16.0040 Ankylosing Spondylitis Study

Phase 3

Completed

• Conditions: Ankylosing Spondylitis
• Interventions: Drug: Etanercept

• Registration Number: NCT00356356
• Lead Sponsor: Amgen

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.

Study Timeline

• Study Start: 2002-04
• Study First Submitted: 2006-07-24
• Study First Submitted QC: 2006-07-24
• Study First Posted: 2006-07-26
• Primary Completion: 2006-08
• Study Completion: 2006-09
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-10
• Last Update Posted: 2013-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 257

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All subjects	Etanercept	257 subjects

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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