New combo therapy aims to tame rare blood vessel disease
NCT ID NCT00647166
First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study tested whether adding azathioprine to standard corticosteroid treatment helps people with certain types of vasculitis (blood vessel inflammation) achieve remission and avoid relapses. 114 newly diagnosed patients without poor prognosis factors took part. The goal was to see if the combination therapy reduces treatment failure or relapse within two years compared to steroids alone.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- corticosteroid and azathioprine
- What this could lead to
- If successful, this could offer a more effective treatment plan for people with certain types of vasculitis, lowering the chance of the disease coming back.
- What could go wrong
- This is a completed phase 3 trial, but the results may not apply to all patients. Adding azathioprine could increase side effects without guaranteeing better outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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114 people
The number who actually took part.
- Start date
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May 2008
- Finished
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Apr 2015
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hopital Cochin Pôle de Médecine UF Médecine Interne
Paris, 75014, France