Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT04589299

Subcutaneous Immunoglobulin in De-novo CIDP (SIDEC)

Led by University of Aarhus · Updated on 2024-05-17

60

Participants Needed

4

Research Sites

551 weeks

Total Duration

On this page

Sponsors

U

University of Aarhus

Lead Sponsor

R

Rigshospitalet, Denmark

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Subcutaneous Immunoglobulin in De-novo CIDP (SIDEC)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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

Not Eligible

You will not qualify if you...

  • 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)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Department of Neurology, Aalborg University Hospital

Aalborg, Denmark, 9000

Not Yet Recruiting

2

Department of Neurology, Aarhus University Hospital

Aarhus C, Denmark, 8000

Actively Recruiting

3

Department of Neurology, Rigshospitalet, Copenhagen University Hospital

Copenhagen, Denmark, 2100

Not Yet Recruiting

4

Department of Neurology, Odense University Hospital

Odense, Denmark, 5000

Not Yet Recruiting

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Research Team

L

Lars Markvardsen, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Subcutaneous Immunoglobulin in De-novo CIDP (SIDEC) | DecenTrialz