Mo I Rana

Researchers are evaluating whether proactive therapeutic drug monitoring (TDM) is better than standard care for maintaining steady disease control in adults with rheumatoid arthritis (RA) who are treated with a subcutaneous tumor necrosis factor inhibitor (adalimumab). This Phase 4 study aims to determine if adjusting drug doses based on regular blood tests for drug levels and anti-drug antibodies can prevent disease flare-ups more effectively than standard dosing without such monitoring. Participants will be randomly assigned to one of two groups. The TDM group will have their adalimumab doses adjusted following specific rules based on blood test results to keep drug levels within a therapeutic range. Dose intervals may be shortened, lengthened, or therapy switched depending on antibody levels and drug concentration. The standard care group will continue treatment without these blood test-based adjustments. The study lasts 18 months with visits at baseline, 4, 8, 12, and 18 months, along with digital visits at 2, 6, 10, 14, and 16 months, including blood sampling at each visit. Participants will have regular blood tests to measure drug levels and antibodies every two months. They will attend on-site and digital visits for assessments of disease control and safety. The primary outcome is sustained disease control without flare over the 18-month follow-up. Researchers will monitor adherence, safety, and treatment effectiveness throughout the study period to compare the two treatment approaches.

Researchers are evaluating if a treat-to-target approach that includes structured imaging assessments leads to better long-term outcomes in patients with psoriatic arthritis compared to a conventional treat-to-target strategy. Psoriatic arthritis is a complex disease that can be hard to assess clinically, and imaging techniques like ultrasound and magnetic resonance imaging (MRI) can reveal inflammation not detected through clinical exams. This study specifically aims to see if adding these imaging assessments improves the chances of sustained remission, defined as very low disease activity at 16, 20, and 24 months. The study randomly assigns patients into two groups for a 24-month follow-up. One group receives conventional treat-to-target care based on clinical disease activity assessments alone. The other group follows an imaging informed treat-to-target strategy that includes ultrasound assessments of joints, tendons, and entheses at every visit and MRI scans of the spine and sacroiliac joints at the start and one year. If imaging shows signs of enthesitis or axial inflammation, patients in the imaging group move directly to biological disease modifying antirheumatic drug treatment. Ongoing inflammation detected by ultrasound indicates the treatment target has not been reached. Participants will be monitored regularly with clinical and imaging assessments to track disease activity, inflammation, quality of life, and any adverse events. Outcomes include sustained remission at 16, 20, and 24 months, as well as other disease activity measures and safety. The study follows current European treatment recommendations, and all patients are treated according to a defined algorithm. The total study duration for each participant is 24 months.