- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01188655
Observational Non-Interventional Study With Enbrel (Etanercept) in Patients With Ankylosing Spondylitis
Observational Non-Interventional Study With Enbrel in Patients With Ankylosing Spondylitis
Studieoversigt
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Infektioner
- Ledsygdomme
- Muskuloskeletale sygdomme
- Gigt
- Rygmarvssygdomme
- Knoglesygdomme
- Spondylarthropatier
- Knoglesygdomme, smitsom
- Ankylose
- Spondylitis
- Spondylarthritis
- Spondylitis, ankyloserende
- Lægemidlers fysiologiske virkninger
- Agenter fra det perifere nervesystem
- Analgetika
- Sensoriske systemagenter
- Anti-inflammatoriske midler, ikke-steroide
- Analgetika, ikke-narkotisk
- Anti-inflammatoriske midler
- Antirheumatiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Gastrointestinale midler
- Etanercept
Andre undersøgelses-id-numre
- 0881X1-4456
- B1801095
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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GlaxoSmithKlineAfsluttet
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mAbxience Research S.L.Rekruttering
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Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Afsluttet
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AmgenAfsluttet
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