Clinical trial NCT06968975: Real-world Study of Treatment Outcomes in Chronic Inflammatory Demyelinating Polyneuropathy/Polyradiculoneuropathy (CIDP)
Official title: Observational, Real-world, Digital Biomarker, and Integrated Treatment Outcomes in Chronic Inflammatory Demyelinating Polyneuropathy/Polyradiculoneuropathy (CIDP)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Polyneuropathy, Inflammatory Demyelinating, Chronic
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2025-05-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants living with CIDP with residual disability

Brief 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 criteria: 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.

Primary outcomes:
measure: I-RODS score at baseline
timeFrame: Baseline
measure: Variations of I-RODS score over the study duration
timeFrame: From Baseline up to End of Study (2 years)
measure: Variations of I-RODS score after treatment change
timeFrame: From baseline up to End of Study (approx. 2 years)
measure: Annualized I-RODS response rate
timeFrame: Up to End of Study (approx. 2 years)
measure: Annualized I-RODS relapse rate
timeFrame: Up to End of Study (approx. 2 years)
Secondary outcomes:
measure: Adjusted INCAT (aINCAT) score at baseline and its variations over the study duration and after treatment change
timeFrame: Baseline and throughout the study (up to 2 years)
measure: Annualized aINCAT response rate
timeFrame: Up to End of Study (approx. 2 years)
measure: Annualized aINCAT relapse rate
timeFrame: Up to End of Study (approx. 2 years)
measure: Interobserver variability of remote INCAT assessment
timeFrame: Up to End of Study (approx. 2 years)
measure: Incidence of select comorbidities at baseline and over the study duration
timeFrame: From Baseline up to End of Study (approx. 2 years)
measure: Frequency of select comorbidities at baseline and over the study duration
timeFrame: From Baseline up to End of Study (approx. 2 years)
measure: Laboratory measurements at baseline and over study duration
timeFrame: From Baseline up to End of Study (approx. 2 years)
measure: CAP-PRI score at baseline and its variations over the study duration and after treatment change
timeFrame: From Baseline to End of Study (approx 2 years)
Other outcomes:
Locations:
Study officials:
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