A Phase 2 interventional study of Rituximab in Autoimmune Diseases and Premature Ovarian Insufficiency, sponsored by Angelica Lindén Hirschberg. Completed at 1 site in Sweden. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2024-12-18.
Sponsored by Angelica Lindén Hirschberg · Phase 2, Interventional, and Treatment
Title: Effects of immunomodulatory therapy on gonadal function in women with autoimmune premature ovarian insufficiency (POI)
Trial objectives and purpose: To study if rituximab therapy can improve ovarian response to gonadotropin stimulation and menstrual function in women with autoimmune POI.
Treatment: Controlled ovarian hyperstimulation before and four months after an infusion of 1-gram rituximab (Mabthera®) twice with two weeks interval. Follow-up period 12 months after infusion.
Primary outcome: Number of antral follicles and the size of the largest follicle in response to ovarian stimulation.
Secondary outcomes:
Safety outcomes: All adverse events. Of particular relevance are any hospital admissions, infections and allergic reactions.
Study population: Fifteen women with autoimmune POI defined as absence of menstruation > 6 months and elevated serum level of follicle stimulation hormone > 40 International units (IU)/L.
Inclusion criteria: Autoimmune POI defined as presence of autoantibodies against 21-hydroxylase (OH), side chain cleavage enzyme (SCC), 17-OH and/or neuronal apoptosis inhibitory protein (NACHT) leucine-rich-repeat protein 5 (NALP5) or other relevant autoantibodies; 18-35 yrs of age; body mass index 19-30.
Exclusion criteria: Hypersensitivity to rituximab; severe infection; severe immunosuppression; cardiac disease; cancer; benign tumours of the hypothalamus, pituitary, or ovary; ovarian enlargement or ovarian cyst; vaginal bleeding of unknown aetiology.
Time plan: The study is expected to start the spring 2017. It is expected to be closed spring 2023.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's enrollment of 15 is below the median of 84 across 1,689 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Angelica Lindén Hirschberg is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Controlled ovarian hyperstimulation will be performed before and four months after two infusions of 1-gram rituximab (Mabthera®).
Drug: Rituximab
1 gram rituximab twice with two weeks interval
Number of antral follicles in response to ovarian stimulation 4 months after last rituximab infusion.
Vaginal ultrasound measurement
Time frame: 4 months
The largest follicle in response to ovarian stimulation 4 months after last rituximab infusion.
Vaginal ultrasound measurement
Time frame: 4 months
Spontaneous menstrual bleedings during the 12 months' study period
Number of spontaneous menstrual bleedings
Time frame: 12 months
Ovulation during the 12 months' study period
Confirmed ovulation (y/n)
Time frame: 12 months
Immunoglobulin levels
Change in immunoglobulin levels (g/L) from baseline
Time frame: 4 and 12 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Angelica Lindén Hirschberg