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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT04589299
Date of registration: 09/09/2020
Prospective Registration: Yes
Primary sponsor: University of Aarhus
Public title: Subcutaneous Immunoglobulin in De-novo CIDP (SIDEC) SIDEC
Scientific title: Randomized, Parallel Study of Subcutaneous Versus Intravenous Immunoglobulin in Treatment-naïve Patients With Chronic Inflammatory Demyelinating Polyneuropathy
Date of first enrolment: June 4, 2020
Target sample size: 60
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT04589299
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 4
Countries of recruitment
Denmark
Contacts
Name:     Lars Markvardsen, MD, PhD
Address: 
Telephone: +45 20231903
Email: larsmark@rm.dk
Affiliation: 
Name:     Henning Andersen, MD,DMSc,PhD
Address: 
Telephone:
Email:
Affiliation:  Aarhus University, Aarhus University Hospital
Key inclusion & exclusion criteria

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)



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
CIDP - Chronic Inflammatory Demyelinating Polyneuropathy
Intervention(s)
Biological: Immunoglobulin
Primary Outcome(s)
Change in disability [Time Frame: Week 0 to 26]
Secondary Outcome(s)
Change in dexterity [Time Frame: Week 0 to 26]
Change in disability [Time Frame: Week 0 to 26]
Change in fatigue severity [Time Frame: Week 0 to 26]
Change in general muscle strength [Time Frame: Week 0 to 26]
Change in grip strength [Time Frame: Week 0 to 26]
Change in pain severity [Time Frame: Week 0 to 26]
Change in quality of life [Time Frame: Week 0 to 26]
Change in sensation [Time Frame: Week 0 to 26]
Change in treatment satisfaction [Time Frame: Week 2 to 26]
Change in walking performance [Time Frame: Week 0 to 26]
Change in walking performance and imbalance [Time Frame: Week 0 to 26]
Fluctuations in the describing parameters (ODSS and RODS) in both groups (SCIG and IVIG) based on measurement at time points for treatment with IVIG [Time Frame: Week 0 to 26]
Serum samples [Time Frame: Week 0 to 26]
Secondary ID(s)
2018-003592-34
AUH-2018-100
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Aalborg University Hospital
Aarhus University Hospital
Odense University Hospital
Rigshospitalet, Denmark
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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