Status:
COMPLETED
The Chinese University of Hong Kong Early Arthritis Study
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The purpose of this study is: 1. To ascertain whether the quantitative assessment of enhancing synovial volume and perfusion indices on serial Magnetic Resonance Imaging (MRI) examination are useful ...
Detailed Description
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 parti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00901550
Start Date
November 1 2008
End Date
October 1 2011
Last Update
August 2 2012
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Medicine and Therapeutics
Hong Kong, China
2
Prince of Wales Hospital
Hong Kong, China
3
The Prince of Wales Hospital
Hong Kong, China