Magnetic resonance Imaging (MRI) inflammation as an imaging biomarker in rheumatoid arthritis: monitoring response to the “Treat to Target” approach

MRI inflammation as an imaging biomarker in rheumatoid arthritis: comparing the change in MRI-inflammation scores between patients receiving treatment for disease flare with combination conventional disease suppressing therapy and those commencing combination methotrexate/anti-tumour necrosis factor (TNF) therapy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12614000895684

Enrollment

Registered

2014-08-22

Start date

2014-10-20

Completion date

2016-08-01

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Many new drug therapies are available for patients with rheumatoid arthritis (RA) but we need to know how effective they are. Currently, the patient’s response is assessed by counting swollen and tender joints, obtaining blood tests that reveal inflammation and combining these into a “Disease Activity Score” (DAS). In NZ we have internationally-recognised expertise in magnetic resonance imaging (MRI); a powerful tool for measuring arthritis activity. An “MRI-inflammation score (MRI-i)” can be obtained and may indicate persistent arthritis activity despite clinically normal joints. It is important to detect this subclinical arthritis activity as it can lead to long-term joint damage. This project draws on our team’s expertise in MRI and compares it with the current clinical gold standard for assessing arthritis activity. It is consistent with the Arthritis New Zealand aim “to restore joint structure and function” as detecting low-grade inflammation may trigger a treatment change, thus avoiding joint damage.

Interventions

The aim of this study is to obtain MRI inflammation scores (osteitis, synovitis, tenosynovitis) before and 3 months after a change in drug therapy for treatment of rheumatoid arthritis. We will explore whether changes in MRI scores mirror changes in clinical measures of disease activity that occur over this time period. As this is an observational study there will be no intervention designated by the researchers. Instead, clinicians treating rheumatoid arthritis patients will choose the appropriate therapy on clinical grounds. We aim to use observational data to compare MRI responses in 2 groups of patients. 1) Patients who have had an inadequate response to methotrexate alone and are about to be escalated to combination conventional disease modifying antirheumatic drug (DMARD) therapy. 2) patients who have had an inadequate response to conventional combination DMARD therapy and are being escalated to methotrexate/anti-TNF therapy.

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

seropositive rheumatoid arthritis Willing and eligible for disease modifying therapy including methotrexate, combination DAMRDS and /or anti-TNF therapy as per treating clinician's decision Willing and eligible to have 2 contrast-enhanced MRI scans (no contraindications)

Exclusion criteria

Contraindications to the medical therapies for rheumatoid arthritis as outlined above Patients will be excluded if there are contraindications to MRI scanning (obesity, claustrophobia, internal metalware) or have impaired renal function and cannot be given IV gadolinium (creatinine clearance must be > 60ml/min).

Outcome results