Subcutaneous Immunoglobulin in De-novo CIDP (SIDEC)

Trial details

Who runs it

University of Aarhus

Trial code

NCT04589299EU 2024-515898-96-01

Record updated

17 May 2024

Original description

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.Read full original descriptionShow less

Randomized, Parallel Study of Subcutaneous Versus Intravenous Immunoglobulin in Treatment-naïve Patients With Chronic Inflammatory Demyelinating Polyneuropathy

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.

Inclusion: 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; Motor distal latency prolongation ≥50% above ULN in two nerves (excluding median neuropathy at the wrist from carpal tunnel syndrome), or; Reduction of motor conduction velocity ≥30% below LLN in two nerves, or; Prolongation of F-wave latency ≥30% above ULN in two nerves (≥50% if amplitude of distal negative peak CMAP ≤80% of LLN values), or; 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; 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; Abnormal dispersion (≥30% duration increase between the proximal and distal negative peak CMAP) in ≥2 nerves, or; 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: Other immune modulating treatment than low dose steroid (prednisolon < 25 mg daily) within the last 6 months prior to inclusion; Initiation of other immune modulating therapy; Increased risk of thromboembolism; Malignancy; Severe medical disease; Hepatitis B or C or HIV infection (screening at inclusion); Known allergy to consents in PRIVIGEN or HIZENTRA; Serious medical disease that affects treatment or examinations; Other causes of neuropathy; Pregnancy (Plasma HCG is tested at inclusion in all fertile women); Breast feeding; Known IgA deficiency; Body weight > 120 kg; After treatment initiation:; Pregnancy; Non-compliance to treatment; Unacceptable side effects; Withdrawal of consent to participate (drop-out).

ClinicalTrials.gov NCT04589299 · EU CTIS 2024-515898-96-01