NCT04761978

Brief Summary

The aim is to assess effectiveness (EASI, SCORAD, IGA, DLQI, pruritus, sleep loss) and safety (clinical and biological adverse events) of JAK inhibitors in adults with moderate-to-severe atopic dermatitis in a real-life French multicenter retrospective cohort

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 2021

Shorter than P25 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

February 15, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

May 28, 2021

Status Verified

May 1, 2021

Enrollment Period

1 year

First QC Date

February 15, 2021

Last Update Submit

May 27, 2021

Conditions

Dermatitis, Atopic

Keywords

EffectivenessSafetyJAK inhibitorsAtopic dermatitisAdults

Outcome Measures

Primary Outcomes (1)

  • reduction in Eczema Area and Severity Index (EASI)

    At 3 months

Secondary Outcomes (6)

  • SCORing Atopic Dermatitis (SCORAD)

    at baseline and at 3 months

  • Investigator's Global Assessment (IGA)

    at baseline and at 3 months

  • Dermatology Life Quality Index (DLQI)

    at baseline and at 3 months

  • patient-reported pruritus score from 0 to 10

    at baseline and at 3 months

  • patient-reported sleep loss from 0 to 10

    at baseline and at 3 months

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients assessed by French members of the Groupe de Recherche sur l'Eczema Atopique.

You may qualify if:

  • Adults
  • moderate to severe atopic dermatitis
  • treated by JAK inhibitors between december 2020 and september 2021
  • inefficiency, loss of efficiency or contra-indication of previous systemic agent, DUPILUMAB or phototherapy
  • ineligibility to French ongoing clinical trials

You may not qualify if:

  • Children
  • mild atopic dermatitis
  • eligibility to CICLOSPORINE, METHOTREXATE, DUPILUMAB, phototherapy
  • eligibility to French ongoing clinical trials
  • patients' opposition for the use of their records
  • follow up \<3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hop Claude Huriez Chu Lille

Lisle-sur-Tarn, 59037, France

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Delphine Staumont-Salle, MD,PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2021

First Posted

February 21, 2021

Study Start

September 1, 2021

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

May 28, 2021

Record last verified: 2021-05

Locations

FR(1)