Com Jebel, Romania

Fixed Triple Inhaled Combination in Asthmatic Patients in a Real-life Setting

Study design: multicenter, national, non-interventional, prospective study evaluating the effectiveness of Trimbow 172/5/9 μg pMDI on symptom scores in 6 months after switch from previous LABA-high dose ICS or LABA-high dose ICS + LAMA containing treatment in asthmatic patients. Dosage regimen and administration Name of the product: Trimbow 172/5/9 micrograms pressurised inhalation, solution. Each delivered dose (the dose leaving the mouthpiece) contains 172 μg of beclometasone dipropionate, 5 μg of formoterol fumarate dihydrate and 9 μg of glycopyrronium (as 11 μg glycopyrronium bromide). Each metered dose (the dose leaving the valve) contains 200 μg of beclometasone dipropionate, 6 μg of formoterol fumarate dihydrate and 10 μg of glycopyrronium (as 12.5 μg glycopyrronium bromide). The recommended dose is two inhalations twice daily. The maximum dose is two inhalations twice daily. 1. Aim of the study (research objective) Primary objective: The main objective is to assess the effectiveness of BDP/FF/G 172/5/9 μg fixed triple combination in a real-world setting, with regards to improvements in symptom scores (ACT - Asthma Control Test). Primary outcome measures: - Change (improvement) of ACT score, during the 6 months of treatment (Visit 3), compared to the score at baseline. - The percentage of patients achieving an improvement in ACT score of 3 points (MCID, minimum clinically important difference) or more, after the 6-month treatment (Visit 3) compared to baseline. Secondary objectives: Secondary objectives are the assessments of improvement in lung function, adherence to treatment, and health-related quality of life. 2. Test sample and method, recruitment principle No patient recruitment will be performed. Eligible patients will be enrolled during the participating physicians' regular asthma patient management and patients' written informed consent. Patient inclusion will take place among patients having severe asthma at outpatient clinics (the chosen study sites are attached as annexes to the study protocol), strictly at the time of the patients' visit. The planned number of patients is up to 300. 3. Structure of the study In accordance with the requirements of non-interventional studies, the assignment of patients to Trimbow 172/5/9 μg pMDI therapy should be made independently of the study. Patient enrolment can take place after the patient has been fully informed about the purpose of the study and all its details, and the patient has read and signed the patient informed consent form, including any questions they may have. Once this has taken place, the data that would have been generated anyway during the outpatient examination of the patient in accordance with daily practice can be recorded. This is considered the first visit of the study (Visit 1). During this visit, the patient's main demographic data, information on comorbidities and concomitant medications, smoking history, previous and current asthma therapies, asthma specific assessment (including ACT), exacerbation history, post-dose lung function values, maintenance and reliever inhaled therapies (former and new) baseline quality of life based on the asthma quality of life (EQ-5D-5L) questionnaire, and adherence to therapy based on Test of Adherence to Inhalers (TAI-12) questionnaire are recorded (data to be recorded in e-CRF). Patients will then attend two additional visits - Visit 2 - 1 month (30 ± 5 days) and Visit 3 - 6 months ± 10 days after enrolment as per routine clinical practice. During these visits, data will be collected, according to routine clinical practice. If the patient's maintenance therapy changes during the study as decided by the treating physician, and the patient is no longer receiving Trimbow 172/5/9 μg pMDI, the patient will be automatically excluded from this NIS. The therapy modification and its exact date must be recorded in the eCRF (electronic Case Report Form) of the next visit. If the change in therapy is related to a suspected adverse reaction, it should be reported separately in the eCRF platform in accordance with the respective section of the protocol. This NIS is open to all eligible patients according to the inclusion and exclusion criteria. Permitted concomitant treatments: allowed all medications according to local clinical practice (any non-inhalation therapy for asthma or other diseases) and reliever (short-acting bronchodilators) inhaled therapies for asthma. 4. Start and duration of the study The enrolment of the patients can start only after the approval of the Bulgarian Drug Agency and Ethics Committee for Clinical Trials. The study is planned to start at the end of January 2025. Each site will have 3 months to enroll patients. Following the completion of patient enrolment, each patient will be followed up for 6 months. After the visit of the last patient, sites will have one month to collect all missing data/correct any data flagged as erroneous during monitoring. The last patient last visit is expected to take place in October/November 2025, and the study is planned to be concluded in March/April 2026. Secondary objectives are the assessments of improvement in lung function, adherence
 to treatment, and health-related quality of life.
 
 2. Test sample and method, recruitment principle No patient recruitment will be
 performed. Eligible patients will be enrolled during the participating physicians'
 regular asthma patient management and patients' written informed consent. Patient
 inclusion will take place among patients having severe asthma at outpatient clinics
 (the chosen study sites are attached as annexes to the study protocol), strictly at
 the time of the patients' visit. The planned number of patients is up to 300.
 
 3. Structure of the study In accordance with the requirements of non-interventional
 studies, the assignment of patients to Trimbow 172/5/9 μg pMDI therapy should be
 made independently of the study. Patient enrolment can take place after the patient
 has been fully informed about the purpose of the study and all its details, and the
 patient has read and signed the patient informed consent form, including any
 questions they may have. Once this has taken place, the data that would have been
 generated anyway during the outpatient examination of the patient in accordance with
 daily practice can be recorded. This is considered the first visit of the study
 (Visit 1). During this visit, the patient's main demographic data, information on
 comorbidities and concomitant medications, smoking history, previous and current
 asthma therapies, asthma specific assessment (including ACT), exacerbation history,
 post-dose lung function values, maintenance and reliever inhaled therapies (former
 and new) baseline quality of life based on the asthma quality of life (EQ-5D-5L)
 questionnaire, and adherence to therapy based on Test of Adherence to Inhalers
 (TAI-12) questionnaire are recorded (data to be recorded in e-CRF). Patients will
 then attend two additional visits - Visit 2 - 1 month (30 ± 5 days) and Visit 3 - 6
 months ± 10 days after enrolment as per routine clinical practice. During these
 visits, data will be collected, according to routine clinical practice. If the
 patient's maintenance therapy changes during the study as decided by the treating
 physician, and the patient is no longer receiving Trimbow 172/5/9 μg pMDI, the
 patient will be automatically excluded from this NIS. The therapy modification and
 its exact date must be recorded in the eCRF (electronic Case Report Form) of the
 next visit. If the change in therapy is related to a suspected adverse reaction, it
 should be reported separately in the eCRF platform in accordance with the respective
 section of the protocol.
 
 This NIS is open to all eligible patients according to the inclusion and exclusion
 criteria. Permitted concomitant treatments: allowed all medications according to
 local clinical practice (any non-inhalation therapy for asthma or other diseases)
 and reliever (short-acting bronchodilators) inhaled therapies for asthma.
 
 4. Start and duration of the study The enrolment of the patients can start only after
 the approval of the Bulgarian Drug Agency and Ethics Committee for Clinical Trials.
 The study is planned to start at the end of January 2025. Each site will have 3
 months to enroll patients. Following the completion of patient enrolment, each
 patient will be followed up for 6 months. After the visit of the last patient, sites
 will have one month to collect all missing data/correct any data flagged as
 erroneous during monitoring. The last patient last visit is expected to take place
 in October/November 2025, and the study is planned to be concluded in March/April
 2026.
 
 5. Study plan A total of 3 visits will be performed for the assessment of the primary and secondary endpoints during the study. Patients may be enrolled in the study and their data may be recorded, only if this data is recorded in accordance with standard medical practice. - Visit 1: time of enrolment - a normal visit, according to routine clinical practice. Informed consent and baseline patient characteristics will be collected. - Visit 2: 1 month after enrolment (30 days ± 5 days after Visit 1) - Visit 3: 6 months after enrolment (± 10 days).

Integrated Approach in Frail Older People with Atrial Fibrillation

Controlled study, testing a structured implementation of an appropriate management of elderly AF patients with multimorbidity in clinical practice (adapting the ABC pathway and integrating the means of CGA) versus usual care; it is designed to provide reliable evidence of an active holistic integrated management approach to a common, multimorbid and 'high risk' clinical condition. AFFIRMO use a novel platform (iABC) in a cluster randomized trial design, randomizing centres to iABC versus usual care. Centres will be selected in each participating country (Bulgaria, Denmark, Italy, Romania, Serbia and Spain) under the responsibility of National Coordinators on the basis of a demonstrated interest in managing patients with AF. The 8-10 participating clusters in each country (see study size below) will be randomized in a 1:1 ratio to receive a quality-improvement intervention (iABC, experimental group) or 'usual care' practice (control group). The randomization will occur in each Country once all clusters selected in the Country have obtained IRB approval. The allocation schedule for random assignment of care models (iABC or usual care) to sites will be computer generated at the Central Coordinating Centre. The clusters in each Country will be stratified in 2 groups: Centres with or without interventional electrophysiology laboratory for AF ablation.

