Pregnant women with rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA), or axial spondyloarthritis (axSpA) Pregnancy and Childbirth
Conditions
Interventions
This trial will compare two existing pathways of care for bDMARD use in pregnancy that are already being used in the UK, albeit with wide variation. MAMA is a pragmatic, comparative effectiveness tria
Sponsors
University of Oxford
Eligibility
Sex/Gender
Female
Age
16 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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 immunological follow-up _____ Previous inclusion criteria: 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. This includes all current bDMARDs in the following classes and any future bDMARD licensed under these same classes: 3.1. Biologic drugs which block Tumour necrosis factor (TNF) 3.2. Biologic drugs which block CD80/86 3.3. Biologic drugs which block Interleukin 6 3.4. Biologics which block interleukin 1 3.5. Biologics which block interleukin 17 3.6. Biologics which block interleukin 23 3.7. Biologics which block interleukin 12/23 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 immunological follow-up
Exclusion criteria
Exclusion criteria: 1. Prescribed rituximab either during pregnancy or in the 6 months prior to conception 2. 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 members 5. 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak disease activity measured by the highest RAPID3 total score [self-report] from randomisation up to 6 months after the end of pregnancy | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at variable time points up to 24 months after the end of pregnancy: 1. Peak disease activity measured by the highest RAPID3 total score [self-report] 2. Peak pain level measured by the highest RAPID3 pain score [self-report] 3. Peak overall wellbeing measured by the highest RAPID3 patient global estimate score [self-report] 4. Any occurrence of arthritis flare [self-report] 5. Need for escalation of therapy due to inflammatory disease activity [self-report], defined as: • New or increased dose of any DMARD for arthritis; • New or increased dose of systemic glucocorticoid (GC) for arthritis (oral or intramuscular injection); • Received intra-articular GC joint injection 6. Any use of NSAIDs and frequency of use for treatment of joint pain [self-report] (described only using summary statistics) 7. Any occurrence of arthritis flare [maternal self-report] (described only using summary statistics) 8. Health-related quality of life measured using the EQ-5D-5L 9. Anxiety and depression measured using the EQ-5D-5L 10. Livebirth 11. Stillbirth (fetal loss greater than or equal to 24 weeks’ gestation)(described using summary statistics) 12. Pregnancy loss less than 24 weeks’ gestation (described using summary statistics) 13. Termination of pregnancy (with or without known congenital anomaly) 14. Mode of birth (described only using summary statistics) 15. Preterm prelabour rupture of membranes (described only using summary statistics) 16. New diagnosis of pre-eclampsia (described only using summary statistics) 17. New diagnosis of gestational diabetes (described only using summary statistics) 18. Venous thromboembolism (described only using summary statistics) 19. Confirmed or suspected maternal infection (defined as positive culture from a usually sterile site and/or maternal treatment with antibiotics) (described only using summary statistics) 20. Gestational age (continuous) and preterm birth at: - 72 hours after birth): microbiologically-confirmed or clinical | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactShan Gray
Outcome results
None listed