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

8 september 2011 uppdaterad 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.

Studieöversikt

Status

Avslutad

Intervention / Behandling

Detaljerad beskrivning

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 .

Studietyp

Observationell

Inskrivning (Faktisk)

89

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / 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.

Andra namn:
  • etanercept

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Participants Achieving BASDAI 40 Response at Week 24
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change From Baseline in BASDAI at Week 12 and 24
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Week 12 and Week 24
Week 12 and Week 24
Percentage of Participants Without Peripheral Arthritis
Tidsram: Week 12 and Week 24
Week 12 and Week 24
Mean Occiput-to-wall Distance at Week 12 and Week 24
Tidsram: Week 12 and Week 24
Week 12 and Week 24
Spine Agility Function by Schober Test
Tidsram: 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
Tidsram: Week 12 and Week 24
The Ott index determines the agility of the thoracic spine.
Week 12 and Week 24

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 maj 2008

Primärt slutförande (Faktisk)

1 mars 2010

Avslutad studie (Faktisk)

1 mars 2010

Studieregistreringsdatum

Först inskickad

24 augusti 2010

Först inskickad som uppfyllde QC-kriterierna

24 augusti 2010

Första postat (Uppskatta)

25 augusti 2010

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

12 september 2011

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

8 september 2011

Senast verifierad

1 september 2011

Mer information

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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