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

Amgen0 sites257 target enrollmentApril 2002

ConditionsAnkylosing Spondylitis

InterventionsEtanercept

DrugsEtanercept

Overview

Phase: Phase 3
Intervention: Etanercept
Conditions: Ankylosing Spondylitis
Sponsor: Amgen
Enrollment: 257
Primary Endpoint: 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
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2002

End Date

September 2006

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Amgen

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

All subjects

257 subjects

Intervention: Etanercept

Outcomes

Primary Outcomes

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

Time Frame: 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

Time Frame: Up to 4 years

Secondary Outcomes

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)