The MAMA trial launches!
Published on Monday, 03 February 2025
1–2% of women are affected by inflammatory arthritis such as rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis or juvenile idiopathic arthritis. Many are treated with new medications known as 'biologics'. More women with inflammatory arthritis are considering starting a family, because treatment with biologics means they are more able to manage their arthritis. They may need to make difficult decisions around treatments during pregnancy.
Uncontrolled arthritis can lead to worse outcomes in pregnancy, so managing arthritis well is very important. Biologics are often avoided during pregnancy because of limited understanding of how these drugs impact pregnancy or arthritis activity during this time. There are concerns about possible effects of these drugs on infants' immune systems, and some infant vaccinations are routinely delayed. Until recently, most women were advised that they should stop their biologic drugs during pregnancy and avoid these drugs in the second and third trimester; however, due to mounting evidence of their safety for women and babies during pregnancy, the 2022 national guidance now states that women can stay on biologics throughout pregnancy. It is currently unknown whether there is any benefit to this strategy in terms of arthritis disease control.
The Monoclonal Antibody Medications in inflammatory Arthritis (MAMA) trial aims to find out the effects of stopping or continuing biologics during pregnancy. It will compare whether women who continue their biologics throughout pregnancy have better arthritis control compared to those who stop, and assess the impact on their pregnancy, their infant, and the costs associated with this decision.
MAMA will recruit 328 women who will have an equal (random) chance to continue their biologic throughout pregnancy, or to stop before the third trimester (28 weeks) of pregnancy, and restart no earlier than 2 weeks post-pregnancy.[SG1]. During pregnancy women will be asked to complete a simple arthritis symptom severity questionnaire monthly via an app (or in written format). After the baby is born, the woman will be asked to report her symptoms via questionnaires at 3, 6 and 12 months, we will also ask some questions about the woman and her child's health and quality of life. Women and infants will be followed up for up to 24 months after the end of pregnancy, to assess general health and their infant's development.
Women will be recruited across 35 obstetric units in the UK. It is planned that recruitment will continue over a 4 year period, with the trial expecting to be completed in February 2030. We are currently looking for additional recruitment sites to join us in this critical research effort. If you are interested in becoming a part of the MAMA trial, please reach out for more information.
For further details please see our Introduction to the MAMA Information video or visit MAMA | NPEU