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NCT00658827
Analysis of Birth Outcomes of Swedish, Danish and Finnish Women Exposed to Remicade With Inflammatory Bowel Disease, Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Psoriasis
trial testing No intervention in Inflammatory Bowel Disease in 370 participants. Completed in 30 September 2016.
30 September 2016
Quick facts
| Lead sponsor | Janssen Biotech, Inc. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 370 |
| Start date | 1 January 2007 |
| Primary completion | 30 September 2016 |
| Estimated completion | 30 September 2016 |
Drugs / interventions tested
- No intervention
Conditions studied
- Inflammatory Bowel Disease — all drugs for Inflammatory Bowel Disease →
Sponsor
Janssen Biotech, Inc. — full company profile →
Who can join
Eligibility, female only, with Inflammatory Bowel Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is collection and analysis of information pertaining to pregnancy outcomes in women exposed to infliximab during pregnancy, relative to the background risk in similar but non-biologic exposed patients; and information pertaining to health status, during the first year following delivery, of infants born to women following prenatal exposure to infliximab and their unexposed counterparts.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00658827
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Inflammatory Bowel Disease
Currently open trials in the same condition.
- NCT07210580 — Testing the Impact of Measurement-Based Care on Quality of Life and Disease Management Among Veterans With Inflammatory · NA · recruiting
- NCT07242248 — A Study to Observe Real-world Evidence of Guselkumab Treatment in Participants With Ulcerative Colitis and Crohn's Disea · recruiting
- NCT07102368 — A Study to Generate Real-world Evidence of Guselkumab Effectiveness in Inflammatory Bowel Disease in Germany · recruiting
- NCT07252427 — Gut Microbiota in IBD With Comorbid Depressive Disorder · recruiting
- NCT06781827 — Research on the Use of Probiotics in the Prevention and Treatment of Inflammatory Bowel Disease · NA · recruiting
Other Janssen Biotech, Inc. trials
Trials by the same sponsor.
- NCT02808780 — An Observational Prospective Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis · active not recruiting
- NCT01314118 — IMAAGEN: Impact of Abiraterone Acetate in Prostate-Specific Antigen · Phase 2 · completed
- NCT01081730 — Ustekinumab Safety and Surveillance Program Using the Ingenix NHI Database · completed
- NCT01081717 — Golimumab Safety and Surveillance Program Using the Ingenix NHI Database · completed
- NCT00606346 — A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00658827 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Janssen Biotech, Inc.
- Last refreshed: 3 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00658827.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing