Clinical Trial: Comparison Between a Long Term and a Conventional Maintenance Treatment With Rituximab

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief Summary:

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follow-up study of MAINRITSAN, up to 30% of patients experienced a relapse 38 months after the last rituximab infusion (unpublished data).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).


Detailed Summary:
Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: Vasculitis score 2003 (BVAS 2003 ) [ Time Frame: 28 months ]

Relapse free survival rates (BVAS > 0)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: March 23, 2015
Date Started: March 2015
Date Completion: January 2019
Last Updated: September 14, 2016
Last Verified: September 2016