Ankylosing Spondylitis
Conditions
Keywords
Ankylosing Spondylitis, infusion
Brief summary
A study of the safety and efficacy of Infliximab (Remicade) versus placebo in subjects with Ankylosing Spondylitis
Detailed description
This is a clinical research study that will determine if there is a reduction in the signs and symptoms (such as back pain and stiffness) of patients with ankylosing spondylitis with infliximab therapy. This study will also study the safety of infliximab in patients with ankylosing spondylitis. The effect of infliximab on physical function, damage to joints and the quality of life in patients with ankylosing spondylitis will also be studied. Subjects received infusions of either placebo at weeks 0, 2, 6, 12, 18 and 5 mg/kg infliximab at weeks 24, 26, 30 and every 6 weeks through week 96, or 5 mg/kg infliximab at weeks 1, 2, 6, 12, 18 and every 6 weeks through week 96
Interventions
DRUGinfliximab
Sponsors
Centocor BV
Centocor, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have had a diagnosis of definite Akylosing Spondylitis for at least 3 months prior to screening * Have active disease with spinal pain * receiving or intolerant to standard anti-inflammatory agents
Exclusion criteria
* Have Rheumatoid Arthritis, systemic lupus erythematosus, or other inflammatory rheumatic disease * Have a documented history of fibromyalgia * Have total ankylosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study was the proportion of subjects who achieved an ASAS 20 response at week 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| The change from baseline in BASFI at week 24, the proportion of subjects who achieved an AS major clinical response at week 24, and the change from baseline in the physical component summary score of the SF-36 at week 24 | — |
Outcome results
None listed