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NCT Number: NCT06968975

Real-world Study of 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Investigational Site

Swiftwater, Pennsylvania, 18370-0187, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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

Exclusion criteria

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.

Treatment and study plan

Primary outcomes

  1. I-RODS score at baseline

    Time frame: 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.

  2. Variations of I-RODS score over the study duration

    Time frame: From Baseline up to End of Study (2 years)

    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.

  3. Variations of I-RODS score after treatment change

    Time frame: From baseline up to End of Study (approx. 2 years)

    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.

  4. Annualized I-RODS response rate

    Time frame: Up to End of Study (approx. 2 years)

    Percent of patients who experienced inflammatory Rasch-built overall disability scale (I-RODS) response over a given time period, normalized to 365 days

  5. Annualized I-RODS relapse rate

    Time frame: Up to End of Study (approx. 2 years)

    Percent of patients who experienced inflammatory Rasch-built overall disability scale (I-RODS) relapse over a given time period, normalized to 365 days

Secondary outcomes

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

    Time frame: Baseline and throughout the study (up to 2 years)

    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.

  2. Annualized aINCAT response rate

    Time frame: Up to End of Study (approx. 2 years)

    Percent of participants who experienced inflammatory neuropathy cause and treatment (INCAT) response over a given time period, normalized to 365 days

  3. Annualized aINCAT relapse rate

    Time frame: Up to End of Study (approx. 2 years)

    Percent of pparticipantss who experienced inflammatory neuropathy cause and treatment (INCAT) relapse over a given time period, normalized to 365 days

  4. Interobserver variability of remote INCAT assessment

    Time frame: Up to End of Study (approx. 2 years)

    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.

  5. Incidence of select comorbidities at baseline and over the study duration

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

    Number of participants with comorbidity events

  6. Frequency of select comorbidities at baseline and over the study duration

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

    Events per patient-year

  7. Laboratory measurements at baseline and over study duration

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

    Complete Blood Count (CBC), serum lipid profile, liver function tests

  8. CAP-PRI score at baseline and its variations over the study duration and after treatment change

    Time frame: From Baseline to End of Study (approx 2 years)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

PicnicHealth For potential study participants

CONTACT

[email protected]

(415) 801-0572

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

CONTACT

[email protected]

800-633-1610 ext. option 6

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Observational, Real-world, Digital Biomarker, and Integrated Treatment Outcomes in Chronic Inflammatory Demyelinating Polyneuropathy/Polyradiculoneuropathy (CIDP)

Acronym: ORBIT-CIDP

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 13, 2025
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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