Clinical trial NCT00356356: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ankylosing Spondylitis
Lead sponsor: Amgen
Sponsor class: INDUSTRY
Collaborators: name: Immunex Corporation
First posted: 2006-07-26
Enrollment: 257
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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
timeFrame: Up to 4 years
measure: 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
timeFrame: Up to 4 years
Secondary outcomes:
measure: DXA and MRI scans (at selected sites)
timeFrame: Up to 144 weeks
measure: X-rays of cervical spine and lumbosacral spine
timeFrame: Up to 4 years
measure: Type and grade of toxicities
timeFrame: Up to 4 years
measure: 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.
timeFrame: Up to 4 years
measure: 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
timeFrame: Up to 4 years
measure: Spinal mobility measured with Schober's test, chest expansion, and occiput to wall distance
timeFrame: Up to 120 weeks
measure: Complete joint assessment
timeFrame: Up to 120 weeks
measure: Laboratory assessment of inflammation using CRP
timeFrame: Up to 120 weeks
measure: Ability to reduce and discontinue concomitant NSAIDs, prednisone, hydroxychloroquine, sulfasalazine, and methotrexate
timeFrame: Up to 4 years
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.