Preconceptional Counselling in Active Rheumatoid Arthritis (PreCARA)
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ClinicalTrials.gov Identifier: NCT01345071 |
Recruitment Status :
Recruiting
First Posted : April 29, 2011
Last Update Posted : April 28, 2016
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Condition or disease |
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Rheumatoid Arthritis Pregnancy |

Study Type : | Observational |
Estimated Enrollment : | 150 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | PreConceptional Counselling in Active Rheumatoid Arthritis |
Study Start Date : | September 2011 |
Estimated Primary Completion Date : | June 2021 |
Estimated Study Completion Date : | May 2025 |

Group/Cohort |
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RA patients
RA patients with active disease or current use of anti-TNF. Treatment is according to treat to target principles.
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- DAS28(3)CRP at all study points [ Time Frame: Every 3 months from baseline till 6 months after delivery ]
- Time to pregnancy [ Time Frame: At baseline and every 3 months till pregnant ]Patient is asked whether is she is pregnant. Pregnancy is defined as positive pregnancy test or ultrasound.
- Number of miscarriages [ Time Frame: After conception, every 3 months ]Patients normally report miscarriages spontaneously at the next visit after miscarriage or contact the research nurse themselves to report this. If not, and patient is not pregnant anymore, reason for ending of pregnancy will be asked.
- Complications during pregnancy [ Time Frame: Every 3 months during pregnancy and first visit after delivery ]Complications are: hypertensive disorders, pre-eclampsia, diabetes, mode of delivery, hospitalization
- Gestational age of child [ Time Frame: First visit after delivery ]
- Birth weight of child [ Time Frame: First visit after delivery ]
- Congenital malformations [ Time Frame: First visit after delivery ]
- Growth of child and tempo of growth during first year [ Time Frame: One year after birth ]
- Maternal serum levels of anti-TNF [ Time Frame: Every three months during pregnancy ]
- Levels of anti-TNF in cord blood [ Time Frame: Collected at birth ]
- Levels of anti-TNF in child [ Time Frame: Every six weeks after birth ]Only if anti-TNF in cord blood was above reference value, blood will be drawn from the newborn every six weeks, till anti-TNF-levels are below reference value
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
For first objective: Women with high disease activity of RA and a pregnancy wish.
For second objective: Women with a rheumatic disease that requires the use of anti-TNF before or during pregnancy
Inclusion criteria for first objective (150 subjects)
- Rheumatoid Arthritis according to 2010 ACR/EULAR criteria
- active pregnancy wish
- either DAS28(3)CRP > 3.2 or the current use of anti-TNF
Inclusion criteria for second objective (no limit on number of subjects needed, recruitment will end when 150 RA patients have been included)
- rheumatic disease that requires the use of anti-TNF before or during pregnancy
- active pregnancy wish
Exclusion criteria:
- none

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01345071
Contact: Marieke van Wier, PhD | +31 10 7032181 | m.vanwier@erasmusmc.nl | |
Contact: Radboud Dolhain, PhD MD | r.dolhain@erasmusmc.nl |
Netherlands | |
ErasmusMC, University Medical Center Rotterdam, dept. of Rheumatology | Recruiting |
Rotterdam, Netherlands, 3000CA | |
Contact: Marieke van Wier, PhD +31 10 7032181 m.vanwier@erasmusmc.nl | |
Principal Investigator: Radboud J. EM Dolhain, PhD |
Principal Investigator: | Radboud Dolhain, PhD MD | Staff Rheumatologist |
Responsible Party: | J.M.W. Hazes, Head of the Department, Erasmus Medical Center |
ClinicalTrials.gov Identifier: | NCT01345071 |
Other Study ID Numbers: |
ErasmusMC-MEC-2011-032 |
First Posted: | April 29, 2011 Key Record Dates |
Last Update Posted: | April 28, 2016 |
Last Verified: | April 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | This will be discussed in the research group |
Rheumatoid Arthritis Pregnancy Anti-TNF Preconceptional counselling Disease activity |
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |