Subcutaneous Immunoglobulin in De-novo CIDP (SIDEC)

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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