dose ranging from 4.5-10 g for patients <65 years old and from 3-10g for patients ≥65 years old) or RTX (2 x 1g (D1, D15) or 4 weekly 375 mg/m2).
- with a stable prednisone dose for 30 days or no more prednisone
Show all 10Show fewer
- after oral immunosuppressive drug cessation if started at remission.
- Patients included in the REOVAS trial and achieving remission can be included at month 12 visit if they fulfil the other criteria
- Patients able to give written informed consent prior to participation in the study.
- Affiliation with a mode of social security (profit or being entitled).
Who cannot join
- patients with GPA, MPA or other vasculitides
- patients with vasculitis not in remission defined as a BVAS >0
- acute or chronic active infections (including HIV, HBV or HCV)
- active or recent cancer ( <5 years), except basocellular carcinoma and low activity prostatic cancer controlled by hormonal treatment
- severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease
- pregnant women and lactation
Show all 20Show fewer
- patients with childbearing potential will have reliable contraception for all the duration of the study and another 12 months after. Women are considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient
- men who refuse to use effective method of contraception (condom) from the date of consent through the end of the study
- patients who had already been treated with rituximab before the last relapse/flare
- patients who have been treated with rituximab with a different induction regimen than 2 x 1g (D1, D14) or 4 weekly 375 mg/m2 infusions
- hypersensitivity to a monoclonal antibody or biologics
- contraindication to rituximab or azathioprine
- other uncontrolled diseases, including drug or alcohol abuse, severe psychiatric diseases, that could interfere with participation
- patients included in other investigational therapeutic study within the previous 3 months except in the REOVAS trial, after which patients achieving remission can be included if they fulfil the other criteria
- patients suspected not to be observant to the proposed treatments
- white blood cell count ≤4,000/mm3
- platelet count ≤100,000/mm3
- ALT or AST level >3 times the upper limit of normal
- patients not able to stop allopurinol and febuxostat which may enhance azathioprine toxicity
- patients unable to give written informed consent prior to participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MAINtenance of Remission With RITuximab Versus Azathioprine for Patients With Newly-diagnosed or Relapsing Eosinophilic Granulomatosis With Polyangiitis. A Prospective, Randomized, Controlled, Double-blind Study: the MAINRITSEG Trial
The purpose of this study is to investigate, after achievement of remission, the efficacy of rituximab compared with azathioprine maintenance therapy on duration of remission, in patients with relapsing or newly-diagnosed Eosinophilic granulomatosis with polyangiitis EPGA receiving standard of care therapy including glucocorticoid therapy reduction/withdrawal.
Read the detailed description
Rituximab, an anti-CD20 monoclonal antibody, has been shown to be as effective as cyclophosphamide to induce GPA and MPA remission, with an acceptable safety profile, leading to its registration by the FDA and EMA as remission-induction therapy in these patients.
In addition, the MAINRITSAN trial has demonstrated that 500 mg rituximab given every 6 months for 18 months was significantly more effective than azathioprine standard of care to maintain remission in patients with GPA or MPA, with a similar profile of tolerance.
EGPA patients were excluded from these trials. Long-term studies have shown that only 29% of EGPA patients achieved long-term remission and that relapses occurred in more than 40% of them, leading to high cumulative morbidity and damage. Moreover, most patients cannot be weaned off corticosteroids due to asthma and rhino-sinusal manifestations, even after vasculitis remission.
However, recent retrospective series indicated that rituximab may also be an effective remission induction and maintenance agent in refractory or relapsing EGPA. REOVAS, the first randomized controlled trial with rituximab as induction therapy in EGPA, has started within the French Vasculitis Study Group network.
The MAINRITSEG trial is a phase III, comparative, multicenter, randomized, double-blind, double-dummy and superiority trial, comparing pre-emptive low-dose rituximab-based regimen with azathioprine standard therapy, for the remission maintenance in newly-diagnosed or relapsing EGPA.
Patients, with newly diagnosed or relapsing EGPA, after achievement of remission, will be randomized in a 1:1 ratio to receive:
- Standard regimen: maintenance oral azathioprine (2 mg/kg/day) for 24 months. This control group will receive conventional therapy plus 4 infusions of placebo-rituximab (every 6 months for 18 months)
- Experimental regimen: pre-emptive 500-mg fixed-dose of rituximab every 6 months for 18 months (4 infusions). This group will receive intravenous rituximab plus orally placebo-azathioprine for 24 months.
All patients will receive standard of care therapy including glucocorticoid therapy reduction/withdrawal.
