16.0040 Ankylosing Spondylitis Study

Ankylosing Spondylitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00356356
• Other study ID #: 20021640
• Secondary ID: 016.0040
• Status: Completed
• Phase: Phase 3
• First received: July 24, 2006
• Last updated: May 10, 2013
• Start date: April 2002
• Est. completion date: September 2006

Study information

• Verified date: May 2013
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaEurope: EMEAUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 257
• Est. completion date: September 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• Etanercept
Etanercept 50 mg/wk administered as 2-25 mg SQ injections at separate injection sites

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Amgen	Immunex Corporation

References & Publications (4)

Baraliakos X, Brandt J, Listing J, Haibel H, Sörensen H, Rudwaleit M, Sieper J, Braun J. Outcome of patients with active ankylosing spondylitis after two years of therapy with etanercept: clinical and magnetic resonance imaging data. Arthritis Rheum. 2005 — View Citation

Boonen A, Patel V, Traina S, Chiou CF, Maetzel A, Tsuji W. Rapid and sustained improvement in health-related quality of life and utility for 72 weeks in patients with ankylosing spondylitis receiving etanercept. J Rheumatol. 2008 Apr;35(4):662-7. Epub 200 — View Citation

Davis JC Jr, van der Heijde DM, Braun J, Dougados M, Clegg DO, Kivitz AJ, Fleischmann RM, Inman RD, Ni L, Lin SL, Tsuji WH. Efficacy and safety of up to 192 weeks of etanercept therapy in patients with ankylosing spondylitis. Ann Rheum Dis. 2008 Mar;67(3) — View Citation

Davis JC, van der Heijde DM, Braun J, Dougados M, Cush J, Clegg D, Inman RD, Kivitz A, Zhou L, Solinger A, Tsuji W. Sustained durability and tolerability of etanercept in ankylosing spondylitis for 96 weeks. Ann Rheum Dis. 2005 Nov;64(11):1557-62. Epub 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	DXA and MRI scans (at selected sites)		Up to 144 weeks	No
Secondary	X-rays of cervical spine and lumbosacral spine		Up to 4 years	No
Secondary	Type and grade of toxicities		Up to 4 years	No
Secondary	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	No
Secondary	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	No
Secondary	Spinal mobility measured with Schober's test, chest expansion, and occiput to wall distance		Up to 120 weeks	No
Secondary	Complete joint assessment		Up to 120 weeks	No
Secondary	Laboratory assessment of inflammation using CRP		Up to 120 weeks	No
Secondary	Ability to reduce and discontinue concomitant NSAIDs, prednisone, hydroxychloroquine, sulfasalazine, and methotrexate		Up to 4 years	No

External Links

•   AmgenTrials clinical trials website
•   FDA-approved Drug Labeling