Ramnicu Valcea

Researchers are evaluating the proposed biosimilar MB04 compared to Enbrel, a known treatment, in patients with moderate to severe rheumatoid arthritis RA who continue to have active disease despite methotrexate therapy. The study aims to assess the effectiveness, safety, how the body processes the drugs, and immune responses to MB04 versus Enbrel. This phase 3 trial will include approximately 458 patients aged 18 to 75 years. Participants will receive a stable dose of methotrexate and folic acid before starting the study. They will be randomly assigned to receive a 50 mg weekly subcutaneous injection of either MB04 or EU-sourced Enbrel during the 36-week main treatment period. After 24 weeks, some patients initially on Enbrel will be re-randomized to either continue Enbrel or switch to MB04, while those on MB04 will continue the same treatment. Following treatment, patients will be monitored for safety for an additional 4 weeks. Throughout the study, patients will undergo regular assessments including measures of joint swelling and tenderness, and blood tests to evaluate inflammation and immune response. The primary outcome is the American College of Rheumatology 20% Response Criteria ACR20 at Week 24, with additional assessments at Week 36. Safety will be monitored continuously, and participant involvement will last approximately 40 weeks including follow-up.

Researchers are evaluating the drug Deucravacitinib BMS-986165 in children and adolescents aged 5 to less than 18 years who have juvenile psoriatic arthritis. This Phase 3 trial aims to study the drugs levels in the body, how well it works, and its safety for this specific pediatric population. The trial is designed as a randomized withdrawal study comparing Deucravacitinib to placebo. Participants receive Deucravacitinib or placebo according to a specified dosing schedule. The study includes an initial treatment period followed by a withdrawal phase to monitor for disease flare. Key outcomes measured include time to first flare during the withdrawal period, drug concentration levels at steady state, achievement of low disease activity or inactive disease, and safety events such as adverse effects and uveitis occurrence. Throughout the study, participants will undergo clinical assessments including joint evaluations, disease activity scores, and psoriasis severity scales. Researchers will monitor for disease flares, remission status, and adverse events up to week 42. The trial includes pharmacokinetic analyses and evaluates participant-reported measures like taste and swallowability of the medication. Participation spans from screening through treatment and follow-up to capture comprehensive safety and efficacy data.

Researchers are evaluating the effectiveness of icotrokinra JNJ-77242113 compared to a placebo in adults with active psoriatic arthritis PsA, including those who have and have not previously used biologic treatments. The study aims to assess how well icotrokinra reduces the signs and symptoms of PsA, focusing on improvements measured by the American College of Rheumatology ACR 20 response at Week 16. Participants are randomly assigned to receive one of two doses of icotrokinra or a matching placebo. Those initially receiving placebo will switch to one of the icotrokinra doses at Week 16. Participants who continue without discontinuing the study drug are eligible to enter a long-term extension phase, where they keep receiving their assigned icotrokinra dose. The treatment period involves regular monitoring and assessment of psoriatic arthritis symptoms. Throughout the study, participants will undergo various assessments, including evaluations of joint swelling and tenderness, skin psoriasis severity, fatigue, physical function, and quality of life. Laboratory tests such as C-reactive protein levels will be measured to monitor inflammation. Researchers will track responses using validated scales like the Psoriatic Area and Severity Index PASI and Investigator Global Assessment IGA. The total duration includes treatment and follow-up visits up to Week 16, with options for extended treatment in the long-term extension phase.