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Observational Non-Interventional Study With Enbrel (Etanercept) in Patients With Ankylosing Spondylitis

8. september 2011 oppdatert av: Pfizer

Observational Non-Interventional Study With Enbrel in Patients With Ankylosing Spondylitis

This observational study will be a documentation of the prescribing and administration practices of Enbrel® and their impact on ankylosing spondylitis patients outcome in a real life setting.

Studieoversikt

Status

Fullført

Intervensjon / Behandling

Detaljert beskrivelse

The study population will be described using standard descriptive statistics for demographic, clinical, medical, characteristics, as well as for standard health-related quality of life and functional disability questionnaires .

Studietype

Observasjonsmessig

Registrering (Faktiske)

89

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

The patient cohort in this non-interventional study will reflect the kind of patients seen in routine clinical practice and will not be specifically pre-selected as it is the case in clinical studies.

Beskrivelse

Inclusion Criteria:

  • Proven diagnosis of Ankylosing Spondylitisin accordance with local guidelines
  • Patients treated as an outpatient

Exclusion Criteria:

  • Patients who suffer from hypersensitivity to the active substance Etanercept or to any of the excipients of Enbrel®.
  • Treatment with Enbrel® should not be initiated in patients with active infections including chronic or localised infections.
  • Patients with sepsis or risk of sepsis should not be treated.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Treatment Group Enbrel

The patients will be treated in accordance with the requirements of the labeling of Enbrel® in Austria. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.

To record complete dosing information, initial dose will be documented at baseline and any change will be documented with date, dose and reason at the subsequent visits.

Andre navn:
  • etanercept

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants Achieving BASDAI 40 Response at Week 24
Tidsramme: Week 24
BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10. Participants who achieved a decrease of 40 percent or more from baseline to the following visits are called as responders.
Week 24

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline in BASDAI at Week 12 and 24
Tidsramme: Baseline, Week 12 and Week 24
BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10.
Baseline, Week 12 and Week 24
Change From Baseline in the BASFI at Weeks 12 and 24
Tidsramme: Baseline, Week 12 and Week 24
BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.
Baseline, Week 12 and Week 24
Participant's Global Assessment Visual Analog Scale at Weeks 12 and 24
Tidsramme: Week 12 and Week 24
Measured using a 100mm VAS ranging from 0=very good to 100=very bad.
Week 12 and Week 24
Physician's Global Assessment Visual Analog Scale at Weeks 12 and 24
Tidsramme: Week 12 and Week 24
Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm= no disease activity.
Week 12 and Week 24
Mean Duration of Morning Stiffness
Tidsramme: Week 12 and Week 24
Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes (24h x 60 minutes) was recorded).
Week 12 and Week 24
Change From Baseline in ASQoL at Week 12 and Week 24
Tidsramme: Baseline, Week 12 and Week 24
ASQoL is a questionnaire that assesses disease-specific quality of life (QoL). It consists of 18 statements that are relevant to the physical and mental conditions for a participant with AS: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each statement is answered by the participant as a 'Yes' (scored as 1) or 'No' (scored as 0). All item scores are summed to give a total score. Total score can range from 0 (good QoL) to 18 (poor QoL).
Baseline, Week 12 and Week 24
Percentage of Participants Without Enthesitis
Tidsramme: Week 12 and Week 24
Week 12 and Week 24
Percentage of Participants Without Peripheral Arthritis
Tidsramme: Week 12 and Week 24
Week 12 and Week 24
Mean Occiput-to-wall Distance at Week 12 and Week 24
Tidsramme: Week 12 and Week 24
Week 12 and Week 24
Spine Agility Function by Schober Test
Tidsramme: Week 12 and Week 24
Schober test determines agility of lumbar spine. It measures participant's ability to flex the lower back. Examiner makes a mark at fifth lumbar vertebra (L5); places 1 finger 5 cm below and another 10 cm above the mark. Participant is asked to touch the toes. Examiner measures the increase in distance between 2 fingers.
Week 12 and Week 24
Spine Agility Function by Ott Test
Tidsramme: Week 12 and Week 24
The Ott index determines the agility of the thoracic spine.
Week 12 and Week 24

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mai 2008

Primær fullføring (Faktiske)

1. mars 2010

Studiet fullført (Faktiske)

1. mars 2010

Datoer for studieregistrering

Først innsendt

24. august 2010

Først innsendt som oppfylte QC-kriteriene

24. august 2010

Først lagt ut (Anslag)

25. august 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

12. september 2011

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. september 2011

Sist bekreftet

1. september 2011

Mer informasjon

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Spondylitt, Bekhterevs

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