VasculitisPhase 4CORTAGENCT00307671
Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years
A Phase 4 study testing prednisone, methylprednisolone,cyclophosphamides, Cyclophosphamide, Azathioprine,prednisone,methylprednisolone and Mycophenolate mofetil,methotrexate in people with Vasculitis and Wegener's Granulomatosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The aim of this trial is to lower the morbidity rate in elderly patients affected with systemic necrotizing vasculitides, by reducing mortality and improving global outcome. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Vasculitis, Wegener's Granulomatosis, Microscopic Polyangiitis
- What is being tested?
- prednisone, methylprednisolone,cyclophosphamides, Cyclophosphamide, Azathioprine,prednisone,methylprednisolone and Mycophenolate mofetil,methotrexate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2005to Jul 2011
- Phase
- Phase 4
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Newly diagnosed WG, MPA, PAN without HBV infection, or CSS
- Patients can be still be enrolled within 1 month after starting corticosteroids if prescribed according to protocol.
- within or after the 65th of anniversary
- Age ≥ 65 years
Who cannot join
- Any cytotoxic drug within previous year
- Co-existence of another systemic autoimmune disease, e.g., SLE, RA
- Virus-associated vasculitides
- HIV positivity
- Malignancy (usually excluded unless approved by the trial coordinator)
- Age < 65 years
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years Comparison of Two Strategies Combining Steroids With or Without Immunosuppressants
The aim of this trial is to lower the morbidity rate in elderly patients affected with systemic necrotizing vasculitides, by reducing mortality and improving global outcome.
Read the detailed description
Systemic necrotizing vasculitides are severe diseases associated with a high mortality rate in elderly.
Although corticosteroids and immunosuppressants are effective, they can induce some side-effects, especially in this latter patients.
Preliminary data indicate that systemic necrotizing vasculitides (SNV) occurring in patients over 65 years have a poorer outcome than in younger patients (mortality rate of 76 % vs. 69 % at 5 years, respectively) and that 68,4 % of the elderly experience treatment side-effects.
In this trial, patients will be randomly assigned to receive either low doses of corticosteroids systematically in combination with immunosuppressants (CYC then azathioprine) or usual regimen with corticosteroids combined with immunosuppressants only if factor(s) of poor prognosis is present (this latter regimen relying on previously published therapeutic guidelines).
- Conditions
- Vasculitis, Wegener's Granulomatosis, Microscopic Polyangiitis, Churg-Strauss Syndrome, Polyarteritis Nodosa
- Being tested
- prednisone, methylprednisolone,cyclophosphamides, Cyclophosphamide, Azathioprine,prednisone,methylprednisolone, Mycophenolate mofetil,methotrexate
- Keywords
- Systemic necrotizing vasculitides, corticosteroids; azathioprine; mycophenolate mofetil;, cyclophosphamide, Elderly patients, Randomized controlled trial
- Medical subject headings
- Vasculitis, Granulomatosis with Polyangiitis, Microscopic Polyangiitis, Churg-Strauss Syndrome, Polyarteritis Nodosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prednisone, methylprednisolone,cyclophosphamidesDrug
treatment conventional
Cyclophosphamide, Azathioprine,prednisone,methylprednisoloneDrug
reduction dose
Mycophenolate mofetil,methotrexateDrug
in the treatment conventional and in the reduction dose
| Study group | Role | What they receive |
|---|---|---|
| A | Other | conventional treatment Receives: Drug: prednisone, methylprednisolone,cyclophosphamides; Drug: Mycophenolate mofetil,methotrexate |
| B | Experimental | reduction dose Receives: Drug: Cyclophosphamide, Azathioprine,prednisone,methylprednisolone; Drug: Mycophenolate mofetil,methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of side effects (morbidity)
Measured: at 3 years
Secondary outcomes (5)
Survival
Measured: at 3 years
Efficacy of treatment (remission rate)
Measured: during the 3 years
Relapse rate
Measured: at 3 years
Cumulative dose exposure to OCS and AZA
Measured: at 3 years
Cumulative BVAS (AUC), VDI, HAQ-DI, SF-36 values
Measured: at 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2006 (estimated)
- Study startJul 2005
- Primary completionJul 2011
- Study completionJul 2011
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 VasculitisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Loïc Guillevin, MD,PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00307671
- Sponsor's protocol ID
- P040425
- Acronym
- CORTAGE
- Status last verified
- Mar 2007
- First submitted
- 27 Mar 2006
- Last updated
- 12 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pagnoux C, Quemeneur T, Ninet J, Diot E, Kyndt X, de Wazieres B, Reny JL, Puechal X, le Berruyer PY, Lidove O, Vanhille P, Godmer P, Fain O, Blockmans D, Bienvenu B, Rollot F, Ait el Ghaz-Poignant S, Mahr A, Cohen P, Mouthon L, Perrodeau E, Ravaud P, Guillevin L; French Vasculitis Study Group. Treatment of systemic necrotizing vasculitides in patients aged sixty-five years or older: results of a multicenter, open-label, randomized controlled trial of corticosteroid and cyclophosphamide-based induction therapy. Arthritis Rheumatol. 2015 Apr;67(4):1117-27. doi: 10.1002/art.39011.
