Actively Recruiting
Observational, Real-world, Digital Biomarker, and Integrated Treatment Outcomes in Chronic Inflammatory Demyelinating Polyneuropathy/Polyradiculoneuropathy (CIDP)
Led by Sanofi · Updated on 2025-06-29
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting an observational study to understand treatment outcomes in people diagnosed with chronic inflammatory demyelinating polyneuropathy/polyradiculoneuropathy (CIDP) in the United States. This study focuses on individuals who have residual impairment, disability, or neurological deficits after at least three months of treatment with standard therapies. The study is descriptive and non-interventional, aiming to gather real-world information on disease impact and treatment effects over time. Participants will be observed for up to two years, with enrollment continuing for one year. Depending on when they join, participants may be followed for between one and two years. The study collects digital biomarker data and tracks integrated treatment outcomes without altering participants' ongoing care. There are no study treatments or interventions administered as part of this research. During the study, participants will have their condition assessed using various scales such as the I-RODS and adjusted INCAT scores, to measure disability and response to treatment. Researchers will monitor changes in these scores over time, including after any treatment changes. Additional assessments include recording the incidence and frequency of comorbidities, laboratory tests, and remote neurological evaluations. All data are collected to better understand disease progression and treatment outcomes in real-world settings.
CONDITIONS
Brief Title
Real-world Study of Treatment Outcomes in Chronic Inflammatory Demyelinating Polyneuropathy/Polyradiculoneuropathy (CIDP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Neurologist-confirmed diagnosis of CIDP documented in medical records with no reversal of diagnosis
- Active use of at least one CIDP treatment for three months or longer, including immunoglobulin, corticosteroids (except low-dose prednisone monotherapy), plasma exchange, efgartigimod alfa, azathioprine, mycophenolate mofetil, cyclosporine, rituximab, or methotrexate
- Signed informed consent
- Residual impairment, disability, or neurological deficits at enrollment defined by a raw I-RODS score of 44 or below
You will not qualify if you...
- Participation in any interventional clinical trial with an investigational drug at enrollment
- Hyperreflexia recorded during neurological exam in the year before enrollment after CIDP diagnosis
- Age below 18 years at enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants with CIDP are observed to track disease progression and treatment outcomes over time.
Regular assessments throughout the study duration
Trial Site Locations
Total: 1 location
1
Investigational Site
Swiftwater, Pennsylvania, United States, 18370-0187
Actively Recruiting
Research Team
T
Trial Transparency email recommended (Toll free for US & Canada)
P
PicnicHealth For potential study participants
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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