Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT00901550 |
Date of registration:
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13/05/2009 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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The Chinese University of Hong Kong Early Arthritis Study
ERA |
Scientific title:
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The Chinese University of Hong Kong Early Arthritis Study |
Date of first enrolment:
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November 2008 |
Target sample size:
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40 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT00901550 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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China
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Contacts
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Name:
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Edmund K Li, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Chinese University of Hong Kong |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Men and women, 18 years of age or older
- Clinical diagnosis of RA with a duration not more than 24 months (Fulfilled the 1987
American College of Rheumatology (ACR) criteria for RA)
- Patients at risk of developing persistent or erosive arthritis
- DAS 28 = 3.2
- Prednisolone < 10mg/day and started at least 4 weeks before baseline
- Either has ESR = 28, CRP = 10, presence of rheumatoid factor or anti-CCP, present of
HLADRB*0401 or DRB1*0404, and radiographic erosions
- Informed consent
Exclusion Criteria:
- Little or no ability for self-care
- Previous treatment with DMARDs other than antimalarials
- Concomitant treatment with an experimental drug
- Malignancy within the last 5 years
- Bone marrow hypoplasia
- Clinically significant renal disease ( serum creatinine level = 150µmol/L) or
estimated creatinine clearance > 75ml/min, alanine aminotransferase (ALT) exceeds the
upper limit of normal
- History of any clinically significant adverse reaction to murine or chimeric proteins
- History of TB in the last 5 years
- Known to have hepatitis B, or hepatitis C
- Had an opportunistic infection (e.g. herpes zoster, cytomegalovirus, Pneumocystis
carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6
months before screening
- History or ongoing chronic or recurrent disease; renal infection, chest infection,
urinary tract infection, ulcer or skin wound
- History of infected joint prosthesis and use of antibiotics for the joint
- Received intravenous antibiotics within 30 days or oral antibiotics within 14 days
for screening
- History of known demyelinating diseases (multiple sclerosis or optic neuritis)
- Current signs or symptoms of severe diseases (renal, hepatic, hematologic, endocrine,
pulmonary, cardiac, neurologic, etc)
- History or concurrent CHF
- History of lymphoproliferative disease, splenomegaly
- Female of childbearing potential, unwilling to use adequate contraception during the
study
- Current or recent ( within the past 3 months) pregnancy and cancer
- Active smoker, alcohol or drug abuse
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Drug: Infliximab
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Drug: Methotrexate
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Primary Outcome(s)
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Changes in the volume of enhancing synovitis measured by Magnetic Resonance Imaging(MRI) as it corresponds to active, inflamed tissue and is therefore expected to be a better marker of disease activity.
[Time Frame: week 24]
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Secondary Outcome(s)
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Correlation between the Magnetic Resonance Imaging(MRI) findings and changes on x-ray
[Time Frame: week 24]
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changes in the synovitis grading and the perfusion indices
[Time Frame: 24 week]
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proportion of patients achieving ACR and EULAR responses
[Time Frame: week 24]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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