Dose-ranging Study With GLPG0634 in Methotrexate-refractory Active Rheumatoid Arthritis Patients

NCT ID: NCT01668641

Last Updated: 2013-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2012-10-31

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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

capsule, 30mg GLPG0634 once a day

3 capsules of 10 mg once a day

Group Type: EXPERIMENTAL

GLPG0634

Intervention Type: DRUG

capsules, 75mg GLPG0634 once a day

3 capsules of 25mg once a day

Group Type: EXPERIMENTAL

GLPG0634

Intervention Type: DRUG

capsules, 150mg GLPG0634 once a day

3 capsules of 50mg once a day

Group Type: EXPERIMENTAL

GLPG0634

Intervention Type: DRUG

capsules, 300mg GLPG0634 once a day

3 capsules of 100mg once a day

Group Type: EXPERIMENTAL

GLPG0634

Intervention Type: DRUG

capsules, placebo once a day

3 capsules placebo once a day

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

GLPG0634

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galapagos NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frédéric Vanhoutte, MD

Role: STUDY_DIRECTOR

Galapagos NV

Locations

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

Countries

Hungary; Moldova; Russia; Ukraine

References

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.

Reference Type: DERIVED

PMID: 28622463 (View on PubMed)

Other Identifiers

GLPG0634-CL-202

Identifier Type: -

Identifier Source: org_study_id