Comparison Between a Long Term and a Conventional Maintenance Treatment With Rituximab

Conditions

• ANCA-associated Vasculitides

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• rituximab — DRUG
  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 — DRUG

Study Details

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study of MAINRITSAN, up to 30% of patients experienced a relapse 38 months after the last rituximab infusion (unpublished data).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

Key Dates

Start date

Mar 31, 2015

Status verified

Oct 2025

Primary completion

Aug 16, 2018

Completion

Aug 16, 2018

Study Design

Enrollment

97 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Rituximab
  500 mg rituximab infusion at the randomization visit and every 6 months for 18 months
• Placebo Comparator: Placebo
  Placebo infusion at the randomization visit and every 6 months for 18 months

Primary Outcome Measure

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