Open-label Study to Evaluate the EULAR-RAID Score, Rheumatoid Arthritis Impact of Disease Score, in Rheumatoid Arthritis Patients Eligible to Etanercept and Who Will Receive Etanercept. - RAINBOW

Phase 1

• Conditions: RHEUMATOID ARTHRITIS

• Registration Number: EUCTR2007-007888-24-FR
• Lead Sponsor: Wyeth Pharmaceuticals France

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-07-17
• Study Completion: 2010-04-09
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

1. Patient aged >= 18 years
2. Meet the 1987 ACR Revised Criteria for Rheumatoid Arthritis.
3. Active rheumatoid arthritis with a DAS > 3,2 and one of the two followings :
- Objective evidence of 4 clinical synovitis
or
- CRP (plasma C-reactive protein) > 10 mg/l or ESR (erythrocyte sedimentation rate) > 28 mm/h
4. Failure of MTX, taken for at least 3 months and at least 15 mg/wk at 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
5. Concomitant treatment for RA : DMARDs, corticosteroids, NSAIDs and analgesics are permitted. DMARDs and corticosteroids should be stable between screening and baseline visits.
6. Functional status Class I, II or III as defined by American College of Rheumatology (ACR) Revised Criteria.
7. 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.
8. Capable of understanding and signing an informed consent form.
9. Able and willing to self-inject ETN or have a designee who can do so.
10. Able to store injectable test article at 2°C to 8°C.

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

1. Prior experience of biologic treatment for their RA including ETN.
2. Sepsis or risk of sepsis.
3. Current or recent infections, including chronic or localized.
4. Planned orthopedic surgery within 3 months (for RA disease)
5. History of orthopedic surgery 1 month before screening
6. Latex sensitivity.
7. Vaccination with live vaccine in the last 4 weeks, or expected to require such vaccination during the course of the study.
8. 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 > 5 mm, or radiographic lung density > 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 = 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 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 > 160 mm Hg or screening diastolic blood pressure > 100 mm Hg), severe pulmonary disease requiring hospitalization or supplemental oxygen.
- At increased risk of malignancy.

Study specific requirements :
- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified