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

Galapagos

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: Placebo; Drug: GLPG0634

Study type: Interventional

Funder types: Industry

Identifiers

NCT01668641

GLPG0634-CL-202

Details and patient eligibility

About

• 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.

Enrollment: 91 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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91 participants in 5 patient groups, including a placebo group

capsule, 30mg GLPG0634 once a day

Experimental group

Description:

3 capsules of 10 mg once a day

Treatment:

Drug: GLPG0634

capsules, 75mg GLPG0634 once a day

Experimental group

Description:

3 capsules of 25mg once a day

Treatment:

Drug: GLPG0634

capsules, 150mg GLPG0634 once a day

Experimental group

Description:

3 capsules of 50mg once a day

Treatment:

Drug: GLPG0634

capsules, 300mg GLPG0634 once a day

Experimental group

Description:

3 capsules of 100mg once a day

Treatment:

Drug: GLPG0634

capsules, placebo once a day

Placebo Comparator group

Description:

3 capsules placebo once a day

Treatment:

Drug: Placebo