Granulomatosis With Polyangiitis Clinical Trial
Official title:
Randomized Trial of Tofacitinib Versus Methotrexate for Maintenance Therapy in Granulomatosis With Polyangiitis
The aim of this study is to identify the optimal maintenance therapy for granulomatosis with polyangiitis (GPA) by comparing the MTX (standard regimen) with Tofacitinib in terms of efficacy, i.e. in preventing relapses.
Status | Recruiting |
Enrollment | 66 |
Est. completion date | July 1, 2024 |
Est. primary completion date | July 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Patients with newly diagnosed or relapsing Granulomatosis with polyangiitis met the criteria of 1990 ACR and 2012 Chapel Hill criteria 2. Patients in disease flare have achieved remission using a treatment combining corticosteroids and IV cyclophosphamide 3. Remission is defined as a Birmingham Vasculitis Activity/ Wegener's granulomatosis (BVAS/WG) score of 0 and receiving 10 mg/day of oral prednisone (or equivalent) at least 2 weeks 4. Age 18 to 75 years 5. Written informed consent obtained before taking part in the study Exclusion Criteria: 1. Severe GPA defined as potentially organ- or life-threatening disease (i.e. alveolar haemorrhage, heart failure caused by myocarditis or pericarditis, progressive neurological symptoms, deaf, blindness, et al.) 2. Serum creatinine>120umol/L or proteinuria>1.0g/d 3. Failure to response after treatment with methotrexate or cyclophosphamide previously 4. Receipt of a JAKi therapy previously 5. Co-existence of another systemic autoimmune disease 6. Secondary vasculitis (following neoplastic disease, an infection or antithyroid drugs) 7. Malignancy or history of malignancy 8. Infection by HIV, HCV, HBV or tuberculosis 9. Severe uncontrolled cardiovascular, pulmonary, liver, gastrointestinal, endocrine, hematological, neurological, or psychiatric diseases that are not related to systemic vasculitis 10. Allergic to any of the medication (cyclophosphamide, corticosteroids, tofacitinib, methotrexate) 11. Blood dyscrasias including confirmed: Hemoglobin <9 g/dL or Hematocrit <30%; White blood cell count <3.0 x 109/L; Absolute neutrophil count <1.5 x 109/L; Platelet count <100 x 109/L; Alanine transaminase or aspartate aminotransferase or total bilirubin>1.5 upper normal limit; Estimated glomerular filtration rate<60ml/min/1.73m2 12. Any medical or psychiatric disorder which, in the investigator's opinion, may prevent the administration of treatment and patient follow-up according to the protocol, and/or which may expose the patient to a too greater risk of an adverse effect. 13. Incapacity or refusal to understand or sign the informed consent form. 14. Pregnancy, breastfeeding. |
Country | Name | City | State |
---|---|---|---|
China | Department of Rheumatology in Zhongshan hospital, Fudan University | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Zhongshan Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Relapse rate (major or minor) at 12 months | The major or minor relapse rate equals to the patients with relapse/ total participants ( A major relapse should be defined as the re-occurrence or new onset of potentially organ- or life-threatening disease activity that cannot be treated with an increase of GC alone and requires further escalation of treatment. All other relapses should be classified as minor.) | From the enrollment to the the end of 12 month. | |
Secondary | Time to first relapse. | The time period from the baseline to the time when the first relapse occurred. | From the enrollment to the the end of 12 month. | |
Secondary | Number of relapse | Total times of relapse during the whole period of 12-month follow-up. | From the enrollment to the the end of 12 month. | |
Secondary | Cumulative dosage of corticosteroids | The cumulative dosage of corticosteroids during the whole period of 12-month follow-up. The cumulative dosage = Sum of different dose of prednisone every day. | From the enrollment to the the end of 12 month. | |
Secondary | Adverse events | All the kinds of adverse event related to the treatment and the disease itself will be recorded. | From the enrollment to the the end of 12 month. |
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