Comparison of Tofacitinib and Methotrexate in the Maintained Treatment of GPA
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|ClinicalTrials.gov Identifier: NCT04944524|
Recruitment Status : Recruiting
First Posted : June 29, 2021
Last Update Posted : July 9, 2021
|Condition or disease||Intervention/treatment||Phase|
|Granulomatosis With Polyangiitis||Drug: Tofacitinib Drug: Methotrexate||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Randomized Trial of Tofacitinib Versus Methotrexate for Maintenance Therapy in Granulomatosis With Polyangiitis|
|Actual Study Start Date :||July 1, 2021|
|Estimated Primary Completion Date :||July 1, 2024|
|Estimated Study Completion Date :||July 1, 2024|
partcipants would be given one tablet of tofacitinib (5mg per tablet), twice per day, the treatment duration will last 12 months during the whole follow-up period.
Other Name: Tof
Active Comparator: Methotrexate
partcipants would be given tablets of methotrexate (2.5mg per tablet) from the initial dose of 15mg (6 tablets) and add to the maximal and optimal dose of 20mg (8 tablets), once per week, the treatment duration will last 12 months during the whole follow-up period.
Other Name: MTX
- Relapse rate (major or minor) at 12 months [ Time Frame: From the enrollment to the the end of 12 month. ]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.)
- Time to first relapse. [ Time Frame: From the enrollment to the the end of 12 month. ]The time period from the baseline to the time when the first relapse occurred.
- Number of relapse [ Time Frame: From the enrollment to the the end of 12 month. ]Total times of relapse during the whole period of 12-month follow-up.
- Cumulative dosage of corticosteroids [ Time Frame: From the enrollment to the the end of 12 month. ]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.
- Adverse events [ Time Frame: From the enrollment to the the end of 12 month. ]All the kinds of adverse event related to the treatment and the disease itself will be recorded.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04944524
|Contact: Lindi Jiang, PhD||+8602164041990 ext firstname.lastname@example.org|
|Contact: Yun Liu, PhD||+8602164041990 ext email@example.com|
|Department of Rheumatology in Zhongshan hospital, Fudan University||Recruiting|
|Shanghai, Shanghai, China, 200032|
|Contact: Lindi Jiang, PhD +86-021-64041990 firstname.lastname@example.org|
|Study Chair:||Lindi Jiang, PhD||Fudan University|