Clinical trial of tocilizumab versus cyclophosphamide for microscopic polyangiitis and granulomatosis with polyangiitis
- Conditions
- Microscopic polyangiitis (MPA) Granulomatosis with polyangiitis (GPA)
- Registration Number
- JPRN-UMIN000024574
- Lead Sponsor
- Tokyo women's medical university Institute of rheumatology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 48
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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