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Ankylosing SpondylitisPhase 3NCT00356356

16.0040 Ankylosing Spondylitis Study

A Phase 3 study testing Etanercept in people with Ankylosing Spondylitis, run by Amgen.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Ankylosing Spondylitis
What is being tested?
Etanercept
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
257 participants
Where
No sites listed yet
Study dates
Apr 2002to Sep 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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.

About this 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

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

Read the 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.

Being tested
Etanercept
Medical subject headings
Spondylitis, Ankylosing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EtanerceptDrug

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

Study groups in NCT00356356
Study groupRoleWhat they receive
All subjectsExperimental257 subjects
Receives: Drug: Etanercept

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Up to 4 years

  2. 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

    Measured: Up to 4 years

Secondary outcomes (9)

  1. DXA and MRI scans (at selected sites)

    Measured: Up to 144 weeks

  2. X-rays of cervical spine and lumbosacral spine

    Measured: Up to 4 years

  3. Type and grade of toxicities

    Measured: Up to 4 years

  4. 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.

    Measured: Up to 4 years

  5. 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

    Measured: Up to 4 years

  6. Spinal mobility measured with Schober's test, chest expansion, and occiput to wall distance

    Measured: Up to 120 weeks

  7. Complete joint assessment

    Measured: Up to 120 weeks

  8. Laboratory assessment of inflammation using CRP

    Measured: Up to 120 weeks

  9. Ability to reduce and discontinue concomitant NSAIDs, prednisone, hydroxychloroquine, sulfasalazine, and methotrexate

    Measured: Up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2006 (estimated)
  2. Study startApr 2002
  3. Primary completionAug 2006
  4. Study completionSep 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
257 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00356356
Sponsor's protocol ID
20021640
Other IDs
016.0040
Status last verified
May 2013
First submitted
24 Jul 2006
Last updated
14 May 2013
Results posted
No

Publications

  • 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.

    PubMed 16342093

  • 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.

    PubMed 18278836

  • 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.

    PubMed 15843448

  • 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.

    PubMed 17967833

  • Baraliakos X, Szumski AE, Kwok KK, Vlahos B, Borlenghi CE. Long-term Etanercept Response for Patients with Radiographic Axial Spondyloarthritis Based on Achievement of Early, Intermediate, or Late Responses During Index Studies. Rheumatol Ther. 2024 Jun;11(3):583-597. doi: 10.1007/s40744-024-00656-3. Epub 2024 Mar 15.

    PubMed 38488976

  • 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.

    PubMed 30473179

  • 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.

    PubMed 18438853

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Etanercept in people with Ankylosing Spondylitis, run by Amgen.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2013. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: Up to 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00356356, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2013; AzTrials last refreshed its copy on 2 Nov 2026.

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