Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-29 @ 5:50 PM
Study NCT ID:
NCT06310057
Status:
COMPLETED
Last Update Posted:
2024-03-13
First Post:
2024-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tofacitinib in the Treatment of Refractory Axial Spondyloarthritis Patients: A Dose Escalation Study
Sponsor:
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Organization:
Study Overview
Official Title:
Tofacitinib in the Treatment of Refractory Axial Spondyloarthritis Patients: A Dose Escalation Study
Status:
COMPLETED
Status Verified Date:
2024-03
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:
The goal of this clinical trial is to assess the efficacy of tofacitinib in refractory axial spodyloarthritis (ax-SpA) with dose escalation from 10mg to 15mg. Patients will start on 10mg and then divided into 2 groups (10 and 15) at 3rd month according to major improvement criteria.
The main question\[s\] it aims to answer are:
* Efficacy and safety of tofacitinib in different doses
* If escalation of tofacitinib is justified if clinical criteria is not fulfilled at 10mg
The main question\[s\] it aims to answer are:
* Efficacy and safety of tofacitinib in different doses
* If escalation of tofacitinib is justified if clinical criteria is not fulfilled at 10mg
Detailed Description:
Axial spondyloarthritis (ax-SpA) is a major cause of chronic low back pain in the young. It causes significant disability and impairs quality of life. Management of (ax-SpA) includes physical therapy along with NSAIDs, followed by TNFi or IL-17i or JAKi in refractory ax-SpA. In Bangladesh, TNFi and IL-17i are expensive, whereas Tofacitinib (JAKi) is affordable and widely used in Bangladesh. However, recent study shows that a significant number of patients, 39.4% do not meet criteria for ASDAS CRP clinically important criteria and only 26% meets the criteria for ASDAS major improvement to tofacitinib 10mg daily. 102 patients of refractory ax-SpA meeting the enrollment criteria will be taken and put on 10mg tofacitinib. Those who fail to attain ASDAS CRP major improvement criteria at 12 weeks will be put on 15mg tofacitinib and both the groups will be compared at week 24 in a dose escalation study.
No studies have been done on 15mg tofacitinib for ax-SpA, such a study will provide us ground for escalation of tofacitinib. Regarding safety issues, FDA has warned against the use of 20mg tofacitinib but not for 15mg. Baseline characteristics and variables will be recorded at initiation of therapy, 4th, 12th and 24th week. The study will take place in Rheumatology outdoor, BSMMU and Modern One Stop Arthritis Care and Research Centre, Dhaka from July 2022- April 2024. Patient's socio-demographic and clinical data will be taken in a semi-structured questionnaire. At every follow up detailed history, thorough physical examination and investigations will be done to evaluate the efficacy and adverse effects. Patients will be assessed for response, ASDAS-CRP, ASDAS-ESR, ASAS-20, BASFI, BASDAI, BASMI, ASQoL, SF-36, MASES and VAS will be noted. CBC, CRP, S. creatinine and S. ALT will be done during follow up.
No studies have been done on 15mg tofacitinib for ax-SpA, such a study will provide us ground for escalation of tofacitinib. Regarding safety issues, FDA has warned against the use of 20mg tofacitinib but not for 15mg. Baseline characteristics and variables will be recorded at initiation of therapy, 4th, 12th and 24th week. The study will take place in Rheumatology outdoor, BSMMU and Modern One Stop Arthritis Care and Research Centre, Dhaka from July 2022- April 2024. Patient's socio-demographic and clinical data will be taken in a semi-structured questionnaire. At every follow up detailed history, thorough physical examination and investigations will be done to evaluate the efficacy and adverse effects. Patients will be assessed for response, ASDAS-CRP, ASDAS-ESR, ASAS-20, BASFI, BASDAI, BASMI, ASQoL, SF-36, MASES and VAS will be noted. CBC, CRP, S. creatinine and S. ALT will be done during follow up.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: