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Infants of women exposed to ruxolitinib cream during pregnancy for Pregnancy (OPERA-1 Trial)

N/A
Recruiting
Research Sponsored by Incyte Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 12 months after birth
Awards & highlights

OPERA-1 Trial Summary

This observational (enrollment into the registry while the pregnancy is ongoing) study is being conducted to compare the frequency of major congenital malformation (MCM)s among infants of women exposed to ruxolitinib cream during pregnancy with infants of women not exposed to ruxolitinib cream during pregnancy.

Eligible Conditions
  • Pregnancy
  • Atopic Dermatitis

OPERA-1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 12 months after birth
This trial's timeline: 3 weeks for screening, Varies for treatment, and through 12 months after birth for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of major congenital malformation (MCM)s
Secondary outcome measures
APGAR Score
Abnormal development
Adverse pregnancy outcomes
+8 more

Side effects data

From 2020 Phase 3 trial • 631 Patients • NCT03745638
9%
Upper respiratory tract infection
6%
Nasopharyngitis
4%
Headache
1%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ruxolitinib 0.75% Cream BID
Vehicle Cream BID
Ruxolitinib 1.5% Cream BID

OPERA-1 Trial Design

2Treatment groups
Experimental Treatment
Group I: Infants of women not exposed to ruxolitinib cream during pregnancyExperimental Treatment1 Intervention
Group II: Infants of women exposed to ruxolitinib cream during pregnancyExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruxolitinib Cream
2018
Completed Phase 3
~640

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor
364 Previous Clinical Trials
54,207 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study to Compare Maternal, Fetal, and Infant Outcomes of Women With Mild to Moderate Atopic Dermatitis Exposed to Ruxolitinib Cream During Pregnancy With an Unexposed Control Population
2023. "Study to Compare Maternal, Fetal, and Infant Outcomes of Women With Mild to Moderate Atopic Dermatitis Exposed to Ruxolitinib Cream During Pregnancy With an Unexposed Control Population". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06259669.
All > High Point > Greensboro
~639 spots leftby Aug 2032
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