Comparing subcutaneous and intravenous immunoglobulin treatments for CIDP
Randomized, Parallel Study of Subcutaneous Versus Intravenous Immunoglobulin in Treatment-naïve Patients With Chronic Inflammatory Demyelinating Polyneuropathy
This study is testing whether a new way of giving immunoglobulin treatment under the skin works better than the traditional method through an IV for people with Chronic Inflammatory Demyelinating Polyneuropathy who haven't been treated before.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Locations | 4 sites (Aalborg and 3 other locations) |
| Trial ID | NCT04589299 on ClinicalTrials.gov |
What this trial studies
The SIDEC study aims to evaluate the effectiveness of subcutaneous immunoglobulin (SCIG) versus intravenous immunoglobulin (IVIG) in treatment-naïve patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). This randomized, parallel study includes an open-label extension phase and follows patients over a total of 86 weeks. Initially, patients receive a fixed dose of either SCIG or IVIG, followed by a gradual reduction in dosage to determine the lowest effective maintenance treatment. Various assessments, including disability scores and quality of life measures, are conducted throughout the study to evaluate patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been diagnosed with definite, probable, or pure motor CIDP and have not previously received IVIG or SCIG treatment.
Not a fit: Patients with prior treatment for CIDP or those with conditions that do not meet the study's inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective and convenient treatment option for patients with CIDP.
How similar studies have performed: Previous studies have shown promising results with immunoglobulin treatments for CIDP, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Fulfilling EFNS/PNS criteria for definite, probable or pure motor CIDP. * No previous treatment with IVIG or SCIG. * Age ≥ 18. * ODSS ≥ 2 - either (arm/leg): 1/1, 2/0 or 0/2 at the time of inclusion. Clinical criteria for typical CIDP * Chronically progressive, stepwise, or recurrent symmetric proximal and distal weakness and sensory dysfunction of all extremities, developing over at least 2 months; cranial nerves may be affected. * Absent or reduced tendon reflexes in all extremities. Criteria for pure motor CIDP • Pure motor affection; otherwise as for typical CIDP. Electrophysiological criteria for CIDP 1. Motor distal latency prolongation ≥50% above ULN in two nerves (excluding median neuropathy at the wrist from carpal tunnel syndrome), or 2. Reduction of motor conduction velocity ≥30% below LLN in two nerves, or 3. Prolongation of F-wave latency ≥30% above ULN in two nerves (≥50% if amplitude of distal negative peak CMAP ≤80% of LLN values), or 4. Absence of F-waves in two nerves of these nerves have distal negative peak CMAP amplitudes ≥20% of LLN + ≥1 other demyelinating parameter in ≥1 other nerve, or 5. Partial motor conduction block: ≥50% amplitude reduction of the proximal negative peak CMAP relative to distal, if distal negative peak CMAP \>20% of LLN, in two nerves, or in one nerve + ≥1 other demyelinating parameter in ≥1 other nerve, or 6. Abnormal dispersion (≥30% duration increase between the proximal and distal negative peak CMAP) in ≥2 nerves, or 7. Distal CMAP duration (interval between onset of the first negative peak an return to baseline of the last negative peak) increase in ≥1 nerve (median ≥6.6 ms, ulnar ≥6.7 ms, peroneal ≥7.6 ms, tibial ≥8.8 ms) + ≥1 other demyelinating parameter in ≥1 other nerve Electrophysiological criteria for probable CIDP (a) ≥30% amplitude reduction of the proximal negative peak CMAP relative to distal, excluding the posterior tibial nerve, if distal negative peak CMAP ≥20% of LLN, in two nerves, or in one nerve + ≥1 other demyelinating parameter in ≥1 other nerve Exclusion Criteria: * Other causes of neuropathy * Increased risk of thromboembolism * Pregnancy (Plasma HCG is tested at inclusion in all fertile women) * Breast feeding * Malignancy * Severe medical disease * Other immune modulating treatment than low dose steroid (prednisolon \< 25 mg daily) within the last 6 months prior to inclusion * Hepatitis B or C or HIV infection (screening at inclusion) * Known IgA deficiency * Known allergy to consents in PRIVIGEN or HIZENTRA * Body weight \> 120 kg After treatment initiation: * Pregnancy * Serious medical disease that affects treatment or examinations * Non-compliance to treatment * Initiation of other immune modulating therapy * Unacceptable side effects * Withdrawal of consent to participate (drop-out)
Where this trial is running
Aalborg and 3 other locations
- Department of Neurology, Aalborg University Hospital — Aalborg, Denmark (Not_yet_recruiting)
- Department of Neurology, Aarhus University Hospital — Aarhus C, Denmark (Recruiting)
- Department of Neurology, Rigshospitalet, Copenhagen University Hospital — Copenhagen, Denmark (Not_yet_recruiting)
- Department of Neurology, Odense University Hospital — Odense, Denmark (Not_yet_recruiting)
Study contacts
- Principal investigator: Henning Andersen, MD,DMSc,PhD — Aarhus University, Aarhus University Hospital
- Study coordinator: Lars Markvardsen, MD, PhD
- Email: larsmark@rm.dk
- Phone: +45 20231903
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.