A Phase 4 interventional study of etanercept and sulphasalazine (SSZ) in Ankylosing Spondylitis, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer. Completed at 83 sites in 18 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-11-08.
Sponsored by Wyeth is now a wholly owned subsidiary of Pfizer · Phase 4, Interventional, and Treatment
The purpose of this study is to compare the efficacy of etanercept and sulphasalazine in the treatment of Ankylosing Spondylitis.
623 studies on the registry are indexed under Spondylitis; 83 are open to participants now.
This study's enrollment of 566 is above the median of 92 across 349 interventional studies indexed under Spondylitis.
Browse Spondylitis studies →Wyeth is now a wholly owned subsidiary of Pfizer is the lead sponsor of 472 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: etanercept
Drug: sulphasalazine (SSZ)
50 mg
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.
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.
Time frame: 16 weeks
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).
Time frame: Baseline and 16 Weeks
Subjects were recruited in multiple countries from December 2005 to September 2007.
| Milestone | Etanercept | Sulphasalazine |
|---|---|---|
| Started | 379 | 187 |
| Completed | 353 | 168 |
| Not completed | 26 | 19 |
| Withdrew: Adverse event | 15 | 12 |
| Withdrew: Lost to follow-up | 3 | 1 |
| Withdrew: Physician decision | 0 | 1 |
| Withdrew: Protocol violation | 1 | 1 |
| Withdrew: Withdrawal by subject | 3 | 2 |
| Withdrew: Lack of efficacy | 4 | 2 |
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.
| participants | Etanercept | Sulphasalazine |
|---|---|---|
| Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS 20) | 287 | 99 |
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).
| units on a scale | Etanercept | Sulphasalazine |
|---|---|---|
| Baseline | 11.03 ± 4.60 | 11.32 ± 4.75 |
| Week 16 | 6.21 ± 5.31 | 9.06 ± 5.68 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Etanercept | — | — | — |
| Sulphasalazine | — | — | — |
| Event | Etanercept | Sulphasalazine |
|---|---|---|
| Abdominal PainGeneral disorders | 0/379 | 1/187 |
| Accidental InjuryGeneral disorders | 0/379 | 1/187 |
| GastritisGastrointestinal disorders | 0/379 | 1/187 |
| DizzinessNervous system disorders | 0/379 | 1/187 |
| PsychosisNervous system disorders | 0/379 | 1/187 |
| MigraineVascular disorders | 1/379 | 0/187 |
| Supraventricular TachycardiaCardiac disorders | 1/379 | 0/187 |
| ColitisGastrointestinal disorders | 1/379 | 0/187 |
| ArthritisMusculoskeletal and connective tissue disorders | 1/379 | 0/187 |
| HypesthesiaNervous system disorders | 1/379 | 0/187 |
| Event | Etanercept | Sulphasalazine |
|---|---|---|
| HeadacheGeneral disorders | 29/379 | 21/187 |
| Injection Site ReactionGeneral disorders | 41/379 | 3/187 |
| Skin and appendagesSkin and subcutaneous tissue disorders | 39/379 | 14/187 |
| NervousNervous system disorders | 24/379 | 19/187 |
| NauseaGastrointestinal disorders | 25/379 | 18/187 |
| Upper Respiratory InfectionRespiratory, thoracic and mediastinal disorders | 31/379 | 17/187 |
| Special SensesEye disorders | 25/379 | 13/187 |
| Metabolic and NutritionalMetabolism and nutrition disorders | 24/379 | 5/187 |
| CardiovascularVascular disorders | 23/379 | 10/187 |
| Age Continuous(years) | Etanercept | Sulphasalazine | Total |
|---|---|---|---|
| Mean | 40.69 ± 11.69 | 40.90 ± 12.23 | 40.76 ± 11.86 |
| Sex: Female, Male(Participants) | Etanercept | Sulphasalazine | Total |
|---|---|---|---|
| Female | 100 | 47 | 147 |
| Male | 279 | 140 | 419 |
| Region of Enrollment(participants) | Etanercept | Sulphasalazine | Total |
|---|---|---|---|
| Qatar | 7 | 3 | 10 |
| Switzerland | 2 | 1 | 3 |
| Finland | 11 | 3 | 14 |
| Spain | 12 | 7 | 19 |
| Ireland | 1 | 0 | 1 |
| Austria | 3 | 1 | 4 |
| Italy | 19 | 8 | 27 |
| United Kingdom | 38 | 19 | 57 |
| France | 4 | 1 | 5 |
| Czech Republic | 36 | 18 | 54 |
| Hungary | 27 | 15 | 42 |
| Poland | 30 | 15 | 45 |
| Australia | 5 | 2 | 7 |
| Denmark | 13 | 6 | 19 |
| Netherlands | 7 | 4 | 11 |
| Germany | 62 | 31 | 93 |
| China | 17 | 9 | 26 |
| Sweden | 4 | 2 | 6 |
| Greece | 4 | 3 | 7 |
| Serbia | 54 | 27 | 81 |
| Mexico | 11 | 6 | 17 |
| Colombia | 8 | 4 | 12 |
| Portugal | 4 | 2 | 6 |
This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.
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Wyeth is now a wholly owned subsidiary of Pfizer