The Chinese University of Hong Kong Early Arthritis Study

NCT ID: NCT00901550

Last Updated: 2012-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2011-10-31

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).

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.

Conditions

Rheumatoid Arthritis

Keywords

MTX; anti-TNF; Early RA

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Methotrexate

A drug for RA patient

Group Type: ACTIVE_COMPARATOR

Methotrexate

Intervention Type: 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

Infliximab

for RA treatment

Group Type: ACTIVE_COMPARATOR

Infliximab

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Infliximab

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

Intervention Type: DRUG

Other Intervention Names

MTX; Remicade

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Lai-Shan Tam

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edmund K Li, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Department of Medicine and Therapeutics

Hong Kong, , China

Prince of Wales Hospital

Hong Kong, , China

The Prince of Wales Hospital

Hong Kong, , China

Countries

China

Other Identifiers

ERA_2008

Identifier Type: -

Identifier Source: org_study_id