NCT04003922

Brief Summary

Since the initial study of cases reported between 2009 and 2015, adalimumab has become in France the immunomodulatory reference treatment used after failure of corticosteroids and immunoglobulins before a possible recourse to the hemispherotomy. This observational study is intended to document the long-term efficacy and safety of Adalimumab therapy in patients with Rasmussen encephalitis.

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
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2020

Longer than P75 for all trials

Geographic Reach
1 country

16 active sites

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

June 20, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 1, 2019

Completed
10 months until next milestone

Study Start

First participant enrolled

April 21, 2020

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

January 8, 2024

Status Verified

January 1, 2024

Enrollment Period

3.9 years

First QC Date

June 20, 2019

Last Update Submit

January 5, 2024

Conditions

Rasmussen Encephalitis

Outcome Measures

Primary Outcomes (2)

  • Efficiency of the treatment measured by the reduction of the number of epileptic seizures

    The change of epileptic seizures (Will be considered as a responder patient any patient with a 50% decrease in the number of seizures between the time of inclusion and 6 months after the start of treatment). This response to treatment is re-evaluated at 12 months then every 6 months for 5 years.

    5 years

  • Efficiency of the treatment measured by the stability if the cognitive assessment

    Stability of the cognitive assessment: variation of less than 10 points on each of the different composite indices (QIT, ICV, IRF, IMT, IVT) of age-appropriate Weschler scales, between two cognitive assessments of 6 months.

    6 months

Interventions

Adalimumab treatmentOTHER

Retrospective observational study initially and then prospective with inclusion of all the patients carrying an ER treated by Adalimumab in France. Follow-up will continue for one year if adalimumab is discontinued.

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The implementation of a treatment with adalimumab in a patient with an ER requires the performance of a CPR within a reference center Epilepsies Rares if one complies with the rules of good clinical practice. Thus, all ER patients treated with adalimumab are referenced in a referral center. There are 7 reference centers in France, they are all partners of the study.

You may qualify if:

  • Confirmed diagnosis of Rasmussen Encephalitis
  • Patient aged more than 2 years
  • Compliant treatment with adalimumab

You may not qualify if:

  • Patient with a differential diagnosis
  • Patient suffering from Rassmussen Encephalitis but not treated with adalimumab
  • Patient who has not signed the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Chu de Bordeaux

Bordeaux, France

NOT YET RECRUITING

Chu Brest

Brest, France

NOT YET RECRUITING

Chru de Lille

Lille, France

NOT YET RECRUITING

Chu Limoges

Limoges, France

NOT YET RECRUITING

Hospices Civils de Lyon

Lyon, France

NOT YET RECRUITING

Service Neuropédiatrie

Marseille, 13005, France

RECRUITING

Chu Montpellier

Montpellier, France

NOT YET RECRUITING

Chu de Nancy

Nancy, France

NOT YET RECRUITING

Chu Necker Ap-Hp

Paris, France

NOT YET RECRUITING

Chu Pitie Salpietriere Ap-Hp

Paris, France

NOT YET RECRUITING

Chu Robert Debre

Paris, France

NOT YET RECRUITING

Fondation Adolphe de Rothshild

Paris, France

NOT YET RECRUITING

Chu de Rennes

Rennes, France

NOT YET RECRUITING

Chu Strasbourg

Strasbourg, France

NOT YET RECRUITING

Chu Toulouse

Toulouse, France

NOT YET RECRUITING

Chru de Tours

Tours, France

NOT YET RECRUITING

MeSH Terms

Conditions

Encephalitis

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeuroinflammatory Diseases

Study Officials

  • Jean-Olivier ARNAUD

    Assistance Publique- Hôpitaux de Marseille

    STUDY DIRECTOR

Central Study Contacts

Anne Lépine

CONTACT

0491387267anne.lepine@ap-hm.fr

DRS AP-HM

CONTACT

0491381499drci@ap-hm.fr

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2019

First Posted

July 1, 2019

Study Start

April 21, 2020

Primary Completion

April 1, 2024

Study Completion

October 1, 2025

Last Updated

January 8, 2024

Record last verified: 2024-01

Locations

FR(16)