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Rheumatoid ArthritisERANCT00901550

The Chinese University of Hong Kong Early Arthritis Study

A study testing Methotrexate and Infliximab in people with Rheumatoid Arthritis, run by Chinese University of Hong Kong at 3 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Methotrexate and Infliximab
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
3 sitesChina
Study dates
Nov 2008to Oct 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 20Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Department of Medicine and Therapeutics

    Hong Kong

  • Prince of Wales Hospital

    Hong Kong

  • The Prince of Wales Hospital

    Hong Kong

Other trials in China

About this study

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).
Read the 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.

Keywords
MTX, anti-TNF, Early RA
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MethotrexateDrug

    Also called MTX

    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

  • InfliximabDrug

    Also called Remicade

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

Study groups in NCT00901550
Study groupRoleWhat they receive
MethotrexateActive comparatorA drug for RA patient
Receives: Drug: Methotrexate
InfliximabActive comparatorfor RA treatment
Receives: Drug: Infliximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: week 24

Secondary outcomes (3)

  1. changes in the synovitis grading and the perfusion indices

    Measured: 24 week

  2. proportion of patients achieving ACR and EULAR responses

    Measured: week 24

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

    Measured: week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2009 (estimated)
  2. Study startNov 2008
  3. Primary completionOct 2011
  4. Study completionOct 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00901550
Sponsor's protocol ID
ERA_2008
Acronym
ERA
Status last verified
Jul 2012
First submitted
13 May 2009
Last updated
2 Aug 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Methotrexate and Infliximab in people with Rheumatoid Arthritis, run by Chinese University of Hong Kong at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00901550.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2012.

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