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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lai-Shan Tam, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00901550
First received: May 13, 2009
Last updated: July 31, 2012
Last verified: July 2012
  Purpose

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 Intervention
Rheumatoid Arthritis
Drug: Methotrexate
Drug: Infliximab

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Chinese University of Hong Kong Early Arthritis Study

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

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. [ Time Frame: week 24 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • changes in the synovitis grading and the perfusion indices [ Time Frame: 24 week ] [ Designated as safety issue: Yes ]
  • proportion of patients achieving ACR and EULAR responses [ Time Frame: week 24 ] [ Designated as safety issue: Yes ]
  • Correlation between the Magnetic Resonance Imaging(MRI) findings and changes on x-ray [ Time Frame: week 24 ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: November 2008
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00901550

Locations
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
Principal Investigator: Edmund K Li, MD Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: Lai-Shan Tam, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00901550     History of Changes
Other Study ID Numbers: ERA_2008
Study First Received: May 13, 2009
Last Updated: July 31, 2012
Health Authority: Hong Kong: Department of Health

Keywords provided by Chinese University of Hong Kong:
MTX
anti-TNF
Early RA

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Infliximab
Methotrexate
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on October 21, 2014