E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
moderately to severely active rheumatoid arthritis |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
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 |
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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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
To be eligible for study entry subjects must fulfil all of the following 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 may benefit from GLPG0634 long-term treatment according to the investigator’s judgment. 2. Females of childbearing potential must accept to continue using adequate contraception during the study and for at least 12 weeks after the last dose of study medication (or longer if required by local regulations), is not lactating, and has had a negative urine pregnancy test on the Entry Visit. 3. Sexually active men must agree to use a medically acceptable form of contraception (double barrier) during the study and continue its use for at least 12 weeks after the last dose of study medication. 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. |
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E.4 | Principal exclusion criteria |
Subjects will be excluded from the study if one or more of the following statements are applicable: 1. Subjects who had been prematurely withdrawn from one of the 2 core studies (GLPG0634-CL-203 or GLPG0634-CL-204), for any reason. 2. Persistent abnormal laboratory values, associated with the use of the study medication during one of the 2 core studies (GLPG0634-CL-203 and GLPG0634-CL-204), according to the investigator’s clinical judgment. 3. Diagnosis since the last visit (previous visit of studies GLPG0634-CL-203 or GLPG0634-CL-204) of rheumatic autoimmune disease or inflammatory joint disease other than RA, except for secondary Sjögren’s syndrome. 4. 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. |
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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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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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. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 |
Argentina |
Australia |
Austria |
Belgium |
Bulgaria |
Chile |
Colombia |
Czech Republic |
France |
Germany |
Guatemala |
Hungary |
Israel |
Latvia |
Mexico |
Peru |
Poland |
Romania |
Russian Federation |
Spain |
Ukraine |
United States |
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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
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last contact of the last subject in the study |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
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 | 5 |
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 |