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HUMIRA® Long-term Treatment in Patients With Non-infectious Intermediate-, Posterior-, or Pan-uveitis

7. oktober 2021 opdateret af: AbbVie

HUMIRA® Special Investigation (Long-term Treatment in Patients With Non-infectious Intermediate-, Posterior-, or Pan-uveitis)

This study evaluates the long- term safety and effectiveness of adalimumab in participants with non-infectious intermediate-, posterior-, or pan-uveitis in daily practice in Japan.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

259

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Japan
      • Kagoshima, Japan, 890-8520
        • Kagoshima Uni Med and Dental /ID# 164150
      • Kakogawa, Japan, 489-0065
        • Kakogawa Central City Hospital /ID# 167706
      • Miyakonojo, Japan, 885-0051
        • Miyata Ophthalmic Hospital /ID# 167707
      • Nishinomiya-shi, Japan, 663-8501
        • Duplicate_The Hospital of Hyogo College /ID# 166913
      • Omihachiman, Japan, 523-0082
        • Omihachiman Community Med Ctr /ID# 164978
      • Osaka, Japan, 572-0854
        • Osaka Hospital /ID# 164151
      • Osaka-shi, Japan
        • Yodogawa Christian Hospital /ID# 161741
      • Seto, Japan, 489-8642
        • Tosei General Hospital /ID# 167708
      • Tokorozawa, Japan, 359-0042
        • Natl Defense Med College Hosp /ID# 162946
      • Tokyo, Japan, 108-6303
        • Abbott Japan /ID# 147893
      • Tokyo, Japan, 162-8543
        • Tokyo Shinjuku Medical Center /ID# 166934
      • Tottori, Japan, 680-8501
        • Tottori Municipal Hospital /ID# 159431
    • Chiba
      • Urayasu-shi, Chiba, Japan, 279-0021
        • Juntendo University Urayasu Hospital /ID# 168358
    • Ehime
      • Matsuyama-shi, Ehime, Japan, 790-0826
        • Matsuyama Red Cross Hospital /ID# 164149
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan, 812-8582
        • Kyushu University Hospital /ID# 163042
      • Fukuoka-shi, Fukuoka, Japan, 814-0180
        • Fukuoka University Hospital /ID# 163043
      • Kurume-shi, Fukuoka, Japan, 830-0011
        • Kurume University Hospital /ID# 162945
    • Gunma
      • Maebashi-shi, Gunma, Japan, 371-8511
        • Gunma University Hospital /ID# 166916
    • Hiroshima
      • Hiroshima-shi, Hiroshima, Japan, 734-8551
        • Hiroshima University Hospital /ID# 166915
    • Hokkaido
      • Sapporo-shi, Hokkaido, Japan, 060-8648
        • Hokkaido University Hospital /ID# 163041
    • Hyogo
      • Kobe-shi, Hyogo, Japan, 650-0017
        • Kobe University Hospital /ID# 165250
    • Ishikawa
      • Kanazawa-shi, Ishikawa, Japan, 920-8641
        • Duplicate_Kanazawa University Hospital /ID# 166914
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 240-8555
        • Yokohama Municipal Citizen's Hospital /ID# 161742
    • Kochi
      • Nankoku-shi, Kochi, Japan, 783-8505
        • Kochi Medical School Hospital /ID# 164144
    • Nagano
      • Matsumoto-shi, Nagano, Japan, 390-8621
        • Shinshu University Hospital /ID# 164153
    • Niigata
      • Niigata-shi, Niigata, Japan, 951-8520
        • Niigata University Medical & Dental Hospital /ID# 169563
    • Osaka
      • Suita-shi, Osaka, Japan, 565-0871
        • Osaka University Hospital /ID# 164147
    • Saitama
      • Iruma-gun, Saitama, Japan, 350-0451
        • Saitama Medical University Hospital /ID# 162944
    • Tochigi
      • Shimotsuga-gun, Tochigi, Japan, 321-0293
        • Dokkyo Medical University Hospital /ID# 164154
    • Tokushima
      • Tokushima-shi, Tokushima, Japan, 770-8503
        • Tokushima University Hospital /ID# 164145
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8431
        • Juntendo University Hospital /ID# 169564
      • Bunkyo-ku, Tokyo, Japan, 113-8519
        • Tokyo Medical And Dental University, Medical Hospital /ID# 165251
      • Bunkyo-ku, Tokyo, Japan, 113-8603
        • Nippon Medical School Hospital /ID# 166938
      • Bunkyo-ku, Tokyo, Japan, 113-8655
        • The University of Tokyo Hospital /ID# 162943
      • Minato-ku, Tokyo, Japan, 105-8471
        • The Jikei University Hospital /ID# 164152
      • Shinjuku-ku, Tokyo, Japan, 160-0023
        • Tokyo Medical University Hospital /ID# 164146
      • Shinjuku-ku, Tokyo, Japan, 162-8655
        • Center Hospital of the National Center for Global Health and Medicine /ID# 164148
      • Shinjuku-ku, Tokyo, Japan, 162-8666
        • Tokyo Women's Medical University Hospital /ID# 165248
    • Yamaguchi
      • Ube-shi, Yamaguchi, Japan, 755-8505
        • Yamaguchi University Hospital /ID# 165249

