[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632142":3},{"organization":4,"outcomesModule":7,"designInfo":53,"detailedDescription":52,"studyPopulation":52,"armGroups":64,"interventions":76,"overallOfficials":52,"centralContacts":86,"locations":92,"responsibleParty":128,"collaborators":52,"id":131,"slug":52,"hasResults":132,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":132,"sex":138,"minAge":139,"maxAge":140,"enrollmentInfo":141,"targetDuration":52,"studyType":144,"phases":145,"briefSummary":147,"conditions":148,"keywords":52,"overallStatus":95,"whyStopped":52,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},{"fullName":5,"class":6},"Karolinska University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":52},[9],{"measure":10,"description":11,"timeFrame":12},"Egg retrieval in response to controlled ovarian hyperstimulation","Egg retrieval (yes\u002Fno) in response to controlled ovarian hyperstimulation at 4 to 6 months after rituximab treatment compared to placebo.","4 to 6 months after rituximab\u002Fplacebo treatment.",[14,18,22,26,29,33,37,40,43,46,49],{"measure":15,"description":16,"timeFrame":17},"Occurrence of spontaneous menstrual bleeding","Occurrence of spontaneous menstrual bleeding (yes\u002Fno) at any point during the 19-month study period.","19-month study period from baseline to end of study.",{"measure":19,"description":20,"timeFrame":21},"Proportion of participants who achieve ovulation","Proportion of participants who achieve ovulation (defined as serum progesterone \\>10 nmol\u002FL) at any time during the study period.","During 19 months from baseline to end of study.",{"measure":23,"description":24,"timeFrame":25},"Changes in serum follicle-stimulating hormone","Changes in serum follicle-stimulating hormone (FSH) IE\u002FL levels from baseline to the end of the study period.","From baseline to the end of the study period (19 months).",{"measure":27,"description":28,"timeFrame":25},"Change in serum anti-Mullerian hormone","Changes in serum anti-Mullerian hormone (AMH) microgram\u002FL levels from baseline to the end of the study period.",{"measure":30,"description":31,"timeFrame":32},"Changes in B-cell count","Changes in B-cell count x109\u002FL from baseline to end of study.","From baseline to the end of the study period (19 month).",{"measure":34,"description":35,"timeFrame":36},"Changes in autoantibody indices","Changes in autoantibody indices from baseline to the end of the study period.","From baseline to the end of the study period (19 months)",{"measure":38,"description":39,"timeFrame":25},"Changes in immunoglobulin (IgG) levels","Changes in immunoglobulin (IgG) g\u002FL levels from baseline to the end of the study period.",{"measure":41,"description":42,"timeFrame":25},"Changes in quality of life scores, as measured by the Addison's Disease Quality of Life questionnaire","Changes in quality of life scores, as measured by the validated instrument Addison's Disease Quality of Life (AddiQol) from baseline to the end of the study period.",{"measure":44,"description":45,"timeFrame":25},"Changes in quality life scores, as measured by the Psychological General Well-being questionnaire","Changes in quality life scores, as measured by the validated Psychological General Well-being (PGWB) from baseline to the end of the study period.",{"measure":47,"description":48,"timeFrame":25},"Changes in quality of life scores, as measured by the Short Form Health Survey","Changes in quality of life scores as measured by the validated instrument Short Form Health Survey (SF-36) from baseline to the end of the study period.",{"measure":50,"description":51,"timeFrame":25},"Changes in quality of life scores as measured by the Menopause Rating Scale","Changes in qualit of life scores, as measured by the validated Menopause Rating Scale (MRS) from baseline to the end of the study period.",null,{"allocation":54,"interventionModel":55,"interventionModelDescription":52,"primaryPurpose":56,"observationalModel":52,"timePerspective":52,"maskingInfo":57},"RANDOMIZED","CROSSOVER","TREATMENT",{"masking":58,"maskingDescription":52,"whoMasked":59},"QUADRUPLE",[60,61,62,63],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[65,71],{"label":66,"type":67,"description":68,"interventionNames":69},"Group A 2 infusions with placebo or Rituximab, and then 2 infusions of Rituximab","ACTIVE_COMPARATOR","Randomized to 2 infusions of placebo or Rituximab (2g) with a 2-week interval between infusions 1 and 2 , and then 2 infusions of Rituximax (2g) ,after a 6-month interval between the first two and the last two infusions.",[70],"Drug: Rituximab (Arm A)",{"label":72,"type":67,"description":73,"interventionNames":74},"Group B , 2 infusions (2 g) Rituximab","Group B a total of 2 infusions (2 g) with Rituximab, 2 weeks apart per occasion.",[75],"Drug: Rituximab (Arm B)",[77,82],{"type":78,"name":79,"description":80,"armGroupLabels":81,"otherNames":52},"DRUG","Rituximab (Arm A)","Total 4 infusions (4 g) of Rituximab",[66],{"type":78,"name":83,"description":84,"armGroupLabels":85,"otherNames":52},"Rituximab (Arm B)","2 infusions (2 g) of Rituximab",[72],[87],{"name":88,"role":89,"phone":90,"phoneExt":52,"email":91},"Angelica Lindén Hirschberg","CONTACT","+46812373326","angelica.linden-hirschberg@regionstockholm.se",[93,114],{"facility":94,"status":95,"city":96,"state":52,"zip":97,"country":98,"countryCode":99,"cosmosGeoPoint":100,"geoPoint":105,"contacts":106},"Department of Obstetrics and Gynecology, Karolinska University Hospital","RECRUITING","Stockholm","171 76","Sweden","SE",{"type":101,"coordinates":102},"Point",[103,104],18.06871,59.32938,{"lat":104,"lon":103},[107,111],{"name":108,"role":89,"phone":109,"phoneExt":52,"email":110},"Angelica L Hirschberg, Professor","+46 8 517 733 26","angelica.linden-hirschberg@karolinska.se",{"name":112,"role":113,"phone":52,"phoneExt":52,"email":52},"Angelica Linden Hirschberg","PRINCIPAL_INVESTIGATOR",{"facility":5,"status":95,"city":96,"state":52,"zip":115,"country":98,"countryCode":99,"cosmosGeoPoint":116,"geoPoint":118,"contacts":119},"17176",{"type":101,"coordinates":117},[103,104],{"lat":104,"lon":103},[120,124,127],{"name":121,"role":89,"phone":122,"phoneExt":52,"email":123},"Liselott Blomberg","+46812373782","liselott.blomberg@regionstockholm.se",{"name":125,"role":89,"phone":52,"phoneExt":122,"email":126},"Anna Cockin","anna.cockin@regionstockholm.se",{"name":112,"role":113,"phone":52,"phoneExt":52,"email":52},{"type":129,"investigatorFullName":88,"investigatorTitle":130,"investigatorAffiliation":5,"oldNameTitle":52,"oldOrganization":52},"SPONSOR_INVESTIGATOR","Professor, senior physician","100632142",false,"NCT07509840","Immunomodulatory Therapy to Restore Ovarian Function and Improve Fertility in Women With Autoimmune Premature Ovarian Insufficiency","Immunomodulatory Therapy to Restore Ovarian Function and Improve Fertility in Women With Autoimmune Premature Ovarian Insufficiency - Double-blind, Placebo-contrelled, Randomized Study.","REFINE","Inclusion Criteria:\n\n1. The subject has given their written consent to participate in the trial\n2. Autoimmune POI (FSH \\> 25 IU\u002FL) including the presence of oligo\u002Famenorrhea lasting at least 4 months, and elevated FSH levels (FSH \\> 25 IU\u002FL) confirmed on two separate occasions, with measurements taken at least 4 weeks apart and Addison's disease or ab positivity for 21-hydroxylase or other relevant autoantibodies (SCC, 17-OH, NALP5)\n3. 18-38 years of age\n4. Body mass index between 19-30\n5. Willing to use effective non-hormonal contraceptive (such as intra uterine device (IUD), sexual abstinence, male or female condom with or without spermicide, cap, diaphragm or sponge with spermicide) method during the 18-month study period\n\nExclusion Criteria:\n\n1. Hypersensitivity to rituximab, any of the AxMPs, or any of the excipients (as detailed in the SmPC for the various IMPs)\n2. Active, severe infection or JCV positivity\n3. Active hepatitis B infection\n4. Severe immunosuppression\n5. Severe cardiac disease\n6. Cancer\n7. Benign tumours of the hypothalamus, pituitary, or ovarian pathology\n8. Vaginal bleeding of unknown etiology\n9. Hormone replacement therapy within four weeks prior study entry\n10. Pregnant or lactating women\n11. Concurrent treatment with other immunosuppressive drugs\n12. Any vaccination within 4 weeks of infusion of study medication\n13. Severe psychiatric disorder\n14. Any condition or any circumstance that in the opinion of the investigator would make it unsafe to undergo treatment with rituximab or controlled ovarian hyperstimulation\n15. Active thrombolic disorder (contraindicated for Ovirelle)\n16. Moderate or severe impairment of kidney or liver function (contraindicated for Orgalutran)\n\n    \\-","FEMALE","18 Years","38 Years",{"count":142,"type":143},40,"ESTIMATED","INTERVENTIONAL",[146],"PHASE3","Several autoimmune diseases such as Addison's disease are associated with failing ovarian function, known as premature ovarian insufficiency (POI), which can lead to early menopause and reduced fertility.The underlying cause of POI in these women is considered to be an immunological attack on the ovaries that causes them to not respond to hormonal stimulation from the brain. Hormone replacement effectively counteracts menopausal symptoms, but today there is no treatment to normalize or even improve fertility. As a patient with POI and an autoimmune diagnosis and the desire to become pregnant, you are asked to participate in the study. The aim of this study is to investigate whether immunomodulatory therapy can improve and ideally normalize ovarian function in women of childbearing age with autoimmune disease and proven POI. Patients with a male partner and a desire for children and who respond positively to the first ovarian stimulation will be offered in vitro fertilization (IVF) and will thus be allowed to complete the study. Other participating patients will undergo a total of three ovarian stimulations and treatment with first two infusions of the registered drug rituximab or placebo (inactive agent) and later two additional infusions where all patients receive rituximab. The first two infusions with rituximab or placebo are double-blind, which means that neither you nor the study staff know what you have received. Follow-up takes place up to 12 months after the last infusion.",[149],"Autoimmune Prematur Ovarian Insuffience","2026-03-29",{"date":152,"type":153},"2026-04-03","ACTUAL",{"date":155,"type":153},"2026-02-12",{"date":157,"type":143},"2031-12-31",{"name":88,"class":6},2]