Overview

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

Status:
Completed
Trial end date:
2012-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Galapagos NV
Treatments:
Methotrexate
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