The Chinese University of Hong Kong Early Arthritis Study

Rheumatoid Arthritis Clinical Trial

— ERA  

Official title:

The Chinese University of Hong Kong Early Arthritis Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00901550
• Other study ID #: ERA_2008
• Status: Completed
• Phase: N/A
• First received: May 13, 2009
• Last updated: July 31, 2012
• Start date: November 2008
• Est. completion date: October 2011

Study information

• Verified date: July 2012
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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

Locations

Country	Name	City	State
China	Department of Medicine and Therapeutics	Hong Kong
China	Prince of Wales Hospital	Hong Kong
China	The Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	changes in the synovitis grading and the perfusion indices		24 week	Yes
Secondary	proportion of patients achieving ACR and EULAR responses		week 24	Yes
Secondary	Correlation between the Magnetic Resonance Imaging(MRI) findings and changes on x-ray		week 24	Yes