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

Sanofi

Status: Not yet enrolling

Conditions: Polyneuropathy, Inflammatory Demyelinating, Chronic

Study type: Observational

Funder types: Industry

Identifiers

NCT06968975

OBS18653

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Participants are excluded from the study if any of the following criteria apply:

• Evidence of participation in any interventional clinical trial with an investigational drug at the time of enrollment
• Hyperreflexia (increased reflexes) recorded in the medical record during a neurological exam the year before enrollment and after CIDP diagnosis
• Aged under 18 at the time of enrollment

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.