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

NCT01303874 | Completed Phase 4

• 2 other identifiers: RR05/71502005-005467-29
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

TRIAL DESIGN

1. 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. 2.Discussion of Trial Design The study is designed to directly compare the effectiveness of combination therapy with MTX + ETN versus
3. 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.

Conditions

Rheumatoid Arthritis; Inflammatory Arthritis

Keywords

Rheumatoid arthritis; Inflammatory arthritis; Undifferentiated arthritis; Etanercept; Combination Therapy

Outcome Measures

Primary Outcomes (1)

• clinical remission

  To determine the number of patients in clinical remission at 12 months, as defined as the absence of symptoms and signs of inflammatory arthritis (i.e. swollen joint count 0; tender joint count 0)

  12 months

Secondary Outcomes (9)

• clinical remission

  18 months

• Conventional disease activity measures

  week 78

• Functional, work and quality of life assessments

  Week 78

• remission

  Week 26

• DAS 44

  Week 78

Study Arms (2)

Combination Therapy

EXPERIMENTAL

Methotrexate \& Etanercept

Drug: Etanercept (ETN)

Single-agent therapy

PLACEBO COMPARATOR

Methotrexate (MTX)

Drug: Placebo

Interventions

Etanercept (ETN) DRUG

ETN 50 mg subcutaneous (SC) injections once weekly and MTX orally once weekly.

Also known as: Enbrel

Combination Therapy

Placebo DRUG

ETN-matching placebo SC injections once weekly and MTX orally once weekly.

Also known as: Maxtrex

Single-agent therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Leeds: lead

Study Sites (1)

Leeds Teaching Hospital HNS Trust

Leeds, West Yorkshire, LS7 4SA, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis

Interventions

Etanercept; Methotrexate

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Paul Emery, Prof

  University of Leeds

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 24, 2011
• First Posted: February 25, 2011
• Study Start: September 1, 2006
• Primary Completion: November 5, 2010
• Study Completion: November 5, 2010
• Last Updated: November 1, 2019

Record last verified: 2019-10

Locations

GB (1)