Dose-ranging Study With GLPG0634 in Methotrexate-refractory Active Rheumatoid Arthritis Patients
26 juni 2013 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
91
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Budapest, Hongarije
- Budai Irgalamsrendi Korhaz, II. Reumatologia Osztaly
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Budapest, Hongarije
- Orszagos Reumatologiai es Fizioterapias Intezet, I. Reumatologia Osztaly
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Eger, Hongarije
- Markhot Ferenc Korhaz, Reumatologiai Osztaly
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Kistarcsa, Hongarije
- Pest Megyei Flor Ferenc Korhaz, Reumatologiai es Fizioterapias Osztaly
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Chisinau, Moldavië, Republiek
- IMSP Institutel de Cardiologie
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Chernivtsi, Oekraïne
- Chernivtsi Regional Clinical Hospital
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Donetsk, Oekraïne
- State Institution 'Institute of Urgent and Recovery Surgery n.a. V.K. Gusaka' of AMS of Ukraine
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Kharkiv, Oekraïne
- Communal Institution of Healthcare
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Kharkiv, Oekraïne
- Institution of Therapy of AMS of Ukraine
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Kharkiv, Oekraïne
- State Institution 'Institute of Microbiology and Immunology of AMS of Ukraine'
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Kiev, Oekraïne
- State Institution 'Republican Clinical Hospital of MoH of Ukraine'
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Lutsk, Oekraïne
- Lutsk City Clinical Hospital
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Vinnytsa, Oekraïne
- Vinnytsa Regional Clinical Hospital
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Zaporizhzhia, Oekraïne
- Zaporizhzhia Regional Clinical Hospital
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Moscow, Russische Federatie
- State Healthcare Institution of city Moscow 'City Clinical Hospital #7'
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Ryazan, Russische Federatie
- State Healthcare Institution 'Ryazan Regional Cardiology Dispensary'
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Saint-Petersburg, Russische Federatie
- Saint-Petersburg State Healthcare Institution 'City Hospital #26'
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Saint-Petersburg, Russische Federatie
- Saint-Petersburg State Healthcare Institution 'City Mariinskiy Hospital'
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Yaroslavl, Russische Federatie
- Municipal Clinical Healthcare Institution 'Medical-Sanitary Unit of Novoyaroslavskiy Oil Refinery'
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 70 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: capsule, 30mg GLPG0634 once a day
3 capsules of 10 mg once a day
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Experimenteel: capsules, 75mg GLPG0634 once a day
3 capsules of 25mg once a day
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Experimenteel: capsules, 150mg GLPG0634 once a day
3 capsules of 50mg once a day
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Experimenteel: capsules, 300mg GLPG0634 once a day
3 capsules of 100mg once a day
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Placebo-vergelijker: capsules, placebo once a day
3 capsules placebo once a day
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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The number of patients with an ACR20 score at Week 4 as a measure of efficacy
Tijdsspanne: Week 4 (end of treatment visit)
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To preliminary evaluate the efficacy of GLPG0634 compared to placebo in terms of the proportion of subjects achieving an ACR20 response at Week 4
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Week 4 (end of treatment visit)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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The number of patients with ACR20/50/70 response, time to response and DAS28 score at every visit as a measure of efficacy
Tijdsspanne: From Day -1 up to end of treatment visit (week 4)
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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]
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From Day -1 up to end of treatment visit (week 4)
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The number of patients with adverse events, abnormal lab tests, vital signs and ECG as a measure of safety and tolerability
Tijdsspanne: From screening up to 10 days after last dose
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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)
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From screening up to 10 days after last dose
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The plasma levels of GLPG0634 as a measure of PK
Tijdsspanne: Week 1, week 2 and week 4 visits
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To characterize the pharmacokinetics (PK) of GLPG0634 by measuring the amount of GLPG0634 in the plasma
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Week 1, week 2 and week 4 visits
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The plasma levels of GLPG0634 and MTX as a measure of PK
Tijdsspanne: Day -1 and Week 2 or 4 visit (8 hour-sampling)
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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
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Day -1 and Week 2 or 4 visit (8 hour-sampling)
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The levels of immune- and inflammation-related parameters in plasma as a measure of PD
Tijdsspanne: Day -1, Week 1, week 2 and week 4 visits
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To characterize the pharmacodynamics (PD) of GLPG0634 by measuring the levels of immune- and inflammation-related parameters in plasma
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Day -1, Week 1, week 2 and week 4 visits
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 mei 2012
Primaire voltooiing (Werkelijk)
1 september 2012
Studie voltooiing (Werkelijk)
1 oktober 2012
Studieregistratiedata
Eerst ingediend
14 augustus 2012
Eerst ingediend dat voldeed aan de QC-criteria
16 augustus 2012
Eerst geplaatst (Schatting)
20 augustus 2012
Updates van studierecords
Laatste update geplaatst (Schatting)
27 juni 2013
Laatste update ingediend die voldeed aan QC-criteria
26 juni 2013
Laatst geverifieerd
1 juni 2013
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- GLPG0634-CL-202
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .