Study Evaluating Etanercept and Sulphasalazine in Ankylosing Spondylitis

October 9, 2012 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

A Randomized, Double-Blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects With Ankylosing Spondylitis

The purpose of this study is to compare the efficacy of etanercept and sulphasalazine in the treatment of Ankylosing Spondylitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

566

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Heidelberg West, Victoria, Australia, 3081
    • Western Australia
      • Shenton Park, Western Australia, Australia, 6000
  • Austria
      • Innsbruck, Austria, 6020
      • Klagenfurt, Austria, A-9020
      • Linz, Austria, A-4020
  • China
      • Beijing, China, 100853
      • Shanghai, China, 200001
  • Czech Republic
      • Ostrava, Czech Republic, 722 00
      • Praha, Czech Republic, 120 00
  • Denmark
      • Frederiksberg, Denmark, DK-2000
      • Kolding, Denmark, 6000
      • Odense, Denmark, 5000
      • Vejle, Denmark, 7100
  • Finland
      • Helsinki, Finland, 00029
      • Kuopio, Finland, 70211
      • Tampere, Finland, 33100
  • France
      • Amiens, France, 80054
      • Bordeaux, France, 33076
      • Boulogne Billancourt, France, 92104
      • Creteil, France, 94010
      • Marseille, France, 13005
      • Nantes, France, 44000
      • Orleans, France, 45032
      • Pierre Mendès, France, 76290
      • Toulouse, France, 31059
  • Germany
      • Berlin, Germany, 12200
      • Berlin, Germany, D-10117
      • Erlangen, Germany, D-91054
      • Gommern, Germany, D-39245
      • Hamburg, Germany, D-22081
      • Herne, Germany, D-44652
      • Heubnerweg, Germany, D-14059
      • Hildesheim, Germany, D-31134
      • Muenchen, Germany, D-80639
      • Pirna, Germany, D-01796
      • Ratingen, Germany, D-40882
      • Wiesbaden, Germany, D-65191
      • Wiesbaden, Germany, 65185
  • Hungary
      • Debrecen, Hungary, 4043
      • Gyor, Hungary, 9025
      • Nyiregyhaza, Hungary, 4400
      • Pecs, Hungary, 7621
      • Szeged, Hungary, 6724
  • Ireland
      • Dublin, Ireland
    • Cork
      • Wilton, Cork, Ireland
  • Italy
      • Benevento, Italy, 82037
      • Bergamo, Italy, 24128
      • Firenze, Italy, 50143
      • Monserrato, Italy, 09042
      • Potenza, Italy, 85100
      • Prato, Italy, 59100
      • Reggio Emilia, Italy, 42100
      • Roma, Italy, 00161
      • Roma, Italy, 00189
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
      • Groningen, Netherlands, 9713GZ
      • Leeuwarden, Netherlands, 8934AD
      • Maastricht, Netherlands, 6229HX
      • Nijmegen, Netherlands, 6522JV
  • Poland
      • Lodz, Poland, 93-513
      • Ustron Zawodzie, Poland, 43-450
      • Warszawa, Poland, 02-637
      • Wroclaw, Poland, 53-137
  • Qatar
      • Doha, Qatar, 3050
  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11426
  • Spain
      • Asturias, Spain, 33012
      • Barcelona, Spain, 08003
      • Cordoba, Spain, 14004
      • Madrid, Spain, 28922
      • Madrid, Spain, 28035
      • Porto, Spain, 4200-319
      • Tenerife, Spain, 38010
    • Barcelona
      • Granollers, Barcelona, Spain, 08400
  • Sweden
      • Ostra kyrkogardsgatan, Sweden, 59333
      • Solna, Sweden, 17176
  • United Kingdom
      • Basingstoke, United Kingdom, RG24 9NA
      • Cambridge, United Kingdom, CB2 2QQ
      • Cannock, United Kingdom, WS11 2XY
      • Glasgow, United Kingdom, G31 2ER
      • Liverpool, United Kingdom, L9 7AL
      • Newcastle Upon Tyne, United Kingdom, NE7 7DN
      • Upper Borough Walls, United Kingdom, BA1 1RL
    • Wirral
      • Upton, Wirral, United Kingdom, L49 5PE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of ankylosing spondylitis
  • Active ankylosing spondylitis

Exclusion Criteria:

  • Complete ankylosis of spine
  • Previous treatment with etanercept

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: B
Drug: sulphasalazine (SSZ)
Sulphasalazine: The target dose for SSZ is 1.5 g (3 tablets) twice daily orally. Subject start the oral TA at 0.5 g daily for the first week and increase by 0.5 g every week until a daily dose of 3 g. Is achieved by the start of study week 5 of the study.
Experimental: A
Drug: etanercept
50 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS 20)
Time Frame: 16 weeks
ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an improvement ≥ 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ankylosing Spondylitis Quality of Life (ASQoL) Total Score Change From Baseline
Time Frame: Baseline and 16 Weeks
ASQoL is a questionnaire to assess disease specific quality of life. It consists of 18 statements that are relevant to the physical and mental conditions for a patient with Ankylosing Spondylitis (AS). Each statement is answered by the patients as a "Yes" (scored as 1) or "No" (scored as 0). All item scores are summed to give a total score. Scores can range from 0 (good QoL) to 18 (poor QoL).
Baseline and 16 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

  • Principal Investigator: Trial Manager, For Australia, medinfo@wyeth.com
  • Principal Investigator: Trial Manager, For Austria, WPVIMED@wyeth.com
  • Principal Investigator: Trial Manager, For Czech Republic, WPPGCLI@wyeth.com
  • Principal Investigator: Trial Manager, For Poland, WPWZMED@wyeth.com
  • Principal Investigator: Trial Manager, For Spain, infomed@wyeth.com
  • Principal Investigator: Trial Manager, For UK/Great Britian, ukmedinfo@wyeth.com
  • Principal Investigator: Trial manager, For Hungary, WPBUMED@wyeth.com
  • Principal Investigator: Trial Manager, For Sweden, MedInfoNord@wyeth.com
  • Principal Investigator: Trial Manager, For Denmark, medinfonord@wyeth.com
  • Principal Investigator: Trial Manager, For Finland, MedInfoNord@wyeth.com
  • Principal Investigator: Trial Manager, For Ireland, ukmedinfo@wyeth.com

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

October 31, 2005

First Submitted That Met QC Criteria

October 31, 2005

First Posted (Estimate)

November 2, 2005

Study Record Updates

Last Update Posted (Estimate)

November 8, 2012

Last Update Submitted That Met QC Criteria

October 9, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0881A3-402

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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