Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Special Investigation (Follow-up Survey of the Study of Adalimumab (D2E7) for Prevention of Joint Destruction in Patients With Rheumatoid Arthritis in Japan (M06-859 (NCT00870467))

8. juni 2018 opdateret af: AbbVie (prior sponsor, Abbott)

Humira 40 mg/0.8 mL Syringe for Subcutaneous Injection - Special Investigation (Follow-up Survey of the Study of Adalimumab (D2E7) for Prevention of Joint Destruction in Patients With Rheumatoid Arthritis in Japan (M06-859)]

The present survey was conducted to evaluate the effectiveness and safety of treatment with adalimumab during the 52-week period following completion of the treatment period in Study NCT00870467 (M06-859) in participants who continued treatment with adalimumab for 52 weeks.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

This survey was conducted to assess the risk and benefit of continuing or discontinuing biological therapy with adalimumab (Humira) during the 52-week period following completion of the treatment period in Study NCT00870467 (M06-859).

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

220

Kontakter og lokationer

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

Studiesteder

  • Japan
      • Anjo, Japan
        • Site Reference ID/Investigator# 54680
      • Aomori, Japan
        • Site Reference ID/Investigator# 54677
      • Chiba, Japan
        • Site Reference ID/Investigator# 54516
      • Chiba, Japan
        • Site Reference ID/Investigator# 54660
      • Chiba, Japan
        • Site Reference ID/Investigator# 54683
      • Fukuoka, Japan
        • Site Reference ID/Investigator# 54521
      • Gifu, Japan
        • Site Reference ID/Investigator# 39854
      • Hamamatsu, Japan
        • Site Reference ID/Investigator# 54666
      • Hiroshima, Japan
        • Site Reference ID/Investigator# 54682
      • Hyogo, Japan
        • Site Reference ID/Investigator# 54669
      • Hyogo, Japan
        • Site Reference ID/Investigator# 54674
      • Ibaraki, Japan
        • Site Reference ID/Investigator# 54653
      • Kagoshima, Japan
        • Site Reference ID/Investigator# 54670
      • Kagoshima, Japan
        • Site Reference ID/Investigator# 54692
      • Kawagoe, Japan
        • Site Reference ID/Investigator# 54679
      • Kawagoe, Japan
        • Site Reference ID/Investigator# 59580
      • Kawasaki, Japan
        • Site Reference ID/Investigator# 54662
      • Kirishima, Japan
        • Site Reference ID/Investigator# 54693
      • Kitakyushu, Japan
        • Site Reference ID/Investigator# 54671
      • Kumamoto, Japan
        • Site Reference ID/Investigator# 54643
      • Kyoto, Japan
        • Site Reference ID/Investigator# 59583
      • Maebashi, Japan
        • Site Reference ID/Investigator# 59582
      • Matsumoto, Japan
        • Site Reference ID/Investigator# 39849
      • Matsuyama, Japan
        • Site Reference ID/Investigator# 54520
      • Miyazaki, Japan
        • Site Reference ID/Investigator# 54644
      • Morioka, Japan
        • Site Reference ID/Investigator# 54645
      • Nagano, Japan
        • Site Reference ID/Investigator# 54654
      • Nagaoka, Japan
        • Site Reference ID/Investigator# 54656
      • Nagasaki, Japan
        • Site Reference ID/Investigator# 63052
      • Nagoya, Japan
        • Site Reference ID/Investigator# 54667
      • Nagoya, Japan
        • Site Reference ID/Investigator# 54673
      • Nara, Japan
        • Site Reference ID/Investigator# 54649
      • Niigata, Japan
        • Site Reference ID/Investigator# 39844
      • Oita, Japan
        • Site Reference ID/Investigator# 54675
      • Okayama, Japan
        • Site Reference ID/Investigator# 39847
      • Okayama, Japan
        • Site Reference ID/Investigator# 54681
      • Osaka, Japan
        • Site Reference ID/Investigator# 39846
      • Osaka, Japan
        • Site Reference ID/Investigator# 54518
      • Rifu, Japan
        • Site Reference ID/Investigator# 54646
      • Sagamihara, Kanagawa, Japan
        • Site Reference ID/Investigator# 54661
      • Saitama, Japan
        • Site Reference ID/Investigator# 54514
      • Saitama, Japan
        • Site Reference ID/Investigator# 54689
      • Sapporo, Japan
        • Site Reference ID/Investigator# 25922
      • Sapporo, Japan
        • Site Reference ID/Investigator# 39850
      • Sapporo, Japan
        • Site Reference ID/Investigator# 54651
      • Sapporo, Japan
        • Site Reference ID/Investigator# 54652
      • Sasebo, Japan
        • Site Reference ID/Investigator# 54522
      • Setouchi, Japan
        • Site Reference ID/Investigator# 54650
      • Shimotsuke, Japan
        • Site Reference ID/Investigator# 39851
      • Shizuoka, Japan
        • Site Reference ID/Investigator# 39845
      • Shizuoka, Japan
        • Site Reference ID/Investigator# 54517
      • Takamatsu, Japan
        • Site Reference ID/Investigator# 59579
      • Takasaki, Japan
        • Site Reference ID/Investigator# 54655
      • Tenri, Japan
        • Site Reference ID/Investigator# 54519
      • Tokorozawa, Japan
        • Site Reference ID/Investigator# 54515
      • Tokyo, Japan
        • Site Reference ID/Investigator# 39842
      • Tokyo, Japan
        • Site Reference ID/Investigator# 39852
      • Tokyo, Japan
        • Site Reference ID/Investigator# 39853
      • Tokyo, Japan
        • Site Reference ID/Investigator# 54647
      • Tokyo, Japan
        • Site Reference ID/Investigator# 54657
      • Tokyo, Japan
        • Site Reference ID/Investigator# 54658
      • Tokyo, Japan
        • Site Reference ID/Investigator# 54678
      • Tokyo, Japan
        • Site Reference ID/Investigator# 54688
      • Tokyo, Japan
        • Site Reference ID/Investigator# 59581
      • Tomigusuku, Japan
        • Site Reference ID/Investigator# 54672
      • Toyama, Japan
        • Site Reference ID/Investigator# 54648
      • Toyama, Japan
        • Site Reference ID/Investigator# 54691
      • Toyoake, Japan
        • Site Reference ID/Investigator# 54690
      • Toyohashi, Japan
        • Site Reference ID/Investigator# 54676
      • Tsu, Japan
        • Site Reference ID/Investigator# 54668
      • Yokohama, Japan
        • Site Reference ID/Investigator# 39843
      • Yokohama, Japan
        • Site Reference ID/Investigator# 54663
      • Yokohama, Japan
        • Site Reference ID/Investigator# 54664
      • Yokohama, Japan
        • Site Reference ID/Investigator# 54665
      • Yotsukaido, Japan
        • Site Reference ID/Investigator# 54659

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

20 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

The participants were patients who continued treatment with adalimumab until the end of the treatment period in the NCT00870467(M06-859) study.

Beskrivelse

Inclusion Criteria:

  • The participants were patients who continued treatment with adalimumab until the end of the treatment period in the NCT00870467(M06-859) study and provided informed consent to participate in the present follow-up survey.

Exclusion Criteria:

  • Participants who used biological agents other than adalimumab after the period of treatment in the NCT00870467(M06-859) study were excluded from the present follow-up study.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Adalimumab
Participants who continued adalimumab treatment after completion of Study NCT00870467 (M06-859)
Non-Adalimumab
Participants who discontinued adalimumab treatment after completion of Study NCT00870467(M06-859)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Disease Activity Score (DAS28)
Tidsramme: Weeks 0, 26, and 52
The Disease Activity Score (DAS28) is a combined index used to measure disease activity in participants with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate (ESR). DAS 28 (ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity.
Weeks 0, 26, and 52

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Matrix Metalloprotease-3 (MMP-3)
Tidsramme: Weeks 0, 26, and 52
MMP-3 level in serum. Positive = >/= 121.0 ng/mL (male) and 59.7 ng/mL (female)
Weeks 0, 26, and 52
Modified Total Sharp Score (mTSS) Change From Week 0 to Week 52
Tidsramme: Week 0 to Week 52
Modified Total Sharp Score (mTSS) is a method of assessing radiographs used in evaluation of inhibition of joint destruction of disease. Digitized X-rays of hands and feet were obtained, then scored in a blinded manner: for erosion (0 [no damage] to 5 [complete collapse or total destruction of joint]) and for joint space narrowing (0 [no damage] to 4 [complete luxation of joint]). Sum of scores was given as total mTSS (0 [normal] to 380 [maximal disease]). Large positive change in mTSS indicates disease progression; small positive/no change indicates slowing/halting of disease progression.
Week 0 to Week 52
Health Assessment Questionnaire Disability Index (HAQ-DI)
Tidsramme: Weeks 0, 26, and 52
Participants assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Participants assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from baseline in the disability index of the HAQ-DI indicated improvement.
Weeks 0, 26, and 52
Number of Participants With Adverse Events (AEs)
Tidsramme: Week 0 to Week 52
Adverse events (AEs) were collected from week 0 till the end of the study. Please see Adverse Event section below for more details.
Week 0 to Week 52

Samarbejdspartnere og efterforskere

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

Sponsor

AbbVie (prior sponsor, Abbott)

Efterforskere

  • Studieleder: Aki Kuroki, AbbVie GK.

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

1. marts 2010

Primær færdiggørelse (Faktiske)

1. oktober 2012

Studieafslutning (Faktiske)

1. oktober 2012

Datoer for studieregistrering

Først indsendt

14. juli 2010

Først indsendt, der opfyldte QC-kriterier

14. juli 2010

Først opslået (Skøn)

15. juli 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. juli 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juni 2018

Sidst verificeret

1. december 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • P12-069

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 .

Kliniske forsøg med Rheumatoid arthritis

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Mongolia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner