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- A 96-Weeks, Prospective, Multicenter, Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare Efficacy and Safety of Masitinib Dose Titration to 4.5 mg/kg/day versus Placebo in the Treatment of Patients with Primary Progressive or Secondary Progressive Multiple Sclerosis Without Relapse.
A 96-Weeks, Prospective, Multicenter, Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare Efficacy and Safety of Masitinib Dose Titration to 4.5 mg/kg/day versus Placebo in the Treatment of Patients with Primary Progressive or Secondary Progressive Multiple Sclerosis Without Relapse.
Datos básicos
- Protocolo:
- AB20009
- EUDRACT:
- 2021-000639-30
- NCT:
- Centro:
- HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
- Año de incio:
- 2022
- Año de finalización:
Objetivos del proyecto
Objetivo Principal: The primary objective of the study is to evaluate whether masitinib treatment will show a significant delay on three-month confirmed disease progression versus placebo in the study patients. Objetivos Secundarios: The secondary objectives of the study are to evaluate the efficacy of masitinib compared with placebo on a range of clinical parameters of multiple sclerosis. The secondary objectives also include the assessment of safety and tolerability of masitinib as compared to placebo in terms of adverse events, vital signs, physical examination, ECG, and clinical laboratory tests.
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Grupos
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Resultados del Ensayo Clínico
[Translated article] Cybersecurity: a priority for pharmacy services in the age of artificial intelligence
Marin, Cayetano M. Hernandez, Monte-Boquet, Emilio, Andres, Jose Luis Poveda
Editorial Material. 10.1016/j.farma.2024.08.009. 2024
[Translated article] Good humanisation practices in the healthcare of patients with rare diseases in Pharmacy Services
Company Albir MJ, Andrés JLP, Solsona MDE
Article. 10.1016/j.farma.2023.10.004. 2024
[Translated article] New challenges in advanced therapies.
Megías-Vericat JE; (...); Poveda Andrés JL
Article. 10.1016/j.farma.2024.05.001. 2024
[Translated article] Pharmacokinetic-guided switching from standard half-life factor VIII to extended half-life pegylated factor VIII in haemophilia A therapy in clinical practice.
Chovi-Trull, Maria; (...); Andres, Jose Luis Poveda
Article. 10.1016/j.farma.2024.12.007. 2025
[Translated article] Real-world effectiveness and safety of nivolumab in patients with relapsed or refractory classical Hodgkin lymphoma.
Fernandez, Laura Lorente; (...); Andres, Jose Luis Poveda
Article. 10.1016/j.farma.2024.09.006. 2024
A Gadolinium(III) Complex Based on Pyridoxine Molecule with Single-Ion Magnet and Magnetic Resonance Imaging Properties.
Orts-Arroyo, Marta; (...); Martinez-Lillo, Jose
Article. 10.3390/ijms25042112. 2024
A multi-criteria decision analysis on the value of nintedanib for interstitial lung diseases.
Zozaya, Neboa; (...); Verde, Luis
Article. 10.1017/S0266462322000459. 2022
Assessing the value of moderate-to-severe atopic dermatitis treatment using multi-criteria decision analysis (MCDA).
Pereyra-Rodríguez JJ; (...); Ortiz de Frutos FJ
Letter. 10.1111/jdv.19432. 2023
Autologous hematopoietic stem cell transplantation in multiple sclerosis: updating outcomes in the Valencian cohort.
Boix Lago, A.; (...); Casanova Estruch, B.
Meeting Abstract. 2023
Automated Cervical Spinal Cord Segmentation in Real-World MRI of Multiple Sclerosis Patients by Optimized Hybrid Residual Attention-Aware Convolutional Neural Networks
Bueno, America; (...); Alberich-Bayarri, Angel
Article. 10.1007/s10278-022-00637-4. 2022
CA125: a new biomarker in patients with Fontan circulation (vol 76, pg 112, 2023)
Fuentes, Francisco Buendia; (...); Soriano, Joaquin Rueda
Correction. 10.1016/j.rec.2023.03.018. 2023
CA125: a new biomarker in patients with Fontan circulation.
