| Item | Content |
|---|
| Research project name |
Practical Research Project for Rare / Intractable Diseases |
| Study title |
Strategic study on development of evidence for medical care for intractable vasculitis |
| Name of principal investigator |
Yoshihiro Arimura |
| Name of institution of the principal investigator |
Kyorin University Faculty of Medicine |
| Target disease |
Microscopic polyangiitis, granulomatosis with polyangiitis |
| Registry name |
A prospective cohort study on rituximab in ANCA-associated vasculitis |
| Purpose of registry |
Epidemiological study, Sample collection, Investigation of biomarkers
|
| Overview of registry |
Recently, the efficacy of rituximab (RTX) for GPA and MPA in randomized controlled studies in Europe and the United States was reported, and RTX for GPA and MPA was listed on the insurance price list in Japan. However, no clinical trial of RTX for the above vasculitis has been conducted in Japan and there is a paucity of information on RTX in treatment of vasculitis. Therefore, this study was initiated to investigate efficacy and safety of RTX for MPA and GPA and to further improve treatment outcome in Japan. All MPA and GPA patients receiving RTX at institutions with the members and collaborators of the study participating in the “study group for intractable vasculitis” and its related institutions are registered. The information including (1) Demographic characteristics and disease characteristics of MPA and GPA; (2) vital and functional prognoses; (3) details of remission induction therapy; (4) induction rates; (5) details of remission maintenance therapy (6) remission maintenance effect (occurrence rate within two years after the start of the treatment); (7) efficacy of treatment; (8) safety of treatment; and (9) benefit-risk balance will be clarified, and their roles for diagnosis with biomarkers, prediction of efficacy and safety, and determination of degree of severity will be investigated.
|
| Research item |
Sex, Date of birth, Past medical history, Complication, History of treatment, Laboratory data, QOL, Prognosis, Cause of death, Others (Disease activity score, organ damage score)
|
| Contact |
Masatoshi Hariya |
| E-mail address |
harigai.masayoshi●twmu.ac.jp |
| Registry URL |
|
* If the E-mail address is shown, replace "●" with "@", please.
