A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study to Explore and Compare Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept (Etanercept Auto-Injector and the Etanercept Prefilled Syringe) in Patients with Rheumatoid Arthritis

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-006591-37-GR
• Date of registration: 20/09/2007
• Prospective Registration: Yes
• Primary sponsor: Wyeth Pharmaceuticals France
• Public title: A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study to Explore and Compare Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept (Etanercept Auto-Injector and the Etanercept Prefilled Syringe) in Patients with Rheumatoid Arthritis
• Scientific title: A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study to Explore and Compare Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept (Etanercept Auto-Injector and the Etanercept Prefilled Syringe) in Patients with Rheumatoid Arthritis
• Date of first enrolment: 26/02/2008
• Target sample size: 264
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-006591-37
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: Other:

Countries of recruitment

Austria, Greece

Key inclusion & exclusion criteria

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 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 screening 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
· Prior experience of 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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Trade Name: Enbrel
Product Name: Pre-filled syringe
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ETANERCEPT
CAS Number: 185243690
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Product Name: Enbrel Auto Injector
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ETANERCEPT
CAS Number: 185243690
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

Main Objective: 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.

Secondary Objective: · To compare patient satisfaction with the two different delivery devices using a dichotomous Yes or No.
· To identify patients 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.

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.

Secondary ID(s)

0881K1-3329