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Preconceptional Counselling in Active Rheumatoid Arthritis

NCT01345071 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2016-04-28

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • Erasmus Medical Center

    collaborator OTHER

  • Dutch Arthritis Association

    collaborator INDUSTRY

  • J.M.W. Hazes

    lead OTHER

Principal Investigators

  • Radboud Dolhain, PhD MD · Staff Rheumatologist

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2021-06-30
Completion
2025-05-31

Countries

  • Netherlands

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01345071 on ClinicalTrials.gov