Microscopic polyangiitis (MPA) Granulomatosis with polyangiitis (GPA)
Conditions
Interventions
TCZ group Week 0-16: TCZ (8mg/kg) will be administrated intravenously every 2 weeks. Week 20 and 24: TCZ (8mg/kg) will be administrated intravenously every 4 weeks. If a participant does not achiev
Sponsors
Tokyo women's medical university Institute of rheumatology
Hokkaido university hospital Saitama medical center Tokyo women'
s medical university hospital Keio university hospital Juntendo university hospital Kyorin university hospital St. Marianna university hospital Okayama university hospital Kagawa university hospital Hospital of the university of occupational and environmental health, Japan Tokyo Medical Center Touhoku University Hospital Kyusyu University Hospital Hiroshima University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Those with ANCA positive active MPA or GPA according to the diagnostic criteria of Japanese MHLW, or those with ANCA positive pauci-immune glomerulonephritis without non-renal vasculitis. They must have newly diagnosed MPA or GPA, or have a disease flare that fulfills the inclusion criteria. 2 They must be 20 years of age or older and be under 80 years old. 3 They must weigh at least 40 kg. 4 They must have active disease with BVAS v3 more than 3 with one or more of the major BVAS items. Or they must have active disease severe enough to require treatment with CY (i.e., an organ threatening disease if not treated appropriately) according to the discretion of site investigators. 5 Serum C-reactive protein level must be grater than1.0 mg/dl. 6 They must be willing to practice medically acceptable contraception until 70 days after the last administration of TCZ and until 90 days after the last administration of IVCY or AZA. 7 For female participants, they must be willing to refrain from breastfeeding throughout the trial. 8 They must be willing to comply with study procedures, including completion of all visits and treatments 9 They must be willing and able to provide informed consent.
Exclusion criteria
Exclusion criteria: Exclusion Criteria Patients who meet any of these criteria will not be enrolled in this study: Eosinophilic granulomatosis with polyangiitis or anti-glomerular basement membrane antibody disease patients. Other collagen diseases or systemic autoimmune diseases patients. Severity: limited disease according to EUVAS criteria. Those having serious lung, renal or heart disease. Those having infarction or bleeding of gastrointestinal tract or having diverticulitis.. Those having a history of severe drug allergic reactions. Those having an active infection or a deep-seated infection within 6 months of randomization. Those having active hepatitis B or a history of infection with HBV. Those having positive anti-HBs antibody or anti-HBc antibody, and HBV-DNA. Those having active hepatitis C or a history of hepatitis C. Those having an ALT or AST level greater than 2.5 times of the upper limit of normal. Those having active tuberculosis or mycosis Those having CMV antigenemia They have or have a history of malignancy, leukemia, lymphoma or lymphoproliferative disease in the past 5 years. Those having uncontrolled other disease. Those having a white blood cell count less than 4,000/mm3 or a platelet count less than 120,000/mm3. Those who have received TCZ or other biological agents. Those who were intolerant to CYC or AZA. Those who started GC or increased a dosage of GC within 4 weeks prior to enrollment. Those who started GC at or increased a dosage of GC to a prednisone-equivalent dose greater than 25mg per day between 5 and 8weeks prior to enrollment. Those who started or increased a dosage of immunosuppressive agents except for GC within 8 weeks prior to enrollment. Those who were treated with plasma exchange or IVIG within 4 weeks prior to enrollment. Those who received a live vaccine within 4 weeks prior to enrollment. Those who were enrolled in another clinical trial and received an investigational agent within 12 weeks prior to enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of participants in complete remission at week 24 after randomization. Complete remission is defined as BVAS v3 = 0 (at week 20 and 24) and daily prednisone at a dose of 7.5mg at week 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of participants maintaining complete remission (BVAS v3 = 0 and daily prednisolone at a dose of 7.5mg) during week 24 to 52 after randomization. Percentage of participants who achieved BVAS v3 = 0 at two consecutive visits during 52 weeks after randomization. Time from randomization to achieving BVAS v3 = 0 at two consecutive visits. Percentage of participants who were able to taper daily prednisolone to a dose of 7.5mg during 52 weeks after randomization. Time from randomization to tapering daily prednisolone to a dose of 7.5mg. Total dosage of prednisolone. Percentage of participants who had flare. Time from randomization to first flare. Changes of BVAS score by categories. VDI SF-36 EQ5D Safety Pharmacokinetics | — |
Countries
Japan
Contacts
Public ContactMichi Tsutsumino
Tokyo women's medical university Institute of Rheumatology
Outcome results
None listed