Polyneuropathy, Inflammatory Demyelinating, ChronicORBIT-CIDPNCT06968975
Real-world Study of Treatment Outcomes in Chronic Inflammatory Demyelinating Polyneuropathy/Polyradiculoneuropathy (CIDP)
An observational study of Polyneuropathy, Inflammatory Demyelinating, Chronic, run by Sanofi at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polyneuropathy, Inflammatory Demyelinating, Chronic
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2025to 17 May 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants living with CIDP with residual disability
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Trial Transparency email recommended (Toll free for US & Canada) contact
PicnicHealth For potential study participants contact
United States1 site, 1 recruiting
- Recruiting
Investigational Site
Swiftwater, Pennsylvania, 18370-0187
About this study
Official title: Observational, Real-world, Digital Biomarker, and Integrated Treatment Outcomes in Chronic Inflammatory Demyelinating Polyneuropathy/Polyradiculoneuropathy (CIDP)
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.
- Medical subject headings
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Up to End of Study (approx. 2 years)
Secondary outcomes (8)
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: From Baseline to End of Study (approx 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start11 Apr 2025
- Primary completion17 May 2027 (estimated)
- Study completion17 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polyneuropathy, Inflammatory Demyelinating, ChronicStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06968975
- Sponsor's protocol ID
- OBS18653
- Acronym
- ORBIT-CIDP
- Status last verified
- Jul 2026
- First submitted
- 4 Apr 2025
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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