16.0040 Ankylosing Spondylitis Study

May 10, 2013 updated by: Amgen

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

257

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: Up to 4 years
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
Up to 4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
DXA and MRI scans (at selected sites)
Time Frame: Up to 144 weeks
Up to 144 weeks
X-rays of cervical spine and lumbosacral spine
Time Frame: Up to 4 years
Up to 4 years
Type and grade of toxicities
Time Frame: Up to 4 years
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.
Time Frame: Up to 4 years
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
Time Frame: Up to 4 years
Up to 4 years
Spinal mobility measured with Schober's test, chest expansion, and occiput to wall distance
Time Frame: Up to 120 weeks
Up to 120 weeks
Complete joint assessment
Time Frame: Up to 120 weeks
Up to 120 weeks
Laboratory assessment of inflammation using CRP
Time Frame: Up to 120 weeks
Up to 120 weeks
Ability to reduce and discontinue concomitant NSAIDs, prednisone, hydroxychloroquine, sulfasalazine, and methotrexate
Time Frame: Up to 4 years
Up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Collaborators

Immunex Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Primary Completion (Actual)

August 1, 2006

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

July 24, 2006

First Submitted That Met QC Criteria

July 24, 2006

First Posted (Estimate)

July 26, 2006

Study Record Updates

Last Update Posted (Estimate)

May 14, 2013

Last Update Submitted That Met QC Criteria

May 10, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20021640
  • 016.0040

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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