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Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00307645 |
The aim of IMPROVE is to define the optimal maintenance therapy for ANCA-associated vasculitides (AASV) by comparing the AZA (standard regimen) with MMF in terms of efficacy, i.e. in preventing relapses.
HYPOTHESIS :
MMF might be more effective than azathioprine as maintenance drug in AASV patients, reducing by 50% relapse rate, with a same frequency of adverse effects
Condition | Intervention | Phase |
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ANCA Associated Systemic Vasculitis Including Wegener’s Granulomatosis and Microscopic Polyangiitis and Renal Limited Vasculitis |
Drug: Cyclophosphamide Drug: Mycophenolate mofetil Drug: Azathioprine Drug: Prednisone (and methylprednisolone) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy in ANCA Associated Systemic Vasculitis |
Estimated Enrollment: | 160 |
Study Start Date: | May 2003 |
Estimated Study Completion Date: | August 2009 |
AASV, including Wegener’s granulomatosis (WG) and microscopic polyangiitis (MPA) and renal limited vasculitis (RLV), are progressive, multisystem, autoimmune diseases which require the prescription of immunosuppressive therapy. Treatment using corticosteroids and cytotoxic drugs has been standardised (ECSYSVASTRIAL project), but relapse rate remains high and treatment-related toxicity is non negligible. The IMPROVE trial aims to reduce this relapse rate by using mycophenolate mofetil (MMF) for maintenance therapy. The potential benefit of MMF has been suggested in a published open and uncontrolled study. Patients with newly diagnosed systemic AASV will be randomly assigned to receive either MMF or reference treatment with azathioprine (AZA), once remission has been obtained with cyclophosphamide and prednisone. MMF and AZA will be continued for a total of 42 months of therapy with concomitant prednisone dose tapering. The study will last 48 months. Hence, within the last 6 months of the study duration, the patients will not receive any immunosuppressive drugs. The primary end-point will the disease-free period, taken as the period of time from remission until relapse or study end; secondary end-points will be adverse events, cumulative damage (assessed using damage score VDI) and immunosuppressive drug cumulative dose.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Inability for informed consent
France | |
Hopital Cochin | |
PARIS, France, 75679 | |
United Kingdom | |
Addenbrooke's Hospital - Departement of Medecine | |
Cambridge, United Kingdom, CB2 2SP |
Principal Investigator: | Loïc GUILLEVIN, MD,PhD | Assistance Publique - Hôpitaux de Paris |
Study ID Numbers: | P991003 |
Study First Received: | March 27, 2006 |
Last Updated: | April 7, 2006 |
ClinicalTrials.gov Identifier: | NCT00307645 History of Changes |
Health Authority: | France: Ministry of Health |
ANCA associated systemic vasculitis Maintenance therapy Azathioprine Mycophenolate mofetil |
Antimetabolites Anti-Inflammatory Agents Prednisone Immunologic Factors Methylprednisolone Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Mycophenolic Acid Antiemetics Prednisolone acetate Cyclophosphamide Neuroprotective Agents Hormones Anti-Bacterial Agents Azathioprine |
Mycophenolate mofetil Alkylating Agents Methylprednisolone Hemisuccinate Vasculitis Antineoplastic Agents, Hormonal Vascular Diseases Methylprednisolone acetate Immunosuppressive Agents Glucocorticoids Microscopic Polyangiitis Prednisolone Antineoplastic Agents, Alkylating Peripheral Nervous System Agents Antirheumatic Agents |
Anti-Inflammatory Agents Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Methylprednisolone Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Mycophenolic Acid Antiemetics Prednisolone acetate Cyclophosphamide Antibiotics, Antineoplastic Hormones |
Neuroprotective Agents Azathioprine Therapeutic Uses Mycophenolate mofetil Cardiovascular Diseases Alkylating Agents Methylprednisolone Hemisuccinate Vasculitis Antineoplastic Agents, Hormonal Gastrointestinal Agents Vascular Diseases Methylprednisolone acetate Enzyme Inhibitors Glucocorticoids Protective Agents |