Tokyo, July 18 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062267) titled 'A Study of Infusion Treatment Intervals in Patients Receiving Maintenance Therapy for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)' on July 17.
Study Type:
Observational
Primary Sponsor:
Institute - CSL Behring K.K.
Condition:
Condition - Chronic inflammatory demyelinating polyneuropathy (CIDP)
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To characterize adherence to IVIG dosing intervals in maintenance therapy for CIDP in routine clinical practice.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. A confirmed diagnosis of CIDP was recorded during the calendar month including the first day of the IVIG induction therapy cycle or within the preceding 6 months.
2. A nerve conduction study was recorded during the calendar month including the first day of the IVIG induction therapy cycle or within the preceding 6 months.
3. The patient was aged 18 years or older on the first day of the IVIG induction therapy cycle.
Key exclusion criteria - Patients who had a confirmed diagnosis (excluding suspected diagnoses) of an autoimmune neuropathy requiring differential diagnosis from CIDP during the calendar month including the first day of the IVIG induction therapy cycle (inclusive) or within the preceding 6 months. For the purposes of this study, the following conditions are considered autoimmune neuropathies:
-Multifocal motor neuropathy(MMN)
-Guillain-Barre syndrome (GBS)
-Fisher syndrome
-Anti-myelin-associated glycoprotein (anti-MAG) neuropathy
-POEMS syndrome
-Paraneoplastic neurological syndrome and Lambert-Eaton myasthenic syndrome (LEMS}
Target Size - 1000
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 07 Month 07 Day
Anticipated trial start date - 2026 Year 07 Month 07 Day
Last follow-up date - 2026 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071238
Disclaimer: Curated by HT Syndication.