Fuentes, Francisco Buendia; (...); Soriano, Joaquin Rueda
Article. 10.1016/j.rec.2022.05.029. 2022
Cavernous Sinus Thrombosis Secondary to Streptococcus Constellatus Pharynges
Jaramillo-Angel, Natalia; (...); Carceller, Miguel Armengot
Article. 10.1007/s12070-024-04511-3. 2024
Central nervous system manifestations in acute and chronic graft-versus-host disease.
Lambert N; (...); Maquet P
Article. 10.1093/brain/awae340. 2024
Clinical and Molecular Characterization of Patients with Therapy Related Myeloid Neoplasms ( TRMN)
Calvete, Oriol; (...); Kanagal-Shamanna, Rashmi
Meeting Abstract. 10.1182/blood-2023-188701. 2023
Clinical Outcomes and Additional Treatment Course in a MS Cohort Treated with Cladribine
Oreja-Guevara, C.; (...); Gomez-Estevez, I.
Meeting Abstract. 2023
CMV REACTIVATIONS IN ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANT FROM HLA-MATCHED AND HAPLOIDENTICAL DONORS WITH POST-TRANSPLANT CYCLOPHOSPHAMIDE.
Article. 10.1016/j.jtct.2024.01.082. 2024
Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.
Montoro-Ronsano JB; (...); Soto-Ortega I
Article. 10.1016/j.farma.2023.01.003. 2023
Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.
Montoro-Ronsano, Jose Bruno; (...); Soto-Ortega, Inmaculada
Article. 10.1016/j.farma.2023.04.002. 2023
COST-EFFECTIVENESS ANALYSIS OF DIFELIKEFALIN FOR THE TREATMENT OF CHRONIC KIDNEY DISEASE ASSOCIATED-PRURITUS IN SPAIN
Sanchez-Alvarez, Emilio E.; (...); Hernaez Colque, M.
Meeting Abstract. 2024
Cybersecurity, a priority for pharmacy services in the age of artificial intelligence.
Hernández Marín CM, Monte-Boquet E, Poveda Andrés JL
Editorial Material. 10.1016/j.farma.2024.08.001. 2024
Determining value in the treatment of activated PI3Kdelta syndrome in Spain: a multicriteria decision analysis from the perspective of key stakeholders.
Abad, Maria Reyes; (...); Gil, Alicia
Article. 10.33393/grhta.2024.3041. 2024
Determining what represents value in the treatment of prurigo nodularis and its key unmet needs in Spain through Multi-Criteria Decision Analysis
Silvestre, Juan Francisco; (...); Serra-Baldrich, Esther
Article. 10.1002/jvc2.275. 2024
Elevation of serum neurofilament light-chain levels disclose possible occult progressive multifocal leukoencephalopathy and immune reconstitution syndrome in a patient receiving ozanimod: a case report.
Quintanilla-Bordás C; (...); Pérez-Miralles FC
Case Reports. 10.3389/fimmu.2024.1465678. 2024
Gastric Bleeding in Stem Cell Transplantation: A Focus on Gastric Vascular Ectasia Under Post-Transplant Cyclophosphamide, Sirolimus, and Mycophenolate Mofetil Prophylaxis.
Eirís J; (...); Sanz J
Article. 10.1016/j.jtct.2024.10.009. 2024
Genetic Variants Associated with Biological Treatment Response in Inflammatory Bowel Disease: A Systematic Review.
Plaza J; (...); Moret-Tatay I
Article. 10.3390/ijms25073717. 2024
How can artificial intelligence optimize value-based contracting?
Poveda, Jose Luis; (...); Medrano, Ignacio H.
Letter. 10.1186/s40545-022-00475-3. 2022
IDIOPATHIC UPPER GASTROINTESTINAL BLEEDING AFTER ALLOGENEIC STEM CELL TRANSPLANTATION: AN UNPRECEDENTED COMPLICATION
Eiris, Juan; (...); Balaguer-Rosello, Aitana
Meeting Abstract. 2024
Impact of Anti-CD20 therapies on the immune homeostasis of gastrointestinal mucosa and their relationship with de novo intestinal bowel disease in multiple sclerosis: a review.
Quesada-Simo, A.; (...); Gil-Perotin, S.
