The Chinese University of Hong Kong Early Arthritis Study

NCT00901550 | Completed

• 1 other identifier: ERA_2008
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is:

1. 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. 2.To assess the cost-effectiveness of Tumor Necrosis Factor (TNF) blockers compared with Methotrexate(MTX) monotherapy for Rheumatoid Arthritis(RA).

Conditions

Rheumatoid Arthritis

Keywords

MTX; anti-TNF; Early RA

Outcome Measures

Primary Outcomes (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.

  week 24

Secondary Outcomes (3)

• changes in the synovitis grading and the perfusion indices

  24 week

• proportion of patients achieving ACR and EULAR responses

  week 24

• Correlation between the Magnetic Resonance Imaging(MRI) findings and changes on x-ray

  week 24

Study Arms (2)

Methotrexate

ACTIVE COMPARATOR

A drug for RA patient

Drug: Methotrexate

Infliximab

ACTIVE COMPARATOR

for RA treatment

Drug: Infliximab

Interventions

Methotrexate DRUG

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

Also known as: MTX

Methotrexate

Infliximab DRUG

Patients in combination group receive infliximab 3mg/kg at weeks 0, 2, and 6 and every 8 week thereafter.

Also known as: Remicade

Infliximab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (3)

Department of Medicine and Therapeutics

Hong Kong, China

Location

Prince of Wales Hospital

Hong Kong, China

Location

The Prince of Wales Hospital

Hong Kong, China

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Methotrexate; Infliximab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Edmund K Li, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 13, 2009
• First Posted: May 14, 2009
• Study Start: November 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: August 2, 2012

Record last verified: 2012-07

Locations

CN (3)