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New combo therapy aims to tame rare blood vessel disease

NCT ID NCT00647166

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

114 people

The number who actually took part.

Start date

May 2008

Finished

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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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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

  • Hopital Cochin Pôle de Médecine UF Médecine Interne

    Paris, 75014, France