NCT04589299 Subcutaneous Immunoglobulin in De-novo CIDP (SIDEC)
| NCT ID | NCT04589299 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Aarhus |
| Condition | CIDP - Chronic Inflammatory Demyelinating Polyneuropathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2020-06-04 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 60 participants in total. It began in 2020-06-04 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
SIDEC - (Subcutaneous Immunoglobulin in De-novo CIDP) ia a study designed as a randomized, parallel study with an open-label extension phase. The aims are to compare the effect of SCIG and IVIG in 60 treatment-naïve CIDP patients, and to detect the lowest effective dosage for maintenance treatment.
Eligibility 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)
Contact & Investigator
Henning Andersen, MD,DMSc,PhD
PRINCIPAL INVESTIGATOR
Aarhus University, Aarhus University Hospital
Frequently Asked Questions
Who can join the NCT04589299 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying CIDP - Chronic Inflammatory Demyelinating Polyneuropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04589299 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04589299 currently recruiting?
Yes, NCT04589299 is actively recruiting participants. Contact the research team at larsmark@rm.dk for enrollment information.
Where is the NCT04589299 trial being conducted?
This trial is being conducted at Aalborg, Denmark, Aarhus C, Denmark, Copenhagen, Denmark, Odense, Denmark.
Who is sponsoring the NCT04589299 clinical trial?
NCT04589299 is sponsored by University of Aarhus. The principal investigator is Henning Andersen, MD,DMSc,PhD at Aarhus University, Aarhus University Hospital. The trial plans to enroll 60 participants.