A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis

• Register: EUCTR
• Last refreshed on: 12 March 2024
• Main ID: EUCTR2016-003630-25-HU
• Date of registration: 12/04/2017
• Prospective Registration: Yes
• Primary sponsor: Galapagos NV
• Public title: A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis
• Scientific title: 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: 29/05/2017
• Target sample size: 2640
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-003630-25
• Study type: Interventional clinical trial of medicinal product
• Study design: 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
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Belgium, Bulgaria, Canada, Chile, Colombia, Czech Republic, Czechia, France, Georgia, Germany, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Republic of, Malaysia, Mexico, Moldova, Republic of, Netherlands, New Zealand, Peru, Poland, Romania, Russian Federation, Slovakia, South Africa, Spain, Switzerland, Taiwan, Thailand, Ukraine, United Kingdom, United States

Contacts

• Name: Clinical Trials Information Desk
• Affiliation: Galapagos NV

• Name: Clinical Trials Information Desk
• Affiliation: Galapagos NV

Key inclusion & exclusion criteria

Inclusion criteria:
1) Able and willing to sign the informed consent as approved by the
IRB/IEC. Written consent must be provided before initiating any Day -1 evaluations for this study. Subjects must have read and understood the ICF, must fully understand the requirements of the study, and must be willing to comply with all study visits and assessments; subjects who cannot read or understand the ICF may not be enrolled by a guardian or any other individual.
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) Administration of a live/ attenuated vaccine within 30 days prior to
Day 1
5) Currently on any therapy for chronic infection (such as pneumocystis, cytomegalovirus, herpes zoster, and atypical mycobacteria)
6) History of disseminated/complicated herpes zoster infection (multi
dermatomal involvement, ophthalmic zoster, central nervous system
involvement or postherpetic neuralgia)
7) 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
8) Use of prohibited medication as outlined in the protocol
9) Subjects who meet discontinuation criteria in outlined in the protocol


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Rheumatoid arthritis
MedDRA version: 23.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Intervention(s)

Trade Name: Jyseleca 100mg 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-

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-

Primary Outcome(s)

Primary end point(s): Safety, evaluated through AEs, clinical laboratory tests, and vital signs.

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.

Timepoint(s) of evaluation of this end point: 156 weeks

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.

Secondary Outcome(s)

Secondary end point(s): ACR-N responses in each arm.

Timepoint(s) of evaluation of this end point: 156 weeks

Secondary ID(s)

2016-003630-25-SK

GS-US-417-0304

Source(s) of Monetary Support

Gilead Sciences, Inc.

Galapagos NV

Ethics review

Status: Approved
Approval date: 22/05/2017
Contact: