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
- Conditions
- moderately to severely active rheumatoid arthritisMedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2012-003655-11-CZ
- Lead Sponsor
- Gilead Sciences Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 739
1. Male or female subjects who are =18 years of age, having completed the
qualifying core study GLPG0634-CL-203 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
The principle exclusion criteria are:
1. Subjects who had been prematurely withdrawn from the core study (GLPG0634-CL-203), for any reason, including fulfilling the individual stopping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 the core study GLPG0634-CL-203, 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 core study 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 core study.
7. Subjects with symptoms suggestive of GI tract ulceration and/or
active diverticulitis since the inclusion to GLPG0634-CL-203 core study.
8. Subjects with symptoms suggestive of possible lymphoproliferative
disease including lymphadenopathy or splenomegaly since the inclusion
to GLPG0634-CL-203 core study.
9. Subjects with symptoms suggestive of malignancy since the inclusion
to GLPG0634-CL-203 core study.
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 core study.
11. History of drug and alcohol abuse since the inclusion to GLPG0634-
CL-203 core study.
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.;Primary end point(s): Primary Endpoint:<br>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 Outcome Measures
Name Time Method Secondary end point(s): Secondary Endpoints:<br>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.