Condition or disease | Intervention/treatment | Phase |
---|---|---|
Microscopic Polyangiitis (MPA) | Drug: Rituximab Drug: placebo | Phase 3 |
Microscopic polyangiitis (MPA), is a small-sized vessel necrotizing vasculitis associated with anti-neutrophils cytoplasmic antibody (ANCA). Treatment of ANCA associated vasculitis (AAV) was previously based on glucocorticoids (GC) and cyclophosphamide. It has been demonstrated in two prospective randomized trials that rituximab is as effective as cyclophosphamide in the induction treatment of GPA and severe MPA. In addition, it was shown in GPA and MPA that rituximab is superior to azathioprine as maintenance therapy.
Patients with MPA without poor prognosis factor (Five factor score (FFS)=0) have not been included in the previous studies and GC alone is considered as the reference treatment in these patients. However, as much as 50% of these patients experience relapses after a 24 months follow-up and only 40% of patients have a long lasting remission.
In the group of patients with MPA without any poor prognosis factor (FFS=0), an additional treatment with rituximab might decrease the relapse rate from 40% to 15% after an 18 months' follow-up. The efficacy and safety of this proposal must be tested.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 106 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Efficacy and Safety of Rituximab in the Treatment of Good Prognosis Microscopic Polyangiitis |
Actual Study Start Date : | October 24, 2020 |
Estimated Primary Completion Date : | April 2024 |
Estimated Study Completion Date : | April 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: Rituximab
Experimental regimen: One year Glucocorticoid treatment and Rituximab IV 1 gram on Day 1 and 15
|
Drug: Rituximab
1 gram IV on Day 1 and 15 after premedication with 100 mg méthylprednisolone, 1 gramm paracetamol and 5 mg dexchlorpheniramine
|
Placebo Comparator: Rituximab-Placebo
Standard regimen: One-year Glucocorticoid treatment and Placebo-Rituximab IV on Day 1 and 15
|
Drug: placebo
Placebo-Rituximab 1 gram IV on Day 1 and 15 after premedication with 100 mg méthylprednisolone, 1 gramm paracetamol and 5 mg dexchlorpheniramine
|
Failure free survival in patients with microscopic polyangiitis treated with rituximab and glucocorticoids compared to glucocorticoids alone.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patient already receiving immunosuppressant or biological agent.
Prior treatment with any of the following:
Contact: Alexis REGENT, MD | +33 1 58 41 14 55 | alexis.regent@aphp.fr | |
Contact: Eric DUFOUR | +33 1 58 41 12 11 | eric.dufour@aphp.fr |
France | |
Cochin Hospital | Recruiting |
Paris, France, 75014 | |
Contact: Alexis REGENT, MD +33 1 58 41 14 55 alexis.regent@aphp.fr | |
Contact: Luc Mouthon, MD, PhD +33 1 58 41 20 31 luc.mouthon@aphp.fr |
Study Chair: | Luc Mouthon, MD PhD | Assistance Publique - Hôpitaux de Paris |
Tracking Information | |||||||||
---|---|---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | February 18, 2019 | ||||||||
First Posted Date ICMJE | April 19, 2019 | ||||||||
Last Update Posted Date | April 19, 2021 | ||||||||
Actual Study Start Date ICMJE | October 24, 2020 | ||||||||
Estimated Primary Completion Date | April 2024 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Disease free survival rate [ Time Frame: 18 months ] Failure free survival in patients with microscopic polyangiitis treated with rituximab and glucocorticoids compared to glucocorticoids alone.
|
||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
|
||||||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Efficacy and Safety of Rituximab in the Treatment of Good Prognosis Microscopic Polyangiitis | ||||||||
Official Title ICMJE | Efficacy and Safety of Rituximab in the Treatment of Good Prognosis Microscopic Polyangiitis | ||||||||
Brief Summary | The purpose of the study is to determine wether a rituximab-based treatment compared to standard therapy (glucocorticoid alone) in patients with microscopic polyangiitis without any bad prognosis marker increases the remission and reduces the relapse free survival rate. | ||||||||
Detailed Description |
Microscopic polyangiitis (MPA), is a small-sized vessel necrotizing vasculitis associated with anti-neutrophils cytoplasmic antibody (ANCA). Treatment of ANCA associated vasculitis (AAV) was previously based on glucocorticoids (GC) and cyclophosphamide. It has been demonstrated in two prospective randomized trials that rituximab is as effective as cyclophosphamide in the induction treatment of GPA and severe MPA. In addition, it was shown in GPA and MPA that rituximab is superior to azathioprine as maintenance therapy. Patients with MPA without poor prognosis factor (Five factor score (FFS)=0) have not been included in the previous studies and GC alone is considered as the reference treatment in these patients. However, as much as 50% of these patients experience relapses after a 24 months follow-up and only 40% of patients have a long lasting remission. In the group of patients with MPA without any poor prognosis factor (FFS=0), an additional treatment with rituximab might decrease the relapse rate from 40% to 15% after an 18 months' follow-up. The efficacy and safety of this proposal must be tested. |
||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 3 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
||||||||
Condition ICMJE | Microscopic Polyangiitis (MPA) | ||||||||
Intervention ICMJE |
|
||||||||
Study Arms ICMJE |
|
||||||||
Publications * |
|
||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
106 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | April 2024 | ||||||||
Estimated Primary Completion Date | April 2024 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||||||
Sex/Gender ICMJE |
|
||||||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
|
||||||||
Listed Location Countries ICMJE | France | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03920722 | ||||||||
Other Study ID Numbers ICMJE | P170909J 2018-000637-12 ( EudraCT Number ) |
||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
|
||||||||
IPD Sharing Statement ICMJE |
|
||||||||
Responsible Party | Assistance Publique - Hôpitaux de Paris | ||||||||
Study Sponsor ICMJE | Assistance Publique - Hôpitaux de Paris | ||||||||
Collaborators ICMJE | French Vasculitis Study Group | ||||||||
Investigators ICMJE |
|
||||||||
PRS Account | Assistance Publique - Hôpitaux de Paris | ||||||||
Verification Date | April 2021 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |