E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Rheumatoid arthritis is a disease where the body's immune system attacks its own joints producing pain, stiffness and disabling joint damage. |
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E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
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 of the study is to assess the efficacy of bimekizumab versus placebo as add-on therapy to MTX in subjects with moderate to severe RA who are biologically naïve and have an inadequate response to MTX. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective of the study is to assess the safety, and tolerability of bimekizumab in subjects with moderate to severe RA who are biologically naïve and have an inadequate response to MTX. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Subject must have a diagnosis of adult-onset moderate to severe RA of ≤15 years duration as
defined by ACR/ European League Against Rheumatism 2010 classification criteria
-Subject must have had a stable dose MTX for ≥3 months prior to Visit 1. The stable dose of MTX should be a minimum of 15mg/week; however, a minimum of 10mg/week is acceptable if the subject was previously not able to tolerate 15mg/week
-Subject must be biologically naïve
-Subject must have the following:
- ≥6 tender joints (out of 68)
- ≥6 swollen joints (out of 66)
- CRP≥10mg/L
-Female subjects must either be: postmenopausal, permanently sterilized or if childbearing potential
applicable willing to use 1 highly effective method of contraception |
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E.4 | Principal exclusion criteria |
- Subject has a past medical history or family history of primary immunodeficiency
- infected with Tubercolosis (TB) or high risk of acquiring TB infection
- female subject who is breastfeeding, pregnant or plans to become pregnant during the study or within 20 weeks following the last IMP dose
- Subject has renal or liver impairment, defined as: Serum creatinine level of >=1.4mg/dL (124mol/L) for females and >=1.5mg/dL (133mol/L) for males
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >=2x upper limit of
normal (ULN)
Total bilirubin >1.5xULN (an isolated total bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin is <35%; (ie, is due to Gilbert's syndrome)
- Subject has any other acute or chronic condition which, in the Investigator’s judgment, would make the subject unsuitable for inclusion in the study
- Subject has a concomitant diagnosis of any other inflammatory condition
- Subject had previous exposure to any biologic treatment (ie, anti-TNF or anti-IL-17 inhibitors) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Percentage of ACR50 (American College of Rheumatology 50% Improvement) Responders at Week 12 |
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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) |
- ACR (American College of Rheumatology) criteria (ACRn[transformed]) at Week 12
- Percentage of ACR20 (American College of Rheumatology 20% Improvement) Responders at Week 12
- Percentage of ACR70 (American College of Rheumatology 70% Improvement) Responders at Week 12
- Percentage of Subjects Achieving Disease Activity Score 28 (DAS28 (CRP)) Remission Status (DAS28 (CRP) < 2.6) at Week 12
-Percentage of Subjects Achieving Disease Activity Score 28 (DAS28 (CRP)) low disease activity (DAS28 (CRP) < 3.2) at Week 12
-Change From Baseline in the Disease Activity Score 28 (DAS28 (CRP)) Response at Week 12 |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
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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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 8 |
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 |
Bulgaria |
Georgia |
Hungary |
Macedonia, the former Yugoslav Republic of |
Moldova, Republic of |
Poland |
Romania |
Russian Federation |
Serbia |
United Kingdom |
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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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The end of the study is defined as the date of the last visit 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 | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 0 |