- Being tested
- Rituximab, Azathioprine, Placebo-rituximab, Placebo-azathioprine
- Keywords
- Eosinophilic granulomatosis with polyangiitis in remission, double-blind randomized controlled trial, maintenance therapy, rituximab versus azathioprine, vasculitis remission, asthma control, rhinosinusal manifestations control, glucocorticoid therapy reduction/withdrawal, steroid sparing effect, damage
- Medical subject headings
- Churg-Strauss Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
pre-emptive 500-mg fixed-dose of IV rituximab every 6 months (total duration of 18 months = 4 infusions)
AzathioprineDrug
oral tablets : 2 mg/kg/day for 24 months
Placebo-rituximabDrug
4 infusions for 18 months
Placebo-azathioprineDrug
oral tablets for 24 months
| Study group | Role | What they receive |
|---|---|---|
| Rituximab | Experimental | * pre-emptive 500-mg fixed-dose of IV rituximab every 6 months (total duration of 18 months = 4 infusions)
* plus orally placebo-azathioprine for 24 months Receives: Drug: Rituximab; Drug: Placebo-azathioprine |
| Azathioprine | Active comparator | * standard maintenance oral azathioprine therapy (2 mg/kg/day) for 24 months
* plus 4 placebo-rituximab infusions given every 6 months for 18 months Receives: Drug: Azathioprine; Drug: Placebo-rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of remission in weeks
accrued number of weeks where a patient remains in remission with BVAS=0 and prednisone dose ≤7.5 mg/day
Measured: 28 months
Secondary outcomes (21)
proportion of patients remaining in remission with a BVAS=0 and prednisone dose ≤7.5 mg/day
Measured: 28 months
Accrued number of weeks where a patient remains in remission with BVAS=0 and prednisone dose ≤4 mg/day
Measured: 28 months
proportion of patients remaining in remission with a BVAS=0 over the 28 months study period
Measured: 28 months
proportion of participants who achieved remission of vasculitis (BVAS = 0) while receiving prednisone at a dose of 4.0 mg or less per day at month 6
Measured: 6 months
proportion of participants who achieved remission of vasculitis (BVAS = 0) while receiving prednisone at a dose of 4.0 mg or less per day at month 12
Measured: 12 months
proportion of participants who achieved remission of vasculitis (BVAS = 0) while receiving prednisone at a dose of 4.0 mg or less per day at month 18
Measured: 18 months
proportion of participants who achieved remission of vasculitis (BVAS = 0) while receiving prednisone at a dose of 4.0 mg or less per day at month 28
Measured: 28 months
proportion of patients with at least one vasculitis relapse (major, minor, either)
Measured: 28 months
proportion of patients with at least one clinically significant asthma/rhino-sinusal exacerbation
defined as a worsening of asthma/rhino-sinusal disease leading to the doubling (or more) of the existing maintenance dose of corticosteroids for 3 or more days or hospital admission or an emergency department visit.
Measured: 28 months
time to first vasculitis relapse
Measured: 28 months
time to first clinically significant asthma/rhino-sinusal exacerbation
defined as a worsening of asthma/rhino-sinusal disease leading to the doubling (or more) of the existing maintenance dose of corticosteroids for 3 or more days or hospital admission or an emergency department visit.
Measured: 28 months
variation of the obstructive pulmonary disease
assessed by change of FEV1 at pulmonary function tests after use of a bronchodilator
Measured: 28 months
prednisone dose at months 6, 12, 18, 24 and 28, and area under the curve over the 28 month study period
Measured: 28 months
proportion of patients with adverse events
Measured: 28 months
proportion of patients with serious adverse events
Measured: 28 months
proportion of patients with selected severe adverse events including grade 3 or 4 adverse effects (Common Terminology Criteria for Adverse Events)
necessitating hospitalization, all cause deaths, cancers or infusion reactions (within 24 hours of infusion) that contraindicated further infusions
Measured: 28 months
number and causes of deaths over the 28 month study period
Measured: 28 months
damage assessed by the mean variation of the Vasculitis Damage Index (VDI)
Measured: 28 months
quality of life assessed by the mean variation of the SF-36
Measured: 28 months
disability assessed by the mean variation of the Health Assessment Questionnaire (HAQ)
Measured: 28 months
number of days of hospitalization
Measured: 28 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study start7 Mar 2018
- Primary completion23 Sep 2024
- Study completion23 Sep 2024
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 Eosinophilic Granulomatosis With PolyangiitisStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- French Vasculitis Study Group, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Benjamin Terrier, Study chair, National Referral Center for Rare Systemic Autoimmune Diseases - Hôpital Cochin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03164473
- Sponsor's protocol ID
- P150922
- Other IDs
- 2016-000627-53, 2016
- Acronym
- MAINRITSEG
- Status last verified
- Oct 2025
- First submitted
- 22 May 2017
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Puechal X, Pugnet G, Thoreau B, de Moreuil C, Jouneau S, Quemeneur T, Baron G, Smets P, Neel A, Le Gallou T, Noel N, Uzunhan Y, Comarmond-Ortoli C, Urbanski G, Benhamou Y, Berezne A, Mekinian A, Hamidou M, Campagne J, Abisror N, Cohen P, Guillevin L, Ravaud P, Terrier B; French Vasculitis Study Group. Rituximab vs Azathioprine for Eosinophilic Granulomatosis With Polyangiitis Maintenance Therapy: A Randomized Clinical Trial. JAMA. 2026 Oct 22:e2615278. doi: 10.1001/jama.2026.15278. Online ahead of print.
