Ankylosing Spondylitis
Conditions
Brief summary
The purpose of this study was to evaluate extended safety and efficacy of etanercept in adults with Ankylosing Spondylitis.
Detailed description
This multicenter, open-label extension study will evaluate the safety and clinical benefit of etanercept in the treatment of Ankylosing Spondylitis in subjects previously enrolled in Protocol 16.0037.
Interventions
DRUGEtanercept
Etanercept 50 mg/wk administered as 2-25 mg SQ injections at separate injection sites
Sponsors
Immunex Corporation
Amgen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Subjects completing 24 weeks of study drug in protocol 16.0037 qualify to enroll into this study Other patients to meet the following criteria: * Negative pregnancy test * Subjects agree to use appropriate contraception throughout study * Should be able to self-inject study drug or have someone who can do so * Capable of understanding protocol and willing to provide written informed consent
Exclusion criteria
* Any change in NSAID or prednisone dose within 2 weeks of baseline * Any change in hydroxychloroquine, sulfasalazine, or MTX dose within 4 weeks of baseline * Use of DMARDs other than those mentioned above, within 4 weeks of enrollment * Previous receipt of ani-TNF agents, other than etanercept * Receipt of any other investigational drug within 30 days of baseline * Grade 3 or 4 adverse event attributed to etanercept which recurred when etanercept was resumed * Abnormality in chemistry or hematology profiles or significant concurrent medical events.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment Response (using ASAS criteria) of at least 20% and absolute improvement of at least 10 units on a 0-100 scale in at least 3 of the 4 domains | Up to 4 years |
| Absence of deterioration (using ASAS criteria) of at least 20% and absolute improvement of at least 10 units on a 0-100 scale in the potential remaining ASAS domain | Up to 4 years |
Secondary
| Measure | Time frame |
|---|---|
| Type and grade of toxicities | Up to 4 years |
| ASAS Response Criteria at weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, and the ASAS Response Criteria at 50% and 70% levels at weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, and 144. | Up to 4 years |
| Frequency and time to partial remission as defined in Anderson, 2001: Value of <20 (on a scale of 0-100) in each of the following 4 domains: VAS Patient Global Assessment, VAS Pain Score, BASFI, and BASDAI morning stiffness-related scores | Up to 4 years |
| DXA and MRI scans (at selected sites) | Up to 144 weeks |
| Complete joint assessment | Up to 120 weeks |
| Laboratory assessment of inflammation using CRP | Up to 120 weeks |
| Ability to reduce and discontinue concomitant NSAIDs, prednisone, hydroxychloroquine, sulfasalazine, and methotrexate | Up to 4 years |
| Spinal mobility measured with Schober's test, chest expansion, and occiput to wall distance | Up to 120 weeks |
| X-rays of cervical spine and lumbosacral spine | Up to 4 years |
Outcome results
None listed