Information for Participants
The MAMA study is designed to find out whether it is better for women who are pregnant with inflammatory arthritis to stop or to continue taking biologic medications. There is good evidence that these medications are safe for the developing baby. Recent national guidance (British Society for Rheumatology, 2023) has stated that biologics may be continued throughout pregnancy if required to control active/severe disease. Therefore, most people who are taking biologic medications for arthritis will continue to take them in the first half of pregnancy.
We know that these medications may affect the way a baby's immune system responds to live vaccinations. Some women will choose to stop biologics in the last 3 months of their pregnancy, in order that their baby can have a full routine vaccination schedule. Some women, however, will continue to take biologics throughout their entire pregnancy, and their baby will have one or two of their vaccinations (known as the “live” vaccinations) delayed for 6 months.
Managing arthritis well in pregnancy is important because severe arthritis can lead to worse outcomes in pregnancy and biologics can help manage pain and inflammation levels. Stopping biologic medications may mean that arthritis is at risk of flaring, which would require treatment with steroids or other medications which can impact on the pregnancy.
It is not a straightforward decision when it comes to stopping or continuing biologic medications in the second half of pregnancy. We don't know the impact of stopping or continuing biologics on how well a person's arthritis is controlled in pregnancy or in the postnatal period (after the baby is born). The MAMA study is looking to answer this question.
How will we do this?
Women who take part in the MAMA Trial will be allocated at random to one of the following groups:
The continuing group. Women in this gorup will continue taking their biologic thoughout pregnancy.
OR
The stopping group. Women in this group will stop their biologics before the third trimester (28 weeks) of pregnancy, and restart no earlier that 2 weeks post-pregnancy.
Other than stopping or continuing your current biologic by 28 weeks gestation no other changes will be made to your arthritis treatment as a result of being in this study.
Both continuing and stopping using biologics beyond 28 weeks of pregnancy are routine practice in the UK.
Who can take part in the trial
Pregnant women less than 28 completed weeks of gestation prescribed a biologic for Autoimmune Inflammatory Arthritis and meet the eligibility criteria for the MAMA trial.
