Primary objective: To assess the efficacy of I10E in improving the disability of patients with CIDP. Secondary objective: To assess the safety of I10E in patients with CIDP.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Patients who meet all eligibility criteria will receive one dose of IMP at 2g/kg over 2-5 days followed by 7 doses of IMP at 1g/kg over 1-2 day(s), every 3 weeks. Duration of treatment period: 21 weeks +/- 7 days.
Efficacy Endpoint: Responder Rate at End of Study
Responders were defined as patients with a decrease ≥1 point in the adjusted INCAT disability score compared to baseline. Adjusted INCAT disability score can vary from 0 (normal) to 9 (maximal disability). If a patient was treated with a not-allowed treatment during the study period, then all adjusted INCAT disability score measured after the intake of these not-allowed treatments were censored. If the score at EoS visit was missing, then the Last Observation Carried Forward (LOCF) approach was applied to replace this missing value.
Time frame: 24 weeks after first treament injection
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux, France
Hôpital général du CHU de Dijon
Dijon, France
CHU de Nice - Hôpital l'Archet
Nice, France
CHU Paris - Hôpital Pitié salpétrière
Paris, France
Hôpital Pontchaillou
Rennes, France
CHU de saint Etienne - Hôpital nord
Saint-Etienne, France
Hôpital de Hautepierre
Strasbourg, France
IRRCS Azienda Ospedaliera Universitaria
Genova, Italy
IRCCS - Istituto Clinico Humanitas
Milan, Italy
IRRCS Istituto Nazionale Neurologico Besta
Milan, Italy
...and 23 more locations