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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03920722
Recruitment Status Not yet recruiting
First Posted April 19, 2019
Last update posted April 19, 2019
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.
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.
Experimental regimen: One year Glucocorticoid treatment and Rituximab IV 1 gram on Day 1 and 15
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
Placebo-Rituximab 1 gram IV on Day 1 and 15 after premedication with 100 mg méthylprednisolone, 1 gramm paracetamol and 5 mg dexchlorpheniramine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
1. Patient (male or female) over 18 year old
2. Patient agree to participate in the study and signed written informed consent
3. Patient with MPA according to the CHCC established in 2012
4. Absence of any poor prognosis factor (modified five factor score (FFS) 1996 = 0)
5. Patient with recent onset or relapse of the disease (1 month and > 10mg/day either for
vasculitis or for any other reason.
6. Patient already receiving immunosuppressant or biological agent.
Prior treatment with any of the following:
- azathioprine, methotrexate, mycophenolate mophetil, mycophenolic acid within 4
weeks before inclusion
- alkylant agent such as cyclophosphamide within 6 months before inclusion
- anti-TNF inhibitors : infliximab within 8 weeks, adalimumab and etanercept within
2 weeks before inclusion
- anti-CD20 therapy within one year before inclusion.
7. Patient with a previous diagnosis of cancer < 5 years (except for in situ cervical cancer and skin carcinoma with R0 resection) 8. Patient with acute infections or chronic active infections (HIV, hepatitis B or C) 9. Breast feeding woman or woman refusing the use of a contraceptive method for the 18 months' duration of the study 10. Contraindication to treatment (glucocorticoids or rituximab) 11. Unable to receive written informed consent of patient. Patient unable to understand the protocol 12. Patient already in another therapeutic protocol 13. Patient without social security 14. Patient with severe cardiac failure defined as class IV in New York Heart Association classification or severe, uncontrolled cardiac disease. 15. Patients with hypersensitivity to a monoclonal antibody or biological agent. 16. Patients in a severely immunocompromised state.
Contact: Alexis REGENT, MD +33 1 58 41 14 55 email@example.com
Contact: Alexandra BRUNEAU +33 1 58 41 12 13 firstname.lastname@example.org
Assistance Publique - Hôpitaux de Paris
French Vasculitis Study Group
Study Chair: Luc Mouthon, MD PhD Assistance Publique - Hôpitaux de Paris
Guillevin L, Pagnoux C, Karras A, Khouatra C, Aumaître O, Cohen P, Maurier F, Decaux O, Ninet J, Gobert P, Quémeneur T, Blanchard-Delaunay C, Godmer P, Puéchal X, Carron PL, Hatron PY, Limal N, Hamidou M, Ducret M, Daugas E, Papo T, Bonnotte B, Mahr A, Ravaud P, Mouthon L; French Vasculitis Study Group. Rituximab versus azathioprine for maintenance in ANCA-associated vasculitis. N Engl J Med. 2014 Nov 6;371(19):1771-80. doi: 10.1056/NEJMoa1404231.
Specks U, Merkel PA, Seo P, Spiera R, Langford CA, Hoffman GS, Kallenberg CG, St Clair EW, Fessler BJ, Ding L, Viviano L, Tchao NK, Phippard DJ, Asare AL, Lim N, Ikle D, Jepson B, Brunetta P, Allen NB, Fervenza FC, Geetha D, Keogh K, Kissin EY, Monach PA, Peikert T, Stegeman C, Ytterberg SR, Mueller M, Sejismundo LP, Mieras K, Stone JH; RAVE-ITN Research Group. Efficacy of remission-induction regimens for ANCA-associated vasculitis. N Engl J Med. 2013 Aug 1;369(5):417-27. doi: 10.1056/NEJMoa1213277.
Stone JH, Merkel PA, Spiera R, Seo P, Langford CA, Hoffman GS, Kallenberg CG, St Clair EW, Turkiewicz A, Tchao NK, Webber L, Ding L, Sejismundo LP, Mieras K, Weitzenkamp D, Ikle D, Seyfert-Margolis V, Mueller M, Brunetta P, Allen NB, Fervenza FC, Geetha D, Keogh KA, Kissin EY, Monach PA, Peikert T, Stegeman C, Ytterberg SR, Specks U; RAVE-ITN Research Group. Rituximab versus cyclophosphamide for ANCA-associated vasculitis. N Engl J Med. 2010 Jul 15;363(3):221-32. doi: 10.1056/NEJMoa0909905.
Jones RB, Tervaert JW, Hauser T, Luqmani R, Morgan MD, Peh CA, Savage CO, Segelmark M, Tesar V, van Paassen P, Walsh D, Walsh M, Westman K, Jayne DR; European Vasculitis Study Group. Rituximab versus cyclophosphamide in ANCA-associated renal vasculitis. N Engl J Med. 2010 Jul 15;363(3):211-20. doi: 10.1056/NEJMoa0909169.
Samson M, Puéchal X, Devilliers H, Ribi C, Cohen P, Bienvenu B, Ruivard M, Terrier B, Pagnoux C, Mouthon L, Guillevin L; French Vasculitis Study Group (FVSG). Long-term follow-up of a randomized trial on 118 patients with polyarteritis nodosa or microscopic polyangiitis without poor-prognosis factors. Autoimmun Rev. 2014 Feb;13(2):197-205. doi: 10.1016/j.autrev.2013.10.001. Epub 2013 Oct 23.