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

1 sekund til 100 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Participants with Non-infectious Intermediate-, Posterior-, or Pan-uveitis

Beskrivelse

Inclusion Criteria:

  • Participants receiving adalimumab for the treatment of Non-infectious Intermediate-, Posterior-, or Pan-uveitis

Exclusion Criteria:

  • Participants previously treated with adalimumab

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Participants receiving adalimumab
Participants receiving adalimumab for the treatment of Non-infectious Intermediate-, Posterior-, or Pan-uveitis

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of adverse drug reactions (ADR)
Tidsramme: Up to Week 52
ADR is the causal relationship between adalimumab and adverse events.
Up to Week 52

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Visual Functioning Questionnaire (VFQ)-25 score
Tidsramme: From Week 0 (baseline) to Week 52
The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning. The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The overall composite score ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning.
From Week 0 (baseline) to Week 52
Change in Visual acuity in each eye
Tidsramme: From Week 0 (baseline) to Week 52
Visual acuity change is assessed.
From Week 0 (baseline) to Week 52
Change in Anterior Chamber (AC) cell grade (standardization of uveitis nomenclature (SUN) criteria) in each eye
Tidsramme: From Week 0 (baseline) to Week 52

Slit lamp examinations will be conducted at each visit to assess AC cell count. The number of AC cells observed within a 1 mm × 1 mm slit beam will be used to determine the grade according to the Standardization of Uveitis Nomenclature (SUN) criteria:

Grade 0 = < 1 cell

Grade 0.5+ = 1 - 5 cells

Grade 1+ = 6 - 15 cells

Grade 2+ = 16 - 25 cells

Grade 3+ = 26 - 50 cells

Grade 4+ = > 50 cells.
From Week 0 (baseline) to Week 52
Percentage of Overall improvement
Tidsramme: Up to Week 52
This is assessed by physicians.
Up to Week 52
Change in retinal lesions in each eye
Tidsramme: From Week 0 (baseline) to Week 52
The change in retinal lesion are assessed.
From Week 0 (baseline) to Week 52
Change in central retinal thickness in each eye
Tidsramme: From Week 0 (baseline) to Week 52
This is assessed by Optical Coherence Tomography (OCT)
From Week 0 (baseline) to Week 52
Change in Vitreous Haze grade in each eye
Tidsramme: From Week 0 (baseline) to Week 52

Vitreous haze will be measured using dilated indirect ophthalmoscopy (DIO) and assessed by the Investigator according to National Eye Institute (NEI)/ SUN criteria:

Grade 0: No evident vitreous haze;

Grade 0.5+: Slight blurring of the optic disc margin because of the haze; normal striations and reflex of the nerve fiber layer cannot be visualized;

Grade 1+: Permits a better definition of both the optic nerve head and the retinal vessels (compared to higher grades);

Grade 2+: Permits better visualization of the retinal vessels (compared to higher grades);

Grade 3+: Permits the observer to see the optic nerve head, but the borders are quite blurry;

Grade 4+: Optic nerve head is obscured.
From Week 0 (baseline) to Week 52

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

AbbVie

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

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 (Faktiske)

15. november 2016

Primær færdiggørelse (Faktiske)

14. oktober 2020

Studieafslutning (Faktiske)

14. oktober 2020

Datoer for studieregistrering

Først indsendt

14. september 2016

Først indsendt, der opfyldte QC-kriterier

24. september 2016

Først opslået (Skøn)

27. september 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. oktober 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. oktober 2021

Sidst verificeret

1. oktober 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • P15-665

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Uafklaret

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

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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