Real-world Study of Treatment Outcomes in Chronic Inflammatory Demyelinating Polyneuropathy/Polyradiculoneuropathy (CIDP)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSanofi
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Participants living with CIDP with residual disability
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
I-RODS score at baseline
The inflammatory Rasch-built overall disability scale (I-RODS) is a 24-item patient-reported questionnaire that captures disease impact on daily tasks with a score ranging from 0 (maximum disability) to 48 (no disability). It contains 24 items across an activity domain and a social participation domain. Each item is rated as "0": Not possible to perform; "1": possible, but with some difficulty, or "2" possible, without any difficulty.
Time frame
Baseline2
Variations of I-RODS score over the study duration
Difference in I-RODS between baseline and: 6 months after enrollment, 12 months after enrollment, end of study. The inflammatory Rasch-built overall disability scale (I-RODS) is a 24-item patient-reported questionnaire that captures disease impact on daily tasks with a score ranging from 0 (maximum disability) to 48 (no disability). It contains 24 items across an activity domain and a social participation domain. Each item is rated as "0": Not possible to perform; "1": possible, but with some difficulty, or "2" possible, without any difficulty.
Time frame
From Baseline up to End of Study (2 years)3
Variations of I-RODS score after treatment change
Difference in I-RODS tests between the most recent assessments prior to and subsequent to a change in treatment class. The inflammatory Rasch-built overall disability scale (I-RODS) is a 24-item patient-reported questionnaire that captures disease impact on daily tasks with a score ranging from 0 (maximum disability) to 48 (no disability). It contains 24 items across an activity domain and a social participation domain. Each item is rated as "0": Not possible to perform; "1": possible, but with some difficulty, or "2" possible, without any difficulty.
Time frame
From baseline up to End of Study (approx. 2 years)4
Annualized I-RODS response rate
Percent of patients who experienced inflammatory Rasch-built overall disability scale (I-RODS) response over a given time period, normalized to 365 days
Time frame
Up to End of Study (approx. 2 years)Secondary outcomes
1
Adjusted INCAT (aINCAT) score at baseline and its variations over the study duration and after treatment change
The adjusted score is identical to the inflammatory neuropathy cause and treatment (INCAT) disability score, except for the exclusion of changes in the upper-limb function from 0 (normal) to 1 (minor symptoms or signs in 1 or both arms, but not affecting any of the functions listed in the scale), or from 1 to 0.
Time frame
Baseline and throughout the study (up to 2 years)2
Annualized aINCAT response rate
Percent of participants who experienced inflammatory neuropathy cause and treatment (INCAT) response over a given time period, normalized to 365 days
Time frame
Up to End of Study (approx. 2 years)3
Annualized aINCAT relapse rate
Percent of pparticipantss who experienced inflammatory neuropathy cause and treatment (INCAT) relapse over a given time period, normalized to 365 days
Time frame
Up to End of Study (approx. 2 years)4
Interobserver variability of remote INCAT assessment
Intraclass correlation coefficient (ICC) will be used to evaluate interobserver variability. ICC value can range from 0 to 1. Values less than 0.5 are indicative of poor reliability, values between 0.5 and 0.75 indicate moderate reliability, values between 0.75 and 0.9 indicate good reliability, and values greater than 0.90 indicate excellent reliability.
Time frame
Up to End of Study (approx. 2 years) Source ClinicalTrials.gov