Treatment outcomes for people with chronic inflammatory demyelinating polyneuropathy (CIDP)
Observational, Real-world, Digital Biomarker, and Integrated Treatment Outcomes in Chronic Inflammatory Demyelinating Polyneuropathy/Polyradiculoneuropathy (CIDP)
See if current CIDP treatments are helping people who still have nerve weakness or disability after at least three months on standard therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sanofi Industry-sponsored |
| Drugs / interventions | rituximab, methotrexate, prednisone |
| Locations | 1 site (Swiftwater, Pennsylvania) |
| Trial ID | NCT06968975 on ClinicalTrials.gov |
What this trial studies
This is an ambispective, observational, non‑interventional project that follows people in the United States with a neurologist‑confirmed CIDP diagnosis and ongoing impairment after standard therapy. Participants must have used at least one listed CIDP therapy for three months or longer and show residual disability (I-RODS score ≤44) at enrollment. Enrollment continues for about one year and each participant is followed for between one and two years through the end of study. The project collects real-world clinical information from records and follow-up visits without changing patients' prescribed treatments.
Who should consider this trial
Good fit: Adults in the United States with a neurologist-confirmed CIDP diagnosis who have residual impairment (I-RODS ≤44) after at least three months on one or more approved CIDP therapies and who can give informed consent are ideal candidates.
Not a fit: People without a confirmed CIDP diagnosis, those with no residual impairment, those who have discontinued therapy, or those only on prednisone (or equivalent) monotherapy at 10 mg/day or less are unlikely to gain useful information from this observational protocol.
Why it matters
Potential benefit: If successful, the findings could help clinicians understand real-world effectiveness of standard CIDP treatments and guide care decisions for patients with persistent deficits.
How similar studies have performed: Other observational registries and real-world analyses in CIDP have yielded useful information about treatment patterns and outcomes, though randomized controlled trials are needed to prove treatment efficacy.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Swiftwater, Pennsylvania
- Investigational Site — Swiftwater, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
- Email: contact-us@sanofi.com
- Phone: 800-633-1610
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.