Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
Inclusion Criteria:1. Patients must have RA according to the American College of Rheumatology (ACR) 1987 or 2010 criteria 2. Patients must be willing and able to participate in the study (including follow up visits and providing blood samples) after providing informed consent. 3. 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 4. Patients must be in remission with a DAS28 CRP of less than or equal to 2.6. 5. 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. 6. Consultant must be looking to taper patient's standard care medication 7. Aged 18 years or over
Exclusion Criteria:1. Anyone who has switched anti-TNF agent in the last 12 months 2. Anyone without a recent DAS score (within the previous month) 3. Anyone taking any anti-TNF therapy that isn't Adalimumab, Etanercept or Certolizumab. 4. Anyone who has received steroids within past 3 months (enteral, parenteral or intra-articular) 5. Anyone who is currently pregnancy, or pregnancy planned within next 6 months 6. Anyone with any planned major surgery 7. Anyone with the inability to provide informed consent
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|University of Manchester|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Rheumatoid Arthritis, Psoriatic Arthritis|
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 the group where no feedback is required will have their dosing interval doubled (from 2 to 4 weeks for certolizumab and adalimumab; from 1 to 2 weeks for etanercept).
- - For participants randomised to the arm where results are received by the treating clinician, advice will accompany the results.
- - Baseline (at the point of consent, when the decision to taper is made) - 6 months after tapering starts - 12 months after tapering starts Participants in TAPER will need to have their blood samples taken the day before their next anti-TNF injection date.
Experimental: Feedback Arm
Trough blood samples taken and analysed at baseline, 6m and 12m. Results fed back to recruiting clinical team who can choose to use these to influence their tapering decisions.
Active Comparator: No Feedback Arm
Trough blood samples taken and analysed at baseline, 6m and 12m. Results not fed back to recruiting clinical team.
Diagnostic Test: - Drug level testing
These will be carried out at the CfMR labs at the University of Manchester.
This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:
Anne C Barton, FRCP PhD
For additional contact information, you can also visit the trial on clinicaltrials.gov.