ANCA + Vasculitides Relapsing Either Under CorticosteroidPhase 3NCT00307658

Intravenous Immunoglobulin After Relapse in Vasculitis

A Phase 3 study testing Intravenous immunoglobulins (human immunoglobulins G) in people with ANCA + Vasculitides Relapsing Either Under Corticosteroid and and Immunosuppressant Therapies or After One Year, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The aim of this study is to study the efficacy of intravenous immunoglobulins for inducing remission in patients relapsing of systemic vasculitides. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: ANCA + Vasculitides Relapsing Either Under Corticosteroid, and Immunosuppressant Therapies or After One Year, Post Treatment.
What is being tested?: Intravenous immunoglobulins (human immunoglobulins G)
Type of treatment: Injection or infusion
How many people: 40 participants
Where: 2 sitesFrance
Study dates: Mar 2001to Jul 2006
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

Wegener's granulomatosis, Microscopic polyangiitis and Churg-Strauss syndrome (satisfying ACR or chapel Hill classification) relapsing either under corticosteroid and immunosuppressant therapies or after one year post treatment
Age > 18 years old
Written informed consent

Who cannot join

Systemic vasculitides not previously treated with corticosteroid and immunosuppressant(s)
Systemic vasculitides treated with corticosteroids and immunosuppressant therapies, but with treatment cessation more than 12 months ago
Polyarteritis nodosa
Absence of poor prognosis criteria (according to FFS)
Nephritis ± renal impairment
Cancer or malignancy

Show all 10Show fewer

Psychiatric disease, lack of compliance
Age under 18 years old
Lack of written informed consent
Other vasculitides (post viral infection and skin localisation)

Trial locations and contacts

2 sites in 1 country.

France2 sites

Hopital Cochin
Paris, 75679
Hôpital COCHIN
Paris, 75679

Other trials in France

About this study

Official title: Intravenous Immunoglobulin After Relapse in Vasculitis (Microscopic Polyangiitis, Wegener's Granulomatosis and SHURG-STRAUSS Syndrome) During and After Corticosteroids and Immunosuppressant Therapies a Multicenter Prospective Trial

The aim of this study is to study the efficacy of intravenous immunoglobulins for inducing remission in patients relapsing of systemic vasculitides.

Read the detailed description

The aim of this study will assess the effects of intravenous immunoglobulin in ANCA+ vasculitides (Microscopic Polyangiitis, Wegener's granulomatosis and Churg-Strauss syndrome) who relapse under corticosteroid and immunosuppressant therapies or after one year post treatment.

Conditions: ANCA + Vasculitides Relapsing Either Under Corticosteroid, and Immunosuppressant Therapies or After One Year, Post Treatment.
Being tested: Intravenous immunoglobulins (human immunoglobulins G)
Keywords: ANCA associated Vasculitides, Relapse, intravenous Immunoglobulins, Corticosteroid, Immunosuppressant
Medical subject headings: Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intravenous immunoglobulins (human immunoglobulins G)Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

the remission rate after 9 months of therapy with intravenous immunoglobulins,
in relapsing patients with ANCA+ vasculitides (Microscopic Polyangiitis, Wegener's granulomatosis and Churg-Strauss syndrome)
during 6 months, after relapse

Secondary outcomes (1)

Safety, i.e. side-effects classified according to the WHO guidelines

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2001Jul 2006

First posted28 Mar 2006 (estimated)
Study startMar 2001
Study completionJul 2006

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 ANCA + Vasculitides Relapsing Either Under CorticosteroidStudies 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 40 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00307658
Sponsor's protocol ID: P991006
Status last verified: Apr 2003
First submitted: 27 Mar 2006
Last updated: 22 May 2006
Results posted: No

Publications

Martinez V, Cohen P, Pagnoux C, Vinzio S, Mahr A, Mouthon L, Sailler L, Delaunay C, Sadoun A, Guillevin L; French Vasculitis Study Group. Intravenous immunoglobulins for relapses of systemic vasculitides associated with antineutrophil cytoplasmic autoantibodies: results of a multicenter, prospective, open-label study of twenty-two patients. Arthritis Rheum. 2008 Jan;58(1):308-17. doi: 10.1002/art.23147.
PubMed 18163506

Study at a glance

From the registry record, last updated by the sponsor on 22 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intravenous Immunoglobulin After Relapse in Vasculitis (Microscopic Polyangiitis, Wegener's Granulomatosis and SHURG-STRAUSS Syndrome) During and After Corticosteroids and Immunosuppressant Therapies a Multicenter Prospective Trial
ClinicalTrials.gov ID: NCT00307658
Acronym / sponsor ID: P991006
Conditions: ANCA + Vasculitides Relapsing Either Under Corticosteroid, and Immunosuppressant Therapies or After One Year, Post Treatment.
Keywords: ANCA associated Vasculitides, Relapse, intravenous Immunoglobulins, Corticosteroid, Immunosuppressant
Phase: Phase 3
Study type: Interventional
Recruitment status: Terminated
Enrolment: 40 participants
Lead sponsor: Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
Study start: Mar 2001
Study completion: Jul 2006
First posted: 28 Mar 2006 (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.

The aim of this study is to study the efficacy of intravenous immunoglobulins for inducing remission in patients relapsing of systemic vasculitides.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Wegener's granulomatosis, Microscopic polyangiitis and Churg-Strauss syndrome (satisfying ACR or chapel Hill classification) relapsing either under corticosteroid and immunosuppressant therapies or after one year post treatment
Age > 18 years old
Written informed consent

Key exclusion criteria (10 listed)

Systemic vasculitides not previously treated with corticosteroid and immunosuppressant(s)
Systemic vasculitides treated with corticosteroids and immunosuppressant therapies, but with treatment cessation more than 12 months ago
Polyarteritis nodosa
Absence of poor prognosis criteria (according to FFS)
Nephritis ± renal impairment

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
Intravenous immunoglobulins (human immunoglobulins G)	Drug	–

Primary outcome

the remission rate after 9 months of therapy with intravenous immunoglobulins,
in relapsing patients with ANCA+ vasculitides (Microscopic Polyangiitis, Wegener's granulomatosis and Churg-Strauss syndrome)
during 6 months, after relapse

1 secondary outcome

Safety, i.e. side-effects classified according to the WHO guidelines

Results and safety

The study was stopped early. Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2006.
Derived from this study: PubMed 18163506Martinez V, Cohen P, Pagnoux C, Vinzio S, Mahr A, Mouthon L, Sailler L, Delaunay C, Sadoun A, Guillevin L; French Vasculitis Study Group. Intravenous immunoglobulins for relapses of systemic vasculitides associated with antineutrophil cytoplasmic autoantibodies: results of a multicenter, prospective, open-label study of twenty-two patients. Arthritis Rheum. 2008 Jan;58(1):308-17. doi: 10.1002/art.23147.

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.

Loïc GUILLEVIN, MD,PhD principal investigator

Assistance Publique - Hôpitaux de Paris

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 10 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: stopped early, as of the sponsor's last update on 22 May 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 was stopped early. Results are not available in the source record.

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?

the remission rate after 9 months of therapy with intravenous immunoglobulins,. The study lists 3 primary outcomes in all. 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 NCT00307658, 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 22 May 2006.