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
Dutch Association of Rheumatology NVR
Information provided by (Responsible Party):
J.M.W. Hazes, Erasmus Medical Center Identifier:
First received: April 13, 2011
Last updated: November 3, 2011
Last verified: November 2011
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.

Rheumatoid Arthritis
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)

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.

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 identifier: NCT01345071

Contact: Y A de Man, PhD MD
Contact: J MW Hazes, Prof PhD MD

ErasmusMC, University Medical Center Rotterdam, dept. of Rheumatology Recruiting
Rotterdam, Netherlands, 3000CA
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
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 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
TNFalfa inhibitors
Preconceptional counselling
Disease activity

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on February 08, 2016