The MAMA Trial
Research type
Research Study
Full title
The Monoclonal Antibody Medications in inflammatory Arthritis: stopping or continuing in pregnancy (MAMA) trial
IRAS ID
1009876
Contact name
Marian Knight
Contact email
Sponsor organisation
University of Oxford
ISRCTN Number
ISRCTN89126536
Research summary
1-2% of women are affected by inflammatory arthritis. Many are treated with medications known as ‘biologics’. More women with inflammatory arthritis are considering starting a family, because biologics mean they are more able to manage their arthritis. They may face difficult decisions around treatments during pregnancy. Uncontrolled arthritis can lead to worse outcomes in pregnancy, so managing arthritis well is important. Biologics are often avoided during pregnancy because of limited understanding of how these drugs impact pregnancy or arthritis activity. There are concerns about possible effects of these drugs on babies’ immune systems, and some baby vaccinations are routinely delayed. Until recently, most women were advised to stop their biologics during pregnancy; however, due to mounting evidence of their safety, national guidance now states that women can stay on biologics throughout pregnancy. It is unknown whether there is any benefit to this in terms of arthritis control. Certain other medicines used to treat arthritis flares in pregnancy, can pose potential harm. MAMA aims to find out the effects of stopping or continuing biologics during pregnancy. It will compare whether women who continue their biologics have better arthritis control compared to those who stop, and assess the impact on their pregnancy, their baby, and the costs associated with this decision. MAMA will recruit 328 women who will have an equal (random) chance to continue their biologics throughout pregnancy, or to stop by the 28 weeks of pregnancy. During pregnancy women will be asked to complete a simple arthritis symptom severity questionnaire, monthly via an app (or in writing) and at 3, 6 and 12 months after the baby is born. The woman will be asked if they would be happy for their baby to have blood tests to check their immune response to vaccinations. Mums and babies will be followed up until 24 months after the end of pregnancy, their general health and their baby's development.
REC name
London - Central Research Ethics Committee
REC reference
24/LO/0678
Date of REC Opinion
30 Sep 2024
REC opinion
Further Information Favourable Opinion