The Chinese University of Hong Kong Early Arthritis Study

• 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
• 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 = 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

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)

Correlation between the Magnetic Resonance Imaging(MRI) findings and changes on x-ray [Time Frame: week 24]

changes in the synovitis grading and the perfusion indices [Time Frame: 24 week]

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