PubMed 42911562
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MAINtenance of Remission With RITuximab Versus Azathioprine for Patients With Newly-diagnosed or Relapsing Eosinophilic Granulomatosis With Polyangiitis. A Prospective, Randomized, Controlled, Double-blind Study: the MAINRITSEG Trial
- ClinicalTrials.gov ID
- NCT03164473
- Acronym / sponsor ID
- MAINRITSEG / P150922
- Keywords
- Eosinophilic granulomatosis with polyangiitis in remission, double-blind randomized controlled trial, maintenance therapy, rituximab versus azathioprine, vasculitis remission, asthma control, rhinosinusal manifestations control, glucocorticoid therapy reduction/withdrawal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- French Vasculitis Study Group, URC-CIC Paris Descartes Necker Cochin
- Study start
- 7 Mar 2018 (actual)
- Primary completion
- 23 Sep 2024 (actual)
- Study completion
- 23 Sep 2024 (actual)
- First posted
- 23 May 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.
The purpose of this study is to investigate, after achievement of remission, the efficacy of rituximab compared with azathioprine maintenance therapy on duration of remission, in patients with relapsing or newly-diagnosed Eosinophilic granulomatosis with polyangiitis EPGA receiving standard of care therapy including glucocorticoid therapy reduction/withdrawal.
Detailed description
Rituximab, an anti-CD20 monoclonal antibody, has been shown to be as effective as cyclophosphamide to induce GPA and MPA remission, with an acceptable safety profile, leading to its registration by the FDA and EMA as remission-induction therapy in these patients.
In addition, the MAINRITSAN trial has demonstrated that 500 mg rituximab given every 6 months for 18 months was significantly more effective than azathioprine standard of care to maintain remission in patients with GPA or MPA, with a similar profile of tolerance.
EGPA patients were excluded from these trials. Long-term studies have shown that only 29% of EGPA patients achieved long-term remission and that relapses occurred in more than 40% of them, leading to high cumulative morbidity and damage. Moreover, most patients cannot be weaned off corticosteroids due to asthma and rhino-sinusal manifestations, even after vasculitis remission.
However, recent retrospective series indicated that rituximab may also be an effective remission induction and maintenance agent in refractory or relapsing EGPA. REOVAS, the first randomized controlled trial with rituximab as induction therapy in EGPA, has started within the French Vasculitis Study Group network.
The MAINRITSEG trial is a phase III, comparative, multicenter, randomized, double-blind, double-dummy and superiority trial, comparing pre-emptive low-dose rituximab-based regimen with azathioprine standard therapy, for the remission maintenance in newly-diagnosed or relapsing EGPA.
Patients, with newly diagnosed or relapsing EGPA, after achievement of remission, will be randomized in a 1:1 ratio to receive:
- Standard regimen: maintenance oral azathioprine (2 mg/kg/day) for 24 months. This control group will receive conventional therapy plus 4 infusions of placebo-rituximab (every 6 months for 18 months)
- Experimental regimen: pre-emptive 500-mg fixed-dose of rituximab every 6 months for 18 months (4 infusions). This group will receive intravenous rituximab plus orally placebo-azathioprine for 24 months.
All patients will receive standard of care therapy including glucocorticoid therapy reduction/withdrawal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rituximab | Experimental | Drug: Rituximab, Drug: Placebo-azathioprine* pre-emptive 500-mg fixed-dose of IV rituximab every 6 months (total duration of 18 months = 4 infusions) * plus orally placebo-azathioprine for 24 months |
| Azathioprine | Active comparator | Drug: Azathioprine, Drug: Placebo-rituximab* standard maintenance oral azathioprine therapy (2 mg/kg/day) for 24 months * plus 4 placebo-rituximab infusions given every 6 months for 18 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- patients with a diagnosis of EGPA according to Lanham and/or ACR 1990 criteria and/or Revised Chapel Hill Nomenclature and/or MIRRA study inclusion criteria
- 18 years of age or more
- with newly-diagnosed EGPA or after a vasculitis flare and remission achieved within the past year
- independently of ANCA status
- within 30-360 days following achievement of vasculitis remission (corresponding to a Birmingham Vasculitis Activity Score (BVAS)=0) achieved with an induction regimen including the one used in the REOVAS trial: either CS alone or in association with CYC (total dose ranging from 4.5-10 g for patients <65 years old and from 3-10g for patients ≥65 years old) or RTX (2 x 1g (D1, D15) or 4 weekly 375 mg/m2).