PubMed 25693055
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years Comparison of Two Strategies Combining Steroids With or Without Immunosuppressants
- ClinicalTrials.gov ID
- NCT00307671
- Acronym / sponsor ID
- CORTAGE / P040425
- Conditions
- Vasculitis, Wegener's Granulomatosis, Microscopic Polyangiitis, Churg-Strauss Syndrome, Polyarteritis Nodosa
- Keywords
- Systemic necrotizing vasculitides, corticosteroids; azathioprine; mycophenolate mofetil;, cyclophosphamide, Elderly patients, Randomized controlled trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- 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 trial is to lower the morbidity rate in elderly patients affected with systemic necrotizing vasculitides, by reducing mortality and improving global outcome.
Detailed description
Systemic necrotizing vasculitides are severe diseases associated with a high mortality rate in elderly.
Although corticosteroids and immunosuppressants are effective, they can induce some side-effects, especially in this latter patients.
Preliminary data indicate that systemic necrotizing vasculitides (SNV) occurring in patients over 65 years have a poorer outcome than in younger patients (mortality rate of 76 % vs. 69 % at 5 years, respectively) and that 68,4 % of the elderly experience treatment side-effects.
In this trial, patients will be randomly assigned to receive either low doses of corticosteroids systematically in combination with immunosuppressants (CYC then azathioprine) or usual regimen with corticosteroids combined with immunosuppressants only if factor(s) of poor prognosis is present (this latter regimen relying on previously published therapeutic guidelines).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Other | Drug: prednisone, methylprednisolone,cyclophosphamides, Drug: Mycophenolate mofetil,methotrexateconventional treatment |
| B | Experimental | Drug: Cyclophosphamide, Azathioprine,prednisone,methylprednisolone, Drug: Mycophenolate mofetil,methotrexatereduction dose |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Newly diagnosed WG, MPA, PAN without HBV infection, or CSS
- Patients can be still be enrolled within 1 month after starting corticosteroids if prescribed according to protocol.
- within or after the 65th of anniversary
- Age ≥ 65 years
Key exclusion criteria (7 listed)
- Any cytotoxic drug within previous year
- Co-existence of another systemic autoimmune disease, e.g., SLE, RA
- Virus-associated vasculitides
- HIV positivity
- Malignancy (usually excluded unless approved by the trial coordinator)
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 |
|---|---|---|
| prednisone, methylprednisolone,cyclophosphamidestreatment conventional | Drug | A |
| Cyclophosphamide, Azathioprine,prednisone,methylprednisolonereduction dose | Drug | B |
| Mycophenolate mofetil,methotrexatein the treatment conventional and in the reduction dose | Drug | A, B |
Primary outcome
Number of side effects (morbidity)
Time frame: at 3 years
5 secondary outcomes
Survival
Time frame: at 3 years
Efficacy of treatment (remission rate)
Time frame: during the 3 years
Relapse rate
Time frame: at 3 years
Cumulative dose exposure to OCS and AZA
Time frame: at 3 years
Cumulative BVAS (AUC), VDI, HAQ-DI, SF-36 values
Time frame: at 3 years
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 2011.
- Derived from this study: PubMed 25693055Pagnoux C, Quemeneur T, Ninet J, Diot E, Kyndt X, de Wazieres B, Reny JL, Puechal X, le Berruyer PY, Lidove O, Vanhille P, Godmer P, Fain O, Blockmans D, Bienvenu B, Rollot F, Ait el Ghaz-Poignant S, Mahr A, Cohen P, Mouthon L, Perrodeau E, Ravaud P, Guillevin L; French Vasculitis Study Group. Treatment of systemic necrotizing vasculitides in patients aged sixty-five years or older: results of a multicenter, open-label, randomized controlled trial of corticosteroid and cyclophosphamide-based induction therapy. Arthritis Rheumatol. 2015 Apr;67(4):1117-27. doi: 10.1002/art.39011.
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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.
Loïc Guillevin, MD,PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing prednisone, methylprednisolone,cyclophosphamides, Cyclophosphamide, Azathioprine,prednisone,methylprednisolone and Mycophenolate mofetil,methotrexate in people with Vasculitis and Wegener's Granulomatosis, 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 4 inclusion and 7 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 2011. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Number of side effects (morbidity) (time frame: at 3 years). 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 NCT00307671, 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 12 Sep 2011.