Ignite Creation Date:
2024-05-06 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 2:18 PM
Study NCT ID:
NCT05136976
Status:
RECRUITING
Last Update Posted:
2023-10-16
First Post:
2021-11-16
Brief Title:
Rituximab Therapy in Anti-Myelin Associated Glycoprotein Patients With Characteristics of Good Responders
Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Organization:
Centre Hospitalier Universitaire de Saint Etienne
Study Overview
Official Title:
Rituximab Therapy in Anti-Myelin Associated Glycoprotein Patients With Characteristics of Good Responders
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
THERAMAG
Brief Summary:
Anti-MAG neuropathy is a progressively disabling orphan rare disorder due to a monoclonal immunoglobulin MIgM gammopathy displaying reactivity toward MAG a glycoprotein of the peripheral nervous system Its prevalence is around 1100000 and to date no treatment has proven efficacy in this disease including rituximab in 2 Randomized Controlled TrailsRCTs
Detailed Description:
However these trials have included unselected anti-MAG patients and methodological issues have been raised
In COFRAMAG study the largest cohort worldwide of anti-MAG patients predictors of clinical response to rituximab were identified through analysis of 92 treated patients shorter disease duration and anti-MAG titre above 10000 BTU Thus this study will focus on rituximab efficacy in a subset of patients with disease duration of less than 2 years and anti-MAG titre above 10000 Buhlmann Titer Units BTU The investigators selected Inflammatory Rasch-built Overall Disability Scale I-RODS as primary outcome measure because its responsiveness was proven higher than INCAT Overall Neuropathy Limitation Score ONLS scales to detect clinical meaningful changes in newly treated patients with inflammatory neuropathies
In COFRAMAG study the largest cohort worldwide of anti-MAG patients predictors of clinical response to rituximab were identified through analysis of 92 treated patients shorter disease duration and anti-MAG titre above 10000 BTU Thus this study will focus on rituximab efficacy in a subset of patients with disease duration of less than 2 years and anti-MAG titre above 10000 Buhlmann Titer Units BTU The investigators selected Inflammatory Rasch-built Overall Disability Scale I-RODS as primary outcome measure because its responsiveness was proven higher than INCAT Overall Neuropathy Limitation Score ONLS scales to detect clinical meaningful changes in newly treated patients with inflammatory neuropathies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-000009-25 | EUDRACT_NUMBER | None | None |