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CIDP - Chronic Inflammatory Demyelinating PolyneuropathyPhase 4SIDECNCT04589299

Subcutaneous Immunoglobulin in De-novo CIDP (SIDEC)

A Phase 4 study testing Immunoglobulin in people with CIDP - Chronic Inflammatory Demyelinating Polyneuropathy, run by University of Aarhus at 4 sites in Denmark.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Immunoglobulin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
4 sitesDenmark
Study dates
4 Jun 2020to 31 Dec 2030
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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
  • Electrophysiological criteria for probable CIDP
  • ≥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

Who cannot join

  • 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
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  • 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)

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lars Markvardsen, MD, PhD contact

+45 20231903

larsmark@rm.dk

Denmark4 sites, 4 recruiting

  • Department of Neurology, Aalborg University Hospital

    Aalborg, 9000

    Izabella Obál, Md, PhD, 9766 2200, i.obal@rn.dk

    Not yet recruiting

  • Department of Neurology, Aarhus University Hospital

    Aarhus C, 8000

    Henning Andersen, DMSc, hennande@rm.dk

    Lars Markvardsen, MD, +45 7846 3337, larsmark@rm.dk

    Recruiting

  • Department of Neurology, Rigshospitalet, Copenhagen University Hospital

    Copenhagen, 2100

    Tina D Jeppesen, MD,DMSc,PhD, tina.dysgaard.jeppesen@regionh.dk

    Tina D Jeppesen, MD,DMSc,PhD

    Not yet recruiting

  • Department of Neurology, Odense University Hospital

    Odense, 5000

    Søren Sindrup, MD, DMSc, +45 6541 2485, soeren.sindrup@rsyd.dk

    Not yet recruiting

Other trials in Denmark

About this study

Official title: Randomized, Parallel Study of Subcutaneous Versus Intravenous Immunoglobulin in Treatment-naïve Patients With Chronic Inflammatory Demyelinating Polyneuropathy

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.

Read the 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.

Being tested
Immunoglobulin
Keywords
Immunoglobulins, Intravenous, Injections, Subcutaneous
Medical subject headings
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ImmunoglobulinBiological

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

Study groups in NCT04589299
Study groupRoleWhat they receive
Patients treated with immunoglobulin intravenously (IVIG)Active comparatorImmunoglobulin (PRIVIGEN) intravenously 2 g/kg/4week for 26 weeks. After this 60 weeks of reduction every 12 weeks (90%, 75%, 50%, 25% and 0%).
Receives: Biological: Immunoglobulin
Patients treated with immunoglobulin subcutaneously (SCIG)Active comparatorImmunoglobulin (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%).
Receives: Biological: Immunoglobulin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in disability

    Evaluated with overall disability sum score (ODSS)

    Measured: Week 0 to 26

Secondary outcomes (13)

  1. Change in grip strength

    Grip strength (JAMAR)

    Measured: Week 0 to 26

  2. Change in general muscle strength

    MRC-score

    Measured: Week 0 to 26

  3. Change in sensation

    INCAT-Sensory Sum Score (ISS)

    Measured: Week 0 to 26

  4. Change in walking performance

    10-meter-walk test (10-MWT)

    Measured: Week 0 to 26

  5. Change in walking performance and imbalance

    6-spot-step test (6-SST)

    Measured: Week 0 to 26

  6. Change in dexterity

    9-hole-peg test (9-HPT)

    Measured: Week 0 to 26

  7. Change in quality of life

    QoL (EQ-5D-5L incl. VAS)

    Measured: Week 0 to 26

  8. Change in fatigue severity

    Fatigue Severity Scale (FSS)

    Measured: Week 0 to 26

  9. Change in pain severity

    Neuropathic Pain Symptom Inventory (NPSI)

    Measured: Week 0 to 26

  10. Change in disability

    Rasch built overall disability scale (RODS)

    Measured: Week 0 to 26

  11. Change in treatment satisfaction

    Life Quality Index (LQI)

    Measured: Week 2 to 26

  12. Serum samples

    Plasma IgG Hematology: hemoglobin, reticulocyte count, haptoglobin, bilirubin, plasma haemoglobin, leukocyte count, thrombocyte count.

    Inflammatory biomarkers: sCD163 and neurofilament

    Measured: Week 0 to 26

  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

    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)

    Measured: Week 0 to 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2020
  2. Study start4 Jun 2020
  3. Primary completion31 Dec 2030 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04589299
Sponsor's protocol ID
AUH-2018-100
Other IDs
2018-003592-34, 2018
Acronym
SIDEC
Status last verified
May 2024
First submitted
9 Sep 2020
Last updated
17 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bus SR, Wieske L, Keddie S, van Schaik IN, Eftimov F. Subcutaneous immunoglobulin for chronic inflammatory demyelinating polyradiculoneuropathy. Cochrane Database Syst Rev. 2026 Aug 11;8:CD014542. doi: 10.1002/14651858.CD014542.pub2.

    PubMed 42578463

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Immunoglobulin in people with CIDP - Chronic Inflammatory Demyelinating Polyneuropathy, run by University of Aarhus at 4 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lars Markvardsen, MD, PhD (+45 20231903, larsmark@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in disability (time frame: Week 0 to 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04589299, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.

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