Status:
ACTIVE_NOT_RECRUITING
Tapering of Biologics in Inflammatory Arthritis Patients in Remission
Lead Sponsor:
University of Manchester
Conditions:
Rheumatoid Arthritis
Psoriatic Arthritis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 an...
Detailed Description
Participants will be randomly allocated to feedback of their drug levels / antidrug antibody status to their consultant prior to tapering, or not, in a 1:1 ratio. * Those participants randomised to t...
Eligibility Criteria
Inclusion
- Patients must have RA according to the American College of Rheumatology (ACR) 1987 or 2010 criteria
- Patients must be willing and able to participate in the study (including follow up visits and providing blood samples) after providing informed consent.
- Patients must currently be on stable treatment a one of the following single anti-TNF agents Adalimumab, Etanercept or Certolizumab. They must have been taking this biologic/ biosimilar therapy for a minimum of 12 months
- Patients must be in remission with a DAS28 CRP of less than or equal to 2.6.
- A DAS28 score must be provided at baseline. This must have been taken within the month before study recruitment. If this DAS score is not available, the patient is not eligible to take part.
- Consultant must be looking to taper patient's standard care medication
- Aged 18 years or over
Exclusion
- Anyone who has switched anti-TNF agent in the last 12 months
- Anyone without a recent DAS score (within the previous month)
- Anyone taking any anti-TNF therapy that isn't Adalimumab, Etanercept or Certolizumab.
- Anyone who has received steroids within past 3 months (enteral, parenteral or intra-articular)
- Anyone who is currently pregnancy, or pregnancy planned within next 6 months
- Anyone with any planned major surgery
- Anyone with the inability to provide informed consent
Key Trial Info
Start Date :
May 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT04429776
Start Date
May 13 2021
End Date
December 31 2024
Last Update
May 10 2024
Active Locations (1)
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1
Manchester University Hospitals NHS Foundation Trust
Manchester, North West, United Kingdom, M13 9WL