Long-Term Study on Safety and Effectiveness of Biological Treatments for Inflammatory Joint Diseases

What this Trial Is About

Researchers are evaluating the long-term safety and effectiveness of biological disease modifying anti-rheumatic drugs DMARDs in people with inflammatory joint diseases such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and other related conditions. This observational study aims to measure disease activity, quality of life, joint function, joint damage, and work productivity, as well as the cost-effectiveness and predictors of treatment outcomes. The study also focuses on ensuring systematic follow-up of patients treated with these therapies. The study involves regular visits starting at the beginning of a new biological DMARD or kinase inhibitor treatment, with follow-up visits at 3, 6, and 12 months, then every 12 months thereafter. Each visit includes clinical assessments, patient questionnaires, and laboratory tests including blood samples collected for biobank storage at baseline and 3 months. Serious adverse events are systematically recorded, with additional information collected through linkage to other registries. Participants will be involved in ongoing monitoring through clinical evaluations, patient-reported outcomes, and laboratory tests such as blood inflammatory markers. Various disease activity scores and questionnaires are used at multiple time points up to five years to track treatment effects and safety. The study is designed to provide long-term data on the use of biological DMARDs in real-world clinical practice with continued follow-up and safety monitoring.

The Norwegian Antirheumatic Drug Register