Safety and Preliminary Efficacy of GLPG0634 in Methotrexate-refractory Active Rheumatoid Arthritis Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01384422
• Date of registration: 27/06/2011
• Prospective Registration: No
• Primary sponsor: Galapagos NV
• Public title: Safety and Preliminary Efficacy of GLPG0634 in Methotrexate-refractory Active Rheumatoid Arthritis Patients
• Date of first enrolment: June 2011
• Target sample size: 36
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01384422
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Moldova, Republic of

Contacts

• Name: Frédéric Vanhoutte, MD
• Affiliation: Galapagos NV

Key inclusion & exclusion 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 six months or longer and at a stable dose of 7.5 to 25
mg/week (extremes included) for at least four 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 four weeks prior to screening;

- If taking non-steroidal anti-inflammatory drugs (NSAIDs), these must be at a stable
dose for at least two 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 (12 consecutive months
without menses);

- 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 four 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;

- Receipt of an intra-articular or parenteral corticosteroid injection within four
weeks prior to screening;

- Known hypersensitivity to study drug ingredients or a significant allergic reaction
to any drug as determined by the Investigator, such as anaphylaxis, requiring
hospitalization;

- Positive serology for human immunodeficiency virus (HIV)1 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;

- Pregnant or lactating women.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: GLPG0634

Primary Outcome(s)

The number of patients with an ACR20 score at Week 4 as a measure of efficacy [Time Frame: 4 weeks]

Secondary Outcome(s)

The plasma levels of GLPG0634 as a measure of PK and the levels of immune- and inflammation-related parameters in blood as a measure of PD [Time Frame: No]

The number of patients with ACR20/50/70 response, time to response and DAS28 score at every visit as a measure of efficacy [Time Frame: No]

The number of patients with adverse events, abnormal lab tests, vital signs and ECG as a measure of safety and tolerability [Time Frame: Yes]

Secondary ID(s)

GLPG0634-CL-201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors