Dose-ranging Study With GLPG0634 in Methotrexate-refractory Active Rheumatoid Arthritis Patients
26 juin 2013 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
91
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Moscow, Fédération Russe
- State Healthcare Institution of city Moscow 'City Clinical Hospital #7'
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Ryazan, Fédération Russe
- State Healthcare Institution 'Ryazan Regional Cardiology Dispensary'
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Saint-Petersburg, Fédération Russe
- Saint-Petersburg State Healthcare Institution 'City Hospital #26'
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Saint-Petersburg, Fédération Russe
- Saint-Petersburg State Healthcare Institution 'City Mariinskiy Hospital'
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Yaroslavl, Fédération Russe
- Municipal Clinical Healthcare Institution 'Medical-Sanitary Unit of Novoyaroslavskiy Oil Refinery'
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Budapest, Hongrie
- Budai Irgalamsrendi Korhaz, II. Reumatologia Osztaly
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Budapest, Hongrie
- Orszagos Reumatologiai es Fizioterapias Intezet, I. Reumatologia Osztaly
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Eger, Hongrie
- Markhot Ferenc Korhaz, Reumatologiai Osztaly
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Kistarcsa, Hongrie
- Pest Megyei Flor Ferenc Korhaz, Reumatologiai es Fizioterapias Osztaly
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Chisinau, Moldavie, République de
- IMSP Institutel de Cardiologie
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Chernivtsi, Ukraine
- Chernivtsi Regional Clinical Hospital
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Donetsk, Ukraine
- State Institution 'Institute of Urgent and Recovery Surgery n.a. V.K. Gusaka' of AMS of Ukraine
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Kharkiv, Ukraine
- Communal Institution of Healthcare
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Kharkiv, Ukraine
- Institution of Therapy of AMS of Ukraine
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Kharkiv, Ukraine
- State Institution 'Institute of Microbiology and Immunology of AMS of Ukraine'
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Kiev, Ukraine
- State Institution 'Republican Clinical Hospital of MoH of Ukraine'
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Lutsk, Ukraine
- Lutsk City Clinical Hospital
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Vinnytsa, Ukraine
- Vinnytsa Regional Clinical Hospital
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Zaporizhzhia, Ukraine
- Zaporizhzhia Regional Clinical Hospital
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 70 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: capsule, 30mg GLPG0634 once a day
3 capsules of 10 mg once a day
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Expérimental: capsules, 75mg GLPG0634 once a day
3 capsules of 25mg once a day
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Expérimental: capsules, 150mg GLPG0634 once a day
3 capsules of 50mg once a day
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Expérimental: capsules, 300mg GLPG0634 once a day
3 capsules of 100mg once a day
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Comparateur placebo: capsules, placebo once a day
3 capsules placebo once a day
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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The number of patients with an ACR20 score at Week 4 as a measure of efficacy
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 mai 2012
Achèvement primaire (Réel)
1 septembre 2012
Achèvement de l'étude (Réel)
1 octobre 2012
Dates d'inscription aux études
Première soumission
14 août 2012
Première soumission répondant aux critères de contrôle qualité
16 août 2012
Première publication (Estimation)
20 août 2012
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
27 juin 2013
Dernière mise à jour soumise répondant aux critères de contrôle qualité
26 juin 2013
Dernière vérification
1 juin 2013
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- GLPG0634-CL-202
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .