Brief Title
Subcutaneous Immunoglobulin in De-novo CIDP (SIDEC)
Official Title
Randomized, Parallel Study of Subcutaneous Versus Intravenous Immunoglobulin in Treatment-naïve Patients With Chronic Inflammatory Demyelinating Polyneuropathy
Brief 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.
Detailed 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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Change in disability
Secondary Outcome
Change in grip strength
Condition
CIDP - Chronic Inflammatory Demyelinating Polyneuropathy
Intervention
Immunoglobulin
Study Arms / Comparison Groups
Patients treated with immunoglobulin intravenously (IVIG)
Description: Immunoglobulin (PRIVIGEN) intravenously 2 g/kg/4week for 26 weeks. After this 60 weeks of reduction every 12 weeks (90%, 75%, 50%, 25% and 0%).
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
60
Start Date
June 4, 2020
Completion Date
December 31, 2025
Primary Completion Date
December 31, 2025
Eligibility 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)
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Henning Andersen, MD,DMSc,PhD, +45 20231903, [email protected]
Location Countries
Denmark
Location Countries
Denmark
Administrative Informations
NCT ID
NCT04589299
Organization ID
AUH-2018-100
Secondary IDs
2018-003592-34
Responsible Party
Sponsor
Study Sponsor
University of Aarhus
Collaborators
Rigshospitalet, Denmark
Study Sponsor
Henning Andersen, MD,DMSc,PhD, Principal Investigator, Aarhus University, Aarhus University Hospital
Verification Date
March 2020