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Preconceptional Counselling in Active Rheumatoid Arthritis (PreCARA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Erasmus Medical Center
Sponsor:
Collaborators:
Erasmus Medical Center
Dutch Arthritis Association
Information provided by (Responsible Party):
J.M.W. Hazes, Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT01345071
First received: April 13, 2011
Last updated: April 26, 2016
Last verified: April 2016
  Purpose
The first objective of the study is to evaluate a treat to target treatment strategy in women with moderate to high disease activity of RA and a pregnancy wish, from pre-pregnancy. The treatment strategy is based on deliberate treatment decisions to lower disease activity, including the continuation or start of biological treatment (in particular anti-Tumor Necrosis Factor [anti-TNF]), based on a standard care protocol in the Erasmus MC. The second objective is to evaluate the safety of the use of anti-TNF during pregnancy among women with a rheumatic disease that require the use of anti-TNF before or during pregnancy.

Condition
Rheumatoid Arthritis
Pregnancy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: PreConceptional Counselling in Active Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Erasmus Medical Center:

Primary Outcome Measures:
  • DAS28(3)CRP at all study points [ Time Frame: Every 3 months from baseline till 6 months after delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to pregnancy [ Time Frame: At baseline and every 3 months till pregnant ] [ Designated as safety issue: Yes ]
    Patient is asked whether is she is pregnant. Pregnancy is defined as positive pregnancy test or ultrasound.

  • Number of miscarriages [ Time Frame: After conception, every 3 months ] [ Designated as safety issue: Yes ]
    Patients normally report miscarriages spontaneously at the next visit after miscarriage or contact the research nurse themselves to report this. If not, and patient is not pregnant anymore, reason for ending of pregnancy will be asked.

  • Complications during pregnancy [ Time Frame: Every 3 months during pregnancy and first visit after delivery ] [ Designated as safety issue: Yes ]
    Complications are: hypertensive disorders, pre-eclampsia, diabetes, mode of delivery, hospitalization

  • Gestational age of child [ Time Frame: First visit after delivery ] [ Designated as safety issue: Yes ]
  • Birth weight of child [ Time Frame: First visit after delivery ] [ Designated as safety issue: Yes ]
  • Congenital malformations [ Time Frame: First visit after delivery ] [ Designated as safety issue: Yes ]
  • Growth of child and tempo of growth during first year [ Time Frame: One year after birth ] [ Designated as safety issue: Yes ]
  • Maternal serum levels of anti-TNF [ Time Frame: Every three months during pregnancy ] [ Designated as safety issue: Yes ]
  • Levels of anti-TNF in cord blood [ Time Frame: Collected at birth ] [ Designated as safety issue: Yes ]
  • Levels of anti-TNF in child [ Time Frame: Every six weeks after birth ] [ Designated as safety issue: Yes ]
    Only if anti-TNF in cord blood was above reference value, blood will be drawn from the newborn every six weeks, till anti-TNF-levels are below reference value


Biospecimen Retention:   Samples With DNA
Blood of mother before, during and after pregnancy; cordblood of newborn; blood of newborn if anti-TNF in cord blood was above reference level.

Estimated Enrollment: 150
Study Start Date: September 2011
Estimated Study Completion Date: May 2025
Estimated Primary Completion Date: June 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts
RA patients
RA patients with active disease or current use of anti-TNF. Treatment is according to treat to target principles.

  Show Detailed Description

  Eligibility

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

For first objective: Women with high disease activity of RA and a pregnancy wish.

For second objective: Women with a rheumatic disease that requires the use of anti-TNF before or during pregnancy

Criteria

Inclusion criteria for first objective (150 subjects)

  • Rheumatoid Arthritis according to 2010 ACR/EULAR criteria
  • active pregnancy wish
  • either DAS28(3)CRP > 3.2 or the current use of anti-TNF

Inclusion criteria for second objective (no limit on number of subjects needed, recruitment will end when 150 RA patients have been included)

  • rheumatic disease that requires the use of anti-TNF before or during pregnancy
  • active pregnancy wish

Exclusion criteria:

- none

  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: Marieke van Wier, PhD +31 10 7032181 m.vanwier@erasmusmc.nl
Contact: Radboud Dolhain, PhD MD r.dolhain@erasmusmc.nl

Locations
Netherlands
ErasmusMC, University Medical Center Rotterdam, dept. of Rheumatology Recruiting
Rotterdam, Netherlands, 3000CA
Contact: Marieke van Wier, PhD    +31 10 7032181    m.vanwier@erasmusmc.nl   
Principal Investigator: Radboud J. EM Dolhain, PhD         
Sponsors and Collaborators
J.M.W. Hazes
Erasmus Medical Center
Dutch Arthritis Association
Investigators
Principal Investigator: Radboud Dolhain, PhD MD Staff Rheumatologist
  More Information

Additional Information:
Publications:
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: April 26, 2016
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: Ministry of Health, Welfare and Sport
Individual Participant Data  
Plan to Share IPD: Undecided
Plan Description: This will be discussed in the research group

Keywords provided by Erasmus Medical Center:
Rheumatoid Arthritis
Pregnancy
Anti-TNF
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 September 28, 2016