A Phase 4 interventional study of Immunoglobulin in CIDP - Chronic Inflammatory Demyelinating Polyneuropathy, sponsored by University of Aarhus. Recruiting at 4 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-17.
Sponsored by University of Aarhus · Phase 4, Interventional, and Treatment
Among 24 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in Denmark — 8 open to participants now, 11 under way, 6 of them phase 3. Polyradiculoneuropathy, Chronic Inflammatory Demyelinating · Denmark.
Among the 24 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in Denmark, this one is the 12th largest by planned enrollment of the 17 interventional ones that give a count, is one of 3 that started in 2020, is the only one in phase 4, reaches primary completion later than 10 of the 10 other live ones, and was the 14th registered.
137 studies on the registry are indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; 51 are open to participants now.
Browse Polyradiculoneuropathy, Chronic Inflammatory Demyelinating studies →8 of the 24 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in Denmark are open now. Recruiting first, the newest first:
argenx · Sites in Denmark, United States, Argentina and 22 more countries
Ages 18+
Takeda · Sites in Denmark, United States, Argentina and 8 more countries
Ages 18+
Takeda · Sites in Denmark, United States, Germany
Ages 18+
Immunovant Sciences GmbH · Sites in Denmark, United States, Argentina and 27 more countries
Ages 18+
Dianthus Therapeutics · Sites in Denmark, United States, Argentina and 28 more countries
Ages 18–75
A study can be open while its sites in Denmark have not opened yet or have stopped. Only those recruiting at a site in Denmark →
Of the 36 Polyradiculoneuropathy, Chronic Inflammatory Demyelinating studies recruiting now, 24 (67%) set no upper age limit and 9 (25%) stop at 75 or younger; 4 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
24 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 3 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 60 is above the median of 37 across 85 interventional studies indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating.
Median enrollment 109 across the 17 interventional studies, 39 across the 7 observational. Of the 12 that completed or were terminated, 5 (42%) have results posted.
This tab as a report to print or save as PDF → With an account.
15 of 24 have an industry lead sponsor. The 10 most frequent:
University of Aarhus is the lead sponsor of 1,300 studies on the registry; 189 are open to participants now.
University of Aarhus has 6 studies filed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating — fewer than ten, so there is no comparison to draw.
5 of the studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in Denmark that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06290141Phase 3SanofiA Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous Immunoglobulin (IVIg) in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | 2027-07-09 |
| NCT07091630Phase 3argenxA Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP | 2027-10-07 |
| NCT06040567Rigshospitalet, DenmarkPolyneuropathy, Impairments and Physical Activity - The PolyImPAct Study | 2026-12-31 |
| NCT04280718argenxA Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves) | 2027-04-30 |
| NCT06538064TakedaA Study of HyQvia in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) in Routine Clinical Care | 2027-08-17 |
Add all 5 to your calendar (.ics) → With an account.
Among the 24 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in Denmark, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Clinical criteria for typical CIDP
Criteria for pure motor CIDP • Pure motor affection; otherwise as for typical CIDP.
Electrophysiological criteria for CIDP
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:
After treatment initiation:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Change in disability
Evaluated with overall disability sum score (ODSS)
Time frame: Week 0 to 26
Change in grip strength
Grip strength (JAMAR)
Time frame: Week 0 to 26
Change in general muscle strength
MRC-score
Time frame: Week 0 to 26
Change in sensation
INCAT-Sensory Sum Score (ISS)
Time frame: Week 0 to 26
Change in walking performance
10-meter-walk test (10-MWT)
Time frame: Week 0 to 26
Change in walking performance and imbalance
6-spot-step test (6-SST)
Time frame: Week 0 to 26
Change in dexterity
9-hole-peg test (9-HPT)
Time frame: Week 0 to 26
Change in quality of life
QoL (EQ-5D-5L incl. VAS)
Time frame: Week 0 to 26
Change in fatigue severity
Fatigue Severity Scale (FSS)
Time frame: Week 0 to 26
Change in pain severity
Neuropathic Pain Symptom Inventory (NPSI)
Time frame: Week 0 to 26
Change in disability
Rasch built overall disability scale (RODS)
Time frame: Week 0 to 26
Change in treatment satisfaction
Life Quality Index (LQI)
Time frame: Week 2 to 26
Serum samples
Plasma IgG Hematology: hemoglobin, reticulocyte count, haptoglobin, bilirubin, plasma haemoglobin, leukocyte count, thrombocyte count. Inflammatory biomarkers: sCD163 and neurofilament
Time frame: Week 0 to 26
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)
Time frame: Week 0 to 26
The lowest dose of IVIG or SCIG reached during the 60 weeks of reduction (Fase II).
Monitored on ODSS and the same secondary parameters as in week 0 to 26
Time frame: Week 26 to 86
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2020 (actual). Primary completion is estimated for Dec 2030, 126 months after the start.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Immunoglobulins
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating →