MPAPhase 3CHUSPAN2NCT00647166
Association Corticosteroid/Azathioprine in Microscopic Polyangiitis/ Polyarteritis Nodosa or Eosinophilic Granulomatosis With Polyangiitis (Churg Strauss Syndrome)
A Phase 3 study testing corticosteroid and azathioprine in people with MPA and PAN or EGPA With FFS=0, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
To determine whether a combination of corticosteroids and azathioprine can achieve a higher remission rate and a lower subsequent relapse rate in patients with newly-diagnosed microscopic polyangiitis, polyarteritis nodosa or eosinophilic granulomatosis with polyangiitis (Churg Strauss syndrome) with no poor prognosis… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MPA, PAN or EGPA With FFS=0, At Diagnosis or Within the First 15 Days Following Initiation of Corticosteroids
- What is being tested?
- corticosteroid and azathioprine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteFrance
- Study dates
- May 2008to Apr 2015
- 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
- male or female patients
- aged over 18 years
- new diagnosis of microscopic polyangiitis, polyarteritis nodosa or eosinophilic granulomatosis with polyangiitis (Churg Strauss syndrome), satisfying ACR 1990 and/or Chapel Hill Nomenclature criteria (positive biopsy is not mandatory providing those criteria are fulfilled)
- with no factor of poor prognosis according to the French five factors score (FFS=0)
- at diagnosis or within the first 21 days following initiation of corticosteroids
- signed information and consent form
- patients covered by Health Insurance
- having had a baseline physical examination
Who cannot join
- patients with microscopic polyangiitis, polyarteritis nodosa or eosinophilic granulomatosis with polyangiitis (Churg Strauss syndrome) with one or more factor(s) of poor prognosis according to the French five factors score (FFS ≥ 1)
- patients with polyarteritis nodosa with ANCA, not satisfying the criteria for microscopic polyangiitis
- patients with clinically overt alveolar hemorrhage or respiratory distress syndrome
- patient treated with corticosteroids for more than 15 days or already receiving another immunosuppressant
- relapsing vasculitis
- other vasculitis, especially secondary vasculitides
Show all 14Show fewer
- vasculitis secondary or associated with a viral infection, such as hepatitis B or C virus, or HIV
- malignancy
- pregnancy and breast feeding,women of child-bearing age not willing or with contra-indication to receive contraception
- contra-indication to any of the study agents
- need to continue allopurinol for those patients taking allopurinol
- consent deny or inability to receive information and give consent
- participation in another concomitant therapeutic trial
- no affiliation to any of the general French health care system
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a New Treatment Strategy for Patients With Microscopic Polyangiitis, Polyarteritis Nodosa or Eosinophilic Granulomatosis With Polyangiitis (Churg Strauss Syndrome) Without Poor Prognosis Factors
To determine whether a combination of corticosteroids and azathioprine can achieve a higher remission rate and a lower subsequent relapse rate in patients with newly-diagnosed microscopic polyangiitis, polyarteritis nodosa or eosinophilic granulomatosis with polyangiitis (Churg Strauss syndrome) with no poor prognosis factor (FFS=0), and without significantly increasing the rate of adverse events, as compared to corticosteroids alone. The study hypothesis is a reduction of the absolute risk of treatment failure or relapse within the first 24 months following initiation of therapy of least 25%.
Read the detailed description
Patients with new diagnosis of 1) microscopic polyangiitis, polyarteritis nodosa or eosinophilic granulomatosis with polyangiitis (Churg Strauss syndrome) and 2) without any factor of poor prognosis according to the French five factors score (FFS - including creatininemia >140µmol/l, proteinuria >1 g/24 h, specific gastro-intestinal involvement, specific cardiomyopathy, and CNS involvement) can be included at diagnosis or within the first 15 days following initiation of corticosteroids. Treatment is randomly assigned, centrally, and received in a double-blinded fashion. It consists in a combination of azathioprine (2 mg/kg/day) and corticosteroids (starting at 1 mg/kg/day for 3 weeks then progressively tapered over a mean of 50 weeks, varying according to patient's weight) or, for the control group, the same corticosteroid therapy plus placebo. Duration of azathioprine or placebo is 12 months, and patients are followed for 12 additional months, yielding in a total duration of the protocol of 24 months after entry for each patient. End point is the number of patients who achieve sustained remission and who do not suffer a relapse during the 24 months of the study protocol. Based on the results of the early CHUSPAN trial for similar patients treated with corticosteroids alone, the cumulative rate of failures and relapses can be estimated at 40% at 24 months. The primary hypothesis of the CHUSPAN 2 is a reduction by at least 25% for the rate of this combined parameter of remission-treatment failure and relapse at 24 months. Based on this hypothesis, using a bilateral test, with a significance level of 5%, a beta level of 80% and an estimated 5% of lost-of-follow-up, 104 patients must be included. Secondary end points include the initial remission rate (independently of subsequent relapses), rate of adverse events and their severity according to the WHO toxicity grading system, number of deaths, number of patients who could not be weaned of corticosteroids, area under the curve for corticosteroids, and different scales, such as BVAS (activity of the disease), VDI (damage), HAQ, SF36, ADL and the evaluation of the need for health care facilities.
- Conditions
- MPA, PAN or EGPA With FFS=0, At Diagnosis or Within the First 15 Days Following Initiation of Corticosteroids
- Being tested
- corticosteroid and azathioprine, corticosteroid and placebo
- Keywords
- Vasculitis, Polyarteritis nodosa (PAN), Microscopic polyangiitis (MPA), Eosinophilic granulomatosis with polyangiitis (EGPA), Churg Strauss syndrome (CSS), Azathioprine
- Medical subject headings
- Polyarteritis Nodosa, Vasculitis, Microscopic Polyangiitis, Churg-Strauss Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
corticosteroid and azathioprineDrug
- Corticosteroid 1 mg/kg/day with a conventional decrease dose
- Azathioprine : 2 mg/kg/day during one year in 2 to 3 times a day by oral route
corticosteroid and placeboDrug
- Corticosteroid 1 mg/kg/day with a conventional decrease dose
- Placebo : 2 mg/kg/day during one year in 2 to 3 times a day by oral route
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Drug: corticosteroid and azathioprine Receives: Drug: corticosteroid and azathioprine |
| 2 | Placebo comparator | Drug: corticosteroid and placebo Receives: Drug: corticosteroid and placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
combined rate of remission-treatment failures and minor or major relapses at 24 months
Measured: 24 months
Secondary outcomes (10)
initial remission rate (independently of subsequent relapse)
Measured: 24 months
number of patients who have a minor or major relapse
Measured: 24 months
number of serious treatment-related adverse effects
Measured: 24 months
number of patients with at least one treatment-related adverse effect
Measured: 24 months
severity of treatment-related effects according to the WHO toxicity grading system (grades 1 to 4; grades 3 and 4 for the severity)
Measured: 24 months
number of deaths and causes
Measured: 24 months
number of patients who could not be weaned of corticosteroids and dose required
Measured: 24 months
area under the curve for corticosteroids
Measured: 24 months
different scales, such as BVAS (activity of the disease), VDI (damage), HAQ, SF36, ADL and the evaluation of the need for health care facilities.
Measured: 24 months
number of flares with or without asthma and/or eosinophilia (only for EGPA analysis)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2008 (estimated)
- Study startMay 2008
- Primary completionMar 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MPAStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Loic Guillevin, MD, PhD, Study director, French Vasculitis Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00647166
- Sponsor's protocol ID
- P 060243
- Acronym
- CHUSPAN2
- Status last verified
- Sep 2025
- First submitted
- 26 Mar 2008
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Puechal X, Pagnoux C, Baron G, Quemeneur T, Neel A, Agard C, Lifermann F, Liozon E, Ruivard M, Godmer P, Limal N, Mekinian A, Papo T, Ruppert AM, Bourgarit A, Bienvenu B, Geffray L, Saraux JL, Diot E, Crestani B, Delbrel X, Sailler L, Cohen P, Le Guern V, Terrier B, Groh M, Le Jeunne C, Mouthon L, Ravaud P, Guillevin L; French Vasculitis Study Group. Adding Azathioprine to Remission-Induction Glucocorticoids for Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss), Microscopic Polyangiitis, or Polyarteritis Nodosa Without Poor Prognosis Factors: A Randomized, Controlled Trial. Arthritis Rheumatol. 2017 Nov;69(11):2175-2186. doi: 10.1002/art.40205. Epub 2017 Oct 15.
PubMed 28678392Puechal X, Pagnoux C, Baron G, Lifermann F, Geffray L, Quemeneur T, Saraux JL, Wislez M, Cottin V, Ruivard M, Limal N, Aouba A, Bonnotte B, Neel A, Agard C, Cohen P, Terrier B, Le Jeunne C, Mouthon L, Ravaud P, Guillevin L; French Vasculitis Study Group investigators. Non-severe eosinophilic granulomatosis with polyangiitis: long-term outcomes after remission-induction trial. Rheumatology (Oxford). 2019 Dec 1;58(12):2107-2116. doi: 10.1093/rheumatology/kez139.
PubMed 31056661
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a New Treatment Strategy for Patients With Microscopic Polyangiitis, Polyarteritis Nodosa or Eosinophilic Granulomatosis With Polyangiitis (Churg Strauss Syndrome) Without Poor Prognosis Factors
- ClinicalTrials.gov ID
- NCT00647166
- Acronym / sponsor ID
- CHUSPAN2 / P 060243
- Conditions
- MPA, PAN or EGPA With FFS=0, At Diagnosis or Within the First 15 Days Following Initiation of Corticosteroids
- Keywords
- Vasculitis, Polyarteritis nodosa (PAN), Microscopic polyangiitis (MPA), Eosinophilic granulomatosis with polyangiitis (EGPA), Churg Strauss syndrome (CSS), Azathioprine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- May 2008
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 31 Mar 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 determine whether a combination of corticosteroids and azathioprine can achieve a higher remission rate and a lower subsequent relapse rate in patients with newly-diagnosed microscopic polyangiitis, polyarteritis nodosa or eosinophilic granulomatosis with polyangiitis (Churg Strauss syndrome) with no poor prognosis factor (FFS=0), and without significantly increasing the rate of adverse events, as compared to corticosteroids alone. The study hypothesis is a reduction of the absolute risk of treatment failure or relapse within the first 24 months following initiation of therapy of least 25%.
Detailed description
Patients with new diagnosis of 1) microscopic polyangiitis, polyarteritis nodosa or eosinophilic granulomatosis with polyangiitis (Churg Strauss syndrome) and 2) without any factor of poor prognosis according to the French five factors score (FFS - including creatininemia >140µmol/l, proteinuria >1 g/24 h, specific gastro-intestinal involvement, specific cardiomyopathy, and CNS involvement) can be included at diagnosis or within the first 15 days following initiation of corticosteroids. Treatment is randomly assigned, centrally, and received in a double-blinded fashion. It consists in a combination of azathioprine (2 mg/kg/day) and corticosteroids (starting at 1 mg/kg/day for 3 weeks then progressively tapered over a mean of 50 weeks, varying according to patient's weight) or, for the control group, the same corticosteroid therapy plus placebo. Duration of azathioprine or placebo is 12 months, and patients are followed for 12 additional months, yielding in a total duration of the protocol of 24 months after entry for each patient. End point is the number of patients who achieve sustained remission and who do not suffer a relapse during the 24 months of the study protocol. Based on the results of the early CHUSPAN trial for similar patients treated with corticosteroids alone, the cumulative rate of failures and relapses can be estimated at 40% at 24 months. The primary hypothesis of the CHUSPAN 2 is a reduction by at least 25% for the rate of this combined parameter of remission-treatment failure and relapse at 24 months. Based on this hypothesis, using a bilateral test, with a significance level of 5%, a beta level of 80% and an estimated 5% of lost-of-follow-up, 104 patients must be included. Secondary end points include the initial remission rate (independently of subsequent relapses), rate of adverse events and their severity according to the WHO toxicity grading system, number of deaths, number of patients who could not be weaned of corticosteroids, area under the curve for corticosteroids, and different scales, such as BVAS (activity of the disease), VDI (damage), HAQ, SF36, ADL and the evaluation of the need for health care facilities.
