Abadin (casco Urbano), Spain
A Study to Evaluate the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants With Active, Difficult to Treat Rheumatoid Arthritis
The study consists of several periods. During the Screening Period (5 weeks) participants will undergo screening procedures to determine eligibility. In Period 1 (Open-Label Treatment), all eligible participants will receive open-label treatment with IMVT-1402 at a dose of 600 mg subcutaneous (SC) once weekly (QW) for 16 weeks. Participants who meet the ACR20 response criteria at Weeks 14 and 16 will be randomized in a 1:1:1 ratio to receive blinded treatment with either IMVT-1402 600 mg SC QW, IMVT-1402 300 mg SC QW, or placebo SC QW for 12 weeks in Period 2 (Randomized Withdrawal). Eligible participants who complete Period 2 at Week 28 will have the option to receive IMVT-1402 for an additional 48 weeks in Period 3 (Long -Term Extension). A follow-up visit will occur 4 weeks after the last dose of study treatment to monitor safety. The primary endpoint of the study is the proportion of participants achieving an ACR20 response at the end of Period 2. Secondary objectives include evaluating the safety and tolerability of IMVT-1402, as well as its effects on other efficacy measures. This study aims to provide valuable data on the use of IMVT-1402 in treating adults with active, difficult-to-treat, ACPR-positive RA.
Phase
2Span
142 weeksSponsor
Immunovant Sciences GmbHBilbao
Recruiting
Utility of ROTEM® for Risk Stratification of Post-Invasive Procedure Hemorrhage in Patients With Cirrhosis (CIR-ROTEM)
Phase
N/ASpan
183 weeksSponsor
Instituto de Investigación Marqués de ValdecillaBilbao
Recruiting
A Study to Investigate the Long-term Safety and Efficacy of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease
Phase
3Span
265 weeksSponsor
GlaxoSmithKlineBilbao
Recruiting
Wide-Antral Pulmonary Vein Isolation in Atrial Fibrillation Ablation with a Single-shot Technique (WIDER-PVI)
Ablation has become a first-line therapy in the rhythm control strategy for atrial fibrillation (AF). Pulmonary vein electrical isolation (PVI) is the cornerstone of ablation therapy, based on its efficacy profile, safety and lack of alternatives. Single shot techniques have been increasingly used as the initial approach for PVI, employing cryoablation, i.e. release of cryoenergy into the endocardium via an inflatable catheter, to achieve isolation. The most commonly used diameter in cryoablation is 28 mm. These generate antral isolation whose profile depends on the distance between veins. When the application is made with larger devices, as has been observed with the cryoballoon with an expandable diameter of 31 mm or ablation devices using pulsed electric fields, the isolation is also antral at the level of the carina, making the result of PVI more similar to that obtained when ablation is performed with a Wide Antral Circumferential Ablation (WACA) strategy using point-to-point radiofrequency (the gold standard for PVI). The WIDER-PVI study aims to answer the question of whether single-shot ablation with a 31 mm diameter device is superior to conventional ablation with a 28 mm diameter device. The answer to this question is relevant in the context of the development of new, larger devices and concerns about the impact of larger ablation on atrial function.
Phase
N/ASpan
139 weeksSponsor
Hospital Universitario 12 de OctubreBilbao
Recruiting
Multicenter Study Comparing AI-Based Navicam vs. Conventional Pillcam in Small Bowel Pathology
This is a prospective, multicenter, randomized, observational study involving multiple hospitals across Spain. At each site, patients will ingest both the Pillcam SB3 and Navicam capsules in a randomized order. Reading times, transit times, and diagnostic yield will be compared between the two devices. A central reading committee of experienced gastroenterologists will conduct blinded evaluations of both explorations using predefined criteria. The primary endpoint is the diagnostic concordance between Navicam's AI-driven ProScan™ system and the conventional reading of Pillcam SB3, measured by Cohen's kappa index. The secondary endpoints include to assess the correlation in lesion detection, video download times, gastric and small bowel transit times, total reading times, and adverse events. The sample size is 147 patients, accounting for an expected 10% dropout rate, based on previous studies showing a diagnostic concordance kappa index of 0.6. This study aims to establish that the AI-based Navicam capsule is at least as effective as the conventional Pillcam SB3 in diagnosing small bowel lesions, with potentially reduced reading times, thus enhancing clinical efficiency in small bowel diagnostics.
Phase
N/ASpan
84 weeksSponsor
Hospital Clinic of BarcelonaBilbao
Recruiting
Study of Treatment With Sacituzumab and Zimberelimab for Patients With Lung Cancer Confined to the Chest and Previously Operated on Who Were Not Disease-free.
This is an open-label, phase III, randomized, stratified (PDL1- vs PDL1+), 3 arms, multicenter clinical trial. Patients stage IB to IIIA-IIIB (T3N2) after surgical resection if they did not achieve a pathological com-plete response (pCR) will be randomized 1:1:1 to: - ARM 1: Observational Arm for 10 months - ARM 2: Immunotherapy (Zimberelimab) treatment for 13 cycles, Q3W - ARM 3: Sacituzumab Govitecan + Zimberelimab Q3W for 8 cycles + Zimberelimab Q3W for 5 cycles. Patients will receive 8 cycles of the combination and 5 cycles of Zimberelimab monotherapy. The primary objective is to evaluate the disease-free survival (DFS): defined as the length of time from randomization to the earliest event defined as disease recurrence, any new lung cancer (even in the opposite lung), or death from any cause at any known point in time. Disease Free survival (DFS): The time from random assignment to cancer recurrence or death from any cause. Secondary objectives: - Overall survival (OS): at 12, 24 and 36 months after the start of adjuvant treatment - Safety and tolerability of the combination of Sacituzumab Govitecan + Zimberelimab according to CTCAE v5.0. Exploratory objectives - To evaluate whether there is a significant association between change in levels of ctDNA between baseline and after adjuvant treatment and OS and DFS. The total trial duration will be 7 years approximately. Approval-start up: 4-6 months. Patient accrual is expected to be completed within 2 years. One year of treatment and 3 years of follow up, and close-out: 4-6 months. The study will end once survival follow-up has concluded
Phase
3Span
356 weeksSponsor
Fundación GECPBilbao
Recruiting
Study of Antitumor Immune Response After cCRT and IO Treatment in Non-resectable III Stage NSCLC Patients
The study is based on the collection of blood samples and tumor sample analysis, in real world NSCLC stage IIIA/B and IIIC; PD-L1>1%; non-resectable patients on treatment with IO after cCRT without progression. The patients participating in this study will not receive treatment in relation to the study, no drugs will be provided. Patients will be treated as per standard clinical practice. All data collected for this study will be collected retrospectively from patient clinical chart. Only secondary data collected will be analyzed together will samples analysis information.The duration of the study is expected to be 3 years.
Phase
N/ASpan
161 weeksSponsor
Fundación GECPBilbao
Recruiting
The Influence of the Vaginal Microbiome on Clinical Pregnancy in Patients Undergoing a Euploid Embryo Transfer: a Prospective Blinded Multicentre Cohort Study
Phase
N/ASpan
76 weeksSponsor
Fundación IVIBilbao
Recruiting
A Study of Maribavir in Adults With Post-transplant Cytomegalovirus (CMV) Infection
This study will include two main periods of retrospective data collection from medical charts: the pre-index period and the post-index period. The index date is defined as the date of initiation of maribavir dosing, as documented in the medical records. The pre-index period covers the time from the transplant date to the index event, while the post-index period starts at the index event and ends at the date of chart abstraction, death, or loss to follow-up, whichever comes first.
Phase
N/ASpan
42 weeksSponsor
TakedaBilbao
Recruiting
Bilbao
Recruiting