Dose-ranging Study With GLPG0634 in Methotrexate-refractory Active Rheumatoid Arthritis Patients
26 juni 2013 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
91
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Chisinau, Moldavien, Republiken
- IMSP Institutel de Cardiologie
-
-
-
-
-
Moscow, Ryska Federationen
- State Healthcare Institution of city Moscow 'City Clinical Hospital #7'
-
Ryazan, Ryska Federationen
- State Healthcare Institution 'Ryazan Regional Cardiology Dispensary'
-
Saint-Petersburg, Ryska Federationen
- Saint-Petersburg State Healthcare Institution 'City Hospital #26'
-
Saint-Petersburg, Ryska Federationen
- Saint-Petersburg State Healthcare Institution 'City Mariinskiy Hospital'
-
Yaroslavl, Ryska Federationen
- Municipal Clinical Healthcare Institution 'Medical-Sanitary Unit of Novoyaroslavskiy Oil Refinery'
-
-
-
-
-
Chernivtsi, Ukraina
- Chernivtsi Regional Clinical Hospital
-
Donetsk, Ukraina
- State Institution 'Institute of Urgent and Recovery Surgery n.a. V.K. Gusaka' of AMS of Ukraine
-
Kharkiv, Ukraina
- Communal Institution of Healthcare
-
Kharkiv, Ukraina
- Institution of Therapy of AMS of Ukraine
-
Kharkiv, Ukraina
- State Institution 'Institute of Microbiology and Immunology of AMS of Ukraine'
-
Kiev, Ukraina
- State Institution 'Republican Clinical Hospital of MoH of Ukraine'
-
Lutsk, Ukraina
- Lutsk City Clinical Hospital
-
Vinnytsa, Ukraina
- Vinnytsa Regional Clinical Hospital
-
Zaporizhzhia, Ukraina
- Zaporizhzhia Regional Clinical Hospital
-
-
-
-
-
Budapest, Ungern
- Budai Irgalamsrendi Korhaz, II. Reumatologia Osztaly
-
Budapest, Ungern
- Orszagos Reumatologiai es Fizioterapias Intezet, I. Reumatologia Osztaly
-
Eger, Ungern
- Markhot Ferenc Korhaz, Reumatologiai Osztaly
-
Kistarcsa, Ungern
- Pest Megyei Flor Ferenc Korhaz, Reumatologiai es Fizioterapias Osztaly
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 70 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: capsule, 30mg GLPG0634 once a day
3 capsules of 10 mg once a day
|
|
|
Experimentell: capsules, 75mg GLPG0634 once a day
3 capsules of 25mg once a day
|
|
|
Experimentell: capsules, 150mg GLPG0634 once a day
3 capsules of 50mg once a day
|
|
|
Experimentell: capsules, 300mg GLPG0634 once a day
3 capsules of 100mg once a day
|
|
|
Placebo-jämförare: capsules, placebo once a day
3 capsules placebo once a day
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The number of patients with an ACR20 score at Week 4 as a measure of efficacy
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The number of patients with ACR20/50/70 response, time to response and DAS28 score at every visit as a measure of efficacy
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 maj 2012
Primärt slutförande (Faktisk)
1 september 2012
Avslutad studie (Faktisk)
1 oktober 2012
Studieregistreringsdatum
Först inskickad
14 augusti 2012
Först inskickad som uppfyllde QC-kriterierna
16 augusti 2012
Första postat (Uppskatta)
20 augusti 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
27 juni 2013
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
26 juni 2013
Senast verifierad
1 juni 2013
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- GLPG0634-CL-202
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .