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The Chinese University of Hong Kong Early Arthritis Study

18 Years
80 Years
Not Enrolling
Rheumatoid Arthritis

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Trial Information

The Chinese University of Hong Kong Early Arthritis Study

This was a 24-week open-label randomized study. Forty patients are randomly assigned to
receive either combination infliximab plus Methotrexate(MTX) (n=20) or Methotrexate(MTX)
alone (n=20)

All participants received oral Methotrexate(MTX), starting at 7.5 mg/week. In patients with
persistent tender or swollen joints, the dose was escalated in a graduated manner (2.5
mg/week every 1-2 weeks) to 15 mg/week by week 4 or 20 mg/week by week 8 Patients in
combination group receive infliximab 3mg/kg at weeks 0, 2, and 6 and every 8 week
thereafter. Comprehensive assessment will be made on week 0, 12, 24.

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

- Current or recent ( within the past 3 months) pregnancy and cancer

- Active smoker, alcohol or drug abuse

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

week 24

Safety Issue:


Principal Investigator

Edmund K Li, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chinese University of Hong Kong


Hong Kong: Department of Health

Study ID:




Start Date:

November 2008

Completion Date:

October 2011

Related Keywords:

  • Rheumatoid Arthritis
  • MTX
  • anti-TNF
  • Early RA
  • Arthritis
  • Arthritis, Rheumatoid