Preconceptional Counselling in Active Rheumatoid Arthritis (PreCARA)
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| First Received Date ICMJE | April 13, 2011 | ||||||||
| Last Updated Date | November 3, 2011 | ||||||||
| Start Date ICMJE | August 2011 | ||||||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01345071 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Preconceptional Counselling in Active Rheumatoid Arthritis | ||||||||
| Official Title ICMJE | 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. | ||||||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: blood of mother before, during and after pregnancy cordblood of newborn blood of newborn |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Women with high disease activity of RA and a pregnancy wish. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 40 | ||||||||
| Completion Date | Not Provided | ||||||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years to 45 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Netherlands | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01345071 | ||||||||
| Other Study ID Numbers ICMJE | ErasmusMC-MEC-2011-032 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | J.M.W. Hazes, Erasmus Medical Center | ||||||||
| Study Sponsor ICMJE | Erasmus Medical Center | ||||||||
| Collaborators ICMJE | Dutch Association of Rheumatology NVR | ||||||||
| Investigators ICMJE |
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| Information Provided By | Erasmus Medical Center | ||||||||
| Verification Date | November 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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