Safety and Efficacy of Tofacitinib in the Treatment of NSAID Refractory Axial Spondyloarthritis:A Clinical Trial

PHASE2/PHASE3UnknownINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

September 1, 2017

Primary Completion Date

December 30, 2018

Study Completion Date

December 31, 2018

Conditions
Axial Spondyloarthritis
Interventions
DRUG

Tofacitinib

"The study subjects fulfilling the inclusion criteria will receive tofacitinib 5mg BD.~All the patients in the study group will go through disease history, clinical examination and baseline investigations. Baseline charachteristics and variables will be recorded at initiation of therapy, 4th, 12th and 24th week. Primary endpoint of efficacy will be assessed using ASAS 20 response at the end of 12 th wk. At the end of 12 th week, those patients will achieve primary endpoint will continue with the same dose and those patients who will not achieve primary endpoint will be put on tofacitinib10 mg BD. Those patients who will not respond to treatment at the end of 24 th wk will discontinue the therapy and put on alternative treatment."

Trial Locations (1)

1205

RECRUITING

Bangabandhu sheikh mujib medical university, Dhaka

Sponsors
All Listed Sponsors
collaborator

Globe pharmaceuticals Ltd, Dhaka, Bangladesh

UNKNOWN

lead

Globe Pharmaceuticals Limited

OTHER

NCT03738956 - Safety and Efficacy of Tofacitinib in the Treatment of NSAID Refractory Axial Spondyloarthritis:A Clinical Trial | Biotech Hunter | Biotech Hunter