Observational, Real-world, Digital Biomarker, and Integrated Treatment Outcomes in Chronic Inflammatory Demyelinating Polyneuropathy/Polyradiculoneuropathy (CIDP)

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

This study is an observational, ambispective, descriptive, non-interventional study of people with a chronic inflammatory demyelinating polyneuropathy/polyradiculoneuropathy (CIDP) diagnosis in the United States with residual impairment, disability, or neurological deficits after at least three months of treatment with standard of care therapy. The study is expected to last two years. Enrollment is expected to continue for one year. Depending on when the participant is enrolled, a participant can be followed for between one and two years, through the end of study, approximately two years after the study starts.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

∙ Participants are eligible to be included in the study only if all of the following criteria apply:

• Neurologist-confirmed diagnosis of CIDP found in the medical record, with the last neurologist visit prior to enrollment containing no information that suggests this diagnosis was reversed

• Active use of at least one of the following CIDP treatments for three months or longer, with no evidence of discontinuation of this therapy as of the last neurologist visit prior to enrollment

‣ immunoglobulin

⁃ corticosteroids, with the exception of prednisone (or equivalent) monotherapy at 10mg or less per day

⁃ plasma exchange

⁃ efgartigimod alfa

⁃ azathioprine

⁃ mycophenolate mofetil

⁃ cyclosporine

⁃ rituximab

⁃ methotrexate

• Signed informed consent

• Residual impairment, disability, or neurological deficits at enrollment, as defined by a raw I-RODS score of 44 or below

Locations
United States
Pennsylvania
Investigational Site
RECRUITING
Swiftwater
Contact Information
Primary
Trial Transparency email recommended (Toll free for US & Canada)
contact-us@sanofi.com
800-633-1610
Backup
PicnicHealth For potential study participants
orbit-cidp-study@picnichealth.com
(415) 801-0572
Time Frame
Start Date: 2025-04-11
Estimated Completion Date: 2027-05-17
Participants
Target number of participants: 200
Sponsors
Leads: Sanofi

This content was sourced from clinicaltrials.gov