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Recruiting Phase 4

Subcutaneous Immunoglobulin in De-novo CIDP (SIDEC)

NCT04589299 · tracked via the Priya Life Science Denmark tracker
Phase
Phase 4
Started
2020-06-04
Last updated
2024-05-17

Condition(s) studied

CIDP - Chronic Inflammatory Demyelinating Polyneuropathy

Investigational drug(s) / intervention(s)

Immunoglobulin →

Immunoglobulin: Randomization 1:1 to the same total dose of either SCIG or IVIG for 26 weeks of stable dose + 60 weeks of redcution.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

  • Change in disability — Week 0 to 26
    Evaluated with overall disability sum score (ODSS)

Trial sites (4)

FacilityCityRegionStatus
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04589299 on ClinicalTrials.gov ↗ ← All trials in Denmark