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Found 2 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating treatments for adults with psoriatic arthritis (PsA) who have not responded well to tumor necrosis factor inhibitors (TNFi). The study aims to compare switching to guselkumab, a selective interleukin 23 inhibitor, versus switching to another TNFi called golimumab. This Phase 3 trial tests whether changing to a new mechanism of action provides better results than trying a second TNFi, addressing an important question for patients with PsA who have inadequate responses to current therapy. Participants will receive either guselkumab or golimumab, both given as subcutaneous injections. The study is open-label and randomized, meaning both patients and researchers know which treatment is given, and patients are randomly assigned to one of the two options. The trial will observe patients over 12 months to assess treatment effectiveness. During the study, participants will have regular assessments including measuring disease activity with the clinical Disease Activity index for Psoriatic Arthritis (cDAPSA) and evaluating psoriasis severity. Researchers will monitor safety and treatment response through these measures and the Investigator Global Assessment of Psoriasis. The total participation duration is 12 months, allowing time to capture treatment effects and side effects.

Age: 18Years - 80YearsAll GendersPhase 3
14 locations
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Actively Recruiting

Researchers are evaluating treatment strategies for people with active rheumatoid arthritis (RA) who have not improved despite using tumor necrosis factor inhibitor (TNFi) biologic drugs. The study compares switching to a non-TNFi biologic drug (such as rituximab, abatacept, tocilizumab, or sarilumab) versus switching to a targeted synthetic disease-modifying antirheumatic drug (tsDMARD) like tofacitinib, baricitinib, or upadacitinib. This comparative effectiveness research addresses a critical gap in evidence, as current treatment choices are often based on physician experience or insurance preferences rather than strong data. The study uses patient-reported outcomes (PROs) to provide meaningful information for patient-centered care. Participants will be assigned to receive either a non-TNFi biologic or a tsDMARD as their new treatment for active RA after TNFi biologic therapy. The study allows participants to continue certain conventional synthetic DMARDs (such as methotrexate, sulfasalazine, hydroxychloroquine, or leflunomide) if they have been stable on these for a specified period. Treatment choice is supported by insurance or patient assistance programs to ensure access. This pragmatic trial is designed to reflect real-world practice and includes patients with comorbidities to assess effectiveness and safety in a broad population. During the study, participants will be monitored for changes in functional ability over 12 months using the Health Assessment Questionnaire (HAQ), a sensitive measure for RA impact. Researchers will also evaluate quality of life, productivity, and side effects. The study aims to generate evidence that helps patients and payers make informed decisions about RA treatments based on outcomes that matter most to patients. Total participation includes baseline assessments and follow-up evaluations throughout the 12-month treatment period.

Age: 18Years +All GendersPhase 3
49 locations