A Study to Compare Efficacy, Pharmacokinetics, Safety and Immunogenicity of MB04 [proposed Etanercept Biosimilar] to Enbrel® [EU-sourced] in Rheumatoid Arthritis

The study will randomize approximately 458 patients aged between 18 and 75 years with active Rheumatoid Arthritis despite methotrexate therapy. All patients shall receive methotrexate for ≥12 weeks and on a stable dose (10 to 25 mg/week) for ≥8 weeks prior to randomization, and folic acid (≥5 mg/week) from 4 weeks prior to screening until the end of the treatment period (Week 36). Screening evaluations will be completed within 28 days prior to randomization. There will be 2 periods in the study: Main Treatment period and Transition period. During the Main Treatment Period, eligible patients will be randomized, at a 1:1 ratio, to administer a 50 mg weekly dose of MB04 or EU- sourced Enbrel® subcutaneously (SC) using an Interactive Response System (IRT). After completing Week 24 assessment, patients will continue to receive the study treatment up to Week 36. Those patients who were originally assigned to EU-sourced Enbrel® will be randomized, at a 1:1 ratio, to receive either MB04 or EU-sourced Enbrel® SC, while patients originally assigned to MB04 will continue with the same treatment until Week 36. After treatment discontinuation, patients will undergo a Safety follow-up period for 4 weeks, up to week 40.

A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria

This is a global, multicenter, randomized, double-blind, parallel group, placebo-controlled phase 3 study investigating the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) who are symptomatic despite treatment with non-sedating second generation H1-antihistamines at 1-4 times the locally approved dose. There is a screening period of up to 4 weeks, followed by a 24-week placebo-controlled treatment period, a 28-week active treatment period where all participants receive barzolvolimab followed by a 16-week treatment free period. Approximately 915 adult participants (610 in the active arms and 305 in the placebo arm) will be randomly assigned to the treatment arms.

A Study of TAK-279 in Participants With Moderate-to-Severe Plaque Psoriasis

This study consists of 2 parts: Part A and Part B. Part A: Participants who did not participate in either parent study (TAK-279-3001 [NCT06088043] or TAK-279-3002 [NCT06108544]) may be enrolled and will be treated for up to 52 weeks. Participants who successfully complete Part A of the study are eligible to continue in Part B, but investigators must confirm their eligibility to continue in Part B. Part B: Participants who complete the treatment period of TAK-279-3001 (NCT06088043) or TAK-279-3002 (NCT06108544) parent studies or who complete Part A are eligible to enroll directly into open label extension treatment in Part B and will be treated for up to 156 weeks.

Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function

The purpose of this study is to investigate the effect of balcinrenone/dapagliflozin compared with dapagliflozin, on the risk of CV death, HF event with and without hospitalisation, in patients with chronic HF, impaired kidney function, and who have had a recent HF event. Eligible patients will randomly be assigned with a 1:1:1 ratio to receive once daily administration of one capsule and one tablet of one of the following treatments: 1. Balcinrenone/dapagliflozin 15 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet 2. Balcinrenone/dapagliflozin 40 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet 3. Dapagliflozin 10 mg tablet and matching placebo for balcinrenone/dapagliflozin capsule The study is event driven, and the average study duration for a participant is estimated to be 22 months including screening period, 20 months blinded treatment period and a one-month follow-up period on open-label dapagliflozin. The study will be conducted at approximately 700 sites in approximately 40 countries globally.

Phase 3 Study of Plozasiran in Adults With Hypertriglyceridemia

Study of Plozasiran in Adults With Severe Hypertriglyceridemia

CORE-OLE: A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG)

This is a multi-center, open-label extension (OLE) study of approximately 800 participants with SHTG who would be rolled over from studies ISIS 678354-CS5 (NCT05079919) or ISIS 678354-CS6 (NCT05552326). Day 1 of this study may be same as the Week 53 visit of either ISIS 678354-CS5 or ISIS 678354-CS6, as applicable. Participants will receive olezarsen during the 157-week treatment period. The study will include a 31-day qualification Period, a 157-week treatment period, and a 13-week post-treatment period.

The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)