Evaluation of long-term safety, tolerability and efficacy of GLPG0634 treatment in subjects with rheumatoid arthritis regarding subject’s disability, fatigue, and quality of life

• Register: EUCTR
• Last refreshed on: 2 March 2022
• Main ID: EUCTR2012-003655-11-BG
• Date of registration: 19/02/2014
• Prospective Registration: Yes
• Primary sponsor: Galapagos NV
• Public title: Evaluation of long-term safety, tolerability and efficacy of GLPG0634 treatment in subjects with rheumatoid arthritis regarding subject’s disability, fatigue, and quality of life
• Scientific title: A multicenter, open-label, long-term follow-up safety and efficacy study of GLPG0634 treatment in subjects with moderately to severely active rheumatoid arthritis
• Date of first enrolment: 27/03/2014
• Target sample size: 739
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-003655-11
• 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
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Belgium, Bulgaria, Chile, Colombia, Czech Republic, Czechia, France, Germany, Guatemala, Hungary, Israel, Latvia, Mexico, Moldova, Republic of, Poland, Romania, Russian Federation, Spain, Ukraine, United States

Contacts

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

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

Key inclusion & exclusion criteria

Inclusion criteria:
The principle inclusion criteria are:
1-Male or female subjects who are =18 years of age, having completed
one of the qualifying core studies GLPG0634-CL-203 or GLPG0634-CL-
204 and, who in the opinion of the investigator, will continue to benefit
from treatment in the extension study.
2. Females of childbearing potential must continue using highly effective
methods of birth control during the study and for at least 12 weeks after
the last dose of study medication (or longer if required by local
regulations).
3-Sexually active men must agree to use a highly effective method of
contraception (e.g. double barrier) during the study and continue its use
for at least 12 weeks after the last dose of study medication.
Please see study protocol for full details
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 480
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

Exclusion criteria:
The principle exclusion criteria are:
1-Subjects who had been prematurely withdrawn from one of the 2 core
studies
(GLPG0634-CL-203 or GLPG0634-CL-204), for any reason, including
fulfilling the individual stopping criteria.
2. Subjects who are deemed not to be benefiting from the study
medication based
upon lack of improvement or worsening of their symptoms. Local
guidelines for subject treatment need to be followed.
3. Subjects with persistent abnormal laboratory values, associated with
the use of
the study medication (including but not limited to hematology, liver and
renal function values) during one of the 2 core studies (GLPG0634-CL-
203 and GLPG0634-CL-204), according to the investigator's clinical
judgment.
Please see study protocol for full details


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

Health Condition(s) or Problem(s) studied

moderately to severely active 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] - Immune System Diseases [C20]

Intervention(s)

Product Name: Filgotinib
Product Code: GS-6034
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: FILGOTINIB
Current Sponsor code: GS-6034
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Main Objective: The primary objective is to evaluate the long-term safety and tolerability of GLPG0634 for the treatment of rheumatoid arthritis (RA).

Secondary Objective: The secondary objectives are to evaluate the long-term efficacy of GLPG0634 and to evaluate the long-term effects of GLPG0634 administration on subject’s disability, fatigue, and quality of life.

Timepoint(s) of evaluation of this end point: 60 months

Primary end point(s): Primary Endpoint:
Safety and tolerability of long-term dosing of GLPG0634 200 mg q.d. and 100 mg b.i.d.

Secondary Outcome(s)

Secondary end point(s): Secondary Endpoints:
Evolution in the percentage of subjects achieving American College of Rheumatology (ACR)20, ACR50, ACR70, and ACR-N responses; European League Against Rheumatism (EULAR) responses; ACR/EULAR remission, clinical disease activity index (CDAI), simplified disease activity index (SDAI), and the disease-activity score based on 28 joints (DAS28 c-reactive protein [CRP]) every 12 weeks or until the Final Visit or the Early Discontinuation Visit (EDV). Change from Baseline in the Quality of Life (functional assessment of chronic illness therapy [FACIT] fatigue scale and 36-item short form health survey [SF-36] scores) every 48 weeks or until the Final Visit or the EDV.

Timepoint(s) of evaluation of this end point: every visit; and at the end of 96 months.

Secondary ID(s)

GLPG0634-CL-205

2012-003655-11-BE

NCT02065700

Source(s) of Monetary Support

Galapagos, NV

Gilead Sciences Inc.

Ethics review

Status: Approved
Approval date: 18/02/2014
Contact: