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EUCTR2016-003630-25

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

Data source: WHO (Imported from 22.11.2020)
Changed: 22.11.2020
Disease category:

Health conditions (Data source: WHO)

Rheumatoid arthritis
MedDRA version: 23.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Interventions (Data source: WHO)


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

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

Inclusion/Exclusion Criteria (Data source: WHO)

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)Male and 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 (female) or 90 days (male) 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 as outlined in the protocol

Further information on the trial in WHO primary registry

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-003630-25

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2016-003630-25-BE

Further information on trial

Date trial registered

12.04.2017

Incorporation of the first participant

01.08.2017

Recruitment status

Authorised-recruitment may be ongoing or finished

Academic title (Data source: WHO)

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

Type of trial (Data source: WHO)

Interventional clinical trial of medicinal product

Design of the trial (Data source: WHO)

Controlled: noRandomised: yesOpen: yesSingle blind: noDouble blind: noParallel group: noCross over: noOther: noIf controlled, specify comparator, Other Medicinial Product: noPlacebo: noOther: noNumber of treatment arms in the trial: 2

Phase (Data source: WHO)

Human pharmacology (Phase I): noTherapeutic exploratory (Phase II): noTherapeutic confirmatory - (Phase III): yesTherapeutic use (Phase IV): no

Primary end point (Data source: WHO)

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.;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.;Primary end point(s): Safety, evaluated through AEs, clinical laboratory tests, and vital signs.;Timepoint(s) of evaluation of this end point: 156 weeks

Secundary end point (Data source: WHO)

Secondary end point(s): ACR-N responses in each arm.;Timepoint(s) of evaluation of this end point: 156 weeks

Contact information (Data source: WHO)

Gilead Sciences, Inc.

Trial results (Data source: WHO)

Results summary

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

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Countries (Data source: WHO)

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

Contact for further information on the trial

Contact for general information (Data source: WHO)

Clinical Trials Mailbox
Flowers Building, Granta Park
Gilead Sciences International Ltd.
+441223897476
clinical.trials@gilead.com

Contact for scientific information (Data source: WHO)

Clinical Trials Mailbox
Flowers Building, Granta Park
Gilead Sciences International Ltd.
+441223897476
clinical.trials@gilead.com

Principal Sponsor/Investigator

Principal sponsor (Data source: WHO)

Gilead Sciences, Inc.

Further trial identification numbers

Secondary ID (Data source: WHO)

GS-US-417-0304
2016-003630-25-SK