Subcutaneous Immunoglobulin in De-novo CIDP (SIDEC)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    60
  • sponsor
    University of Aarhus
Updated on 25 January 2021

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-nave CIDP patients, and to detect the lowest effective dosage for maintenance treatment.

Description

In fase I the patients are followed for 26 weeks on a fixed dose of 0.54 g/kg/week in the SCIG group (total 14 g/kg) and 2 g/kg/4week in the IVIG group (total 14 g/kg). The patients automatically continue in fase II in which treatment is reduced every 12 weeks (90%, 75%, 50%, 25% and 0%) over a course 60 weeks. The patients are evaluated at every visit with overall disability sum score (ODSS), grip strength, medical research council score (MRC-score), INCAT-Sensory Sum Score (ISS), 10-meter-walk test (10-MWT), 6-spot-step test (6-SST), 9-hole-peg test (9-HPT), quality of life (EQ-5D-5L), Fatigue Severity Scale (FSS), Neuropathic Pain Symptom Inventory (NPSI), Rasch built overall disability scale (RODS) and Life Quality Index (LQI) and blood samples.

Details
Condition CIDP - Chronic Inflammatory Demyelinating Polyneuropathy, CIDP - Chronic Inflammatory Demyelinating Polyneuropathy, CIDP - Chronic Inflammatory Demyelinating Polyneuropathy
Treatment immunoglobulin
Clinical Study IdentifierNCT04589299
SponsorUniversity of Aarhus
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

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
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 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)
Clear my responses

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