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

Rheumatoid Arthritis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01384422
• Other study ID #: GLPG0634-CL-201
• Status: Completed
• Phase: Phase 2
• First received: June 27, 2011
• Last updated: August 14, 2012
• Start date: June 2011
• Est. completion date: November 2011

Study information

• Verified date: August 2012
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Health authority: Moldova: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

• Thirty six patients suffering from active rheumatoid arthritis despite continued treatment with methotrexate will be evaluated for improvement of disease activity when taking GLPG0634 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• GLPG0634

Locations

Country	Name	City	State
Moldova, Republic of	Innophar MO S.R.L.	Chisinau

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Country where clinical trial is conducted

Moldova, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of patients with an ACR20 score at Week 4 as a measure of efficacy	To preliminarily evaluate the efficacy of GLPG0634 compared to placebo in terms of the proportion of subjects achieving an ACR20 response at Week 4	4 weeks	No
Secondary	The number of patients with ACR20/50/70 response, time to response and DAS28 score at every visit as a measure of efficacy	To evaluate the efficacy of GLPG0634 compared to placebo in terms of ACR response criteria at every visit (ACR20, ACR50, ACR70), time to response, and disease status (DAS28[C-reactive protein, CRP]		No
Secondary	The number of patients with adverse events, abnormal lab tests, vital signs and ECG as a measure of safety and tolerability	To evaluate the safety and tolerability of GLPG0634 in comparison with placebo in terms of adverse events (AEs), laboratory test abnormalities, vital signs and electrocardiogram (ECG)		Yes
Secondary	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	To characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0634 in subjects with rheumatoid arthritis (RA)		No