Region Stockholm — Biomedical Watch V2

Traitements7programmes

Essais3liés

Publications9liées

SourceDBlocale

Traitements

7

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
Anti-CD20 Monoclonal AntibodyThe overall aim of the study is to gain knowledge about consequences for the child´s humoral immunosystem in mothers with multiple sclerosis and due to their immunomodulating treatments. Of special interest is when the mother is treated with monoclonal CD20-antibody like rituximab, ocrelizumab and ofatumumab shortly before (within six months prior to conception) and during pregnancy. Specific aims of the study are to: * Investigate if the humoral immunosystem is fully functioning at birth in children born to mothers with MS * Investigate if the humoral immunosystem at birth in children born to mothers with MS is influenced by the mothers immunomodulating treatment * Investigate if monoclonal CD20-antibodies are fully eliminated in women treated with monoclonal CD20-antibodies within 12 months prior to conception. * Determine if children who have been exposed to monoclonal CD20-antibody in utero have reduced markers of successful B-cell production at birth. * Investigate the response to the Rota virus vaccine, a life-vaccine that is offered 6 weeks after birth to all children born after September 2019, in children to women treated with rituximab before or during pregnancy. * Investigate the response to other vaccines (DTP, Polio, HiB, pneumococcus given at 3 and 5 months after birth) the earliest one months after vaccination. * Investigate the occurrence of infections in the first-year post-partum for the mother and child due to hypogammaglobulinemia, b-cell depletion, and exposure to monoclonal CD20-antibody. * Investigate if oral exposure to rituximab through mother´s breastmilk is resulting in B-cell reduction in the child.	SEP	À vérifier	Immunomodulation		À vérifier
monoclonal CD-20 antibodiesThe goal of this observational study is to learn about consequences for the child when the mother is treated with rituximab (or other monoclonal CD-20 antibodies) before or during pregnancy. The main questions it aims to answer are: * Is the infant's immune system effected with lower levels of B-cell markers, higher rates of infections or poor vaccine response? * Are the monoclonal CD20-antibodies fully eliminated in women treated within 6 (12) months prior to conception? Participants will: * At the time of clinical routine blood sampling (at the end of each trimester) the becoming mother will give some additional blood samples for analysis of drug concentration * Within the first year postpartum the child will leave a blood sample to detect antibodies induced by vaccination or infections * Within our routine contacts with the participant (mother) will be asked about infections in both the mother and the child	SEP	À vérifier	Immunomodulation	Sweden	À vérifier
No DrugThe goal of this observational study is to learn about consequences for the child when the mother is treated with rituximab (or other monoclonal CD-20 antibodies) before or during pregnancy. The main questions it aims to answer are: * Is the infant's immune system effected with lower levels of B-cell markers, higher rates of infections or poor vaccine response? * Are the monoclonal CD20-antibodies fully eliminated in women treated within 6 (12) months prior to conception? Participants will: * At the time of clinical routine blood sampling (at the end of each trimester) the becoming mother will give some additional blood samples for analysis of drug concentration * Within the first year postpartum the child will leave a blood sample to detect antibodies induced by vaccination or infections * Within our routine contacts with the participant (mother) will be asked about infections in both the mother and the child	SEP	À vérifier	Immunomodulation	Sweden	À vérifier
Simultaneous T2-FLAIR and T1 Brain MRI With ENRAGED FLAIR in Multiple SclerosisThis study will evaluate a new brain MRI technique called ENRAGED FLAIR in patients with multiple sclerosis. MRI is central in the diagnosis and follow-up of multiple sclerosis because it can show inflammatory lesions in the brain. A standard MS brain MRI examination usually includes T2-FLAIR images, which are used to detect and assess MS lesions, and T1-weighted images, which provide anatomical information and help with interpretation of lesion location. These image types are usually acquired as separate scans. ENRAGED FLAIR is designed to acquire both T2-FLAIR and T1-weighted images during the same MRI sequence. The purpose of this study is to compare ENRAGED FLAIR with standard clinical MRI in patients with multiple sclerosis. Adult patients with multiple sclerosis who are already scheduled for a clinical brain MRI may be asked to participate. Participants will undergo one additional MRI sequence during the same visit. No extra contrast agent will be given, and no extra visit is required. The additional scan is expected to increase the examination time by about 5 to 10 minutes. The study will assess whether ENRAGED FLAIR provides image quality and MS lesion visualization comparable to standard MRI. If successful, this technique may help shorten future MRI examinations for patients with multiple sclerosis while preserving clinically useful image information.	SEP	Non applicable	Immunomodulation	Sweden	À vérifier
monoclonal CD-20 antibodiesThe goal of this observational study is to learn about consequences for the child when the mother is treated with rituximab (or other monoclonal CD-20 antibodies) before or during pregnancy. The main questions it aims to answer are: * Is the infant's immune system effected with lower levels of B-cell markers, higher rates of infections or poor vaccine response? * Are the monoclonal CD20-antibodies fully eliminated in women treated within 6 (12) months prior to conception? Participants will: * At the time of clinical routine blood sampling (at the end of each trimester) the becoming mother will give some additional blood samples for analysis of drug concentration * Within the first year postpartum the child will leave a blood sample to detect antibodies induced by vaccination or infections * Within our routine contacts with the participant (mother) will be asked about infections in both the mother and the child	SEP	À vérifier	Immunomodulation	Sweden	À vérifier
Simultaneous T2-FLAIR and T1 Brain MRI With ENRAGED FLAIR in Multiple SclerosisThis study will evaluate a new brain MRI technique called ENRAGED FLAIR in patients with multiple sclerosis. MRI is central in the diagnosis and follow-up of multiple sclerosis because it can show inflammatory lesions in the brain. A standard MS brain MRI examination usually includes T2-FLAIR images, which are used to detect and assess MS lesions, and T1-weighted images, which provide anatomical information and help with interpretation of lesion location. These image types are usually acquired as separate scans. ENRAGED FLAIR is designed to acquire both T2-FLAIR and T1-weighted images during the same MRI sequence. The purpose of this study is to compare ENRAGED FLAIR with standard clinical MRI in patients with multiple sclerosis. Adult patients with multiple sclerosis who are already scheduled for a clinical brain MRI may be asked to participate. Participants will undergo one additional MRI sequence during the same visit. No extra contrast agent will be given, and no extra visit is required. The additional scan is expected to increase the examination time by about 5 to 10 minutes. The study will assess whether ENRAGED FLAIR provides image quality and MS lesion visualization comparable to standard MRI. If successful, this technique may help shorten future MRI examinations for patients with multiple sclerosis while preserving clinically useful image information.	SEP	Non applicable	Immunomodulation	Sweden	À vérifier
Anti-CD20 Monoclonal AntibodyThe overall aim of the study is to gain knowledge about consequences for the child´s humoral immunosystem in mothers with multiple sclerosis and due to their immunomodulating treatments. Of special interest is when the mother is treated with monoclonal CD20-antibody like rituximab, ocrelizumab and ofatumumab shortly before (within six months prior to conception) and during pregnancy. Specific aims of the study are to: * Investigate if the humoral immunosystem is fully functioning at birth in children born to mothers with MS * Investigate if the humoral immunosystem at birth in children born to mothers with MS is influenced by the mothers immunomodulating treatment * Investigate if monoclonal CD20-antibodies are fully eliminated in women treated with monoclonal CD20-antibodies within 12 months prior to conception. * Determine if children who have been exposed to monoclonal CD20-antibody in utero have reduced markers of successful B-cell production at birth. * Investigate the response to the Rota virus vaccine, a life-vaccine that is offered 6 weeks after birth to all children born after September 2019, in children to women treated with rituximab before or during pregnancy. * Investigate the response to other vaccines (DTP, Polio, HiB, pneumococcus given at 3 and 5 months after birth) the earliest one months after vaccination. * Investigate the occurrence of infections in the first-year post-partum for the mother and child due to hypogammaglobulinemia, b-cell depletion, and exposure to monoclonal CD20-antibody. * Investigate if oral exposure to rituximab through mother´s breastmilk is resulting in B-cell reduction in the child.	SEP	À vérifier	Immunomodulation		À vérifier

