Ramnicu Valcea

Researchers are evaluating the efficacy, pharmacokinetics, safety, and immunogenicity of MB04, a proposed etanercept biosimilar, compared to Enbrel4 (EU-sourced) in adults aged 18 to 75 years with active moderate to severe rheumatoid arthritis despite methotrexate therapy. This Phase 3 study includes approximately 458 patients who have been on a stable methotrexate dose for at least 8 weeks before randomization. The goal is to compare these treatments over time to understand their effects in this patient population. Participants will be randomly assigned in a 1:1 ratio to receive either MB04 or EU-sourced Enbrel4 as a 50 mg subcutaneous injection once weekly during the main treatment period. After completing 24 weeks of treatment, those initially receiving Enbrel4 will be re-randomized to either continue Enbrel4 or switch to MB04 until week 36. Patients who started on MB04 will continue the same treatment through week 36. All participants will continue their stable methotrexate and folic acid regimen throughout the study. Participants will undergo screening within 28 days before randomization and will be monitored through week 40, including a 4-week safety follow-up after treatment ends. Researchers will assess treatment response using the American College of Rheumatology 20% Response Criteria (ACR20) at week 24, along with safety, pharmacokinetics, and immunogenicity evaluations. Regular assessments and monitoring will help determine how patients respond to the treatments and ensure their safety throughout the study.

Researchers are studying Deucravacitinib (BMS-986165) to understand its drug levels, effectiveness, and safety in children and adolescents aged 5 to less than 18 years who have juvenile psoriatic arthritis. This condition involves arthritis affecting multiple joints in young patients, and the study is designed as a phase 3, multicenter, double-blind, placebo-controlled, randomized withdrawal trial. The goal is to see how well the medication works and how safe it is in this population. Participants will receive either Deucravacitinib or a placebo, both given at specified doses on specified days. The study includes a withdrawal period starting from week 16 up to week 42, during which researchers will monitor the time to first flare of the disease. This design helps to evaluate the lasting effects and safety of the treatment over time. Throughout the study, participants will be closely monitored for treatment response and safety. Researchers will track disease flares and collect data on how the drug is processed in the body. The total participation duration includes the treatment and withdrawal periods, allowing for thorough assessment of drug efficacy and safety in pediatric patients with juvenile psoriatic arthritis.

Researchers are evaluating the effectiveness of icotrokinra (JNJ-77242113) compared to a placebo in adults with active psoriatic arthritis (PsA). This study includes both participants who have previously used biologic treatments and those who have not. The goal is to assess how well the drug reduces the signs and symptoms of PsA by the 16th week of treatment. This is a Phase 3, multicenter, randomized, double-blind clinical trial designed to provide reliable evidence on the drug's impact on this condition. Participants will receive either icotrokinra or a placebo. The treatments will be administered according to the study protocol, but specific dosing details are not provided. Participants will be monitored over 16 weeks to evaluate their response to the treatment, focusing on the American College of Rheumatology (ACR) 20 response, which measures improvement in disease activity. The study compares the active drug against placebo to determine its efficacy and safety in this patient group. During the study, participants will undergo assessments to monitor their psoriatic arthritis symptoms, including joint swelling and tenderness, as well as blood tests to measure inflammation markers like C-reactive protein. Female participants who can become pregnant will have pregnancy tests before and during the study to ensure safety. Researchers will collect data on disease activity and safety throughout the study period to understand the treatment's effects. Total participation time and additional follow-up details are not specified.

Researchers are evaluating the efficacy, safety, and tolerability of subcutaneous ianalumab given every 4 weeks or every 12 weeks compared to placebo, all combined with standard-of-care therapy, in adults with active lupus nephritis. This phase 3 trial focuses on participants with specific classes of lupus nephritis confirmed by recent kidney biopsy and meeting established diagnostic criteria. Participants will receive either ianalumab every 4 weeks, ianalumab every 12 weeks, or a placebo, all given by subcutaneous injection alongside standard lupus nephritis treatment. Standard-of-care includes induction therapy with high-dose corticosteroids and mycophenolic acid (MPA). Treatment schedules and doses are carefully monitored throughout the study. Participants will be involved in regular assessments including kidney function tests, urine protein measurements, and clinical evaluations up to week 72 to monitor treatment response and safety. The primary outcome is the frequency of participants achieving stable complete renal response by week 72. Safety and tolerability are also closely tracked during the trial period.