Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years - Full Text View

Sponsored by:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00307671

Purpose

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.

Condition	Intervention	Phase
Vasculitis Wegener's Granulomatosis Microscopic Polyangiitis Churg-Strauss Syndrome Polyarteritis Nodosa	Drug: prednisone, methylprednisolone,cyclophosphamides Drug: Cyclophosphamide, Azathioprine,prednisone,methylprednisolone Drug: Mycophenolate mofetil,methotrexate	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years Comparison of Two Strategies Combining Steroids With or Without Immunosuppressants

Resource links provided by NLM:

MedlinePlus related topics: Vasculitis Wegener's Granulomatosis

Drug Information available for: Cyclophosphamide Prednisone Methotrexate Azathioprine sodium salt Methylprednisolone Mycophenolate mofetil hydrochloride Mycophenolate Mofetil Azathioprine

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

Number of side effects (morbidity) [ Time Frame: at 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Survival [ Time Frame: at 3 years ] [ Designated as safety issue: Yes ]
Efficacy of treatment (remission rate) [ Time Frame: during the 3 years ] [ Designated as safety issue: Yes ]
Relapse rate [ Time Frame: at 3 years ] [ Designated as safety issue: Yes ]
Cumulative dose exposure to OCS and AZA [ Time Frame: at 3 years ] [ Designated as safety issue: Yes ]
Cumulative BVAS (AUC), VDI, HAQ-DI, SF-36 values [ Time Frame: at 3 years ] [ Designated as safety issue: No ]

Enrollment:	108
Study Start Date:	July 2005
Estimated Study Completion Date:	July 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A conventional treatment	Drug: prednisone, methylprednisolone,cyclophosphamides treatment conventional Drug: Mycophenolate mofetil,methotrexate in the treatment conventional and in the reduction dose
B: Experimental reduction dose	Drug: Cyclophosphamide, Azathioprine,prednisone,methylprednisolone reduction dose Drug: Mycophenolate mofetil,methotrexate in the treatment conventional and in the reduction dose

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).

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00307671

Locations

France
Hôpital Cochin
Paris, France, 75679

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

Loïc Guillevin, MD,PhD

Assistance Publique - Hôpitaux de Paris

More Information

No publications provided

Responsible Party:	delegation clinical research ( Myriem CARRIER )
Study ID Numbers:	P040425, AOM04008
Study First Received:	March 27, 2006
Last Updated:	February 15, 2008
ClinicalTrials.gov Identifier:	NCT00307671 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Systemic necrotizing vasculitides
corticosteroids; azathioprine; mycophenolate mofetil;
cyclophosphamide
Elderly patients
Randomized controlled trial

Study placed in the following topic categories:

Anti-Inflammatory Agents
Prednisone
Methylprednisolone
Hormone Antagonists
Mycophenolic Acid
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Hormones
Mycophenolate mofetil
Methotrexate
Kidney Diseases
Methylprednisolone Hemisuccinate
Lung Diseases, Interstitial
Antineoplastic Agents, Hormonal
Glucocorticoids

Microscopic Polyangiitis
Folic Acid
Polyarteritis Nodosa
Lung Diseases
Antimetabolites
Immunologic Factors
Churg-Strauss Syndrome
Folate
Prednisolone acetate
Cyclophosphamide
Neuroprotective Agents
Vitamin B9
Anti-Bacterial Agents
Azathioprine
Urologic Diseases

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Prednisone
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Methylprednisolone
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Mycophenolic Acid
Antiemetics
Hormones
Pathologic Processes
Therapeutic Uses
Abortifacient Agents
Mycophenolate mofetil
Methotrexate

Cardiovascular Diseases
Kidney Diseases
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Methylprednisolone Hemisuccinate
Lung Diseases, Interstitial
Antineoplastic Agents, Hormonal
Abortifacient Agents, Nonsteroidal
Glucocorticoids
Lung Diseases
Polyarteritis Nodosa
Antimetabolites
Immunologic Factors
Churg-Strauss Syndrome
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 11, 2009