RecruitingPhase 4NCT04589299

Subcutaneous Immunoglobulin in De-novo CIDP (SIDEC)

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

Sponsor

University of Aarhus

Enrollment

60 participants

Start Date

Jun 4, 2020

Study Type

INTERVENTIONAL

Conditions

CIDP - Chronic Inflammatory Demyelinating Polyneuropathy

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

Min Age: 18 Years

Inclusion Criteria18

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 Criteria18

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)