Comparing immunoadsorption and immunoglobulins for treating CIDP
Immunoadsorption Versus Immunoglobulins for Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
PHASE2 · University of Ulm · NCT04881682
This study is testing whether a new treatment called immunoadsorption works better than immunoglobulin for people with CIDP who haven't improved with other medications.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Ulm (other) |
| Locations | 1 site (Ulm, Baden-Wurttemberg) |
| Trial ID | NCT04881682 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a randomized controlled study that evaluates the safety and efficacy of repeated immunoadsorption compared to immunoglobulin treatment in patients with steroid-refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). The study focuses on individuals diagnosed with CIDP who have not responded adequately to previous treatment with methyl-prednisolone. Participants will be monitored for their response to the two different treatment approaches over the course of the trial.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a diagnosis of CIDP and insufficient response to methyl-prednisolone.
Not a fit: Patients with active systemic infections or those who have contraindications to immunoadsorption or immunoglobulin therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with CIDP who do not respond to standard therapies.
How similar studies have performed: While there have been studies on immunoglobulins for CIDP, the specific comparison of immunoadsorption versus immunoglobulins in this context is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of possible, probable, or definite CIDP (typical or atypical) according to European Federation of Neurological Societies (EFNS) guidelines * Disease duration of 3 years or less * Age 18 years or above * Previous treatment with methyl-prednisolone and insufficient therapeutic response as judged by the treating physician, or contraindications against methyl-prednisolone, or clinically significant side effects under methyl-prednisolone therapy as judged by the treating physician Exclusion Criteria: * Clinical or laboratory evidence of manifest systemic infection, i.e., C-reactive protein (CRP) above 20 mg/l, or evidence of nitrite-positive urinary tract infection * Intake of angiotensin converting enzyme inhibitor within 1 week before first treatment * immunoglobulin A deficiency * Other contraindications against immunoadsorption or intravenous immunoglobulins
Where this trial is running
Ulm, Baden-Wurttemberg
- Department of Neurology, University of Ulm — Ulm, Baden-Wurttemberg, Germany (RECRUITING)
Study contacts
- Principal investigator: Johannes Dorst, Prof — University of Ulm
- Study coordinator: Johannes Dorst, Prof
- Email: johannes.dorst@uni-ulm.de
- Phone: +49 731 177 5285
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.
Conditions: CIDP