Subcutaneous Immunoglobulin in De-novo CIDP (SIDEC)

NCT04589299 | Recruiting Phase 4 DMC

• 2 other identifiers: AUH-2018-1002018-003592-34
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

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.

Conditions

CIDP - Chronic Inflammatory Demyelinating Polyneuropathy

Keywords

Immunoglobulins, Intravenous; Injections, Subcutaneous

Outcome Measures

Primary Outcomes (1)

• Change in disability

  Evaluated with overall disability sum score (ODSS)

  Week 0 to 26

Secondary Outcomes (13)

• Change in grip strength

  Week 0 to 26

• Change in general muscle strength

  Week 0 to 26

• Change in sensation

  Week 0 to 26

• Change in walking performance

  Week 0 to 26

• Change in walking performance and imbalance

  Week 0 to 26

Other Outcomes (1)

• The lowest dose of IVIG or SCIG reached during the 60 weeks of reduction (Fase II).

  Week 26 to 86

Study Arms (2)

Patients treated with immunoglobulin intravenously (IVIG)

ACTIVE COMPARATOR

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

Patients treated with immunoglobulin subcutaneously (SCIG)

ACTIVE COMPARATOR

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

Interventions

Immunoglobulin BIOLOGICAL

Randomization 1:1 to the same total dose of either SCIG or IVIG for 26 weeks of stable dose + 60 weeks of redcution.

Patients treated with immunoglobulin intravenously (IVIG); Patients treated with immunoglobulin subcutaneously (SCIG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fulfilling EFNS/PNS criteria for definite, probable or pure motor CIDP.
• No previous treatment with IVIG or SCIG.
• Age ≥ 18.
• 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
• Motor distal latency prolongation ≥50% above ULN in two nerves (excluding median neuropathy at the wrist from carpal tunnel syndrome), or
• Reduction of motor conduction velocity ≥30% below LLN in two nerves, or
• Prolongation of F-wave latency ≥30% above ULN in two nerves (≥50% if amplitude of distal negative peak CMAP ≤80% of LLN values), or
• 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
• 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
• Abnormal dispersion (≥30% duration increase between the proximal and distal negative peak CMAP) in ≥2 nerves, or
• 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

You may not qualify if:

• Other causes of neuropathy
• Increased risk of thromboembolism
• Breast feeding
• Malignancy
• Severe medical disease
• 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)

Sponsors & Collaborators

• University of Aarhus: lead
• Rigshospitalet, Denmark: collaborator
• Aarhus University Hospital: collaborator
• Odense University Hospital: collaborator
• Aalborg University Hospital: collaborator

Study Sites (4)

Department of Neurology, Aalborg University Hospital

Aalborg, 9000, Denmark

NOT YET RECRUITING

Department of Neurology, Aarhus University Hospital

Aarhus C, 8000, Denmark

RECRUITING

Department of Neurology, Rigshospitalet, Copenhagen University Hospital

Copenhagen, 2100, Denmark

NOT YET RECRUITING

Department of Neurology, Odense University Hospital

Odense, 5000, Denmark

NOT YET RECRUITING

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Interventions

Immunoglobulins

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Henning Andersen, MD,DMSc,PhD

  Aarhus University, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lars Markvardsen, MD, PhD

CONTACT

+45 20231903; larsmark@rm.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: October 19, 2020
• Study Start: June 4, 2020
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (4)