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 |
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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 | 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 |
1. Evaluate the safety and tolerability of UCB4940 as an add-on therapy to CZP and background conventional DMARDs compared to placebo plus CZP treatment and background conventional DMARDs 2. Evaluate the efficacy of UCB4940 as an add-on therapy to CZP and background conventional DMARDs compared to placebo plus CZP treatment and background conventional DMARDs at Week 20
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E.2.2 | Secondary objectives of the trial |
Evaluate treatment with UCB4940 as add-on therapy to CZP and background conventional DMARDs compared to placebo plus CZP treatment and background conventional DMARDs with regard to disease activity of RA at different time points
Evaluate the PK of multiple doses of UCB4940 in the presence of CZP
Evaluate the PK of multiple doses of CZP in the presence of UCB4940
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Subject is informed and given approved written Informed Consent Form (ICF). • Subject is considered reliable and capable of adhering to the protocol. • Subject must have a diagnosis of adult-onset moderate-to-severe RA of at least 6 months’ duration as defined by ACR/EULAR 2010 classification criteria. • Subject must have: - ≥6 tender joints (out of 68) - ≥6 swollen joints (out of 66) - CRP≥10.0mg/L . • Subject must have had inadequate response to at least 1 synthetic DMARD. • Subject is at least 18 years and less than 70 years of age at Visit 1 (Screening). • Female subjects must either be: - postmenopausal - permanently sterilized or, - if of childbearing potential, must be willing to use at least 2 effective methods of contraception, • Male subjects with partners of childbearing potential must be willing to use a condom when sexually active, during the study and for 5 months after last administration of study drug.
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E.4 | Principal exclusion criteria |
• Subject has previously participated in this study or has previously been assigned to treatment in a study of the investigational medicinal product (IMP) under investigation in this study (UCB4940 and/or CZP). • Subject has a history or active systemic/respiratory infection due to fungal, parasitic, or mycotic pathogens. • Subjects with known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent TB infection are excluded. • Subject is at high risk of infection. • Subject has an active infection or has had a serious infection within 12 weeks prior to the first dose of study drug at Week 0. • Subject has renal or liver impairment. • Subject has a current or past history of gastrointestinal ulceration. • Subject has active neoplastic disease or history of neoplastic disease. • Subject has a concomitant diagnosis of any other inflammatory condition. • Subject has a secondary, non-inflammatory condition or a known diagnosis of fibromyalgia. |
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E.5 End points |
E.5.1 | Primary end point(s) |
• Incidence of adverse events • Change from Baseline 2 in DAS28(CRP) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
• Incidence of adverse events from screening (D-28) till final study visit (week 44) • Change from Baseline 2 in DAS28(CRP) - week 20 |
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E.5.2 | Secondary end point(s) |
• Percent improvement in ACR criteria (ACRn) based on Baseline 2 • ACR20 response based on Baseline 2 • ACR50 response based on Baseline 2 • ACR70 response based on Baseline 2 • DAS28(CRP) remission |
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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 | Yes |
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 | 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 | 3 |
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 | 16 |
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 |
Georgia |
Moldova, Republic of |
Russian Federation |
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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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
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 | 2 |
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 |