Preconceptional Counselling in Active Rheumatoid Arthritis (PreCARA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Erasmus Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Dutch Association of Rheumatology NVR
Information provided by (Responsible Party):
J.M.W. Hazes, Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT01345071
First received: April 13, 2011
Last updated: November 3, 2011
Last verified: November 2011

April 13, 2011
November 3, 2011
August 2011
September 2013   (final data collection date for primary outcome measure)
number of pregnancies [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Percentage of women that become pregnant during 2 year period of time, with accurate controlled disease activity of RA.
Same as current
Complete list of historical versions of study NCT01345071 on ClinicalTrials.gov Archive Site
health of newborn exposed to TNFalfa inhibitors [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Development (growth and health) of newborns exposed to TNFalfa in utero / early in pregnancy.
Same as current
Not Provided
Not Provided
 
Preconceptional Counselling in Active Rheumatoid Arthritis
Preconception Counselling for Women With a Pregnancy Wish and High Disease Activity of Rheumatoid Arthritis (RA) With a Prospective Observational Study Addressing Health Issues of Mother and Child.

Fertile women postpone their wish to conceive when they have active disease activity of rheumatoid arthritis (RA). Since treatment options are restricted and inappropriate in many women with high disease activity, an observational study among fertile women with a wish to conceive, treated with a regular care program, among which a consultation of gynecologist and a rheumatologist will be provided, in order to enlarge the chance of conceiving. Treatment options will be discussed with the patient, and when needed TNFalfa inhibitors will be prescribed until 20th week of gestation. Follow-up of disease activity of RA, complications of treatment, and pregnancy outcome of women are part of the observational study. As well as the observational study on the newborn on activity of TNFalfa inhibitors in (cord)blood, growth analysis and general health.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

blood of mother before, during and after pregnancy cordblood of newborn blood of newborn

Non-Probability Sample

Women with high disease activity of RA and a pregnancy wish.

  • Rheumatoid Arthritis
  • Pregnancy
  • TNFalfa Inhibitors
  • Preconceptional Counselling
  • Disease Activity
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
Not Provided
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adults (>18 years)
  • Rheumatoid Arthritis (according to 1987 criteria)
  • wish to conceive
  • moderate to high disease activity of RA (DAS28> 3.2)
  • good understanding of Dutch language(spoken and written)

Exclusion Criteria:

  • high risks of inborn errors
Female
18 Years to 45 Years
No
Contact: Y A de Man, PhD MD y.a.deman@erasmusmc.nl
Contact: J MW Hazes, Prof PhD MD j.hazes@erasmusmc.nl
Netherlands
 
NCT01345071
ErasmusMC-MEC-2011-032
No
J.M.W. Hazes, Erasmus Medical Center
Erasmus Medical Center
Dutch Association of Rheumatology NVR
Principal Investigator: Johanna MW Hazes, Prof. dr. Head of department
Erasmus Medical Center
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP