Study Evaluating Etanercept for the Treatment of Active, Severe, and Advanced Axial Ankylosing Spondylitis

NCT00420238 | Completed Phase 4 Results

• 1 other identifier: 0881A3-403
• Study Type: interventional
• Target: 82
• Locations: 4 countries
• Sites: 21

Brief Summary

Evaluation of the efficacy and safety of etanercept (Enbrel) in patients with active, severe and advanced ankylosing spondylitis.

Conditions

Ankylosing Spondylitis

Keywords

Axial Ankylosing Spondylitis; Adult

Outcome Measures

Primary Outcomes (1)

• Normalized Net Incremental Area Under the Curve (AUC) for the Bath Ankylosing Spondylitis Disease Activities Index (BASDAI) Between Randomization and Week 12

  BASDAI subject asessment of discomfort, pain and fatigue measured using a 100 millimeter Visual Analog Scale; range: 0=none to 100=very severe. Normalized net incremental area under the curve (AUC) = area between baseline and the BASDAI curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all areas below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.

  Baseline, Week 2, Week 4, Week 8, Week 12

Secondary Outcomes (64)

• Percent of Subjects Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response

  Baseline, Week 2, Week 4, Week 8, Week 12

• Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 20 at Weeks 2, 4, 8, 12

  Week 2, Week 4, Week 8, Week 12

• Percent of Subjects Acheiving Assessment Ankylosing Spondylitis (ASAS) 20 at Weeks 14, 18, 24

  Week 14, Week 18, Week 24

• Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 50 at Weeks 2, 4, 8, 12

  Week 2, Week 4, Week 8, Week 12

• Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 50 at Weeks 14, 18, 24

  Week 14, Week 18, Week 24

Study Arms (2)

A

EXPERIMENTAL

Drug: Etanercept (Enbrel)

B

PLACEBO COMPARATOR

Other: Placebo

Interventions

Etanercept (Enbrel) DRUG

50 mg injection once weekly

A

Placebo OTHER

placebo

B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Active and severe ankylosing spondylitis
• Ankylosing spondylitis refractory to standard anti-rheumatic treatment
• Between 18 and 70 years of age

You may not qualify if:

• Prior exposure to any TNF-inhibitor, including etanercept
• DMARDs (other than hydroxychloroquine, methotrexate and sulphasalazine) within 4 weeks of study drug initiation
• Dose of NSAIDs changed within two weeks of study drug initiation

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (21)

Unknown Facility

Amiens, 80094, France

Location

Unknown Facility

Arles, 13200, France

Location

Unknown Facility

Avignon, 84000, France

Location

Unknown Facility

Bordeaux, 33076, France

Location

Unknown Facility

Cabestany, 66330, France

Location

Unknown Facility

Corbeil-Essonnes, 91100, France

Location

Unknown Facility

Montpellier, 34295, France

Location

Unknown Facility

Nice, 6202, France

Location

Unknown Facility

Orléans, 45032, France

Location

Unknown Facility

Paris (Ambroise Pare), 92401, France

Location

Unknown Facility

Paris (Bichat), 75018, France

Location

Unknown Facility

Paris (cochin), 75679, France

Location

Unknown Facility

Paris (Pitie Salpetriere), 75651, France

Location

Unknown Facility

Paris (Saint Antoine), 75571, France

Location

Unknown Facility

Strasbourg, 67098, France

Location

Unknown Facility

Toulouse, 31000, France

Location

Unknown Facility

Berlin, 12200, Germany

Location

Unknown Facility

Herne, 446652, Germany

Location

Unknown Facility

Budapest, 1023, Hungary

Location

Unknown Facility

Debrecen, 4004, Hungary

Location

Unknown Facility

Maastricht, 6229 HX, Netherlands

Location

Related Publications (3)

• Dougados M, Braun J, Szanto S, Combe B, Geher P, Leblanc V, Logeart I. Continuous efficacy of etanercept in severe and advanced ankylosing spondylitis: results from a 12-week open-label extension of the SPINE study. Rheumatology (Oxford). 2012 Sep;51(9):1687-96. doi: 10.1093/rheumatology/kes125. Epub 2012 May 30.

  PMID: 22653382 DERIVED

• Dougados M, Braun J, Szanto S, Combe B, Geher P, Leblanc V, Logeart I. Nonsteroidal antiinflammatory drug intake according to the Assessment of SpondyloArthritis International Society Score in clinical trials evaluating tumor necrosis factor blockers: example of etanercept in advanced ankylosing spondylitis. Arthritis Care Res (Hoboken). 2012 Feb;64(2):290-4. doi: 10.1002/acr.20671.

  PMID: 22006544 DERIVED

• Dougados M, Braun J, Szanto S, Combe B, Elbaz M, Geher P, Thabut G, Leblanc V, Logeart I. Efficacy of etanercept on rheumatic signs and pulmonary function tests in advanced ankylosing spondylitis: results of a randomised double-blind placebo-controlled study (SPINE). Ann Rheum Dis. 2011 May;70(5):799-804. doi: 10.1136/ard.2010.139261. Epub 2011 Feb 13.

  PMID: 21317434 DERIVED

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

Results Point of Contact

• Title: U. S. Contact Center
• Organization: Wyeth

clintrialresults@wyeth.com

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

• Trial Manager

  For France, infomedfrance@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Germany, medinfoDEU@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Netherlands, trials-NL@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Hungary: WPBUMED@wyeth.com

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 8, 2007
• First Posted: January 11, 2007
• Study Start: January 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: May 1, 2009
• Last Updated: June 29, 2010
• Results First Posted: June 15, 2010

Record last verified: 2010-06

Locations

HU (2); FR (16); DE (2); NL (1)