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.
Study Type
OBSERVATIONAL
Enrollment
200
Investigational Site
Swiftwater, Pennsylvania, United States
RECRUITINGI-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: Baseline
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)
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)
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)
Annualized I-RODS relapse rate
Percent of patients who experienced inflammatory Rasch-built overall disability scale (I-RODS) relapse over a given time period, normalized to 365 days
Time frame: Up to End of Study (approx. 2 years)
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)
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)
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)
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)
Incidence of select comorbidities at baseline and over the study duration
Number of participants with comorbidity events
Time frame: From Baseline up to End of Study (approx. 2 years)
Frequency of select comorbidities at baseline and over the study duration
Events per patient-year
Time frame: From Baseline up to End of Study (approx. 2 years)
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Laboratory measurements at baseline and over study duration
Complete Blood Count (CBC), serum lipid profile, liver function tests
Time frame: From Baseline up to End of Study (approx. 2 years)
CAP-PRI score at baseline and its variations over the study duration and after treatment change
The chronic acquired polyneuropathy- patient reported index \[CAP-PRI(8)\] is a participant reported outcome (PRO) that was developed to capture quality of life in people living with neuropathies. It contains 15 items, with a lower score indicating higher quality of life. Each item is rated as "0": not at all; "1": a little bit, or "2" a lot.
Time frame: From Baseline to End of Study (approx 2 years)