E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10039073 |
E.1.2 | Term | <Manually entered code. Term in E.1.1> |
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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 |
To compare patient satisfaction with two different delivery devices for etanercept after 12 weeks of use, using a 10 point scale form totally dissatisfied to totally satisfied. |
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E.2.2 | Secondary objectives of the trial |
· To compare patient satisfaction with the two different delivery devices using a dichotomous Yes or No. · To identify patient and device attributes associated with patient satisfaction. · To compare device attributes and patient perceptions with two different delivery devices for etanercept after 4 & 12 weeks of use. · To identify patient attributes associated with patient perceptions. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
· Diagnosis of RA according to the ACR-Criteria · Eligible for treatment with etanercept according to Summary of Product Characteristics (SmPC), and applicable local guidelines. · Aged 18 years or more · Willing and able to self-inject etanercept or has a carer (voluntary care giver) who is willing and able to perform the injections. In addition the carer must be able to attend visit 1 and receive the device training with the subject. · Able to store test drug at 2-8°C. · Negative serum ß-human chorionic gonadotropin (ß-HCG) pregnancy test at baseline (week 0) for all women of childbearing potential. Sexually active women of childbearing potential must use a medically acceptable form of contraception. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, transdermal patches, vaginal rings, intrauterine devices, or properly used barrier contraception. Sexually active men must agree to use a medically accepted form of contraception during the study. · Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol-specific procedures are performed. |
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E.4 | Principal exclusion criteria |
· Prior experience of biologics and anti-TNF treatment for their RA including etanercept. · Sepsis or risk of sepsis. · Current or recent infections, including chronic or localized. · Latex sensitivity. · Vaccination with live vaccine in last 4 weeks, or expected to require such vaccination during the course of the study.Patients with the following conditions or risk factors should only be entered into the study if the investigator has conducted and documented a full risk/benefit evaluation: · History of recurring or chronic infection, or underlying condition which may predispose patients to infections e.g. Tuberculosis (TB) infection (Note: follow local country guidelines for appropriate screening and treatment of tuberculosis in the setting of anti-TNF therapy), serious infection (infection associated with hospitalisation and/or intravenous antibiotics) within 1 month of test article administration or active infection at screening, open cutaneous ulcers, known human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) positive. · Current or prior history of blood dyscrasias. Abnormal safety baseline blood test e.g. hemoglobin ≤85 g/L; hematocrit ≤27 %; platelet count ≤125 x 109 /L; white blood cell count ≤3.5 x 109 /L; serum creatinine ≥175 µmol/L; aspartate aminotransferase (AST [SGOT]) and alanine aminotransferase (ALT [SGPT]) ≥2 times the laboratory’s upper limit of normal. · Pre-existing or recent onset CNS demyelinating disease. · Cardiovascular conditions, e.g., myocardial infarction within 12 months of the screening visit, unstable angina pectoris, class III or IV congestive heart failure as defined by the New York Heart Association classification (4) or decompensated congestive heart failure. · Uncontrolled conditions, e.g., diabetes mellitus, hypertension (defined as screening systolic blood pressure > 160mm Hg or screening diastolic blood pressure > 100 mm Hg), severe pulmonary disease requiring hospitalisation or supplemental oxygen. · At increased risk of malignancy.
Non-study specific requirements in line with ICH GCP: · Reasonable expectation that the subject will not be able to satisfactorily complete the study. History of or current psychiatric illness, alcohol or drug abuse that would interfere with the subject’s ability to comply with protocol requirements or give informed consent. · Previous clinical trial involvement in last 3 months. · Employment by the investigator or reporting directly or indirectly to the investigator. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint will be patient satisfaction at week 12. This endpoint will be measured by asking patients: “How satisfied are you with your injection device?”, using a 10 point scale from totally dissatisfied to totally satisfied at Visits 2 and 3. If there is no evaluation available after the first administration of test agent, the subject will not be considered for the analysis of the primary endpoint. |
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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 | No |
E.6.5 | Efficacy | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
Explore and compare perceptions and satisfaction for Etanercept PFF vs. AI. |
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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 | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 25 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 79 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
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 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 | 1 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | |
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 | 1 |