MAMA
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, national guidance (British Society for Rheumatology, 2022) has stated that biologics may be continued throughout pregnancy if required to control active/severe disease.
It is currently unknown whether there is any benefit to this strategy in terms of arthritis disease control. We also know that certain other medicines used to treat arthritis flares in pregnancy, such as steroids, can pose potential harm.
Trial Aim
This trial aims to fill the gap in evidence and enable evaluation of arthritis disease activity, pregnancy and infant outcomes in women randomly allocated to continuing their biologics medication throughout pregnancy, or to stopping their biologic medication prior to 28 completed weeks' gestation.
The MAMA trial will recruit 328 women in approximately 35 obstetric units with a maternal medicine service in the 16 Maternal Medicine Networks in England over a 4 year recruitment period.
About Us
MAMA is coordinated by the National Perinatal Epidemiology Unit Clinical Trial Unit (NPEU CTU) at the University of Oxford and is funded by the National Institute of National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) programme.