Evaluating the effects of adalimumab in patients with Rasmussen Encephalitis
Observational Study on Patients With Rasmussen Encephalitis Treated With Adalimumab: Efficacy and Tolerance in the Short and Long Term
Assistance Publique Hopitaux De Marseille · NCT04003922
This study is testing if the medication adalimumab can help people with Rasmussen Encephalitis who haven't had success with other treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 2 Years and up |
| Sex | All |
| Sponsor | Assistance Publique Hopitaux De Marseille (other) |
| Drugs / interventions | adalimumab |
| Locations | 16 sites (Bordeaux and 15 other locations) |
| Trial ID | NCT04003922 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the long-term efficacy and safety of adalimumab, an immunomodulatory treatment, in patients diagnosed with Rasmussen Encephalitis. The study will document patient outcomes following adalimumab therapy after previous treatments, such as corticosteroids and immunoglobulins, have failed. By focusing on a rare and severe inflammatory brain disorder, the research seeks to provide valuable insights into the management of this condition and the potential role of adalimumab in treatment protocols.
Who should consider this trial
Good fit: Ideal candidates include patients over 2 years old with a confirmed diagnosis of Rasmussen Encephalitis who are compliant with adalimumab treatment.
Not a fit: Patients with a differential diagnosis or those not treated with adalimumab will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from Rasmussen Encephalitis.
How similar studies have performed: While there have been few studies on immunomodulatory treatments for Rasmussen Encephalitis, the use of adalimumab has shown promise in preliminary cases, though this specific approach remains relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Confirmed diagnosis of Rasmussen Encephalitis * Patient aged more than 2 years * Compliant treatment with adalimumab Exclusion Criteria: * Patient with a differential diagnosis * Patient suffering from Rassmussen Encephalitis but not treated with adalimumab * Patient who has not signed the informed consent
Where this trial is running
Bordeaux and 15 other locations
- 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, 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)
Study contacts
- Study coordinator: Anne Lépine
- Email: anne.lepine@ap-hm.fr
- Phone: 0491387267
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Rasmussen Encephalitis