Back to results16.0040 Ankylosing Spondylitis Study
Primary Purpose
Ankylosing Spondylitis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Etanercept
Sponsored by
About this trial
This is an interventional treatment trial for Ankylosing Spondylitis
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All subjects
Arm Description
257 subjects
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
DXA and MRI scans (at selected sites)
X-rays of cervical spine and lumbosacral spine
Type and grade of toxicities
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.
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
Spinal mobility measured with Schober's test, chest expansion, and occiput to wall distance
Complete joint assessment
Laboratory assessment of inflammation using CRP
Ability to reduce and discontinue concomitant NSAIDs, prednisone, hydroxychloroquine, sulfasalazine, and methotrexate
Full Information
NCT ID
NCT00356356
First Posted
July 24, 2006
Last Updated
May 10, 2013
Sponsor
Amgen
Collaborators
Immunex Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00356356
Brief Title
16.0040 Ankylosing Spondylitis Study
Official Title
Open-label, Long-term Extension Study of Etanercept in the Treatment of Patients With Ankylosing Spondylitis Who Participated in Protocol 16.0037
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
September 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
Collaborators
Immunex Corporation
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
257 (Actual)
8. Arms, Groups, and Interventions
Arm Title
All subjects
Arm Type
Experimental
Arm Description
257 subjects
Intervention Type
Drug
Intervention Name(s)
Etanercept
Intervention Description
Etanercept 50 mg/wk administered as 2-25 mg SQ injections at separate injection sites
Primary Outcome Measure Information:
Title
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
Title
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 Outcome Measure Information:
Title
DXA and MRI scans (at selected sites)
Time Frame
Up to 144 weeks
Title
X-rays of cervical spine and lumbosacral spine
Time Frame
Up to 4 years
Title
Type and grade of toxicities
Time Frame
Up to 4 years
Title
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
Title
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
Title
Spinal mobility measured with Schober's test, chest expansion, and occiput to wall distance
Time Frame
Up to 120 weeks
Title
Complete joint assessment
Time Frame
Up to 120 weeks
Title
Laboratory assessment of inflammation using CRP
Time Frame
Up to 120 weeks
Title
Ability to reduce and discontinue concomitant NSAIDs, prednisone, hydroxychloroquine, sulfasalazine, and methotrexate
Time Frame
Up to 4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
16342093
Citation
Baraliakos X, Brandt J, Listing J, Haibel H, Sorensen 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 Dec 15;53(6):856-63. doi: 10.1002/art.21588.
Results Reference
result
PubMed Identifier
18278836
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 2008 Feb 15.
Results Reference
result
PubMed Identifier
15843448
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. doi: 10.1136/ard.2004.035105. Epub 2005 Apr 20.
Results Reference
result
PubMed Identifier
17967833
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):346-52. doi: 10.1136/ard.2007.078139. Epub 2007 Oct 29.
Results Reference
result
PubMed Identifier
30473179
Citation
Baraliakos X, Szumski A, Koenig AS, Jones H. The role of C-reactive protein as a predictor of treatment response in patients with ankylosing spondylitis. Semin Arthritis Rheum. 2019 Jun;48(6):997-1004. doi: 10.1016/j.semarthrit.2018.10.019. Epub 2018 Nov 2.
Results Reference
derived
PubMed Identifier
18438853
Citation
van der Heijde D, Landewe R, Einstein S, Ory P, Vosse D, Ni L, Lin SL, Tsuji W, Davis JC Jr. Radiographic progression of ankylosing spondylitis after up to two years of treatment with etanercept. Arthritis Rheum. 2008 May;58(5):1324-31. doi: 10.1002/art.23471.
Results Reference
derived
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
URL
http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf
Description
Notice regarding posted summaries of trial results
URL
http://download.veritasmedicine.com/REGFILES/amgen/20021640.pdf
Description
To access clinical trial results information click on this link
URL
http://www.enbrel.com/
Description
FDA-approved Drug Labeling
Learn more about this trial
16.0040 Ankylosing Spondylitis Study
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