Preconceptional Counselling in Active Rheumatoid Arthritis (PreCARA)
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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. |
- 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.
- 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 |
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| Contact: Y A de Man, PhD MD | y.a.deman@erasmusmc.nl | |
| Contact: J MW Hazes, Prof PhD MD | j.hazes@erasmusmc.nl |
| 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. | |
| 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 May 16, 2013