GLPG0259 in Methotrexate-refractory Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by:
Galapagos NV
ClinicalTrials.gov Identifier:
NCT01211249
First received: September 28, 2010
Last updated: April 22, 2011
Last verified: April 2011
  Purpose

Part A: 30 patients suffering from active rheumatoid arthritis despite continued treatment with methotrexate will receive once daily two capsules containing either GLPG0259 (25 mg/capsule) or matching placebo, for 12 weeks. In the course of the study the patients will be examined for severity of disease, as well as for any adverse effects that may occur. If needed, dosing may be split to one capsule twice daily, or reduced to one capsule of 25 mg.

Part B: If results of Part A suggest test medication to have a therapeutic advantage over placebo and to be well-tolerated, more patients will be recruited for Part B, where various dosages will be assessed. These dosages will be established based on results from Part A.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: GLPG0259 oral capsule
Drug: Placebo
Drug: GLPG0259 (Part B)
Drug: Placebo (Part B)
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
Official Title: Randomized, Double-Blind, Placebo-Controlled, Multicenter, Exploratory Phase II Study to Compare Three Dose Regimens of GLPG0259 vs Placebo, in Combination With Methotrexate, Administered for 12 Weeks to Subjects With Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate

Resource links provided by NLM:


Further study details as provided by Galapagos NV:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The primary efficacy endpoint will be the number and percentage of subjects in each GLPG0259 dose group and placebo group achieving an American College of Rheumatology (ACR)20 (ACR20 response rate) at Week 12.


Secondary Outcome Measures:
  • Efficacy [ Time Frame: intermediate timepoints for 12 weeks ] [ Designated as safety issue: No ]
    ACR20, ACR50, ACR75 and DAS28 (and components) at weeks 1, 2, 4, 8 and 12;

  • Safety [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    At each return visit, patients will be asked about adverse events, and undergo examination of heart (ECG) and bloodpressure; blood- and urine-samples will be collected to monitor organ functions.

  • Pharmacokinetics [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    On several timepoints throughout the study bloodsamples will be taken from the patient to establish the amount of the study medication in the blood, and to determine how long it stays in the blood.


Enrollment: 30
Study Start Date: October 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GLPG0259 (Part A) Drug: GLPG0259 oral capsule
Two capsules, each containing 25 mg of GLPG0259 (i.e. 50 mg/day), to be given once daily; in case of adverse events the dose may be split over two administrations, or reduced to 25 mg/day (one single capsule)
Placebo Comparator: Placebo (Part A) Drug: Placebo
Placebo capsules; two capsules to be taken in the morning, in case of adverse events the dose may be split over two administrations, or reduced to one single capsule
Experimental: GLPG0259 (Part B) Drug: GLPG0259 (Part B)
Capsule, dosage to be established based on results of Part A
Placebo Comparator: Placebo (Part B) Drug: Placebo (Part B)
Capsules, dosage to be established after Part A, and matching GLPG0259 (Part B)

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have active RA (≥5 tender or painful joints on motion and ≥5 joints swollen AND a C-reactive protein (CRP) concentration ≥1.5 mg/dL).
  • Must have been on methotrexate for ≥6 months at a stable dose of 7.5-25 mg/week for ≥12 weeks, to be continued throughout study;
  • If on oral steroids, these should be at a dose ≤10 mg/day of prednisone eq and stable for ≥4 weeks prior to screening;
  • If on NSAIDs, these must be at a stable dose for ≥2 weeks prior to screening;
  • Women must have negative pregnancy test unless surgically sterile or post-menopausal for ≥1 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 ≥12 weeks after the last dose of study drug.
  • Informed consent

Exclusion Criteria:

  • Must not have received treatment with DMARDs, other than background methotrexate;
  • Must not be receiving or have received RA treatment with a biological agent, except if administered in a clinical study ≥six months prior to screening (12 months for rituximab or other B cell depleting agents);
  • Must not have received any treatment with a cytotoxic agent, other than methotrexate, before screening (e.g. chlorambucil, cyclophosphamide, nitrogen mustard, or other alkylating agents);
  • Must not have received intra-articular or parenteral corticosteroid injection within four weeks prior to screening;
  • Must not regularly be using aspirin or any other anti-coagulant medication;
  • Must not have a known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug as determined by the Investigator, such as anaphylaxis, requiring hospitalization;
  • Must not have positive serology for human immunodeficiency virus (HIV)1 or 2 or hepatitis B or C, or any history of HIV or hepatitis from any cause with the exception of hepatitis A;
  • Must not have a history of any inflammatory rheumatological disorders other than RA;
  • Must not have undergone (or planned) surgical treatments for RA;
  • Must not have symptoms of clinically significant illness other than RA (including but not limited to cardiopulmonary, renal, metabolic, hematologic, or psychiatric disorders) within three months prior to screening;
  • Must not have a history of active infections requiring intravenous antibiotics within the past four weeks;
  • Must not have a history of malignancy within the past five years (except for basal cell carcinoma of the skin or carcinoma in situ of the cervix that has been treated with no evidence of recurrence);
  • Must not have a history of tuberculosis (TB) infection as determined by a positive diagnostic TB test result (defined as a positive QuantiFERON TB Gold test), AND a recent chest radiograph (both posterior-anterior and lateral views), read by a qualified radiologist, with evidence of current active TB or old inactive TB.
  • Must not have been administered a live vaccine within four weeks prior to screening;
  • Must not have participated in any investigational drug/device clinical study within four weeks prior to screening, in biological agents clinical studies within six months prior to screening, and B cell-depleting agent clinical studies within 12 months prior to screening;
  • Must not have a history within the previous two years or current evidence of drug or alcohol abuse;
  • Must not have any condition or circumstances which in the opinion of the Investigator may make a subject unlikely or unable to complete the study or comply with study procedures and requirements, or may pose a risk to the patient's safety.
  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: NCT01211249

Locations
Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
KU Leuven
Leuven, Belgium, 3000
AZ Alma
Sijsele-Damme, Belgium, 8340
Netherlands
UMC Leiden
Leiden, Netherlands, 2300RC
Poland
Specjalistyczne Centrum Medyczne NZOZ NOWOMED
Kraków, Poland, 30-349
"Linea Corporis" - Chirurgia Plastyczna Sp. z o.o.
Warszawa, Poland, 00-235
Mokotowskie Centrum Osteoporozy S.C.
Warszawa, Poland, 02-620
Akademia Medyczna im. Piastów Śląskich we Wroclawiu Katedra i Klinika Reumatologii i Chorób Wewnętrznych UM we Wrocławiu
Wrocław, Poland, 50-556
Synexus SCM Sp. z o.o.
Wrocław, Poland, 50-088
Russian Federation
State Healthcare Institution of City Moscow "City Clinical Hospital #1 n.a. Pirogov"
Moscow, Russian Federation, 119049
State Educational Institution of Higher Professional Education "Moscow State Medico-Stomatological University of Roszdrav" at the State Healthcare Institution of city Moscow "City Clinical Ordena Trudovogo Krasnogo Znameny hospital #23 n.a. "M
Moscow, Russian Federation, 121374
Institution Russian Academy of Medical Sciences Scientific Research Institution of Rheumatology RAMN
Moscow, Russian Federation, 115522
State Healthcare Institution of city Moscow "City Clinical Ordena Trudovogo Krasnogo Znameny Hospital #23 n.a. "Medsantrud"
Moscow, Russian Federation, 109240
State Healthcare Institution of City Moscow "City Clinical Hospital #7"
Moscow, Russian Federation, 115446
State Healthcare Institution of City Moscow "City Clinical Hospital #4"
Moscow, Russian Federation, 115093
Saint-Petersburg State Healthcare Institution "City Hospital #26"
Moscow, Russian Federation, 196247
State Educational Institution of Higher Professional Education "Russian State Medical University of Roszdrav" State Healthcare Institution of City Moscow "City Clinical Hospital #15 n.a. O.M. Filatov"
Moscow, Russian Federation, 111539
State Educational Institution of Higher Professional Education "Moscow State Medico-Stomatological University of Roszdrav" State Healthcare Institution of City Moscow "City Clinical Ordena Trudovogo Krasnogo Znameny Hospital #23 n.a. "Medsantrud"
Moscow, Russian Federation, 109240
Institution of Russian Academy of Sciences Saint-Petersburg Clinical Hospital RAN
St Petersburg, Russian Federation, 194017
Saint-Petersburg State Healthcare Institution "City Pokrovskaya Hospital"
St Petersburg, Russian Federation, 119106
Saint-Petersburg State Healthcare Institution "City Mariinskiy Hospital"
St-Petersburg, Russian Federation, 191104
State Educational Institution of Higher Professional Education "Saint-Petersburg State Pediatric Medical Academy of Roszdrav"
St. Petersburg, Russian Federation, 194100
Ukraine
Chernivtsi Regional Clinical Hospital
Chernivtsi, Ukraine, 58000
Donetsk City Hospital No5
Donetsk, Ukraine, 83000
Kharkiv City Clinical Hospital No.27
Kharkiv, Ukraine, 61002
Kharkiv City Clinical Hospital No.8
Kharkiv, Ukraine, 61176
Institute of Gerontology AMS of Ukraine
Kyiv, Ukraine, 04114
Kyiv City Clinical Hospital No.3
Kyiv, Ukraine, 02125
Central Pool-type Clinical Hospital MoH of Ukraine
Kyiv, Ukraine, 04053
University Clinic, Crimean Medical University
Simferopol, Ukraine, 95006
Vinnytsia Regional Hospital
Vinnytsia, Ukraine, 21018
Zaporizhzhia Regional Hospital
Zaporizhzhya, Ukraine, 69600
Sponsors and Collaborators
Galapagos NV
Investigators
Study Director: Johan Beetens, PhD Galapagos NV
  More Information

No publications provided by Galapagos NV

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Senior Vice President Development, Galapagos NV
ClinicalTrials.gov Identifier: NCT01211249     History of Changes
Other Study ID Numbers: GLPG0259-CL-201, 2009-015898-12
Study First Received: September 28, 2010
Last Updated: April 22, 2011
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Russia: Ministry of Health of the Russian Federation
Ukraine: Ministry of Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Galapagos NV:
Methotrexate-refractory

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

ClinicalTrials.gov processed this record on October 22, 2014