Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Patient aged up to or equal 18 years
Meet the 1987 ACR Revised Criteria for Rheumatoid Arthritis.
Active rheumatoid arthritis with a DAS greater than 3,2 and one of the two followings : Objective evidence of 4 clinical synovitis or CRP (plasma C-reactive protein) greater than 10 mg/l or ESR (erythrocyte sedimentation rate) greater than 28 mm/h
Failure of MTX, taken for at least 3 months and at least 15 mg/wk or maximal tolerated dosage . In patients with contraindications or intolerance to MTX, failure of another drug with structural efficacy (leflunomide or sulfasalazine), taken for at least 3 months at the optimal tolerated dosage Concomitant treatment for RA : DMARDs, corticosteroids, NSAIDs and analgesics are permitted. DMARDs and corticosteroids should be stable between screening and baseline visits.
Functional status Class I, II or III as defined by American College of Rheumatology (ACR) Revised Criteria.
Negative serum beta-human chorionic gonadotropin (beta-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, intrauterine devices, or properly used barrier contraception. Sexually active men must agree to use a medically accepted form of contraception during the study.
Able and willing to self-inject ETN or have a designee who can do so.
Able to store injectable test article at 2 Celcius degree to 8 Celcius degree

Exclusion Criteria:

Prior experience of biologic treatment for their RA including ETN.
Sepsis or risk of sepsis.
Current or recent infections, including chronic or localized.
Planned orthopedic surgery within 3 months (for RA disease)
History of orthopedic surgery 1 month before screening
Latex sensitivity.
Vaccination with live vaccine in the last 4 weeks, or expected to require such vaccination during the course of the study.
Previous clinical trial involvement in the last 3 months.
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 SmPC and French guidelines for appropriate screening and treatment of TB in the setting of anti-tumor necrosis factor (anti-TNF) therapy. Patients with latent TB (contact with TB patients, history of primary TB, intradermal test with 5 IU of tuberculin greater than 5 mm, or radiographic lung density greater than 1 cm and consistent with TB) should receive appropriate prophylactic therapy as recommended by the French Agency for healthcare Product Safety (AFSSAPS, http//afassaps.sante.fr/), serious infection (infection associated with hospitalization 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 less than 27 %; platelet count less than 125 x 109/L; white blood cell count less than 3.5 x 109/L; serum creatinine greater than 175 µmol/L; aspartate aminotransferase (AST [SGOT]) and alanine aminotransferase (ALT [SGPT]) greater than 2 times the laboratory's upper limit of normal.
Pre-existing or recent onset central nervous system (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 or decompensated congestive heart failure.
Uncontrolled conditions, e.g., diabetes mellitus, hypertension (defined as screening systolic blood pressure greater than 160 mm Hg or screening diastolic blood pressure greater than 100 mm Hg), severe pulmonary disease requiring hospitalization or supplemental oxygen.
At increased risk of malignancy.
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.
Employment by the investigator or reporting directly or indirectly to the investigator.