NCT01345071

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2011

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 29, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

April 28, 2016

Status Verified

April 1, 2016

Enrollment Period

9.8 years

First QC Date

April 13, 2011

Last Update Submit

April 26, 2016

Conditions

Rheumatoid ArthritisPregnancy

Keywords

Rheumatoid ArthritisPregnancyAnti-TNFPreconceptional counsellingDisease activity

Outcome Measures

Primary Outcomes (1)

  • DAS28(3)CRP at all study points

    Every 3 months from baseline till 6 months after delivery

Secondary Outcomes (10)

  • Time to pregnancy

    At baseline and every 3 months till pregnant

  • Number of miscarriages

    After conception, every 3 months

  • Complications during pregnancy

    Every 3 months during pregnancy and first visit after delivery

  • Gestational age of child

    First visit after delivery

  • Birth weight of child

    First visit after delivery

  • +5 more secondary outcomes

Study Arms (1)

RA patients

RA patients with active disease or current use of anti-TNF. Treatment is according to treat to target principles.

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • \- none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ErasmusMC, University Medical Center Rotterdam, dept. of Rheumatology

Rotterdam, 3000CA, Netherlands

RECRUITING

Related Publications (4)

  • de Man YA, Dolhain RJ, Hazes JM. Disease activity or remission of rheumatoid arthritis before, during and following pregnancy. Curr Opin Rheumatol. 2014 May;26(3):329-33. doi: 10.1097/BOR.0000000000000045.

    PMID: 24614279BACKGROUND

  • de Man YA, Dolhain RJ, van de Geijn FE, Willemsen SP, Hazes JM. Disease activity of rheumatoid arthritis during pregnancy: results from a nationwide prospective study. Arthritis Rheum. 2008 Sep 15;59(9):1241-8. doi: 10.1002/art.24003.

    PMID: 18759316BACKGROUND

  • de Man YA, Hazes JM, van der Heide H, Willemsen SP, de Groot CJ, Steegers EA, Dolhain RJ. Association of higher rheumatoid arthritis disease activity during pregnancy with lower birth weight: results of a national prospective study. Arthritis Rheum. 2009 Nov;60(11):3196-206. doi: 10.1002/art.24914.

    PMID: 19877045BACKGROUND

  • Quaak CH, Kluivers ACM, Baart SJ, Smeele HTW, Neuman RI, Saleh L, Visser W, Danser AHJ, Dolhain RJEM. Tumor Necrosis Factor Inhibitor Use Increases Birthweight in Pregnant Women With Rheumatoid Arthritis Independently of the Soluble Fms-Like Tyrosine Kinase-1/Placental Growth Factor Ratio. J Am Heart Assoc. 2024 Apr 2;13(7):e032655. doi: 10.1161/JAHA.123.032655. Epub 2024 Mar 27.

    PMID: 38533985DERIVED

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.

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Radboud Dolhain, PhD MD

    Staff Rheumatologist

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marieke van Wier, PhD

CONTACT

+31 10 7032181m.vanwier@erasmusmc.nl

Radboud Dolhain, PhD MD

CONTACT

r.dolhain@erasmusmc.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of the Department

Study Record Dates

First Submitted

April 13, 2011

First Posted

April 29, 2011

Study Start

September 1, 2011

Primary Completion

June 1, 2021

Study Completion

May 1, 2025

Last Updated

April 28, 2016

Record last verified: 2016-04

Locations

NL(1)