Efficacy and Safety of Adalimumab Plus Medium Dose Oral Glucocorticosteroid for Refractory Behçet's Uveitis

Sponsor
Peking Union Medical College Hospital
Study ID
NCT05105347
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Uveitis

Eligibility Criteria

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

Interventions

  • Adalimumab plus different doses of oral glucocorticosteroid — DRUG
    A loading dose of 80mg adalimumab will be given subcutaneously and then change to 40mg adalimumab every two weeks. Medium dose oral glucocorticosteroid (30mg/d prednisone or equivalent) will be given to the experimental dose group and high dose oral glucocorticosteroid (60mg/d prednisone or equivalent) will be given to the high dose group.

Study Details

This study is a multi-center randomized non-inferiority study that aims to observe the short-term (3 months) efficacy and safety of adalimumab plus medium-dose glucocorticosteroid (30mg/d prednisone or equivalent) with slow tapering for recurrent Behçet's uveitis (BU) attack compared with adalimumab plus high-dose glucocorticosteroid (60mg/d prednisone or equivalent) with slow tapering.

Key Dates

Start date
Nov 10, 2021
Status verified
Oct 2021
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

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

Arms

  • Experimental: Medium dose group (Adalimumab plus medium dose oral glucocorticosteroid)
    Patients will be given adalimumab with 30mg daily prednisone or equivalent with a fixed slow tapering plan.
  • Active Comparator: High dose group (Adalimumab plus high dose oral glucocorticosteroid)
    Patients will be given adalimumab with 60mg daily prednisone or equivalent with a fixed slow tapering plan.

Primary Outcome Measure

Uveitis control [ Time Frame: 3 months ]

Central Contacts

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