Real-world Study of Treatment Outcomes in Chronic Inflammatory Demyelinating Polyneuropathy/Polyradiculoneuropathy (CIDP)

NCT06968975 | Recruiting

• 1 other identifier: OBS18653
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Polyneuropathy, Inflammatory Demyelinating, Chronic

Outcome Measures

Primary Outcomes (5)

• 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

  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)

Secondary Outcomes (8)

• Adjusted INCAT (aINCAT) score at baseline and its variations over the study duration and after treatment change

  Baseline and throughout the study (up to 2 years)

• Annualized aINCAT response rate

  Up to End of Study (approx. 2 years)

• Annualized aINCAT relapse rate

  Up to End of Study (approx. 2 years)

• Interobserver variability of remote INCAT assessment

  Up to End of Study (approx. 2 years)

• Incidence of select comorbidities at baseline and over the study duration

  From Baseline up to End of Study (approx. 2 years)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants living with CIDP with residual disability

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Investigational Site

Swiftwater, Pennsylvania, 18370-0187, United States

RECRUITING

Related Links

• OBS18653, CIDP Website for potential participants

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610; contact-us@sanofi.com

PicnicHealth For potential study participants

CONTACT

(415) 801-0572; orbit-cidp-study@picnichealth.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: May 13, 2025
• Study Start: April 11, 2025
• Primary Completion (Estimated): May 17, 2027
• Study Completion (Estimated): May 17, 2027
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)