Ankylosing Spondylitis
Conditions
Brief summary
This study will assess the efficacy of etanercept for the treatment of Ankylosing Spondylitis (AS).
Interventions
DRUGetanercept
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of AS, as defined by Modified New York Criteria for Ankylosing Spondylitis, aged between 18 and 70 years of age. * BASDAI greater than or equal to 40 (all scores on a scale of 0 to 100). * Negative result of serum human chorionic gonadotropin (HCG) pregnancy test taken at screening in all women except those surgically sterile or at least 1 year postmenopausal.
Exclusion criteria
* Complete ankylosis (fusion) of spine. * Previous receipt of etanercept, antibody to TNFα, or other TNFα inhibitors. * Use of disease modifying antirheumatic drugs (DMARDs) other than hydroxychloroquine, sulphasalazine, and methotrexate within 4 weeks of baseline. Patients treated with hydroxychloroquine, sulphasalazine, and methotrexate may continue these drugs during this study but doses must be held stable for 4 weeks before baseline examination and for the duration of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the efficacy of etanercept (25 mg, twice weekly) based on the percentage of patients who achieve the Assessment in Ankylosing Spondylitis (ASAS) Response Criteria at 20% level at week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy at 50% and 70% levels week 12; frequency and time to partial remission; safety; patient and physician global assessment, nocturnal and total back pain, BASFI, BASDAI; spinal mobility; complete joint assessment; hip involvement; ESR, CRP. | — |
Outcome results
None listed