RECRUITING

Real-world Study of Treatment Outcomes in Chronic Inflammatory Demyelinating Polyneuropathy/Polyradiculoneuropathy (CIDP)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-04-11
Study Completion:2027-05-17
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06968975

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * 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
  3. * immunoglobulin
  4. * corticosteroids, with the exception of prednisone (or equivalent) monotherapy at 10mg or less per day
  5. * plasma exchange
  6. * efgartigimod alfa
  7. * azathioprine
  8. * mycophenolate mofetil
  9. * cyclosporine
  10. * rituximab
  11. * methotrexate
  12. * Signed informed consent
  13. * Residual impairment, disability, or neurological deficits at enrollment, as defined by a raw I-RODS score of 44 or below
  1. * Evidence of participation in any interventional clinical trial with an investigational drug at the time of enrollment
  2. * Hyperreflexia (increased reflexes) recorded in the medical record during a neurological exam the year before enrollment and after CIDP diagnosis
  3. * Aged under 18 at the time of enrollment

Contacts and Locations

Study Contact

Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
800-633-1610
contact-us@sanofi.com
PicnicHealth For potential study participants
CONTACT
(415) 801-0572
orbit-cidp-study@picnichealth.com

Study Locations (Sites)

Investigational Site
Swiftwater, Pennsylvania, 18370-0187
United States

Collaborators and Investigators

Sponsor: Sanofi

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-11
Study Completion Date2027-05-17

Study Record Updates

Study Start Date2025-04-11
Study Completion Date2027-05-17

Terms related to this study

Additional Relevant MeSH Terms

  • Polyneuropathy, Inflammatory Demyelinating, Chronic