Essais cliniques

3

Molécule	Indication / population	Phase	NCT	Titre	Statut
Anti-CD20 Monoclonal Antibody	SEP	À vérifier	NCT06711354	B-cell Depletion in Offspring to Women With MS Under Immunomodulatory Treatment	UNKNOWN
Simultaneous T2-FLAIR and T1 Brain MRI With ENRAGED FLAIR in Multiple Sclerosis	SEP	Non applicable	NCT07687693	Simultaneous T2-FLAIR and T1 Brain MRI With ENRAGED FLAIR in Multiple Sclerosis	COMPLETED
monoclonal CD-20 antibodies	SEP	À vérifier	NCT07149662	Immune System Effects in Children Born to Women With Multiple Sclerosis Treated With Monoclonal Antibody Therapy During Pregnancy	NOT_YET_RECRUITING

Publications

9

Molécule	Indication / population	Titre	Journal	Date
No Drug		A multiple ascending dose, phase1b study to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of lesigercept, a long-acting IgE-Fc fusion protein, in participants with atopy or allergic diseases.	International immunopharmacology
No Drug		Efficacy and safety of adjunctive orexin receptor antagonist therapy in major depressive disorder: A systematic review and meta-analysis of randomized controlled trials.	Journal of affective disorders
No Drug		Discovery, development, and characterization of SPY002 and SPY072, two novel extended half-life monoclonal antibodies targeting TL1A: in vitro properties, in vivo pharmacology, pharmacokinetics, and preclinical safety.	mAbs
monoclonal CD-20 antibodies		A new, glycoengineered form of anti-CD20 monoclonal antibody, in treatment of multiple sclerosis.	Therapeutic advances in neurological disorders
monoclonal CD-20 antibodies		Dermatologic Adverse Events Associated with T-Cell Engager Therapy.	American journal of clinical dermatology
No Drug		Safety, pharmacodynamics, and pharmacokinetics of oral cannabigerol in healthy adults.	The Journal of pharmacology and experimental therapeutics
No Drug		Ersodetug for Refractory Hypoglycemia Due to Malignant Insulin-Secreting Tumors.	The Journal of clinical endocrinology and metabolism
No Drug		Evaluation of the Safety and Efficacy of SOF/VEL Treatment and Pre-treatment of TAF in Patients with Chronic Hepatitis B Virus/Hepatitis C Virus Coinfection: A Multicenter Study.	Journal of clinical and translational hepatology
monoclonal CD-20 antibodies		Early treatment with ofatumumab increases the likelihood of stabilizing disease in patients with relapsing-remitting multiple sclerosis.	Archives of medical science : AMS