Risk of Tuberculous and Other Infections in Patients of Spondyloarthritis Treated With Tofacitinib in Bangladesh
Status:
Unknown status
Trial end date:
2019-12-31
Target enrollment:
Participant gender:
Summary
Treatment failure of Spondyloarthropathies (SpA) leads to marked functional disability,
higher rates of morbidity, mortality and poor quality of life. In TB endemic countries
effective and safe drugs are to be in hand to manage this group of patients. The aim of this
study will be to evaluation the risk of tuberculosis and other infections in refractory SpA
patients treated with tofacitinib. After having consent 174 adults will be enrolled. Follow
up period will be 9 months (visits 0, 1, 3, 6 and 9). Study subjects (87) will receive
tofacitinib (5 mg 12 hourly). Control patients will get etanercept (50 mg subcutaneously
every 7 days interval for 1st month then 50 mg in 15 days interval for 2nd month then 50 mg
every 21 days interval till final visit.
Treatment efficacy assessment tool will be BASDAI, ASDAS-ESR, ASDAS-CRP and ASQoL for quality
of life. Occurrences of tuberculosis and serious infection will be the primary end point of
this study. The quantitative variables like ESR, CRP, BASDAI, ASDAS-ESR, ASDAS-CRP and ASQoL
scores will be computed as mean and SD. Occurrences of TB and infection will be expressed in
number and percentage. In between groups according to data distribution, students't test or
ManWhitny U test will be done. The P value <0.05 will be considered significant. Each patient
will enjoy every right to participate or refuse or even withdraw from the study at any point
of time. Anonymity and data confidentiality will be maintained strictly. Ethical clearance
will be obtained from Institutional Review Board (IRB) of BSMMU.
The expected utility of this study will be; a) reporting on occurrence of TB and other
infections in SpA patients with tofacitinib and etanercept, b) if identified safe and
effective physician can use the agents without fear, c) for dose spacing of etanercept the
cumulative dose will be low might make the drug affordable and also reduce the risk of TB and
other infections, d) for spaced follow up schedule there will be minimized physician visit,
lab testing etc.
Phase:
Phase 4
Details
Lead Sponsor:
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh