Last reviewed · How we verify
NCT01017159
Randomised, Double-blinded, Placebo-controlled Trial of Subcutaneous Immunoglobulin Treatment in Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Phase 2 trial testing Subcutaneous immunoglobulin in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating in 30 participants. Completed in 1 November 2011.
1 November 2011
Quick facts
| Lead sponsor | University of Aarhus |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 April 2010 |
| Primary completion | 1 November 2011 |
| Estimated completion | 1 November 2011 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Subcutaneous immunoglobulin — full drug profile →
Conditions studied
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating — all drugs for Polyradiculoneuropathy, Chronic Inflammatory Demyelinating →
Sponsor
University of Aarhus
Who can join
Adults 18 to 80, any sex, with Polyradiculoneuropathy, Chronic Inflammatory Demyelinating. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Strength assessed by isokinetic strength measurements, in the active treatment group compared with the placebo group.
Time frame: The study period is 98 days. Isokinetic strength will be measured on day 14, 28, 84 and 98 of the study period. If there is a drop-out before day 84, the strength measurement will take place on this day, and the last two measurements will be left out.
Sponsor's own description
The purpose of this study is to determine whether subcutaneous immunoglobulin given in small doses, is effective in maintaining the force, in patients with chronic inflammatory demyelinating polyradiculoneuropathy compared with placebo (saline infusions), and intravenous immunoglobulin.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Intravenous immunoglobulin as clinical immune-modulating therapy.
Gilardin L, Bayry J, Kaveri SV. · · 2015 · cited 63× · PMID 25667260 · DOI 10.1503/cmaj.130375
Verify or expand the search:
- PubMed search for NCT01017159
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Currently open trials in the same condition.
- NCT05327114 — Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) · Phase 2, PHASE3 · recruiting
Other University of Aarhus trials
Trials by the same sponsor.
- NCT07209540 — European LUpuS Inception-Cohort Developing initiATivE · not yet recruiting
- NCT07317401 — Investigating the Effects of Intermittent Hypoxia-Hyperoxia Treatment (IHHT) in People With Post-Viral Myalgic Encephalo · NA · not yet recruiting
- NCT07531966 — Vascular Complications After Kidney Transplantation · recruiting
- NCT07528339 — Prospective RegIstry for Oncologic Reirradiation (PRIOR-DK) · not yet recruiting
- NCT07451028 — Effect of an Oral Neuromuscular Training Device on Dysphagia · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01017159 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Aarhus
- Last refreshed: 9 November 2011
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01017159.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing