Dose-ranging Study With GLPG0634 in Methotrexate-refractory Active Rheumatoid Arthritis Patients
26. juni 2013 oppdatert av: 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.
Studieoversikt
Studietype
Intervensjonell
Registrering (Faktiske)
91
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Moscow, Den russiske føderasjonen
- State Healthcare Institution of city Moscow 'City Clinical Hospital #7'
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Ryazan, Den russiske føderasjonen
- State Healthcare Institution 'Ryazan Regional Cardiology Dispensary'
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Saint-Petersburg, Den russiske føderasjonen
- Saint-Petersburg State Healthcare Institution 'City Hospital #26'
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Saint-Petersburg, Den russiske føderasjonen
- Saint-Petersburg State Healthcare Institution 'City Mariinskiy Hospital'
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Yaroslavl, Den russiske føderasjonen
- Municipal Clinical Healthcare Institution 'Medical-Sanitary Unit of Novoyaroslavskiy Oil Refinery'
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Chisinau, Moldova, Republikken
- IMSP Institutel de Cardiologie
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Chernivtsi, Ukraina
- Chernivtsi Regional Clinical Hospital
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Donetsk, Ukraina
- State Institution 'Institute of Urgent and Recovery Surgery n.a. V.K. Gusaka' of AMS of Ukraine
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Kharkiv, Ukraina
- Communal Institution of Healthcare
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Kharkiv, Ukraina
- Institution of Therapy of AMS of Ukraine
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Kharkiv, Ukraina
- State Institution 'Institute of Microbiology and Immunology of AMS of Ukraine'
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Kiev, Ukraina
- State Institution 'Republican Clinical Hospital of MoH of Ukraine'
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Lutsk, Ukraina
- Lutsk City Clinical Hospital
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Vinnytsa, Ukraina
- Vinnytsa Regional Clinical Hospital
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Zaporizhzhia, Ukraina
- Zaporizhzhia Regional Clinical Hospital
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Budapest, Ungarn
- Budai Irgalamsrendi Korhaz, II. Reumatologia Osztaly
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Budapest, Ungarn
- Orszagos Reumatologiai es Fizioterapias Intezet, I. Reumatologia Osztaly
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Eger, Ungarn
- Markhot Ferenc Korhaz, Reumatologiai Osztaly
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Kistarcsa, Ungarn
- Pest Megyei Flor Ferenc Korhaz, Reumatologiai es Fizioterapias Osztaly
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 70 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: capsule, 30mg GLPG0634 once a day
3 capsules of 10 mg once a day
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Eksperimentell: capsules, 75mg GLPG0634 once a day
3 capsules of 25mg once a day
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Eksperimentell: capsules, 150mg GLPG0634 once a day
3 capsules of 50mg once a day
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Eksperimentell: capsules, 300mg GLPG0634 once a day
3 capsules of 100mg once a day
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Placebo komparator: capsules, placebo once a day
3 capsules placebo once a day
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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The number of patients with an ACR20 score at Week 4 as a measure of efficacy
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mai 2012
Primær fullføring (Faktiske)
1. september 2012
Studiet fullført (Faktiske)
1. oktober 2012
Datoer for studieregistrering
Først innsendt
14. august 2012
Først innsendt som oppfylte QC-kriteriene
16. august 2012
Først lagt ut (Anslag)
20. august 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
27. juni 2013
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. juni 2013
Sist bekreftet
1. juni 2013
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- GLPG0634-CL-202
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .