Comparing subcutaneous and intravenous immunoglobulin treatments for CIDP

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The SIDEC study aims to evaluate the effectiveness of subcutaneous immunoglobulin (SCIG) versus intravenous immunoglobulin (IVIG) in treatment-naïve patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). This randomized, parallel study includes an open-label extension phase and follows patients over a total of 86 weeks. Initially, patients receive a fixed dose of either SCIG or IVIG, followed by a gradual reduction in dosage to determine the lowest effective maintenance treatment. Various assessments, including disability scores and quality of life measures, are conducted throughout the study to evaluate patient outcomes.

Why it matters

Who can join: the full rules

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)

Where it's running

• Department of Neurology, Aarhus University Hospital
  Aarhus C, Denmark Recruiting
• Department of Neurology, Aalborg University Hospital
  Aalborg, Denmark Not yet recruiting
• Department of Neurology, Rigshospitalet, Copenhagen University Hospital
  Copenhagen, Denmark Not yet recruiting
• Department of Neurology, Odense University Hospital
  Odense, Denmark Not yet recruiting

Study contacts

• Principal investigator: Henning Andersen, MD,DMSc,PhD — Aarhus University, Aarhus University Hospital
• Study coordinator: Lars Markvardsen, MD, PhD
• Email: larsmark@rm.dk
• Phone: +45 20231903

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Nerve function and structure in CMT, anti‑MAG neuropathy, and CIDP

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.