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Observational Non-Interventional Study With Enbrel (Etanercept) in Patients With Ankylosing Spondylitis
Observational Non-Interventional Study With Enbrel in Patients With Ankylosing Spondylitis
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
---|---|
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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Percentage of Participants Achieving BASDAI 40 Response at Week 24
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Change From Baseline in BASDAI at Week 12 and 24
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Week 12 and Week 24
|
Week 12 and Week 24
|
|
Percentage of Participants Without Peripheral Arthritis
Tijdsspanne: Week 12 and Week 24
|
Week 12 and Week 24
|
|
Mean Occiput-to-wall Distance at Week 12 and Week 24
Tijdsspanne: Week 12 and Week 24
|
Week 12 and Week 24
|
|
Spine Agility Function by Schober Test
Tijdsspanne: 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
Tijdsspanne: Week 12 and Week 24
|
The Ott index determines the agility of the thoracic spine.
|
Week 12 and Week 24
|
Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Infecties
- Gewrichtsziekten
- Musculoskeletale aandoeningen
- Artritis
- Spinale ziekten
- Botziekten
- Spondylarthropathieën
- Botziekten, besmettelijk
- Ankylose
- Spondylitis
- Spondylartritis
- Spondylitis, ziekte van Bechterew
- Fysiologische effecten van medicijnen
- Agenten van het perifere zenuwstelsel
- Pijnstillers
- Sensorische systeemagenten
- Ontstekingsremmers, niet-steroïde
- Pijnstillers, niet-narcotisch
- Ontstekingsremmende middelen
- Antireumatische middelen
- Immunosuppressieve middelen
- Immunologische factoren
- Gastro-intestinale middelen
- Etanercept
Andere studie-ID-nummers
- 0881X1-4456
- B1801095
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Spondylitis, ziekte van Bechterew
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Shanghai Junshi Bioscience Co., Ltd.Sponsor GmbHWervingActieve spondylitis ankylopoeticaChina
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AbbVieBoehringer IngelheimVoltooidBI 655066 (Risankizumab) Proof of Concept dosisbepalingsonderzoek bij spondylitis ankylopoetica (AS)Spondylitis ankylopoetica (AS)
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Novartis PharmaceuticalsVoltooidSpondylitis anklyoseDuitsland, Oostenrijk, Spanje, Zwitserland, Verenigd Koninkrijk, Verenigde Staten, Singapore, Russische Federatie, Nederland, Italië, Finland, Tsjechië, Canada
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AbbVieVoltooidSpondylitis ankylopoetica (AS)Verenigde Staten, Australië, België, Canada, Kroatië, Tsjechië, Denemarken, Finland, Frankrijk, Duitsland, Hongarije, Italië, Japan, Korea, republiek van, Nederland, Nieuw-Zeeland, Polen, Portugal, Spanje, Zweden, Verenigd Koninkrijk
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AbbVieVoltooid
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Tongji HospitalWuhan Central Hospital; Wuhan Hospital of Traditional Chinese MedicineWervingSpondylitis ankylopoetica (AS)China
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Chinese University of Hong KongVoltooidSpondylitis ankylopoetica (AS)China
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Tianjin Hemay Pharmaceutical Co., LtdVoltooidActieve spondylitis ankylopoeticaChina
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Ankara City Hospital BilkentWervingAxiale spondyloartritis en spondylitis ankylopoeticaKalkoen
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Jiangsu vcare pharmaceutical technology co., LTDWervingActieve spondylitis ankylopoeticaChina
Klinische onderzoeken op Enbrel
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ASIS CorporationOnbekend
-
Wyeth is now a wholly owned subsidiary of PfizerVoltooidSpondylitis ankylopoeticaDenemarken, Zweden, Finland, Verenigd Koninkrijk
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Coherus Biosciences, Inc.ShireVoltooidVergelijking van CHS-0214 met Enbrel (Etanercept) bij patiënten met chronische plaquepsoriasis (PsO)Plaque PsoriasisVerenigde Staten, Israël, Australië, Duitsland, Zuid-Afrika, Polen, Canada
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mAbxience Research S.L.Werving
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GlaxoSmithKlineVoltooid
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Samsung Bioepis Co., Ltd.Voltooid
-
AmgenVoltooid
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Coherus Biosciences, Inc.Daiichi Sankyo Co., Ltd.VoltooidReumatoïde artritisVerenigde Staten, Spanje, Israël, Wit-Rusland, Japan, Polen, Hongarije, Zuid-Afrika, Duitsland, Russische Federatie, Frankrijk, Verenigd Koninkrijk
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Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Voltooid
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AmgenVoltooid