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

The Chinese University of Hong Kong

Status

Completed

Conditions

Rheumatoid Arthritis

Treatments

Drug: Infliximab

Drug: Methotrexate

Study type

Interventional

Funder types

Other

Identifiers

NCT00901550

ERA_2008

Details and patient eligibility

About

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).

Full 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.

Enrollment

40 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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