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

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ClinicalTrials.gov Identifier: NCT04589299
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Collaborators:
Rigshospitalet, Denmark
Aarhus University Hospital
Odense University Hospital
Aalborg University Hospital
Information provided by (Responsible Party):
University of Aarhus

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.

Condition or disease Intervention/treatment Phase
CIDP - Chronic Inflammatory Demyelinating Polyneuropathy Biological: Immunoglobulin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Parallel Study of Subcutaneous Versus Intravenous Immunoglobulin in Treatment-naïve Patients With Chronic Inflammatory Demyelinating Polyneuropathy
Actual Study Start Date : June 4, 2020
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025


Arm Intervention/treatment
Active Comparator: Patients treated with immunoglobulin intravenously (IVIG)
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%).
Biological: Immunoglobulin
Randomization 1:1 to the same total dose of either SCIG or IVIG for 26 weeks of stable dose + 60 weeks of redcution.

Active Comparator: Patients treated with immunoglobulin subcutaneously (SCIG)
Immunoglobulin (HIZENTRA) subcutaneously 0.54 g/kg/week for 26 weeks. After this 60 weeks of reduction every 12 weeks (90%, 75%, 50%, 25% and 0%).
Biological: Immunoglobulin
Randomization 1:1 to the same total dose of either SCIG or IVIG for 26 weeks of stable dose + 60 weeks of redcution.




Primary Outcome Measures :
  1. Change in disability [ Time Frame: Week 0 to 26 ]
    Evaluated with overall disability sum score (ODSS)


Secondary Outcome Measures :
  1. Change in grip strength [ Time Frame: Week 0 to 26 ]
    Grip strength (JAMAR)

  2. Change in general muscle strength [ Time Frame: Week 0 to 26 ]
    MRC-score

  3. Change in sensation [ Time Frame: Week 0 to 26 ]
    INCAT-Sensory Sum Score (ISS)

  4. Change in walking performance [ Time Frame: Week 0 to 26 ]
    10-meter-walk test (10-MWT)

  5. Change in walking performance and imbalance [ Time Frame: Week 0 to 26 ]
    6-spot-step test (6-SST)

  6. Change in dexterity [ Time Frame: Week 0 to 26 ]
    9-hole-peg test (9-HPT)

  7. Change in quality of life [ Time Frame: Week 0 to 26 ]
    QoL (EQ-5D-5L incl. VAS)

  8. Change in fatigue severity [ Time Frame: Week 0 to 26 ]
    Fatigue Severity Scale (FSS)

  9. Change in pain severity [ Time Frame: Week 0 to 26 ]
    Neuropathic Pain Symptom Inventory (NPSI)

  10. Change in disability [ Time Frame: Week 0 to 26 ]
    Rasch built overall disability scale (RODS)

  11. Change in treatment satisfaction [ Time Frame: Week 2 to 26 ]
    Life Quality Index (LQI)

  12. Serum samples [ Time Frame: Week 0 to 26 ]

    Plasma IgG (IgG1, IgG2, IgG3, IgG4) Hematology: hemoglobin, reticulocyte count, haptoglobin, bilirubin, plasma haemoglobin, leukocyte count, thrombocyte count.

    Inflammatory biomarkers: sCD163 and neurofilament


  13. 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 ]
    Average value of examinations made at week 0, 4 and 20 (prior to IVIG infusion) Average value of examinations made at week 2, 14 and 26 (2 weeks after IVIG infusion)


Other Outcome Measures:
  1. The lowest dose of IVIG or SCIG reached during the 60 weeks of reduction (Fase II). [ Time Frame: Week 26 to 86 ]
    Monitored on ODSS and the same secondary parameters as in week 0 to 26



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04589299


Contacts
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Contact: Lars Markvardsen, MD, PhD +45 20231903 larsmark@rm.dk

Locations
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Denmark
Department of Neurology, Aalborg University Hospital Not yet recruiting
Aalborg, Denmark, 9000
Contact: Izabella Obál, Md, PhD    9766 2200    i.obal@rn.dk   
Department of Neurology, Aarhus University Hospital Recruiting
Aarhus C, Denmark, 8000
Contact: Henning Andersen, DMSc       hennande@rm.dk   
Contact: Lars Markvardsen, MD    +45 7846 3337    larsmark@rm.dk   
Sub-Investigator: Lars Markvardsen, MD         
Principal Investigator: Henning Andersen, DMSc         
Department of Neurology, Rigshospitalet, Copenhagen University Hospital Not yet recruiting
Copenhagen, Denmark, 2100
Contact: Tina D Jeppesen, MD,DMSc,PhD       tina.dysgaard.jeppesen@regionh.dk   
Principal Investigator: Tina D Jeppesen, MD,DMSc,PhD         
Department of Neurology, Odense University Hospital Not yet recruiting
Odense, Denmark, 5000
Contact: Søren Sindrup, MD, DMSc    +45 6541 2485    soeren.sindrup@rsyd.dk   
Sponsors and Collaborators
University of Aarhus
Rigshospitalet, Denmark
Aarhus University Hospital
Odense University Hospital
Aalborg University Hospital
Investigators
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Principal Investigator: Henning Andersen, MD,DMSc,PhD Aarhus University, Aarhus University Hospital
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT04589299    
Other Study ID Numbers: AUH-2018-100
2018-003592-34 ( EudraCT Number )
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Aarhus:
Immunoglobulins, Intravenous
Injections, Subcutaneous
Additional relevant MeSH terms:
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Polyneuropathies
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Polyradiculoneuropathy
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Immunoglobulins
Immunoglobulins, Intravenous
Antibodies
Immunologic Factors
Physiological Effects of Drugs