Evaluation of EULAR-RAID Score in Rheumatoid Arthritis Patients
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Etanercept
Intervention description: Etanercept 50 mg once a week
Intervention MeSH terms: Etanercept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 108.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: EULAR-RAID; active rheumatoid arthritis; etanercept

Summary:

      The Disease Activity Score (DAS) is a system of measurement developed in the 1980s that uses
      certain criteria, including joint counts and patient perceived disease activity, to measure
      disease activity in people with Rheumatoid Arthritis . More recently, the European League
      against Rheumatism (EULAR) has developed a new system of measurement known as the Rheumatoid
      Arthritis Impact of Disease score, or EULAR-RAID score. The EULAR-RAID score is a composite
      score based on patient reported outcomes, and includes such criteria as pain, functional
      disability, fatigue, sleep disturbances, coping, overall assessment of physical well being
      and overall assessment of psychological well being. The objective of this study is to
      evaluate the practical modalities and performance of the EULAR- RAID score in patients with
      rheumatoid arthritis who have been prescribed etanercept as part of usual medical practice.
    

Eligibility 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.