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
Conditions
Interventions
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 t
Sponsors
Galapagos NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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. Female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception and agree to refrain from egg donation and in vitro fertilization as described in the protocol. 3-Fertile male subjects who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception and agree to refrain from sperm donation as described in the protocol. 4. Able and willing to sign the informed consent as approved by the Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the Entry visit and agree to the schedule of assessments. 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
Exclusion criteria: The principle exclusion criteria are: 1-Subjects who had been prematurely withdrawn from one of the 2 core studies (GLPG0634-CL-203 or GLPG0634-CL-204), for any reason, including fulfilling the individual stopping criteria. 2.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. 4. Subjects who require immunization with live/live attenuated vaccine. 5. Subjects with diagnosis since the inclusion to GLPG0634-CL-203 or GLPG0634-CL-204 core studies of rheumatic autoimmune disease or inflammatory joint disease other than RA, except for secondary Sjögren’s syndrome. 6. Subjects with symptoms suggestive of moderate to severe congestive heart failure or major cerebrovascular event since the inclusion to GLPG0634-CL-203 and GLPG0634-CL-204 core studies. 7. Subjects with symptoms suggestive of GI tract ulceration and/or active diverticulitis since the inclusion to GLPG0634-CL-203 and GLPG0634-CL-204 core studies. 8. Subjects with symptoms suggestive of possible lymphoproliferative disease including lymphadenopathy or splenomegaly since the inclusion to GLPG0634-CL-203 and GLPG0634-CL-204 core studies. 9. Subjects with symptoms suggestive of malignancy since the inclusion to GLPG0634-CL-203 and GLPG0634-CL-204 core studies. 10. If applicable to national or local legislation: history of being admitted to an institution under administrative or court order since the inclusion to GLPG0634-CL-203 and GLPG0634-CL-204 core studies. 11. History of drug and alcohol abuse since the inclusion to GLPG0634-CL-203 and GLPG0634–CL-204 core studies. 12. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the long-term safety and tolerability of filgotinib for the treatment of rheumatoid arthritis (RA).;Secondary Objective: The secondary objectives are to evaluate the long-term efficacy of filgotinib and to evaluate the long-term effects of filgotinib administration on subject’s disability, fatigue, and quality of life.;Primary end point(s): Primary Endpoint: Safety and tolerability of long-term dosing of filgotinib 200 mg q.d. or 100 mg b.i.d.;Timepoint(s) of evaluation of this end point: At every visit as defined in the protocol | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Argentina, Australia, Belgium, Bulgaria, Chile, Colombia, Czechia, Czech Republic, France, Germany, Guatemala, Hungary, Israel, Latvia, Mexico, Moldova, Republic of, Poland, Romania, Russian Federation, Spain, Ukraine, United States
Contacts
Public ContactClinical Trial Information Desk
Galapagos NV
Outcome results
None listed