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Study in Rheumatoid Arthritis for Subjects Who Completed Preceding Study M13-390 With Adalimumab

22. oktober 2014 opdateret af: AbbVie (prior sponsor, Abbott)

A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects Who Completed Preceding Study M13-390 With Adalimumab

A Phase 2b, open-label extension (OLE) study in rheumatoid arthritis (RA) patients designed to collect long-term safety, tolerability, efficacy, and immunogenicity data of the proposed new adalimumab formulation.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

All participants who completed Study NCT01712178 had an opportunity to enroll into the study and to receive the new adalimumab formulation at a dose of 40 mg every other week (eow) for an additional 24 weeks.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

88

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Belgien
      • Brussels, Belgien, 1200
        • Site Reference ID/Investigator# 92053
      • Liege, Belgien, 4000
        • Site Reference ID/Investigator# 92054
  • Forenede Stater
    • Arizona
      • Mesa, Arizona, Forenede Stater, 85202
        • Site Reference ID/Investigator# 92113
    • California
      • Hemet, California, Forenede Stater, 92543
        • Site Reference ID/Investigator# 92118
    • Kansas
      • Wichita, Kansas, Forenede Stater, 67203
        • Site Reference ID/Investigator# 92117
    • New Jersey
      • Clifton, New Jersey, Forenede Stater, 07012
        • Site Reference ID/Investigator# 92115
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19152
        • Site Reference ID/Investigator# 92116
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29406
        • Site Reference ID/Investigator# 92114
  • Puerto Rico
      • Vega Baja, Puerto Rico, 00693
        • Site Reference ID/Investigator# 92074
  • Rumænien
      • Bucharest, Rumænien, 020475
        • Site Reference ID/Investigator# 92093
      • Cluj-Napoca, Rumænien, 400006
        • Site Reference ID/Investigator# 92095
      • Ploiesti, Rumænien, 100337
        • Site Reference ID/Investigator# 92094
  • Slovakiet
      • Banska Bystrica, Slovakiet, 97405
        • Site Reference ID/Investigator# 92096
      • Senica, Slovakiet, 905 01
        • Site Reference ID/Investigator# 92097
      • Zilina, Slovakiet, 010 01
        • Site Reference ID/Investigator# 92098
  • Tjekkiet
      • Brno, Tjekkiet, 638 00
        • Site Reference ID/Investigator# 91954
      • Prague 2, Tjekkiet, 128 50
        • Site Reference ID/Investigator# 91955
      • Uherske Hradiste, Tjekkiet, 686 01
        • Site Reference ID/Investigator# 91953
      • Zlin, Tjekkiet, 760 01
        • Site Reference ID/Investigator# 91956
  • Tyskland
      • Ratingen, Tyskland, 40882
        • Site Reference ID/Investigator# 92073

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Subject has completed the preceding Study M13-390 for rheumatoid arthritis and has not developed any discontinuation criteria from that study.

  2. If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy and/or hysterectomy) or is of childbearing potential and is practicing an approved method of birth control throughout the study and for 150 days after last dose of study drug. Examples of approved methods of birth control include the following (see local informed consent for more detail):

    • Condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD);
    • Hormonal contraceptives for 90 days prior to study drug administration;
    • A vasectomized partner.
  3. Subjects must be able and willing to self-administer subcutaneous (SC) injections or have a qualified person available to administer SC injections.
  4. Subject is judged to be in good general health as determined by the Principal Investigator based upon the results of medical history, physical examination, laboratory profile performed at Baseline.
  5. Subjects must be able and willing to provide written informed consent and to comply with the requirements of this study protocol.

Exclusion Criteria:

  1. Ongoing infections at Week 0 that have NOT been successfully treated. Subjects with ongoing infections undergoing treatment may be enrolled BUT NOT dosed until the infection has been successfully treated.
  2. Subject currently uses or plans to use anti-retroviral therapy at any time during the study.
  3. Subject plans to use any live vaccine during the study.
  4. Positive pregnancy test at Baseline (Week 0).
  5. Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Ny formulering af adalimumab 40 mg hver anden uge
Ny formulering adalimumab 40 mg hver anden uge
Biologisk: New formulation adalimumab
New formulation adalimumab 40 mg every other week
Andre navne:
  • Humira

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean Change From Baseline in Disease Activity Score 28 (DAS28) at Weeks 36 and 48
Tidsramme: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Weeks 36 and 48
Tidsramme: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48

American College of Rheumatology 20% (ACR20) response. A participant is a responder if the following 3 criteria for improvement from baseline are met:

  • ≥ 20% improvement in tender joint count;
  • ≥ 20% improvement in swollen joint count; and

  • ≥ 20% improvement in at least 3 of the 5 following parameters:

    • Physician global assessment of disease activity
    • Patient global assessment of disease activity
    • Patient assessment of pain
    • Disability Index of the Health Assessment
    • CRP (Acute phase reactant (Erythrocyte sedimentation rate/C-reactive protein))
Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Weeks 36 and 48
Tidsramme: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48

American College of Rheumatology 50% (ACR50) response. A participant is a responder if the following 3 criteria for improvement from baseline are met:

  • ≥ 50% improvement in tender joint count;
  • ≥ 50% improvement in swollen joint count; and

  • ≥ 50% improvement in at least 3 of the 5 following parameters:

    • Physician global assessment of disease activity
    • Patient global assessment of disease activity
    • Patient assessment of pain
    • Disability Index of the Health Assessment
    • CRP (Acute phase reactant (Erythrocyte sedimentation rate/C-reactive protein))
Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
Mean Change From Baseline in Health Assessment Questionnaire (HAQ-DI) at Weeks 36 and 48
Tidsramme: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is 0.22. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5.
Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Positive for Anti-adalimumab Antibody
Tidsramme: Week 24 through Week 48
Percentage of participants with anti-adalimumab antibody
Week 24 through Week 48

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: Andy Payne, PhD, 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.

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. december 2012

Primær færdiggørelse (Faktiske)

1. oktober 2013

Studieafslutning (Faktiske)

1. oktober 2013

Datoer for studieregistrering

Først indsendt

17. december 2012

Først indsendt, der opfyldte QC-kriterier

18. december 2012

Først opslået (Skøn)

19. december 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

29. oktober 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. oktober 2014

Sidst verificeret

1. oktober 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • M13-692
  • 2012-003881-42 (EudraCT nummer)

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

Kliniske forsøg med New formulation adalimumab

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Thailand

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner