Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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4 March 2024 |
Main ID: |
EUCTR2016-003630-25-DE |
Date of registration:
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13/04/2017 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis
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Scientific title:
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A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis |
Date of first enrolment:
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14/08/2017 |
Target sample size:
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2640 |
Recruitment status: |
Authorised-recruitment may be ongoing or finished |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-003630-25 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Argentina
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Australia
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Belgium
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Bulgaria
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Canada
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Chile
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Colombia
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Czech Republic
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Czechia
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France
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Georgia
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Germany
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Hong Kong
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Hungary
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India
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Ireland
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Israel
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Italy
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Japan
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Korea, Republic of
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Malaysia
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Mexico
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Moldova, Republic of
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Netherlands
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New Zealand
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Peru
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Poland
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Romania
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Russian Federation
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Slovakia
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South Africa
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Spain
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Switzerland
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Taiwan
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Thailand
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Ukraine
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United Kingdom
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United States
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Contacts
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Name:
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Clinical Trials Information Desk
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Address:
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Generaal De Wittelaan L11 A3
2800
Mechelen
Belgium |
Telephone:
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+3215342900 |
Email:
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Medicalinfo@glpg.com |
Affiliation:
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Galapagos NV |
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Name:
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Clinical Trials Information Desk
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Address:
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Generaal De Wittelaan L11 A3
2800
Mechelen
Belgium |
Telephone:
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+3215342900 |
Email:
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Medicalinfo@glpg.com |
Affiliation:
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Galapagos NV |
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Key inclusion & exclusion criteria
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Inclusion criteria: 2) Male or female subjects who may benefit from filgotinib as judged by the investigator AND who completed a Gilead sponsored filgotinib parent study for RA as outlined below: a) Subjects who completed GS-US-417-0301, GS-US-417-0302, or GS-US-417-0303 on study drug OR b) Subjects who completed GS-US-417-0302 on standard of care therapy due to RA non-responder status 3) Females of childbearing potential must have a negative pregnancy test prior to first dose of study drug in the LTE; 4) Lactating female subjects must agree to discontinue nursing at Day -1 for the duration of the study 5) Female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception, during the study and through 35 days after their last dose of study drug or longer as indicated by the product label of the subject’s concurrent csDMARD therapy. 6)Subjects receiving protocol permitted RA medications should be on a stable dose (defined as no change in prescription) within 7 days or 5 half lives (whichever is longer) prior to the first administration of LTE study drug on Day 1, as much as possible. 7) Subjects, who meet study drug interruption criteria at Day 1, are eligible to enter into the LTE, but should not start study drug until deemed medically appropriate as outlined in protocol section 3.5.1. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1320 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1320
Exclusion criteria: 1) Diagnosis of an autoimmune or inflammatory joint disease other than RA, which would put the subject at risk by participating in the study or would interfere with study assessments/data interpretation, per judgment of the investigator 2) Known hypersensitivity to the study drug or its excipients. 3) Any medical condition (including, but not limited to, cardiac or pulmonary disease, alcohol or drug abuse) which would put the subject at risk by participating in the study or would interfere with study assessments/data interpretation, per judgment of the investigator. 4) History of an infected joint prosthesis or other implanted device with retention of the prosthesis or device in situ. 5) Administration of a live/ attenuated vaccine within 30 days prior to Day 1 6) Currently on any therapy for chronic infection (such as pneumocystis, cytomegalovirus, herpes zoster, and atypical mycobacteria) 7) History of disseminated/complicated herpes zoster infection (multi dermatomal involvement, ophthalmic zoster, central nervous system involvement or postherpetic neuralgia) 8) Any condition or circumstances which in the opinion of the investigator or Sponsor may make a subject unlikely or unable to complete the study or comply with study procedures and requirements 9) Use of prohibited medication as outlined in the protocol 10) Subjects who meet discontinuation crtieria as outlined in outlined in the protocol
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Rheumatoid arthritis MedDRA version: 23.1
Level: PT
Classification code 10039073
Term: Rheumatoid arthritis
System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
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Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
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Intervention(s)
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Trade Name: Jyseleca 100 mg film-coated tablets Product Name: Filgotinib Product Code: GS-6034 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use
Trade Name: Jyseleca 200 mg film-coated tablets Product Name: Filgotinib Product Code: GS-6034 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Secondary Objective: - To evaluate the long-term efficacy of filgotinib in subjects with RA - To evaluate the long-term effects of filgotinib on subject-reported outcomes, such as disability, fatigue, and quality of life.
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Main Objective: - To evaluate the long-term safety and tolerability of filgotinib in subjects who have completed one of the parent studies of filgotinib in RA.
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Primary end point(s): Safety, evaluated through AEs, clinical laboratory tests, and vital signs.
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Timepoint(s) of evaluation of this end point: 156 weeks
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Secondary Outcome(s)
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Secondary end point(s): ACR-N responses in each arm.
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Timepoint(s) of evaluation of this end point: 156 weeks
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Secondary ID(s)
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GS-US-417-0304
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2016-003630-25-SK
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Source(s) of Monetary Support
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Galapagos NV
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Gilead Sciences, Inc.
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Ethics review
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Status: Approved
Approval date: 14/08/2017
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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