Status: Finalised First registered on: 24/04/2012
Last updated on: 14/02/2019
1. Study identification
EU PAS Register NumberEUPAS2566
Official titlePregnancy outcome after rheumatologic methotrexate (MTX) treatment prior to or during early pregnancy: a prospective multicenter cohort study.
Study title acronymRheumatologic MTX treatment and pregnancy outcome
Study typeObservational study
Brief description of the studyMethotrexate (MTX) is known as a teratogen that causes a specific embryopathy. This is based on several retrospective case reports (e.g. Seidahmed 2006, Yedlinski 2005, Adam 2003, Chapa 2003, Krähenmann 2002, Wheeler 2002, Bawle 1998, and Milunsky 1968.). MTX has been used as an abortifacient, in cancer therapy, and beginning in the 90th for rheumatoid arthritis and some autoimmune diseases. The dose of MTX varies depending on the treatment indication and is lower in rheumatic diseases. There is still uncertainty concerning the risk of low-dose methotrexate therapy during pregnancy. As there is only one small prospective study, which observed no major birth defects in 28 pregnancies (Lewden 2004), no precise risk evaluation can be made so far. Furthermore, it has been debated how long prior to conception MTX therapy should be stopped. Recently, a broad international panel of rheumatologists recommended stopping MTX at least 3 months before conception (Visser 2009). Study Target: To assess the risk of low-dose MTX exposure in early pregnancy. Primary Outcome:Rate of major birth defects, rate of specific MTX embryopathy (time frame up to approximately 8 weeks after birth), rate of spontaneous abortion, intrauterine growth retardation (IUGR) in malformed and non malformed newborns (criterion: birth weigth), rate of prematurity. There are three prospectively ascertained groups to be compared:1) Exposed group with maternal exposure of low-dose MTX for rheumatic/autoimmune diseases; 2) Control group 1 (“disease group”): Pregnant women with rheumatic /autoimmune diseases without MTX during pregnancy; 3) Non-exposed control group 2 (“general control”): No MTX, no rheumatic / autoimmune diseases.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsEmbryotox Berlin
Department/Research groupPharmakovigilanzzentrum Embryonaltoxikologie
Organisation/affiliationCharité-Universitätsmedizin
Website/Homepagewww.embryotox.de
Details of (Primary) lead investigator
Title Dr
Last name Weber-Schoendorfer
First name Corinna
Is this study being carried out with the collaboration of a research network?
Yes

ENTIS
OTIS
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
International study

Canada
Finland
France
Germany
Israel
Italy
Netherlands
Switzerland
United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed06/02/2012
Start date of data collection06/02/2012
Start date of data analysis09/08/2012
Date of interim report, if expected
Date of final study report31/12/201221/12/2012
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government bodyBundesministerium für Gesundheit80
Research councils
EU funding scheme
OtherSenatsverwaltung Berlin20
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Schaefer
First name Christof
Address line 1Pharmakovigilanzzentrum Embryonaltoxikologie
Address line 2 
Address line 3 
CityBerlin 
Postcode 
CountryGermany
Phone number (incl. country code)493030308119 
Alternative phone number 
Fax number (incl. country code) 
Email address christof.schaefer@charite.de
Public Enquiries
Title Dr 
Last name Weber-Schoendorfer 
First name Corinna 
Address line 1Pharmakovigilanzzentrum Embryonaltoxikologie 
Address line 2 
Address line 3 
CityBerlin 
Postcode 
CountryGermany 
Phone number (incl. country code)493030308115 
Alternative phone number 
Fax number (incl. country code) 
Email address corinna.weber-schoendorfer@charite.de 
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