We'd like your feedback
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Prof
Marian
Knight
marian.knight@npeu.ox.ac.uk
Mrs
Shan
Gray
mama@npeu.ox.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Pregnant women with rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA), or axial spondyloarthritis (axSpA)
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
1-2% of women are affected by inflammatory arthritis. Many are treated with bDMARD 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 the 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. We are inviting pregnant women with rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA) who are prescribed a regularly dosed biologic to join the MAMA. 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 than those who stop, and assess the impact on their pregnancy, their baby, and the costs associated with this decision.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
Current inclusion criteria as of 20/12/2024:
Pregnant women with Autoimmune Inflammatory Arthritis (AIA), satisfying the following criteria:
1. Have a diagnosis of rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA)
2. Pregnant at less than 28 completed weeks’ gestation
3. Prescribed a regularly dosed bDMARD (including biologic originators and biosimilars) for RA, JIA, PsA or axSpA.
4. Aged 16 years or over
5. Has provided informed consent
For Infant Immunology (optional element):
6. Address “within geographical reach” from the Oxford Vaccine Group
7. Ongoing consent from parents for infant
You may not be able to take part if:
1. Prescribed rituximab either during pregnancy or in the 6 months prior to conception2. Prescribed JAK inhibitors 3. Contraindication to cessation of bDMARDs (e.g. active, sight-threatening uveitis)4. Current, active tuberculosis in the immediate or close family or household members5. Plans to move in the first 6 months after birth with their infant to live in a country with a high rate of tuberculosis (incidence >40 per 100,000 population)
For Infant Inmmunology (optional element):6. Temporary exclusion criteria for taking immunology samples from the babies - fever in previous 72 hours (or felt to be systemically unwell)
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Mrs
Shan
Gray
mama@npeu.ox.ac.uk
Prof
Marian
Knight
marian.knight@npeu.ox.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by University of Oxford and funded by Health Technology Assessment Programme.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS: 65203
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
