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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: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00901550
Date of registration: 13/05/2009
Prospective Registration: No
Primary sponsor: Chinese University of Hong Kong
Public title: The Chinese University of Hong Kong Early Arthritis Study ERA
Scientific title: The Chinese University of Hong Kong Early Arthritis Study
Date of first enrolment: November 2008
Target sample size: 40
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00901550
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  N/A
Countries of recruitment
China
Contacts
Name:     Edmund K Li, MD
Address: 
Telephone:
Email:
Affiliation:  Chinese University of Hong Kong
Key inclusion & exclusion criteria

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 = 150┬Ámol/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
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: Infliximab
Drug: Methotrexate
Primary Outcome(s)
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]
Secondary Outcome(s)
changes in the synovitis grading and the perfusion indices [Time Frame: 24 week]
Correlation between the Magnetic Resonance Imaging(MRI) findings and changes on x-ray [Time Frame: week 24]
proportion of patients achieving ACR and EULAR responses [Time Frame: week 24]
Secondary ID(s)
ERA_2008
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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