DRKS00005036CompletedNot Applicable
The safety of anti-tumor necrosis factor-alpha (TNF-a) agents in pregnancy. An observational prospective multicenter study. - TNF-a Blocker in Pregnancy
Pharmakoivigilanz- und Beratungszentrum für Embryonaltoxikologie, Charité Berlin0 sites625 target enrollmentStarted: May 31, 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 625
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- one to one (—)
- Sex
- All
Inclusion Criteria
- •Part 1: Prospectively ascertained pregnancies with first trimester exposure to adalimumab, certolizumab pegol, etanercept, golimumab or infliximab. Maternal therapy might have started earlier and can last longer. Comparison group: prospectively ascertained pregnancies without exposure to adalimumab, certolizumab pegol, etanercept, golimumab or infliximab (or other biologics).
- •Part 2: Prospective ascertainment of long-term follow-up of children being at least 1-year-old or older. They must have been exposed in utero to at least one maternal injection of the named TNF-alpha blockers. Comparison children: Prospective ascertainment of long-term follow-up of children being at least 1-year-old or older matched for sex, gestational week at birth, birth weight and year of birth. No TNF-alpha blockers (or other biologics) during pregnancy.
Exclusion Criteria
- •Excluded from all cohorts are pregnancies with: major teratogens (acitretin, isotretinoin, mycophenolate, thalidomide, valproiic acid) or/and major fetotoxic agents (ACE-inhibitors or sartans when used in 2nd and/or 3rd trimester) or/and acute malignancies. For study part 2: Excluded are children with malformations having an impact on normal development and preterms born before week 34 0/7.
Investigators
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