Etanercept and Methotrexate in Patients to Induce Remission in Early Arthritis (EMPIRE)

• Status: Completed
• Trial end date: 2010-11-05
• Target enrollment: 0
• Participant gender: All

Summary

TRIAL DESIGN

1. Description This is a 18-month, double-blind, randomized, multicentre, outpatient study. The approximate duration of subject participation will be 18 months and the approximate total duration of the study will be 42 months. The duration of subject enrollment will be approximately 24 months.

2. Discussion of Trial Design The study is designed to directly compare the effectiveness of combination therapy with MTX + ETN versus

3. Principal research question/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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Leeds
• Treatments: Etanercept; Methotrexate

Criteria

Inclusion Criteria:

• Is age 18 -80 years old

• Patients have articular synovitis, within 3 months of diagnosis

• Either RF antibody (+) or anti-CCP antibody (+) or SE (+)

• Demonstrates a negative urine pregnancy test at screening if female of childbearing potential

• 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

• Is capable of understanding and signing an informed consent form

• Is able and willing to self-inject study drug or have a designee who can do so

• Is able and willing to take oral medication

• Is able to store injectable test article at 2° C to 8° C

• Demonstrates a negative tuberculosis screening test

Exclusion Criteria:

• Received previous treatment with any DMARDS

• Received previous treatment with ETN or other tumour necrosis factor (TNF) antagonist (e.g. a TNF monoclonal antibody or a soluble TNF-receptor)

• Previous treatment with IL-1 receptor antagonist

• Chronic arthritis diagnosed before 16 years old

• Received any investigational "biological" agent within 3 months of screening visit

• Received treatment with any investigational drug of "chemical" nature within one month prior to study screening

• Known Human Immunodeficiency Virus (HIV)

• Presence of any contraindication to ETN or MTX

• Has significant concurrent medical diseases

• Has cancer or a history of cancer within 5 years of entering the screening period

• Current crystal or infective arthritis

• Chronic infection of the upper respiratory tract, chest, urinary tract or skin

• Any ongoing or active infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics within the preceding 30 days and/or orally administered antibiotics in the preceding 15 days

• Demonstrates liver function abnormality

• Has renal disease

• Has leukopenia

• Has thrombocytopenia

• Has a hemoglobin level of < 9g/L for males and < 85 g/L for females

• Is pregnant or breast-feeding

• Joint surgery within preceding 2 months (at joints to be assessed within this study)

• Received anti-CD4, diphtheria interleukin-2 fusion protein, anti-interleukin-6 (anti-IL-6), rituximab or other immunosuppressive biologic during the last 6 months before screening, and treatment with such agents more than 6 months before screening if there are persistent signs of immunosuppression (with a subsequent abnormal absolute T-cell count) at screening visit

• Received any live (attenuated) vaccines within 4 weeks of screening visit

• Received cyclophosphamide within 6 months of screening visit

• Any corticosteroids within 28days prior to screening

• Uses a dose of NSAID greater than the maximum recommended dose in the product information at the screening visit

• Has a history of confirmed blood dyscrasia

• Has any condition judged by the physician to cause this study to be detrimental to the subject

• Has a history of drug abuse or psychiatric disease that would interfere with the ability to comply with the study protocol

• Has a history of alcohol abuse or excessive alcohol beverage consumption

• Has a history of known liver cirrhosis, fibrosis, or fatty liver

• Has a history of any viral hepatitis within 1 year of screening