Ignite Creation Date:
2024-05-06 @ 3:54 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04799262
Status:
COMPLETED
Last Update Posted:
2022-09-15
First Post:
2021-03-04
Brief Title:
Tofacitinib as a GC Sparing Agent for Polymyalgia Rheumatica
Sponsor:
RenJi Hospital
Organization:
RenJi Hospital
Study Overview
Official Title:
Phase II Study of Efficacy and Safety of Tofacitinib in Patients With Polymyalgia Rheumatica
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Glucocorticoids are the cornerstone treatment for polymyalgia rheumatica but induce adverse events The efficacy of the candidate drug Tofacitinib has not yet been demonstrated in controlled studies The aim of the study is to investigate the efficacy and safety of Tofacitinib as a glucocorticoid sparing agent in patients with polymyalgia rheumatica
Detailed Description:
A two-stage phase 2 clinical trial was conducted to test whether tofacitinib would take into effect as a glucocorticoid sparing agent in patients with polymyalgia rheumatica Tofacitinib was given at the dose of 10mg daily through the 24 weeks Patients were to receive prednisone in a dosage of 15mg daily or equivalent oral GCs at baseline and tapered to 25mg or less daily within 20 weeks The primary endpoint was the response to treatment defined as the achievement of sustained low disease activity PMR-AS7 with GC independence prednisone25mg daily or equivalent oral GCs for 4 weeks from week 20
The trial will be conducted following a two-stage Simon minimax design After 8 participants have completed their 24-week follow up there will be an interim analysis If there are 3 or more failures out of these 8 then the trial will stop with the conclusion that the study of Tofacitinib should be abandoned If there are fewer than 3 failures then the study will continue until a further 6 participants have received treatment giving a total sample size of 14 If amongst these 14 participants there are 4 or more failures then it will be concluded that further study of Tofacitinib should be abandoned If further study of the drug is not abandoned at either the interim of the final analysis then a recommendation to conduct a comparative randomized phase III trial will be made
The trial will be conducted following a two-stage Simon minimax design After 8 participants have completed their 24-week follow up there will be an interim analysis If there are 3 or more failures out of these 8 then the trial will stop with the conclusion that the study of Tofacitinib should be abandoned If there are fewer than 3 failures then the study will continue until a further 6 participants have received treatment giving a total sample size of 14 If amongst these 14 participants there are 4 or more failures then it will be concluded that further study of Tofacitinib should be abandoned If further study of the drug is not abandoned at either the interim of the final analysis then a recommendation to conduct a comparative randomized phase III trial will be made
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None