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: corticosteroid and azathioprineDrug: corticosteroid and azathioprine |
| 2 | Placebo comparator | Drug: corticosteroid and placeboDrug: corticosteroid and placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- male or female patients
- aged over 18 years
- new diagnosis of microscopic polyangiitis, polyarteritis nodosa or eosinophilic granulomatosis with polyangiitis (Churg Strauss syndrome), satisfying ACR 1990 and/or Chapel Hill Nomenclature criteria (positive biopsy is not mandatory providing those criteria are fulfilled)
- with no factor of poor prognosis according to the French five factors score (FFS=0)
- at diagnosis or within the first 21 days following initiation of corticosteroids
Key exclusion criteria (14 listed)
- patients with microscopic polyangiitis, polyarteritis nodosa or eosinophilic granulomatosis with polyangiitis (Churg Strauss syndrome) with one or more factor(s) of poor prognosis according to the French five factors score (FFS ≥ 1)
- patients with polyarteritis nodosa with ANCA, not satisfying the criteria for microscopic polyangiitis
- patients with clinically overt alveolar hemorrhage or respiratory distress syndrome
- patient treated with corticosteroids for more than 15 days or already receiving another immunosuppressant
- relapsing vasculitis
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 |
|---|---|---|
| corticosteroid and azathioprine* Corticosteroid 1 mg/kg/day with a conventional decrease dose * Azathioprine : 2 mg/kg/day during one year in 2 to 3 times a day by oral route | Drug | 1 |
| corticosteroid and placebo* Corticosteroid 1 mg/kg/day with a conventional decrease dose * Placebo : 2 mg/kg/day during one year in 2 to 3 times a day by oral route | Drug | 2 |
Primary outcome
combined rate of remission-treatment failures and minor or major relapses at 24 months
Time frame: 24 months
10 secondary outcomes
initial remission rate (independently of subsequent relapse)
Time frame: 24 months
number of patients who have a minor or major relapse
Time frame: 24 months
number of serious treatment-related adverse effects
Time frame: 24 months
number of patients with at least one treatment-related adverse effect
Time frame: 24 months
severity of treatment-related effects according to the WHO toxicity grading system (grades 1 to 4; grades 3 and 4 for the severity)
Time frame: 24 months
number of deaths and causes
Time frame: 24 months
number of patients who could not be weaned of corticosteroids and dose required
Time frame: 24 months
area under the curve for corticosteroids
Time frame: 24 months
different scales, such as BVAS (activity of the disease), VDI (damage), HAQ, SF36, ADL and the evaluation of the need for health care facilities.
Time frame: 24 months
number of flares with or without asthma and/or eosinophilia (only for EGPA analysis)
Time frame: 24 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 12 Sep 2025.
- Results publication: PubMed 28678392Puechal X, Pagnoux C, Baron G, Quemeneur T, Neel A, Agard C, Lifermann F, Liozon E, Ruivard M, Godmer P, Limal N, Mekinian A, Papo T, Ruppert AM, Bourgarit A, Bienvenu B, Geffray L, Saraux JL, Diot E, Crestani B, Delbrel X, Sailler L, Cohen P, Le Guern V, Terrier B, Groh M, Le Jeunne C, Mouthon L, Ravaud P, Guillevin L; French Vasculitis Study Group. Adding Azathioprine to Remission-Induction Glucocorticoids for Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss), Microscopic Polyangiitis, or Polyarteritis Nodosa Without Poor Prognosis Factors: A Randomized, Controlled Trial. Arthritis Rheumatol. 2017 Nov;69(11):2175-2186. doi: 10.1002/art.40205. Epub 2017 Oct 15.
- Derived from this study: PubMed 31056661Puechal X, Pagnoux C, Baron G, Lifermann F, Geffray L, Quemeneur T, Saraux JL, Wislez M, Cottin V, Ruivard M, Limal N, Aouba A, Bonnotte B, Neel A, Agard C, Cohen P, Terrier B, Le Jeunne C, Mouthon L, Ravaud P, Guillevin L; French Vasculitis Study Group investigators. Non-severe eosinophilic granulomatosis with polyangiitis: long-term outcomes after remission-induction trial. Rheumatology (Oxford). 2019 Dec 1;58(12):2107-2116. doi: 10.1093/rheumatology/kez139.
- Website of the French Vasculitis Study GroupLink provided by the sponsor.
Related trials for MPA
Recruiting
Effect of Anti-inflammatory Diet in Systemic Lupus Erythematous
Systemic Lupus Erthematosus (SLE)
RecruitingPhase 1/2
The Lowest Effective Dose of Post-Transplantation Cyclophosphamide in Combination With Sirolimus and Mycophenolate Mofetil as Graft-Versus-Host Disease Prophylaxis After Reduced Intensity Conditioning and Peripheral Blood Stem Cell Transplantation
Peripheral Blood Stem Cell Transplantation, Hematopoietic Stem Cell Transplantation
Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
Kidney Transplant Recipient
RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Not yet recruitingPhase 3
Safety and Efficacy of Secukinumab Versus Mycophenolate Mofetil in Relapsing Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (SMART)
Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)
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.
Loic Guillevin, MD, PhD study director
French Vasculitis Study Group
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 corticosteroid and azathioprine in people with MPA and PAN or EGPA With FFS=0, 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 8 inclusion and 14 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 12 Sep 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. Some participants in this study may receive a placebo. 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?
combined rate of remission-treatment failures and minor or major relapses at 24 months (time frame: 24 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 NCT00647166, which also lists 2 linked publications.
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 12 Sep 2025.