Baricitinib in the Treatment of Refractory Axial Spondyloarthritis Patients: A Comparison With Tofacitinib

Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Study ID
NCT06114407
Phase
PHASE2
Status
Unknown

Conditions

  • Spondyloarthritis, Axial

Eligibility Criteria

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

Interventions

  • Baricitinib 2mg — DRUG
    Participants of arm 'A' will be treated with tablet baricitinib 2 mg twice daily for 12 weeks
  • Tofacitinib 5 mg — DRUG
    Participants of arm 'B' getting tablet tofacitinib 5 mg twice daily for 12 weeks will be taken as historical control arm from another study on the efficacy of tofacitinib in refractory axial spondyloarthritis

Study Details

Axial Spondylarthritis (ax-SpA) is an important cause of inflammatory back pain in young adults. Janus kinase inhibitors (JAKi) has been approved for treatment of ax-SpA. Tofacitinib and baricitinib are drugs from same family (JAKi). Baricitinib is relatively less expensive than Tofacitinib. The goal of this non-inferiority clinical trial is to learn about the efficacy of baricitinib in refractory axial spondyloarthritis ( ax-SpA) and to compare its effect with that of tofacitinib. The main questions it aims to answer are: 1. Is baricitinib 4 mg effective in refractory ax-SpA? 2. Is baricitinib non-inferior to tofacitinib in refractory ax-SpA? Participants (treatment group, 92 patients) will be treated with baricitinib 2 mg twice daily for 12 weeks. Ninety two patients getting tofacitinib 10 mg/day (comparison group) will be taken as historical control from another study on the efficacy of tofacitinib in refractory ax-SpA?

Key Dates

Start date
Oct 30, 2023
Status verified
Dec 2023
Primary completion
Jun 30, 2024
Completion
Dec 30, 2024

Study Design

Enrollment
184 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Baricitinib
    Participants of 'Baricitinib' arm will be treated with tablet baricitinib 2 mg twice daily for 12 weeks
  • Active Comparator: Tofacitinib
    Participants of 'Tofacininib' arm getting tablet tofacitinib 5 mg twice daily for 12 weeks will be taken as historical control arm from another study on the efficacy of tofacitinib in refractory axial spondyloarthritis

Primary Outcome Measure

Ankylosing Spondylitis Disease Activity Score-C Reative Protein ( ASDAS-CRP) [ Time Frame: ASDAS CRP will be assessed at baseline, 4th and 12th week ]

Central Contacts

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