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The Chinese University of Hong Kong Early Arthritis Study (ERA)

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ClinicalTrials.gov Identifier: NCT00901550
Recruitment Status : Completed
First Posted : May 14, 2009
Last Update Posted : August 2, 2012
Sponsor:
Information provided by (Responsible Party):
Lai-Shan Tam, Chinese University of Hong Kong

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 indicators of responsiveness to treatment in early Rheumatoid Arthritis (RA) using biologic therapy and Methotrexate (MTX) compared with Methotrexate(MTX) alone.
  2. To assess the cost-effectiveness of Tumor Necrosis Factor (TNF) blockers compared with Methotrexate(MTX) monotherapy for Rheumatoid Arthritis(RA).

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Methotrexate Drug: Infliximab Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Chinese University of Hong Kong Early Arthritis Study
Study Start Date : November 2008
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis

Arm Intervention/treatment
Active Comparator: Methotrexate
A drug for RA patient
Drug: Methotrexate
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
Other Name: MTX

Active Comparator: Infliximab
for RA treatment
Drug: Infliximab
Patients in combination group receive infliximab 3mg/kg at weeks 0, 2, and 6 and every 8 week thereafter.
Other Name: Remicade




Primary Outcome Measures :
  1. 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 Measures :
  1. changes in the synovitis grading and the perfusion indices [ Time Frame: 24 week ]
  2. proportion of patients achieving ACR and EULAR responses [ Time Frame: week 24 ]
  3. Correlation between the Magnetic Resonance Imaging(MRI) findings and changes on x-ray [ Time Frame: week 24 ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00901550


Locations
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China
Department of Medicine and Therapeutics
Hong Kong, China
Prince of Wales Hospital
Hong Kong, China
The Prince of Wales Hospital
Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Edmund K Li, MD Chinese University of Hong Kong
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Responsible Party: Lai-Shan Tam, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00901550    
Other Study ID Numbers: ERA_2008
First Posted: May 14, 2009    Key Record Dates
Last Update Posted: August 2, 2012
Last Verified: July 2012
Keywords provided by Lai-Shan Tam, Chinese University of Hong Kong:
MTX
anti-TNF
Early RA
Additional relevant MeSH terms:
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Arthritis
Joint Diseases
Musculoskeletal Diseases
Methotrexate
Infliximab
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Gastrointestinal Agents