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Tapering of Biologics in Inflammatory Arthritis Patients in Remission
Sponsor: University of Manchester
Summary
Rheumatoid arthritis (RA) and Psoriatic Arthritis (PsA) are types of inflammatory arthritis. They are disabling conditions caused by inflammation in joints that can lead to pain, stiffness, fatigue and joint damage. There is currently no cure but treatment is aimed at reducing joint inflammation. Some of the most promising new therapies work by interfering with the binding of a molecule called tumour necrosis factor (TNF). In recent years, new anti-TNF drugs (such as adalimumab, etanercept and certolizumab) have been developed that block the action of TNF and reduce this inflammation. These drugs are very effective in controlling inflammation for many patients whose arthritis has not responded to other therapies. Some patients can take these medications for a long time. If a patient is stable on their rheumatoid arthritis biologic or biosimilar, tapering the drug is often considered. The investigators are planning to look at drug level and anti-drug antibody testing to guide anti-TNF tapering (reducing) decisions in UK patients with RA who have stable, reduced arthritis symptoms. The investigators think that measuring these drug levels and anti-drug antibodies in blood samples will be useful for guiding this process, but the investigators can't be sure. It is important to do this safely so the patient doesn't experience a flare of their disease symptoms. The study will be used to determine whether a much larger study to assess the usefulness of these measurements would be achievable. This study will assess whether measuring biomarkers (measurable substances in the blood) that may affect a patient's response to treatment. If a patient are eligible to take part, they will be randomly allocated to one of the following groups; * Their Doctor receiving information and treatment advice based on their blood results or * Their Doctor not receiving this information
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
51
Start Date
2021-05-13
Completion Date
2024-12-31
Last Updated
2024-05-10
Healthy Volunteers
No
Conditions
Interventions
Drug level testing with feedback provided
Feedback about drug levels in blood provided to participant's site
Drug level testing with no feedback provided
Testing drug levels in blood but feedback not provided to participant's site
Locations (1)
Manchester University Hospitals NHS Foundation Trust
Manchester, North West, United Kingdom