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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galapagos NV
ClinicalTrials.gov Identifier:
NCT01384422
First received: June 27, 2011
Last updated: August 14, 2012
Last verified: August 2012
  Purpose
  • 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.

Condition Intervention Phase
Rheumatoid Arthritis
Drug: GLPG0634
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Galapagos NV:

Primary Outcome Measures:
  • The number of patients with an ACR20 score at Week 4 as a measure of efficacy [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    To preliminarily 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:
  • The number of patients with ACR20/50/70 response, time to response and DAS28 score at every visit as a measure of efficacy [ Designated as safety issue: No ]
    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]

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

  • 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 [ Designated as safety issue: No ]
    To characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0634 in subjects with rheumatoid arthritis (RA)


Enrollment: 36
Study Start Date: June 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GLPG0634 100 mg bid oral capsules Drug: GLPG0634
Experimental: GLPG0634 200 mg qd oral capsules Drug: GLPG0634
Placebo Comparator: Placebo oral capsules Drug: GLPG0634

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01384422

Locations
Moldova, Republic of
Innophar MO S.R.L.
Chisinau, Moldova, Republic of, MD-2025
Sponsors and Collaborators
Galapagos NV
Investigators
Study Director: Frédéric Vanhoutte, MD Galapagos NV
  More Information

No publications provided

Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT01384422     History of Changes
Other Study ID Numbers: GLPG0634-CL-201
Study First Received: June 27, 2011
Last Updated: August 14, 2012
Health Authority: Moldova: Ministry of Health

Keywords provided by Galapagos NV:
methotrexate-refractory

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014