Kesimpta for Multiple Sclerosis During Pregnancy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how the medication Kesimpta (ofatumumab) affects pregnancy and infant outcomes in women with multiple sclerosis (MS). It compares three groups: women with MS who took Kesimpta during pregnancy, women with MS who did not take Kesimpta, and healthy women without MS. Pregnant women with MS, particularly those taking Kesimpta, may be suitable candidates for this trial. The researchers aim to better understand the effects of Kesimpta on both mothers and their babies. As an unphased trial, this study provides a unique opportunity to contribute to valuable research that could improve health outcomes for mothers and infants.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but it does exclude women who have taken certain medications like anti-CD20 monoclonal antibodies, S1P modulators, Cladribine, and Teriflunomide within a specific time before conception. It's best to discuss your current medications with the trial team to see if they affect your eligibility.
What prior data suggests that Kesimpta is safe for pregnant women with MS?
Research has shown that ofatumumab, also known as Kesimpta, is generally safe during pregnancy. One study found that pregnancy outcomes for women taking ofatumumab were similar to those in the general population, with about 70.9% resulting in live births, which is typical. Additionally, no birth defects were reported in over 20 pregnancies where ofatumumab was used. Studies in monkeys also did not show an increased risk of birth defects. This evidence suggests that the treatment does not significantly increase the risk of negative pregnancy outcomes.12345
Why are researchers excited about this trial?
Researchers are excited about Kesimpta (Ofatumumab) for treating multiple sclerosis (MS) because it offers a unique approach compared to existing options. Most MS treatments focus on modulating the immune system broadly, but Kesimpta targets a specific type of immune cell called B cells, thanks to its action as a monoclonal antibody. This targeted approach can lead to fewer side effects while maintaining effectiveness. Additionally, Kesimpta is administered via a convenient once-monthly injection, which can be done at home, offering more flexibility and ease for patients compared to some other therapies that require more frequent dosing or clinic visits.
What evidence suggests that this trial's treatments could be effective for MS?
Research has shown that ofatumumab (Kesimpta) effectively treats multiple sclerosis (MS). In studies, over 80% of patients taking ofatumumab did not experience worsening disability over six months. The treatment also significantly reduced disease activity, with about 70% of patients showing no signs of disease activity after one year, resulting in fewer relapses and slower disease progression. Ofatumumab has proven more effective than some other MS treatments, such as teriflunomide, in reducing symptoms. Overall, these findings suggest that ofatumumab is a strong option for managing relapsing forms of MS.
In this trial, one group of participants will include women and infants exposed to Kesimpta during pregnancy to treat MS. Comparison groups will consist of women with MS who have not used Kesimpta during pregnancy and healthy women without MS or autoimmune diseases.678910Who Is on the Research Team?
Novartis Pharmaceuticals
Principal Investigator
Novartis Pharmaceuticals
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Enrollment and Data Collection
Pregnant women and their infants are enrolled and data is collected on pregnancy and infant outcomes
Follow-up
Participants are monitored for safety and effectiveness after data collection
What Are the Treatments Tested in This Trial?
Interventions
- Ofatumumab
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
women and infants who are exposed to Kesimpta during pregnancy to treat MS.
healthy women who are not diagnosed with MS or any other autoimmune disease, have not had exposure to a known human teratogen, and have not taken Kesimpta in pregnancy (healthy comparison group). Since the DMSKW register is an MS population specific register that does not collect data on non-MS population, this cohort is only applicable in the Kesimpta-OTIS sub-study.
comparison group consisting of women diagnosed with MS who have not used Kesimpta during pregnancy (unexposed disease-matched comparison group).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novartis Pharmaceuticals
Lead Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD
Citations
Five-Year Safety and Efficacy Outcomes with Ofatumumab ...
With ofatumumab treatment up to 5 years, > 80% of patients remained free of 6-month confirmed disability worsening (6mCDW). Annualised relapse ...
New Novartis data further support benefits of Kesimpta® in ...
ARTIOS Phase IIIb, open-label, single-arm, prospective study showed a substantial reduction in disease activity in people with relapsing ...
Real-world effectiveness and safety of ofatumumab in ...
Additionally, in our cohort, 79.8 % of patients achieved NEDA-3 at 6 months post- OFA initiation, 69.5 % at 12 months. These findings are ...
Five-Year Safety and Efficacy Outcomes with Ofatumumab ...
Ofatumumab demonstrated superior efficacy and similar safety versus teriflunomide in ASCLEPIOS I/II in people with relapsing multiple sclerosis.
5.
practicalneurology.com
practicalneurology.com/news/kesimpta-shows-sustained-long-term-efficacy-and-safety-in-relapsing-multiple-sclerosis/2483559/Kesimpta Shows Sustained Long-Term Efficacy and Safety in ...
Across both studies, Kesimpta demonstrated high rates of no evidence of disease activity (NEDA-3), sustained suppression of MRI activity, and ...
Kesimpta Pregnancy and Infant Safety Study Using Real ...
The main research question is to determine whether the exposure during pregnancy to Kesimpta increases the risk of adverse pregnancy and infant outcomes in ...
Pregnancy Outcomes in Patients With MS Following ...
As per ofatumumab's label, women of childbearing potential should use effective contraception during treatment and for at least 6 months after discontinuation ...
8.
neurologylive.com
neurologylive.com/view/pregnancy-outcomes-ofatumumab-treated-women-appear-consistent-general-population-ratesPregnancy Outcomes in Ofatumumab-Treated Women ...
Ofatumumab exposure during pregnancy showed outcomes consistent with general population rates, with 70.9% live births and 12.6% each for induced ...
Ofatumumab (Kesimpta®, Arzerra®) - MotherToBaby - NCBI
No birth defects were reported in over 20 pregnancies exposed to ofatumumab. Animal studies done in monkeys have not reported an increased chance of birth ...
10.
clinicaltrials.gov
clinicaltrials.gov/study/NCT06156683?term=AREA%5BBasicSearch%5D(multiple%20sclerosis)%20AND%20AREA%5BLastUpdatePostDate%5D%20RANGE%5B2020-10-29,MAX%5D&rank=10Kesimpta Pregnancy and Infant Safety Study Using Real ...
The main research question is to determine whether the exposure during pregnancy to Kesimpta increases the risk of adverse pregnancy and infant outcomes in ...
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