Key exclusion criteria (20 listed)
- patients with GPA, MPA or other vasculitides
- patients with vasculitis not in remission defined as a BVAS >0
- acute or chronic active infections (including HIV, HBV or HCV)
- active or recent cancer ( <5 years), except basocellular carcinoma and low activity prostatic cancer controlled by hormonal treatment
- severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease
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 |
|---|---|---|
| Rituximabpre-emptive 500-mg fixed-dose of IV rituximab every 6 months (total duration of 18 months = 4 infusions) | Drug | Rituximab |
| Azathioprineoral tablets : 2 mg/kg/day for 24 months | Drug | Azathioprine |
| Placebo-rituximab4 infusions for 18 months | Drug | Azathioprine |
| Placebo-azathioprineoral tablets for 24 months | Drug | Rituximab |
Primary outcome
Duration of remission in weeks
Time frame: 28 months
accrued number of weeks where a patient remains in remission with BVAS=0 and prednisone dose ≤7.5 mg/day
21 secondary outcomes
proportion of patients remaining in remission with a BVAS=0 and prednisone dose ≤7.5 mg/day
Time frame: 28 months
Accrued number of weeks where a patient remains in remission with BVAS=0 and prednisone dose ≤4 mg/day
Time frame: 28 months
proportion of patients remaining in remission with a BVAS=0 over the 28 months study period
Time frame: 28 months
proportion of participants who achieved remission of vasculitis (BVAS = 0) while receiving prednisone at a dose of 4.0 mg or less per day at month 6
Time frame: 6 months
proportion of participants who achieved remission of vasculitis (BVAS = 0) while receiving prednisone at a dose of 4.0 mg or less per day at month 12
Time frame: 12 months
proportion of participants who achieved remission of vasculitis (BVAS = 0) while receiving prednisone at a dose of 4.0 mg or less per day at month 18
Time frame: 18 months
proportion of participants who achieved remission of vasculitis (BVAS = 0) while receiving prednisone at a dose of 4.0 mg or less per day at month 28
Time frame: 28 months
proportion of patients with at least one vasculitis relapse (major, minor, either)
Time frame: 28 months
proportion of patients with at least one clinically significant asthma/rhino-sinusal exacerbation
Time frame: 28 months
time to first vasculitis relapse
Time frame: 28 months
time to first clinically significant asthma/rhino-sinusal exacerbation
Time frame: 28 months
variation of the obstructive pulmonary disease
Time frame: 28 months
prednisone dose at months 6, 12, 18, 24 and 28, and area under the curve over the 28 month study period
Time frame: 28 months
proportion of patients with adverse events
Time frame: 28 months
proportion of patients with serious adverse events
Time frame: 28 months
proportion of patients with selected severe adverse events including grade 3 or 4 adverse effects (Common Terminology Criteria for Adverse Events)
Time frame: 28 months
number and causes of deaths over the 28 month study period
Time frame: 28 months
damage assessed by the mean variation of the Vasculitis Damage Index (VDI)
Time frame: 28 months
quality of life assessed by the mean variation of the SF-36
Time frame: 28 months
disability assessed by the mean variation of the Health Assessment Questionnaire (HAQ)
Time frame: 28 months
number of days of hospitalization
Time frame: 28 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 20 Nov 2025.
- Derived from this study: PubMed 42911562Puechal X, Pugnet G, Thoreau B, de Moreuil C, Jouneau S, Quemeneur T, Baron G, Smets P, Neel A, Le Gallou T, Noel N, Uzunhan Y, Comarmond-Ortoli C, Urbanski G, Benhamou Y, Berezne A, Mekinian A, Hamidou M, Campagne J, Abisror N, Cohen P, Guillevin L, Ravaud P, Terrier B; French Vasculitis Study Group. Rituximab vs Azathioprine for Eosinophilic Granulomatosis With Polyangiitis Maintenance Therapy: A Randomized Clinical Trial. JAMA. 2026 Oct 22:e2615278. doi: 10.1001/jama.2026.15278. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Benjamin Terrier study chair
National Referral Center for Rare Systemic Autoimmune Diseases - Hôpital Cochin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rituximab and Azathioprine in people with Eosinophilic Granulomatosis With Polyangiitis, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 10 inclusion and 20 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 20 Nov 2025. 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 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?
Duration of remission in weeks (time frame: 28 months). 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 NCT03164473, 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 20 Nov 2025.