Ankylosing Spondylitis
Conditions
Brief summary
The primary objective of the study was to compare the efficacy of etanercept (25 mg, twice weekly) with that of placebo based on the percentage of patients who achieve the Assessment in Ankylosing Spondylitis (ASAS) response criteria (ASAS 20%) at week 12.
Interventions
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Main inclusion criteria * Diagnosis of AS (defined by Modified New York Criteria for Ankylosing Spondylitis). * Active AS (defined by the average of scores on the visual analog scale \[VAS\] of ≥ 30 for duration and intensity of morning stiffness and by 2 of the following: VAS for patient global assessment ≥ 30; average of VAS for nocturnal and total pain ≥ 30; BASFI ≥ 30 (all scores on a scale of 0 to 100). * 18 to 70 years of age. Main
Exclusion criteria
* Complete ankylosis (fusion) of spine. * Previous receipt of etanercept, antibody to tumour necrosis factor alpha (TNFα), or other TNFα inhibitors. * Use of disease-modifying antirheumatic drugs (DMARDs) other than hydroxychloroquine, sulphasalazine, or methotrexate within 4 weeks of baseline.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the efficacy of etanercept (25 mg, twice weekly) with that of placebo based on the | — |
| percentage of patients who achieved the assessment in Ankylosing Spondylitis (ASAS 20%) response criteria at week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess: 1) the safety of etanercept in this patient population; 2) the efficacy of etanercept | — |
| compared with that of placebo using the ASAS response criteria at 50% and 70% levels at week 12. | — |
Outcome results
None listed