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
  Purpose

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.


Condition
Rheumatoid Arthritis
Pregnancy
TNFalfa Inhibitors
Preconceptional Counselling
Disease Activity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Erasmus Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples With DNA

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


Estimated Enrollment: 40
Study Start Date: August 2011
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01345071

Contacts
Contact: Y A de Man, PhD MD y.a.deman@erasmusmc.nl
Contact: J MW Hazes, Prof PhD MD j.hazes@erasmusmc.nl

Locations
Netherlands
ErasmusMC, University Medical Center Rotterdam, dept. of Rheumatology Recruiting
Rotterdam, Netherlands, 3000CA
Contact       precara@erasmusmc.nl   
Sub-Investigator: Y. A. de Man, PhD, M.D.         
Principal Investigator: Johanna MW Hazes, Prof. dr.         
Sponsors and Collaborators
Erasmus Medical Center
Dutch Association of Rheumatology NVR
Investigators
Principal Investigator: Johanna MW Hazes, Prof. dr. Head of department
  More Information

No publications provided

Responsible Party: J.M.W. Hazes, Head of the Department, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT01345071     History of Changes
Other Study ID Numbers: ErasmusMC-MEC-2011-032
Study First Received: April 13, 2011
Last Updated: November 3, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: Ministry of Health, Welfare and Sport

Keywords provided by Erasmus Medical Center:
Rheumatoid Arthritis
Pregnancy
TNFalfa inhibitors
Preconceptional counselling
Disease activity

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 23, 2014