Article. 10.3389/fphar.2023.1186016. 2023
Improved outcomes in allo-HCT for multiple myeloma patients with thiotepa-busulfan-fludarabine conditioning regimen and post-transplant cyclophosphamide, sirolimus and mycophenolate mofetil
de la Rubia, Javier; (...); Sanz, Miguel
Meeting Abstract. 2023
Incidence, risk factors and therapy response of acute graft-versus-host disease after myeloablative hematopoietic stem cell transplantation with posttransplant cyclophosphamide.
Asensi Cantó P; (...); Sanz J
Article. 10.1038/s41409-024-02391-3. 2024
Incidence, risk factors, and outcomes of BK hemorrhagic cystitis in hematopoietic stem cell transplantation from HLA-matched and haploidentical donors with post-transplant cyclophosphamide.
Chorao, Pedro; (...); Sanz, Jaime
Article. 10.1016/j.jtct.2024.12.006. 2024
Is erenumab an efficient alternative for the prevention of episodic and chronic migraine in Spain? Results of a cost-effectiveness analysis.
Pozo-Rosich P; (...); Irimia P
Article. 10.1186/s10194-024-01747-w. 2024
Isavuconazole Pharmacokinetics in Critically Ill Patients: Relationship with Clinical Effectiveness and Patient Safety.
Martin-Cerezuela, Maria; (...); Ramirez Galleymore, Paula
Article. 10.3390/antibiotics13080706. 2024
Longitudinal outcome over four decades of allogeneic stem cell transplantation: a single center experience.
Sanz, Miguel Angel; (...); Sanz, Jaime
Article. 10.1038/s41409-024-02319-x. 2024
Long-term experience with cladribine tablets in multiple sclerosis patients
Oreja-Guevara, Celia; (...); Alba Suarez, Elda Maria
Meeting Abstract. 2023
Management of iodine contrast induced salivary gland swelling (sialadenitis): experiences from an observational study.
Saro-Buendía M; (...); Armengot Carceller M
Article. 10.1080/00016489.2022.2162121. 2023
Manipulación de fármacos para su administración por gastrostomía endoscópica percutánea en pacientes con esclerosis lateral amiotrófica y nutrición enteral.
Vázquez Polo A; (...); Vázquez Costa JF
Article. 10.20960/nh.03946. 2022
National Survey on the Use of Mobile Applications in Patients with Hemophilia and Other Coagulopathies
Eduardo Megias, Juan; (...); Poveda Andres, Jose Luis
Meeting Abstract. 10.1182/blood-2022-169938. 2022
Neural organoids to model neuroinflammation: a systematic review focused on microglia's integration
Barea-Moya, L., Gil-Perotin, S., Garcia-Verdugo, J.
Meeting Abstract. 2023
NEUROLOGIC COMPLICATIONS AFTER ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION WITH CALCINEURIN-FREE GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS
Balaguer Rosello, Aitana; (...); Sanz, Jaime
Meeting Abstract. 2023
New challenges of advanced therapies.
Megías-Vericat JE; (...); Poveda Andrés JL
Article. 10.1016/j.farma.2023.11.008. 2024
Observational study to evaluate discontinuation of monotherapy with cobicistat-boosted darunavir in patients with human immunodeficiency virus
Solana-Altabella, Antonio; (...); Poveda-Andres, Jose Luis
Article. 10.1097/MD.0000000000032208. 2022
ODs with a positive TPR conclusion, not subject to a conditional approval, and approved without requering a pass would be more likely to be reimbursed in Spain.
Poveda JL; (...); Badia X
Article. 10.1186/s13023-022-02610-4. 2023
Oligoclonal M bands and cervical spinal cord lesions predict early secondary progressive multiple sclerosis.
Alcala Vicente, Carmen; (...); Casanova, Bonaventura
Article. 10.3389/fneur.2022.991596. 2022
Omics-Based Approaches for the Characterization of Pompe Disease Metabolic Phenotypes
Gomez-Cebrian, Nuria; (...); Puchades-Carrasco, Leonor
Review. 10.3390/biology12091159. 2023
OPTIMIZING MANAGEMENT AND OUTCOMES OF ACTIVATED PHOSPHOINOSITIDE 3-KINASE DELTA SYNDROME (APDS) IN SPAIN: BEWAYAPDS PROJECT
Flores-Moreno, S.; (...); Gil, A.
Meeting Abstract. 2024
Patient's perspective in clinical practice to assess and predict disability in multiple sclerosis.
Gil-Perotin, S.; (...); Solis-Tarazona, L.
Article. 10.1038/s41598-022-23088-x. 2022
Pharmacogenetics in Response to Biological Agents in Inflammatory Bowel Disease: A Systematic Review.
Ballesta-Lopez, Octavio; (...); Poveda-Andres, Jose Luis
Article. 10.3390/ijms26041760. 2025
Post-stapedectomy intravestibular luxation of the stapes
Fornas, Marta Navarro, Vernetta, Carlos de Paula, Polo, Joan Carreres
Editorial Material. 10.1016/j.otorri.2021.08.001. 2022
Post-stapedectomy intravestibular luxation of the stapes.
Navarro Fornas, Marta, de Paula Vernetta, Carlos, Carreres Polo, Joan
Editorial Material. 10.1016/j.otoeng.2022.07.001. 2022
Predictive value of individual serum neurofilament light chain levels in short-term disease activity in relapsing multiple sclerosis.
Solis-Tarazona, Luis; (...); Gil-Perotin, Sara
Article. 10.3389/fneur.2024.1354431. 2024
Presence of good humanization practices in the healthcare of patients with rare diseases in Pharmacy Services
Company Albir MJ, Poveda Andrés JL, Edo Solsona MD
Article. 10.1016/j.farma.2023.06.0131130. 2024
Reduced incidence of neurologic complications after allogeneic hematopoietic stem cell transplantation with calcineurin-free graft-versus-host disease prophylaxis.
Balaguer-Rosello, Aitana; (...); Sanz, Jaime
Article. 10.1016/j.jtct.2023.07.008. 2023
Reliability, validity and distribution of the Spanish female sexual function index in women with relapsing multiple sclerosis.
Gil-Perotin, Sara; (...); Sanchez-Sanchez, Beatriz
Article. 10.1186/s12905-023-02811-4. 2023
The association of salivary caffeine levels with serum concentrations in premature infants with apnea of prematurity
Garcia-Robles, Ana; (...); Saenz Gonzalez, Pilar
Article. 10.1007/s00431-022-04628-z. 2022
The value of the reflective discussion in decision-making using multi-criteria decision analysis (MCDA): an example of determining the value contribution of tabelecleucel for the treatment of the Epstein Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD).
Badia, Xavier; (...); Valles, Joan-Antoni
Article. 10.1186/s13023-024-03324-5. 2024
Toxic-metabolic encephalopathy induced by metronidazole and disulfiram: classics never die.
Chovi-Trull, Maria; (...); Poveda-Andres, Jose Luis
Article. 10.1136/ejhpharm-2024-004184. 2024
Transient reduced diffusion on magnetic resonance imaging due to transneuronal degeneration of the striatum.
Belloch-Ripollés V, Carreres-Polo J
Case Reports. 10.33588/rn.7504.2022035. 2022
Transient restriction of diffusion in magnetic resonance imaging due to transneuronal degeneration of the corpus striatum
Belloch Ripolles, Vicente, Carreres-Polo, Joan
Editorial Material. 2022
Treatment of multiple sclerosis with rituximab: A Spanish multicenter experience.
Gascon-Gimenez, Francisco; (...); Casanova, Bonaventura
Article. 10.3389/fneur.2023.1060696. 2023
Use of individual measure and z-scores to monitor disease course in relapsing multiple sclerosis: a 1-year prospective study in a single center
Solis-Tarazona, L.; (...); Gil-Perotin, S.
Meeting Abstract. 2022
Use of individual measure and Z-scores to monitor disease course in Relapsing Multiple Sclerosis: A 1-year Prospective Study in a Single Center
Solis-Tarazona, Luis Rafael, Reddam, Salma, Gil-Perotin, Sara
Meeting Abstract. 10.1212/WNL.0000000000203193. 2023
VALUE CRITERIA FOR OUTCOMES BASED MANAGED ENTRY AGREEMENT OF CAR-T IN RELAPSED OR REFRACTORY MULTIPLE MYELOMA (RRMM) THROUGH MCDA
Poveda, J. L.; (...); Lizan, L.
Meeting Abstract. 2023