Comparison Between a Long Term and a Conventional Maintenance Treatment With Rituximab (MAINRITSAN3)
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|ClinicalTrials.gov Identifier: NCT02433522|
Recruitment Status : Unknown
Verified February 2018 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was: Active, not recruiting
First Posted : May 5, 2015
Last Update Posted : March 2, 2018
MAINRITSAN study compared Rituximab and azathioprine as maintenance therapy for ANCA-associated vasculitides. In this study, Rituximab (5 infusions at D1, D15, M6, M12, M18) was superior to azathioprine (2 mg/kg/day) to prevent relapses of AAV 28 months after the inclusion (Guillevin et al. NEJM 2014). Nevertheless, in the follow-up study of MAINRITSAN, up to 30% of patients experienced a relapse 38 months after the last rituximab infusion (unpublished data). Right now, no randomized controlled study has been carried in order to evaluate the best duration of the maintenance treatment with rituximab.
The investigators objective is to evaluate the efficacy of a long term rituximab treatment to prevent relapses of ANCA-associated vasculitis in patients in remission after a first phase of rituximab maintenance treatment.
The investigators will conduct a randomized placebo-controlled trial of a long term rituximab maintenance treatment (46 months) against a conventional maintenance treatment (18 months).
|Condition or disease||Intervention/treatment||Phase|
|ANCA-associated Vasculitides||Drug: rituximab Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||97 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Extended Follow Up of the Mainritsan 2 Study. Comparison Between a Long Term and a Conventional Maintenance Treatment With Rituximab: a Placebo- Controlled Randomized Trial|
|Actual Study Start Date :||March 31, 2015|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||September 2018|
500 mg rituximab infusion at the randomization visit and every 6 months for 18 months
500 mg rituximab infusion at the randomization visit and every 6 months for 18 months. Each infusion will be preceded by an infusion of 1000 mg paracetamol, 100 mg methylprednisolone and 5 mg dexchlorpheniramine.
Placebo Comparator: Placebo
Placebo infusion at the randomization visit and every 6 months for 18 months
- Vasculitis score 2003 (BVAS 2003 ) [ Time Frame: 28 months ]Relapse free survival rates (BVAS > 0)
- Number of adverse events, [ Time Frame: 28 months ]adverse events including infectious effects and their severity in each arm
- number of patients experiencing at least one adverse event in both arms [ Time Frame: 28 months ]
- correlation of ANCA level with the clinical events [ Time Frame: 28 months ]
- ANCA level during follow-up [ Time Frame: 28 months ]
- correlation B-Lymphocytes CD-19 level with the clinical events [ Time Frame: 28 months ]
- B-Lymphocytes CD-19 level during follow-up [ Time Frame: 28 months ]
- number of B memory cells during follow-up in both arms [ Time Frame: 28 months ]
- correlation number of B memory cells with the clinical events [ Time Frame: 28 months ]
- Number of patients with ANCA in each arm [ Time Frame: 28 months ]
- Time frame to death in both arms [ Time Frame: 28 months ]
- time frame of first minor relapse [ Time Frame: 28 months ]
- time frame of first major relapse [ Time Frame: 28 months ]"the reappearance of disease activity or worsening, with a Birmingham Vasculitis Activity Score >0, and involvement of one or more major organs, disease-related life-threatening events, or both"
- Cumulated dose of corticosteroid treatment [ Time Frame: 28 months ]
- Number and severity of damages [ Time Frame: 28 months ]
- number of of gammaglobulins [ Time Frame: 28 months ]
- Quality of life : SF36 (The Short Form (36) Health Survey) [ Time Frame: 28 months ]
- functional capacities : HAQ (Health Assessment Questionnaire ) [ Time Frame: 28 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02433522
|Paris, France, 75014|
|Study Chair:||Loic GUILLEVIN, MD-PhD||Assistance Publique - Hôpitaux de Paris|