Risk of Tuberculous and Other Infections in Patients of Spondyloarthritis Treated With Tofacitinib in Bangladesh

Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Study ID
NCT03504072
Phase
PHASE4
Status
Unknown

Conditions

  • Spondyloarthritis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tofacitinib 5 mg, — DRUG
    tofacitinib 5 mg 12 hourly daily for 9 months
  • Etanercept — DRUG
    Etanercept 50 mg sc every 7 days interval in 1st month, every 15 days interval in 2nd month and then every 21 days interval from 3rd month onward upto 9 months

Study Details

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.

Key Dates

Start date
Jan 16, 2018
Status verified
Apr 2018
Primary completion
Jun 30, 2019
Completion
Dec 31, 2019

Study Design

Enrollment
174 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Tofacitinib 5mg
    tofacitinib 5 mg 12 hourly daily for 9 months. Evaluation schedule will be baseline, 1st month, 3rd months and 3 monthly for 9 months. relevant investigations will be done at each visit. occurrence of tuberculosis and infections will be recorded at follow up visits.
  • Active Comparator: Etanercept 50 mg
    Etanercept 50 mg subcutaneously every 7 days interval for 1st month then, Etanercept 50 mg in 15 days interval for 2nd month then 50 mg every 21 days interval for 9 months. Occurrence of tuberculosis and infections will be recorded at follow up visits.

Primary Outcome Measure

Occurrence of Tuberculosis [ Time Frame: 9th months ]

Central Contacts

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