Polyradiculoneuropathy, Chronic Inflammatory DemyelinatingPhase 2NCT01017159
Subcutaneous Immunoglobulin Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
A Phase 2 study testing Subcutaneous immunoglobulin in people with Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, run by University of Aarhus at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
- What is being tested?
- Subcutaneous immunoglobulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2010to Nov 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with typical or pure motor CIDP, who meet the clinical or electrophysiological criteria of the EFNS/PNS for certain or probable CIDP and who are in regular treatment with IVIg on one of the neurological departments in Denmark, are eligible for the study
Who cannot join
- Pregnancy
- Known cancer disease
- Severe medical diseases
- Other immuno modulating treatment than low-dose steroid (prednisolone < 25 mg/day) within the last 6 weeks before inclusion
- Hepatitis B or C or HIV
- Breast-feeding
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- Non-responding to treatment with intravenous immunoglobulin
- Known hypersensitivity to intravenous immunoglobulins or Kiovig
- Adverse events:
- Previous moderate headache or minor rash for a few days during or after infusion is not an exclusion criteria
- In case of severe adverse effects to treatment patients are excluded. Moderate or mild side-effects can be treated with analgetics or steroids for 1-2 weeks during the initial study phase
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University Hospital, Noerrebrogade, Department of Neurology
Aarhus, Aarhus, 8000
About this study
Official title: Randomised, Double-blinded, Placebo-controlled Trial of Subcutaneous Immunoglobulin Treatment in Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
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.
Read the detailed description
CIDP is an autoimmune disease of the peripheral nervous system, responding well to treatment with intravenous immunoglobulin (IVIg), steroids and plasmapheresis. IVIg is effective in treating patients with CIDP, but most of the patients need long time maintenance treatment, which is associated with decreased autonomy and regular hospital admissions. Furthermore many of the patients complain of infusion related side effects such as headache, chills and fatigue, and over time there is problems obtaining intravenous entry because of occlusion of the veins.
There is therefore a critical need for alternative methods to IVIg treatment. The aim of this study is to evaluate the efficacy, tolerability and safety of small doses of immunoglobulin administered subcutaneously (SCIg), compared with placebo. At the same time we compare the efficacy of SCIg with the regular IVIg treatment.
We therefore hypothesize, 1: SCIg is better than subcutaneous placebo infusions, and is as good as IVIg in maintaining muscle function in patients with CIDP. 2: SCIg home treatment is safe and tolerable. 3: SCIg home treatment is preferred to IVIg under hospital admission, by the patients.
- Being tested
- Subcutaneous immunoglobulin
- Keywords
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, Subcutaneous immunoglobulin
- 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.
Subcutaneous immunoglobulinDrug
Also called Subcuvia®
The subcutaneous immunoglobulin is infused in the subcutaneous tissue on the abdomen twice or thrice a week, with a maximal speed of 2 mL/h. Every time 20 mL is infused, the needle is removed to a new place.
| Study group | Role | What they receive |
|---|---|---|
| Subcutaneous immunoglobulin | Active comparator | Not described Receives: Drug: Subcutaneous immunoglobulin |
| Saline | Placebo comparator | Not described Receives: Drug: Subcutaneous immunoglobulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strength assessed by isokinetic strength measurements, in the active treatment group compared with the placebo group.
Measured: 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.
Secondary outcomes (1)
Efficacy and feasibility of subcutaneous immunoglobulin infusions.
Measured: Feasibility will be recorded continously in a patient diary and in the CRF (case report form), and efficacy will be calculated at the end of the study, after approximately three months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2009 (estimated)
- Study startApr 2010
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polyradiculoneuropathy, Chronic Inflammatory DemyelinatingStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation, GCP-unit at Aarhus University Hospital, Aarhus, Denmark
- Responsible party
- Sponsor
- Investigators
- Johannes Jakobsen, Dr., MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01017159
- Sponsor's protocol ID
- EudraCT number: 2009-013930-25
- Status last verified
- Nov 2011
- First submitted
- 6 Nov 2009
- Last updated
- 10 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Double-blinded, Placebo-controlled Trial of Subcutaneous Immunoglobulin Treatment in Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
- ClinicalTrials.gov ID
- NCT01017159
- Acronym / sponsor ID
- EudraCT number: 2009-013930-25
- Keywords
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, Subcutaneous immunoglobulin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation, GCP-unit at Aarhus University Hospital, Aarhus, Denmark
- Study start
- Apr 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 20 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
CIDP is an autoimmune disease of the peripheral nervous system, responding well to treatment with intravenous immunoglobulin (IVIg), steroids and plasmapheresis. IVIg is effective in treating patients with CIDP, but most of the patients need long time maintenance treatment, which is associated with decreased autonomy and regular hospital admissions. Furthermore many of the patients complain of infusion related side effects such as headache, chills and fatigue, and over time there is problems obtaining intravenous entry because of occlusion of the veins.
There is therefore a critical need for alternative methods to IVIg treatment. The aim of this study is to evaluate the efficacy, tolerability and safety of small doses of immunoglobulin administered subcutaneously (SCIg), compared with placebo. At the same time we compare the efficacy of SCIg with the regular IVIg treatment.
We therefore hypothesize, 1: SCIg is better than subcutaneous placebo infusions, and is as good as IVIg in maintaining muscle function in patients with CIDP. 2: SCIg home treatment is safe and tolerable. 3: SCIg home treatment is preferred to IVIg under hospital admission, by the patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subcutaneous immunoglobulin | Active comparator | Drug: Subcutaneous immunoglobulin |
| Saline | Placebo comparator | Drug: Subcutaneous immunoglobulin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with typical or pure motor CIDP, who meet the clinical or electrophysiological criteria of the EFNS/PNS for certain or probable CIDP and who are in regular treatment with IVIg on one of the neurological departments in Denmark, are eligible for the study
Key exclusion criteria (11 listed)
- Pregnancy
- Known cancer disease
- Severe medical diseases
- Other immuno modulating treatment than low-dose steroid (prednisolone < 25 mg/day) within the last 6 weeks before inclusion
- Hepatitis B or C or HIV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subcutaneous immunoglobulinAlso: Subcuvia®The subcutaneous immunoglobulin is infused in the subcutaneous tissue on the abdomen twice or thrice a week, with a maximal speed of 2 mL/h. Every time 20 mL is infused, the needle is removed to a new place. | Drug | Saline, Subcutaneous immunoglobulin |
Primary outcome
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.
1 secondary outcome
Efficacy and feasibility of subcutaneous immunoglobulin infusions.
Time frame: Feasibility will be recorded continously in a patient diary and in the CRF (case report form), and efficacy will be calculated at the end of the study, after approximately three months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2011.
- Derived from this study: PubMed 42578463Bus 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johannes Jakobsen, Dr., MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Subcutaneous immunoglobulin in people with Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, run by University of Aarhus at 1 site 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 1 inclusion and 11 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: finished, as of the sponsor's last update on 10 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). 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 NCT01017159, 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 10 Nov 2011.