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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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
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:
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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Participants living with CIDP with residual disability
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency email recommended (Toll free for US & Canada) | Contact | 800-633-1610 | option 6 | contact-us@sanofi.com |
| PicnicHealth For potential study participants | Contact | (415) 801-0572 | orbit-cidp-study@picnichealth.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Recruiting | Swiftwater | Pennsylvania | 18370-0187 | United States |
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| Label | URL |
|---|---|
| OBS18653, CIDP Website for potential participants | View source |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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| ID | Term |
|---|---|
| D020277 | Polyradiculoneuropathy, Chronic Inflammatory Demyelinating |
| ID | Term |
|---|---|
| D011129 | Polyradiculoneuropathy |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| 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 | Up to End of Study (approx. 2 years) |
| 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 | 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 | 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. | 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 | 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 | From Baseline up to End of Study (approx. 2 years) |
| Laboratory measurements at baseline and over study duration | Complete Blood Count (CBC), serum lipid profile, liver function tests | 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. | From Baseline to End of Study (approx 2 years) |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |