REduCed Dose of TNFi in Patients With Ankylosing SpondyliTis (RECAST)

Sponsor
Hanyang University Seoul Hospital
Study ID
NCT05164198
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab and its biosimilars — BIOLOGICAL
    1. Active substance: Adalimumab 2. Pharmaceutical form: Prefilled syringe 3. Concentration: 100mg/mL 4. Route of administration: Subcutaneous injection
  • Biological: Etanercept and its biosimilars — BIOLOGICAL
    1. Active substance: Etanercept 2. Pharmaceutical form: Prefilled syringe 3. Concentration: 50mg/mL 4. Route of administration: Subcutaneous injection
  • Golimumab — BIOLOGICAL
    1. Active substance: Adalimumab 2. Pharmaceutical form: Prefilled syringe 3. Concentration: 100mg/mL 4. Route of administration: Subcutaneous injection
  • Infliximab biosimilar — BIOLOGICAL
    1. Active substance: Infliximab 2. Pharmaceutical form: Prefilled syringe 3. Concentration: 120mg/mL 4. Route of administration: Subcutaneous injection

Study Details

Participants maintaining stable disease activity of Ankylosing Spondylitis (AS) with standard-dose tumor necrosis factor inhibitor (TNFi) treatment will randomly split into two groups: maintaining standard-dose TNFi, versus reduced-dose TNFi. The proportion of participants not underwent flare between the two groups will be analyzed.

Key Dates

Start date
Jan 15, 2022
Status verified
Oct 2021
Primary completion
Oct 31, 2024
Completion
Oct 31, 2024

Study Design

Enrollment
448 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Open-label reduced-dose TNFi
    Participants in the experimental arm will receive one of the intervention below according to the TNFi agent used at baseline: 1. Adalimumab 40mg subcutaneous every 3 weeks (Q3W) from week 0 to week 48. 2. Etanercept 50mg subcutaneous every 10 days (Q10D) from week 0 to week 48. 3. Golimumab 50mg (100mg if a participant's body weight ≥ 100kg) subcutaneous every 5 weeks (Q5W) from week 0 to week 48. 4. Remsima SC 120mg subcutaneous every 3 weeks (Q3W) from week 0 to week 48.
  • Active Comparator: Open-label full-dose TNFi
    Participants in the comparator arm will receive one of the intervention below according to the TNFi agent used at baseline: 1. Adalimumab 40mg subcutaneous every 2 weeks (Q2W) from week 0 to week 48. 2. Etanercept 50mg subcutaneous every week (QW) from week 0 to week 48. 3. Golimumab 50mg (100mg if a participant's body weight ≥ 100kg) subcutaneous every 4 weeks (Q4W) from week 0 to week 48. 4. Remsima SC 120mg subcutaneous every 2 weeks (Q2W) from week 0 to week 48.

Primary Outcome Measure

Percentage of Participants who did not experience a flare [ Time Frame: From week 0 to week 48 ]

Central Contacts

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