16.0040 Ankylosing Spondylitis Study

NCT00356356 | Completed Phase 3

• 2 other identifiers: 20021640016.0040
• Study Type: interventional
• Target: 257
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (9)

• DXA and MRI scans (at selected sites)

  Up to 144 weeks

• X-rays of cervical spine and lumbosacral spine

  Up to 4 years

• Type and grade of toxicities

  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.

  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

  Up to 4 years

Study Arms (1)

All subjects

EXPERIMENTAL

257 subjects

Drug: Etanercept

Interventions

Etanercept DRUG

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

All subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead
• Immunex Corporation: collaborator

Related Publications (7)

• 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.

  PMID: 16342093 RESULT

• 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.

  PMID: 18278836 RESULT

• 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.

  PMID: 15843448 RESULT

• 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.

  PMID: 17967833 RESULT

• 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.

  PMID: 38488976 DERIVED

• 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.

  PMID: 30473179 DERIVED

• 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.

  PMID: 18438853 DERIVED

Related Links

• AmgenTrials clinical trials website
• Notice regarding posted summaries of trial results
• To access clinical trial results information click on this link
• FDA-approved Drug Labeling

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2006
• First Posted: July 26, 2006
• Study Start: April 1, 2002
• Primary Completion: August 1, 2006
• Study Completion: September 1, 2006
• Last Updated: May 14, 2013

Record last verified: 2013-05