Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06310057
Status:
COMPLETED
Last Update Posted:
2024-03-13
First Post:
2024-03-08
Brief Title:
Tofacitinib in the Treatment of Refractory Axial Spondyloarthritis Patients A Dose Escalation Study
Sponsor:
Bangabandhu Sheikh Mujib Medical University Dhaka Bangladesh
Organization:
Bangabandhu Sheikh Mujib Medical University Dhaka Bangladesh
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 questions 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 questions 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 394 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 Patients 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 Patients 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:
None
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?:
None