16.0040 Ankylosing Spondylitis Study

Study Overview
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Brief Summary
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The purpose of this study was to evaluate extended safety and efficacy of etanercept in adults with Ankylosing Spondylitis.

Detailed Description
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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.

Official Title
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Open-label, Long-term Extension Study of Etanercept in the Treatment of Patients With Ankylosing Spondylitis Who Participated in Protocol 16.0037

Conditions
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Ankylosing Spondylitis

Intervention / Treatment
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* Drug: Etanercept


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All subjects<br>257 subjects | Drug: Etanercept<br>* Etanercept 50 mg/wk administered as 2-25 mg SQ injections at separate injection sites<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DXA and MRI scans (at selected sites) |  | Up to 144 weeks | 
| X-rays of cervical spine and lumbosacral spine |  | Up to 4 years | 
| 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 | 
| Spinal mobility measured with Schober's test, chest expansion, and occiput to wall distance |  | Up to 120 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 |