E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
moderately to severely active rheumatoid arthritis |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10039073 |
E.1.2 | Term | Rheumatoid arthritis |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective is to evaluate the long-term safety and tolerability of GLPG0634 for the treatment of rheumatoid arthritis (RA). |
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E.2.2 | Secondary objectives of the trial |
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. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
|
E.4 | Principal 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1-Subjects who had been prematurely withdrawn from one of the 2 core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 |
|
E.5 End points |
E.5.1 | 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. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | 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. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
every visit; and at the end of 96 months. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 78 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Chile |
Colombia |
Guatemala |
Israel |
Mexico |
Moldova, Republic of |
Russian Federation |
Ukraine |
United States |
Belgium |
Bulgaria |
France |
Germany |
Hungary |
Latvia |
Poland |
Romania |
Spain |
Czechia |
Argentina |
|
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
last contact of the last subject in the study |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 8 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 8 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |