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

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ClinicalTrials.gov Identifier: NCT01668641
Recruitment Status : Completed
First Posted : August 20, 2012
Last Update Posted : June 27, 2013
Sponsor:
Information provided by (Responsible Party):
Galapagos NV

Study Description
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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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: GLPG0634 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study to Compare Four Dose Regimens of GLPG0634 Versus Placebo, in Combination With Methotrexate, Administered for 4 Weeks in the Treatment of Subjects With Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Alone
Study Start Date : May 2012
Actual Primary Completion Date : September 2012
Actual Study Completion Date : October 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: capsule, 30mg GLPG0634 once a day
3 capsules of 10 mg once a day
 Drug: GLPG0634
Experimental: capsules, 75mg GLPG0634 once a day
3 capsules of 25mg once a day
 Drug: GLPG0634
Experimental: capsules, 150mg GLPG0634 once a day
3 capsules of 50mg once a day
 Drug: GLPG0634
Experimental: capsules, 300mg GLPG0634 once a day
3 capsules of 100mg once a day
 Drug: GLPG0634
Placebo Comparator: capsules, placebo once a day
3 capsules placebo once a day
 Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. The number of patients with an ACR20 score at Week 4 as a measure of efficacy [ Time Frame: Week 4 (end of treatment visit) ]
    To preliminary evaluate the efficacy of GLPG0634 compared to placebo in terms of the proportion of subjects achieving an ACR20 response at Week 4


Secondary Outcome Measures :
  1. 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: From Day -1 up to end of treatment visit (week 4) ]
    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]

  2. The number of patients with adverse events, abnormal lab tests, vital signs and ECG as a measure of safety and tolerability [ Time Frame: From screening up to 10 days after last dose ]
    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)

  3. The plasma levels of GLPG0634 as a measure of PK [ Time Frame: Week 1, week 2 and week 4 visits ]
    To characterize the pharmacokinetics (PK) of GLPG0634 by measuring the amount of GLPG0634 in the plasma

  4. The plasma levels of GLPG0634 and MTX as a measure of PK [ Time Frame: Day -1 and Week 2 or 4 visit (8 hour-sampling) ]
    To explore the potential interaction of GLPG0634 on MTX by assessing steady state PK in an 8-hour sampling at Day -1 and at Week 2 or Week 4 visit in a subset of patients

  5. The levels of immune- and inflammation-related parameters in plasma as a measure of PD [ Time Frame: Day -1, Week 1, week 2 and week 4 visits ]
    To characterize the pharmacodynamics (PD) of GLPG0634 by measuring the levels of immune- and inflammation-related parameters in plasma


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01668641


Locations
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Sponsors and Collaborators
Galapagos NV
Investigators
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Study Director: Frédéric Vanhoutte, MD Galapagos NV
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT01668641    
Other Study ID Numbers: GLPG0634-CL-202
First Posted: August 20, 2012    Key Record Dates
Last Update Posted: June 27, 2013
Last Verified: June 2013
Keywords provided by Galapagos NV:
Methotrexate insufficient responders
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases