The Chinese University of Hong Kong Early Arthritis Study (ERA)
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Methotrexate
Infliximab
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring MTX, anti-TNF, Early RA
Eligibility 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
Sites / Locations
- Department of Medicine and Therapeutics
- Prince of Wales Hospital
- The Prince of Wales Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Methotrexate
Infliximab
Arm Description
A drug for RA patient
for RA treatment
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
changes in the synovitis grading and the perfusion indices
proportion of patients achieving ACR and EULAR responses
Correlation between the Magnetic Resonance Imaging(MRI) findings and changes on x-ray
Full Information
NCT ID
NCT00901550
First Posted
May 13, 2009
Last Updated
July 31, 2012
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT00901550
Brief Title
The Chinese University of Hong Kong Early Arthritis Study
Acronym
ERA
Official Title
The Chinese University of Hong Kong Early Arthritis Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is:
To ascertain whether the quantitative assessment of enhancing synovial volume and perfusion indices on serial Magnetic Resonance Imaging (MRI) examination are useful indicators of responsiveness to treatment in early Rheumatoid Arthritis (RA) using biologic therapy and Methotrexate (MTX) compared with Methotrexate(MTX) alone.
To assess the cost-effectiveness of Tumor Necrosis Factor (TNF) blockers compared with Methotrexate(MTX) monotherapy for Rheumatoid Arthritis(RA).
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
MTX, anti-TNF, Early RA
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Methotrexate
Arm Type
Active Comparator
Arm Description
A drug for RA patient
Arm Title
Infliximab
Arm Type
Active Comparator
Arm Description
for RA treatment
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Other Intervention Name(s)
MTX
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Infliximab
Other Intervention Name(s)
Remicade
Intervention Description
Patients in combination group receive infliximab 3mg/kg at weeks 0, 2, and 6 and every 8 week thereafter.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
changes in the synovitis grading and the perfusion indices
Time Frame
24 week
Title
proportion of patients achieving ACR and EULAR responses
Time Frame
week 24
Title
Correlation between the Magnetic Resonance Imaging(MRI) findings and changes on x-ray
Time Frame
week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edmund K Li, MD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medicine and Therapeutics
City
Hong Kong
Country
China
Facility Name
Prince of Wales Hospital
City
Hong Kong
Country
China
Facility Name
The Prince of Wales Hospital
City
Hong Kong
Country
China
12. IPD Sharing Statement
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The Chinese University of Hong Kong Early Arthritis Study
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