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

Dose-ranging Study With GLPG0634 in Methotrexate-refractory Active Rheumatoid Arthritis Patients

26. juni 2013 opdateret af: Galapagos NV

Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study to Compare Four Dose Regimens of GLPG0634 Versus Placebo, in Combination With Methotrexate, Administered for 4 Weeks in the Treatment of Subjects With Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Alone

  • Ninety patients suffering from active rheumatoid arthritis despite continued treatment with methotrexate will be evaluated for improvement of disease activity when taking GLPG0634 (4 different doses will be evaluated) or matching placebo for 4 weeks.
  • During the course of the study, patients will also be examined for any side effects that may occur, and the amount of GLPG0634 present in the blood as well as the effects of GLPG0634 on disease- and mechanism of action-related parameters in the blood will be determined.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

91

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Den Russiske Føderation
      • Moscow, Den Russiske Føderation
        • State Healthcare Institution of city Moscow 'City Clinical Hospital #7'
      • Ryazan, Den Russiske Føderation
        • State Healthcare Institution 'Ryazan Regional Cardiology Dispensary'
      • Saint-Petersburg, Den Russiske Føderation
        • Saint-Petersburg State Healthcare Institution 'City Hospital #26'
      • Saint-Petersburg, Den Russiske Føderation
        • Saint-Petersburg State Healthcare Institution 'City Mariinskiy Hospital'
      • Yaroslavl, Den Russiske Føderation
        • Municipal Clinical Healthcare Institution 'Medical-Sanitary Unit of Novoyaroslavskiy Oil Refinery'
  • Moldova, Republikken
      • Chisinau, Moldova, Republikken
        • IMSP Institutel de Cardiologie
  • Ukraine
      • Chernivtsi, Ukraine
        • Chernivtsi Regional Clinical Hospital
      • Donetsk, Ukraine
        • State Institution 'Institute of Urgent and Recovery Surgery n.a. V.K. Gusaka' of AMS of Ukraine
      • Kharkiv, Ukraine
        • Communal Institution of Healthcare
      • Kharkiv, Ukraine
        • Institution of Therapy of AMS of Ukraine
      • Kharkiv, Ukraine
        • State Institution 'Institute of Microbiology and Immunology of AMS of Ukraine'
      • Kiev, Ukraine
        • State Institution 'Republican Clinical Hospital of MoH of Ukraine'
      • Lutsk, Ukraine
        • Lutsk City Clinical Hospital
      • Vinnytsa, Ukraine
        • Vinnytsa Regional Clinical Hospital
      • Zaporizhzhia, Ukraine
        • Zaporizhzhia Regional Clinical Hospital
  • Ungarn
      • Budapest, Ungarn
        • Budai Irgalamsrendi Korhaz, II. Reumatologia Osztaly
      • Budapest, Ungarn
        • Orszagos Reumatologiai es Fizioterapias Intezet, I. Reumatologia Osztaly
      • Eger, Ungarn
        • Markhot Ferenc Korhaz, Reumatologiai Osztaly
      • Kistarcsa, Ungarn
        • Pest Megyei Flor Ferenc Korhaz, Reumatologiai es Fizioterapias Osztaly

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 til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Have active RA as shown by five or more swollen joints (from the 66-joint count), five or more tender joints (from 68-joint count), and a serum CRP ≥1.0 mg/dL;
  • Have received methotrexate for 12 weeks or longer and at a stable dose of 7.5 to 25 mg/week for at least 4 weeks prior to screening and willing to continue on this regimen for the duration of the study;
  • If taking oral steroids, these should be at a dose ≤10 mg/day of prednisone or prednisone equivalent and stable for at least 4 weeks prior to screening;
  • If taking non-steroidal anti-inflammatory drugs (NSAIDs), these must be at a stable dose for at least 2 weeks prior to screening;
  • Female subjects must have a negative pregnancy test unless they are surgically sterile or have been post-menopausal for at least one year;
  • Women of childbearing potential must use a medically acceptable means of birth control and agree to continue its use during the study and for at least 12 weeks after the last dose of study drug.
  • Sexually active men must agree to use a medically acceptable form of contraception during the study and continue its use for at least 3 months after the last dose of study drug; and
  • Able and willing to sign the informed consent prior to screening evaluations and agree to schedule of assessments.

Exclusion Criteria:

  • Treatment with disease-modifying antirheumatic drugs (DMARDs), other than background methotrexate;
  • Current or previous RA treatment with a biological agent, with the exception of biologics administered in a clinical study setting more than six months prior to screening (12 months for rituximab or other B cell depleting agents);
  • Previous treatment at any time with a cytotoxic agent, other than methotrexate, before screening;
  • Previous use of the study drug GLPG0634;
  • Receipt of an intra-articular or parenteral corticosteroid injection within 4 weeks prior to screening;
  • Known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug as determined by the Investigator;
  • Positive serology for HIV1 or 2 or hepatitis B or C, or any history of hepatitis from any cause with the exception of hepatitis A;
  • History of any inflammatory rheumatological disorders other than RA;
  • History of tuberculosis (TB) infection

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: capsule, 30mg GLPG0634 once a day
3 capsules of 10 mg once a day
Medicin: GLPG0634
Eksperimentel: capsules, 75mg GLPG0634 once a day
3 capsules of 25mg once a day
Medicin: GLPG0634
Eksperimentel: capsules, 150mg GLPG0634 once a day
3 capsules of 50mg once a day
Medicin: GLPG0634
Eksperimentel: capsules, 300mg GLPG0634 once a day
3 capsules of 100mg once a day
Medicin: GLPG0634
Placebo komparator: capsules, placebo once a day
3 capsules placebo once a day
Medicin: Placebo

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The number of patients with an ACR20 score at Week 4 as a measure of efficacy
Tidsramme: Week 4 (end of treatment visit)
To preliminary evaluate the efficacy of GLPG0634 compared to placebo in terms of the proportion of subjects achieving an ACR20 response at Week 4
Week 4 (end of treatment visit)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The number of patients with ACR20/50/70 response, time to response and DAS28 score at every visit as a measure of efficacy
Tidsramme: From Day -1 up to end of treatment visit (week 4)
To evaluate the efficacy of GLPG0634 compared to placebo in terms of ACR response criteria at every visit (ACR20, ACR50, ACR70), time to response, and disease status (DAS28[C-reactive protein, CRP]
From Day -1 up to end of treatment visit (week 4)
The number of patients with adverse events, abnormal lab tests, vital signs and ECG as a measure of safety and tolerability
Tidsramme: From screening up to 10 days after last dose
To evaluate the safety and tolerability of GLPG0634 in comparison with placebo in terms of adverse events (AEs), laboratory test abnormalities, vital signs and electrocardiogram (ECG)
From screening up to 10 days after last dose
The plasma levels of GLPG0634 as a measure of PK
Tidsramme: Week 1, week 2 and week 4 visits
To characterize the pharmacokinetics (PK) of GLPG0634 by measuring the amount of GLPG0634 in the plasma
Week 1, week 2 and week 4 visits
The plasma levels of GLPG0634 and MTX as a measure of PK
Tidsramme: Day -1 and Week 2 or 4 visit (8 hour-sampling)
To explore the potential interaction of GLPG0634 on MTX by assessing steady state PK in an 8-hour sampling at Day -1 and at Week 2 or Week 4 visit in a subset of patients
Day -1 and Week 2 or 4 visit (8 hour-sampling)
The levels of immune- and inflammation-related parameters in plasma as a measure of PD
Tidsramme: Day -1, Week 1, week 2 and week 4 visits
To characterize the pharmacodynamics (PD) of GLPG0634 by measuring the levels of immune- and inflammation-related parameters in plasma
Day -1, Week 1, week 2 and week 4 visits

Samarbejdspartnere og efterforskere

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

Sponsor

Galapagos NV

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

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. maj 2012

Primær færdiggørelse (Faktiske)

1. september 2012

Studieafslutning (Faktiske)

1. oktober 2012

Datoer for studieregistrering

Først indsendt

14. august 2012

Først indsendt, der opfyldte QC-kriterier

16. august 2012

Først opslået (Skøn)

20. august 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

27. juni 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. juni 2013

Sidst verificeret

1. juni 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GLPG0634-CL-202

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 Placebo

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Switzerland

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner