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The purpose of this study is to compare the efficacy of etanercept and sulphasalazine in the treatment of Ankylosing Spondylitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etanercept | Drug | 50 mg |
| |
| sulphasalazine (SSZ) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS 20) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Ankylosing Spondylitis Quality of Life (ASQoL) Total Score Change From Baseline | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Trial Manager | For Poland, WPWZMED@wyeth.com | Principal Investigator |
| Trial Manager | For Italy, descresg@wyeth.com | Principal Investigator |
| Trial Manager | For Hungary, WPBUMED@wyeth.com | Principal Investigator |
| Trial Manager | For Czech Republic, WPPGCLI@wyeth.com | Principal Investigator |
| Trial Manager | For Australia, medinfo@wyeth.com | Principal Investigator |
| Trial Manager | For Germany, medinfoDEU@wyeth.com | Principal Investigator |
| Trial Manager | For Austria, WPVIMED@wyeth.com | Principal Investigator |
| Trial Manager | For Spain, infomed@wyeth.com | Principal Investigator |
| Trial Manager |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heidelberg West | Victoria | 3081 | Australia | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38488976 | Derived | 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. | |
| 30473179 |
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Subjects were screened up to 4 weeks in a 2:1 randomization ratio.
Subjects were recruited in multiple countries from December 2005 to September 2007.
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| ID | Title | Description |
|---|---|---|
| FG000 | Etanercept | etanercept 50 mg once weekly |
| FG001 | Sulphasalazine | Sulphasalazine (SSZ) titration up to 3 g daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
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. |
|
| Baseline and 16 Weeks |
| For Netherlands, trials-NL@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 Sweden, MedInfoNord@wyeth.com | Principal Investigator |
| Trial Manager | For UK/Great Britian, ukmedinfo@wyeth.com | Principal Investigator |
| Trial Manager | For Ireland, ukmedinfo@wyeth.com | Principal Investigator |
| Trial Manager | For France, infomedfrance@wyeth.com | Principal Investigator |
| Trial Manager | For China, medinfo@wyeth.com | Principal Investigator |
| Shenton Park |
| Western Australia |
| 6000 |
| Australia |
| Innsbruck | 6020 | Austria |
| Klagenfurt | A-9020 | Austria |
| Linz | A-4020 | Austria |
| Beijing | 100853 | China |
| Shanghai | 200001 | China |
| Ostrava | 722 00 | Czechia |
| Prague | 120 00 | Czechia |
| Frederiksberg | DK-2000 | Denmark |
| Kolding | 6000 | Denmark |
| Odense | 5000 | Denmark |
| Vejle | 7100 | Denmark |
| Helsinki | 00029 | Finland |
| Kuopio | 70211 | Finland |
| Tampere | 33100 | Finland |
| Amiens | 80054 | France |
| Bordeaux | 33076 | France |
| Boulogne-Billancourt | 92104 | France |
| Créteil | 94010 | France |
| Marseille | 13005 | France |
| Nantes | 44000 | France |
| Orléans | 45032 | France |
| Pierre Mendès | 76290 | France |
| Toulouse | 31059 | France |
| Berlin | 12200 | Germany |
| Berlin | D-10117 | Germany |
| Erlangen | D-91054 | Germany |
| Gommern | D-39245 | Germany |
| Hamburg | D-22081 | Germany |
| Herne | D-44652 | Germany |
| Heubnerweg | D-14059 | Germany |
| Hildesheim | D-31134 | Germany |
| München | D-80639 | Germany |
| Pirna | D-01796 | Germany |
| Ratingen | D-40882 | Germany |
| Wiesbaden | 65185 | Germany |
| Wiesbaden | D-65191 | Germany |
| Debrecen | 4043 | Hungary |
| Győr | 9025 | Hungary |
| Nyíregyháza | 4400 | Hungary |
| Pécs | 7621 | Hungary |
| Szeged | 6724 | Hungary |
| Wilton | Cork | Ireland |
| Dublin | Ireland |
| Benevento | 82037 | Italy |
| Bergamo | 24128 | Italy |
| Florence | 50143 | Italy |
| Monserrato | 09042 | Italy |
| Potenza | 85100 | Italy |
| Prato | 59100 | Italy |
| Reggio Emilia | 42100 | Italy |
| Roma | 00161 | Italy |
| Roma | 00189 | Italy |
| Amsterdam | 1081 HV | Netherlands |
| Groningen | 9713GZ | Netherlands |
| Leeuwarden | 8934AD | Netherlands |
| Maastricht | 6229HX | Netherlands |
| Nijmegen | 6522JV | Netherlands |
| Lodz | 93-513 | Poland |
| Ustron Zawodzie | 43-450 | Poland |
| Warsaw | 02-637 | Poland |
| Wroclaw | 53-137 | Poland |
| Doha | 3050 | Qatar |
| Riyadh | 11426 | Saudi Arabia |
| Granollers | Barcelona | 08400 | Spain |
| Asturias | 33012 | Spain |
| Barcelona | 08003 | Spain |
| Córdoba | 14004 | Spain |
| Madrid | 28035 | Spain |
| Madrid | 28922 | Spain |
| Porto | 4200-319 | Spain |
| Santa Cruz de Tenerife | 38010 | Spain |
| Ostra Kyrkogardsgatan | 59333 | Sweden |
| Solna | 17176 | Sweden |
| Upton | Wirral | L49 5PE | United Kingdom |
| Basingstoke | RG24 9NA | United Kingdom |
| Cambridge | CB2 2QQ | United Kingdom |
| Cannock | WS11 2XY | United Kingdom |
| Glasgow | G31 2ER | United Kingdom |
| Liverpool | L9 7AL | United Kingdom |
| Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Upper Borough Walls | BA1 1RL | United Kingdom |
| 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. |
| 22337244 | Derived | Braun J, Pavelka K, Ramos-Remus C, Dimic A, Vlahos B, Freundlich B, Koenig AS. Clinical efficacy of etanercept versus sulfasalazine in ankylosing spondylitis subjects with peripheral joint involvement. J Rheumatol. 2012 Apr;39(4):836-40. doi: 10.3899/jrheum.110885. Epub 2012 Feb 15. |
| 21630245 | Derived | Braun J, van der Horst-Bruinsma IE, Huang F, Burgos-Vargas R, Vlahos B, Koenig AS, Freundlich B. Clinical efficacy and safety of etanercept versus sulfasalazine in patients with ankylosing spondylitis: a randomized, double-blind trial. Arthritis Rheum. 2011 Jun;63(6):1543-51. doi: 10.1002/art.30223. |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Etanercept | etanercept 50 mg once weekly |
| BG001 | Sulphasalazine | Sulphasalazine (SSZ) titration up to 3 g daily |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS 20) | 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. | All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline efficacy evaluation. Last observation carried forward approach (LOCF) used for missing data imputations. | Posted | Jan 2009 | Number | participants | 16 weeks |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Ankylosing Spondylitis Quality of Life (ASQoL) Total Score Change From Baseline | 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). | The analysis population was limited to subjects whose native language was English, Hungarian and Dutch. | Posted | Jan 2009 | Mean | Standard Deviation | units on a scale | Baseline and 16 Weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Etanercept | etanercept 50 mg once weekly | 7 | 213 | ||||
| EG001 | Sulphasalazine | Sulphasalazine (SSZ) titration up to 3 g daily | 4 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | General disorders | Non-systematic Assessment |
| ||
| Accidental Injury | General disorders | Non-systematic Assessment |
| ||
| Migraine | Vascular disorders | Non-systematic Assessment |
| ||
| Supraventricular Tachycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| Colitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Gastritis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Arthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Non-systematic Assessment |
| ||
| Hypesthesia | Nervous system disorders | Non-systematic Assessment |
| ||
| Neuralgia | Nervous system disorders | Non-systematic Assessment |
| ||
| Paresis | Nervous system disorders | Non-systematic Assessment |
| ||
| Psychosis | Nervous system disorders | Non-systematic Assessment |
| ||
| Ptosis | Nervous system disorders | Non-systematic Assessment |
| ||
| Vertigo | Nervous system disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Non-systematic Assessment |
| ||
| Injection Site Reaction | General disorders | Non-systematic Assessment |
| ||
| Cardiovascular | Vascular disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Metabolic and Nutritional | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Nervous | Nervous system disorders | Non-systematic Assessment |
| ||
| Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Skin and appendages | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Special Senses | Eye disorders | Non-systematic Assessment |
|
The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| U. S. Contact Center | Wyeth | clintrialresults@wyeth.com |
| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
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| ID | Term |
|---|---|
| D000068800 | Etanercept |
| D012460 | Sulfasalazine |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
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| Male |
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| Switzerland |
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| Finland |
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| Spain |
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| Ireland |
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| Austria |
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| Italy |
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| United Kingdom |
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| France |
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| Czech Republic |
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| Hungary |
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| Poland |
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| Australia |
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| Denmark |
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| Netherlands |
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| Germany |
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| China |
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| Sweden |
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| Greece |
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| Serbia |
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| Mexico |
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| Colombia |
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| Portugal |
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