This is a randomized, double-blind, multi-center, placebo-controlled study with two parallel treatment groups (placebo and infliximab) in subjects with ankylosing spondylitis (AS) to evaluate the efficacy of infliximab 3 mg/kg.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
76
Infliximab 3 mg/kg infusions at Weeks 0, 2, and 6 and every 8 weeks thereafter. Subjects who lose response according to a pre-specified criteria at weeks 22 or 38 visit will increase the dose of infliximab to 5 mg/kg (rounded up to the nearest vial).
Placebo infusions at Weeks 0, 2, and 6. Subjects will be evaluated at Week 12 after which they will receive infliximab 3 mg/kg at Weeks 16, 18, and 22 then every 8 weeks. Subjects who lose response according to a pre-specified criteria at weeks 22 or 38 visit will increase the dose of infliximab to 5 mg/kg (rounded up to the nearest vial).
The proportion of AS assessment responders ASAS20 (ie, a minimum 20% improvement from Baseline according to the ASAS response criteria) at Week 12.
Time frame: Week 12
Change from Baseline in the magnetic resonance imaging activity score at Week 12.
Time frame: Week 12
Change from Baseline in BASFI at Week 12 and Week 50.
Time frame: Week 12 and Week 50
Change from Baseline in BASDAI at Week 12 and Week 50.
Time frame: Week 12 and Week 50
Change from Baseline in BASGI at Week 12 and Week 50.
Time frame: Week 12 and Week 50
Change from Baseline in spinal mobility (BASMI) at Week 12 and Week 50.
Time frame: Week 12 and Week 50
Change from Baseline in spinal mobility (EDASMI) at Week 12 and Week 50.
Time frame: Week 12 and Week 50
Proportion of subjects achieving an ASAS40 at Week 12 and Week 50.
Time frame: Week 12 and Week 50
Proportion of subjects achieving an ASAS50 at Week 12 and Week 50.
Time frame: Week 12 and Week 50
Proportion of subjects achieving an ASAS70 at Week 12 and Week 50.
Time frame: Week 12 and Week 50
Change from Baseline in the physical component of the SF-36 at Week 12 and Week 50.
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Time frame: Week 12 and Week 50
Assess the treatment survival.
Time frame: From baseline to week 50
Quantify the number of subjects requiring dose titration.
Time frame: Week 22 and 38
Assess predictors of response.
Time frame: Week 12 and 50
Assess predictors of toxicity.
Time frame: 50 weeks