Early arthritis
Conditions
Interventions
Trade Name: Enbrel
Product Name: Enbrel
Product Code: Etanercept
Pharmaceutical Form: Powder and solvent for solution for injection
Phar
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Is age 18 -80 years 2. Patients have articular synovitis, within 3 months of diagnosis (Synovitis is defined as the presence of soft tissue swelling and atleast 1 of the following 2 criteria: tenderness or decreased range of motion) 3. Either RF antibody (+) or anti-CCP antibody (+) or SE (+) 4. Demonstrates a negative serum pregnancy test at screening if female of childbearing potential. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant. This includes women who are using contraceptives or whose sexual partners are either sterile or using contraceptives. Sexually active women participating in the study must use a medically acceptable form of contraception during the study and for 3 months after the last dose of study medications. Medically acceptable forms of contraception for women include oral contraception, injectable or implantable methods, intrauterine devices, or properly used barrier contraception 5. Agrees to use a medically accepted form of contraception during the study and for 3 months after the last dose of study drug, if sexually active male. Medically acceptable forms of contraception for males are a properly used barrier contraceptive or sterilization. 6. Is capable of understanding and signing an informed consent form 7. Is able and willing to self-inject study drug or have a designee who can do so 8. Is able and willing to take oral medication 9. Is able to store injectable test article at 2„a C to 8„a C 10. Demonstrates a negative tuberculosis screening test 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
Exclusion criteria: 1. Received previous treatment with any DMARDS 2. Received previous treatment with ETN or other tumour necrosis factor (TNF) antagonist (e.g. a TNF monoclonal antibody or a soluble TNF receptor) 3. Previous treatment with IL-1 receptor antagonist 4. Chronic arthritis diagnosed before 16 years old 5. Received any investigational ¡§biological¡¨ agent within 3 months of screening visit 6. Received treatment with any investigational drug of ¡§chemical¡¨ nature within one month prior to study screening 7. Known Human Immunodeficiency Virus (HIV) 8. Presence of any contraindication to ETN or MTX 9. Has significant concurrent medical diseases including uncompensated congestive heart failure, myocardial infarction within 12 months, unstable angina pectoris, uncontrolled hypertension, severe pulmonary disease, or history of human immunodeficiency virus (HIV) infection, immunodeficiency syndromes, central nervous system (CNS) demyelinating events suggestive of multiple sclerosis, renal or gastrointestinal conditions, which in the opinion of the investigator places the subject at an unacceptable risk for participation in the study. 10. Has cancer or a history of cancer (other than resected cutaneous basal cell carcinoma, and in situ cervical cancer) within 5 years of entering the screening period. 11. Current crystal or infective arthritis 12. Chronic infection of the upper respiratory tract (eg,. Sinusitis), chest (eg. Bronchiectatic lung disease), urinary tract or skin (eg. Paronychia, chronic ulcers, open wounds) 13. Any ongoing or active infection or any major episode of infection requirimg hospitalization or treatment with IV antibiotics within the preceeding 30 days and/or orally administered antibiotics in the preceeding 15 days. 14. Demonstrates liver function abnormality (aminotransferase [AST] / alanine aminotransferase [ALT] > 2x upper limit of normal [ULN]) or bilirubin >51umol/L. 15. Has renal disease (creatinine level > 133 ƒÝmol/L) 16. Has leukopenia (white blood cells 20 mg prednisone or equivalent) within 12 weeks of screening visit 25. Uses a dose of NSAID greater than the maximum recommended dose in the product information at the screening visit 26. Has a history of confirmed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the number of patients in clinical remission at 12 months of follow-up, as defined as the absence of symptoms and signs of inflammatory arthritis.; Secondary Objective: 1. The number of patients in clinical remission at 18 months (as defined as absence of symptoms and signs of clinical arthritis) 2. Conventional disease activity measures (VAS pain/fatigue/global/physician, EMS, TJC, SJC, CRP, ESR) 3. Functional, work and quality of life assessments (HAQ, WIS, WDA, EQ-5d, SF-36) 4. Proportion of patients achieving 6 months of remission 5. Disease Activity Score (DAS) 28 6. The number of patients in drug-free remission at 12 and 18 months 7. The number of patients in etanercept-free remission at 12 and 18 months (ETN arm) 8. Remission by ACR Criteria 9. To compare the effects of the combination of ETN and MTX to MTX alone on radiographic change at 12 months and 18 months ;Primary end point(s): clinical remission at 12 months of follow-up | — |
Countries
United Kingdom
Outcome results
None listed