Dose-ranging Study With GLPG0634 in Methotrexate-refractory Active Rheumatoid Arthritis Patients
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
1 other identifier
interventional
91
4 countries
19
Brief Summary
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 rheumatoid-arthritis
Started May 2012
Shorter than P25 for phase_2 rheumatoid-arthritis
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 14, 2012
CompletedFirst Posted
Study publicly available on registry
August 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedJune 27, 2013
June 1, 2013
4 months
August 14, 2012
June 26, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The number of patients with an ACR20 score at Week 4 as a measure of efficacy
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)
Secondary Outcomes (5)
The number of patients with ACR20/50/70 response, time to response and DAS28 score at every visit as a measure of efficacy
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
From screening up to 10 days after last dose
The plasma levels of GLPG0634 as a measure of PK
Week 1, week 2 and week 4 visits
The plasma levels of GLPG0634 and MTX as a measure of PK
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
Day -1, Week 1, week 2 and week 4 visits
Study Arms (5)
capsule, 30mg GLPG0634 once a day
EXPERIMENTAL3 capsules of 10 mg once a day
capsules, 75mg GLPG0634 once a day
EXPERIMENTAL3 capsules of 25mg once a day
capsules, 150mg GLPG0634 once a day
EXPERIMENTAL3 capsules of 50mg once a day
capsules, 300mg GLPG0634 once a day
EXPERIMENTAL3 capsules of 100mg once a day
capsules, placebo once a day
PLACEBO COMPARATOR3 capsules placebo once a day
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Galapagos NVlead
Study Sites (19)
Budai Irgalamsrendi Korhaz, II. Reumatologia Osztaly
Budapest, Hungary
Orszagos Reumatologiai es Fizioterapias Intezet, I. Reumatologia Osztaly
Budapest, Hungary
Markhot Ferenc Korhaz, Reumatologiai Osztaly
Eger, Hungary
Pest Megyei Flor Ferenc Korhaz, Reumatologiai es Fizioterapias Osztaly
Kistarcsa, Hungary
IMSP Institutel de Cardiologie
Chisinau, Moldova
State Healthcare Institution of city Moscow 'City Clinical Hospital #7'
Moscow, Russia
State Healthcare Institution 'Ryazan Regional Cardiology Dispensary'
Ryazan, Russia
Saint-Petersburg State Healthcare Institution 'City Hospital #26'
Saint Petersburg, Russia
Saint-Petersburg State Healthcare Institution 'City Mariinskiy Hospital'
Saint Petersburg, Russia
Municipal Clinical Healthcare Institution 'Medical-Sanitary Unit of Novoyaroslavskiy Oil Refinery'
Yaroslavl, Russia
Chernivtsi Regional Clinical Hospital
Chernivtsi, Ukraine
State Institution 'Institute of Urgent and Recovery Surgery n.a. V.K. Gusaka' of AMS of Ukraine
Donetsk, 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'
Kharkiv, Ukraine
State Institution 'Republican Clinical Hospital of MoH of Ukraine'
Kiev, Ukraine
Lutsk City Clinical Hospital
Lutsk, Ukraine
Vinnytsa Regional Clinical Hospital
Vinnytsa, Ukraine
Zaporizhzhia Regional Clinical Hospital
Zaporizhzhia, Ukraine
Related Publications (1)
Vanhoutte F, Mazur M, Voloshyn O, Stanislavchuk M, Van der Aa A, Namour F, Galien R, Meuleners L, van 't Klooster G. Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Filgotinib, a Selective JAK-1 Inhibitor, After Short-Term Treatment of Rheumatoid Arthritis: Results of Two Randomized Phase IIa Trials. Arthritis Rheumatol. 2017 Oct;69(10):1949-1959. doi: 10.1002/art.40186. Epub 2017 Aug 31.
PMID: 28622463DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Frédéric Vanhoutte, MD
Galapagos NV
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2012
First Posted
August 20, 2012
Study Start
May 1, 2012
Primary Completion
September 1, 2012
Study Completion
October 1, 2012
Last Updated
June 27, 2013
Record last verified: 2013-06