- 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
- 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
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.