Study Evaluating the Safety and Efficacy of Enbrel (Etanercept) in Japan
9. januar 2017 opdateret af: Pfizer
Enbrel Special Use Result Surveillance
The special use-results surveillance is conducted in patients who have never been treated with Enbrel and in whom its long-term therapy may be instituted in the actual setting of use after marketing with the following objectives: 1.
To examine the safety of long-term use of Enbrel including the occurrence of malignant tumors.
2. To confirm the efficacy of Enbrel in the long-term use.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
684
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
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Sapporo, Japan, 060-8638
- Hokkaido University Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
10 år og ældre (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Hospital and Rheumatology clinic
Beskrivelse
Inclusion Criteria:
Inclusion Criteria Patients with rheumatoid arthritis (RA) who fulfill all of the following
- Patients who are refractory to the treatment.
- Patients who have never been treated with Enbrel and in whom its long-term therapy may be instituted.
- Patients without a history of or concurrent malignant tumors.
Exclusion Criteria:
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kun etui
- Tidsperspektiver: Fremadrettet
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants in Safety Analysis Population of Etanercept
Tidsramme: 3 years
|
3 years
|
|
|
Number of Participants With Treatment Related Adverse Events of Etanercept
Tidsramme: 3 years
|
Adverse events are all unfavorable events, including clinically problematic abnormal changes in laboratory test values, which develop in participants after the administration of Etanercept, irrespective of causal relationship to Etanercept.
The causal relationship between an adverse event and Etanercept was evaluated by the sponsor.
|
3 years
|
|
Number of Participants With Serious Treatment Related Adverse Events of Etanercept
Tidsramme: 3 years
|
Serious treatment-related adverse events are defined as any events that lead to death, life-threatening, hospitalization or prolonged hospitalization, a permanent or remarkable disorder/dysfunction, congenital anomaly/congenital deficiency, or other medically significant events or disorder.
|
3 years
|
|
Number of Participants With Unlisted Treatment Related Adverse Events of Etanercept
Tidsramme: 3 years
|
Adverse events are all unfavorable events, including clinically problematic abnormal changes in laboratory test values, which develop in participants after the administration of Etanercept, irrespective of causal relationship to Etanercept.
The causal relationship between an adverse event and Etanercept was evaluated by the sponsor.
Unlisted treatment related adverse events were confirmed with listed adverse drug reactions specified in Japanese package insert.
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3 years
|
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European League Against Rheumatism (EULAR) Disease Activity Score (DAS) 28 Improvement (4/Erythrocyte Sedimentation Rate: ESR)
Tidsramme: 2 years
|
DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment).
Total score range: 0-9.4,
higher score=more disease activity.
DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.
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2 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Modified Health Assessment Questionnaire (mHAQ) Score
Tidsramme: 2 years
|
Modified Health Assessment Questionnaire-(mHAQ): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week.
Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do.
Overall score was computed as the sum of domain scores and divided by the number of domains answered.
Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
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2 years
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Visual Analog Fatigue Scale (VAFS)
Tidsramme: 2 years
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Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.
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2 years
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European League Against Rheumatism (EULAR) Disease Activity Score (DAS) 28 Improvement (3/Erythrocyte Sedimentation Rate: ESR)
Tidsramme: 2 years
|
DAS28-3 (ESR) was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joints count and ESR (mm/hour).
Total score range: 0-9.4,
higher score=more disease activity.
DAS28-3 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) <2.6 = remission.
|
2 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juli 2007
Primær færdiggørelse (Faktiske)
1. april 2013
Studieafslutning (Faktiske)
1. april 2013
Datoer for studieregistrering
Først indsendt
16. juli 2007
Først indsendt, der opfyldte QC-kriterier
16. juli 2007
Først opslået (Skøn)
18. juli 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
28. februar 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. januar 2017
Sidst verificeret
1. januar 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i immunsystemet
- Autoimmune sygdomme
- Ledsygdomme
- Muskuloskeletale sygdomme
- Reumatiske sygdomme
- Bindevævssygdomme
- Gigt
- Gigt, reumatoid
- 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
- 0881A1-4426
- B1801045 (Anden identifikator: Alias Study Number)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
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