Chronic Inflammatory Demyelinating PolyradiculoneuropathyPHARMACOPIDNCT02404298
Transcriptome Analysis of the Peripheral Blood in CIDP
A study testing IVIg in people with Chronic Inflammatory Demyelinating Polyradiculoneuropathy and Autoimmune Diseases, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is an immune-mediated disorder of peripheral nerves. Intravenous immunoglobulins (IVIg) are a first line therapy for CIDP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Inflammatory Demyelinating Polyradiculoneuropathy, Autoimmune Diseases, Clarkson Syndrome
- What is being tested?
- IVIg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2015to Sep 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Obtained informed consent
- Patient having a definite or probable CIDP according to EFNS/PNS criteria or atypical CIDP corresponding to patients having the EFNS/PNS clinical criteria and at least two EFNS/PNS supportive criteria
- Or
- Patient having a muscular autoimmune disease, or a Clarkson syndrome or other autoimmune disease
- Currently treated by IVIG
Who cannot join
- pregnancy
- breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of the Mechanisms of Action of Intravenous Immunoglobulins in CIDP by Analysis of the Genetic Expression Profile in Blood Mononuclear Cells
Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is an immune-mediated disorder of peripheral nerves. Intravenous immunoglobulins (IVIg) are a first line therapy for CIDP. The investigators used a transcriptomic approach to compare the gene expression profiles in the peripheral blood of patients having a CIDP or autoimmune diseases, before and after IVIg treatment, in order to identify their mechanism of action in this condition, to lead to a better understanding of CIDP pathophysiology, and potentially determine factors associated with the response to the treatment.
Read the detailed description
We study the change of the:
- gene profile on transcriptome analysis of peripheral blood
- T cell repertory
- igG dosage
- immunological profile
Before IVIG (T1 time) and and 3 weeks after IVIg treatment (T2 time). On a population of patients having: CIDP, autoimmune muscular disease, Clarkson syndrome, or autoimmune diseases.
We also search for polymorphism of FCgammareceptor, TKPC et CASP3 genes in CIDP patients
- Conditions
- Chronic Inflammatory Demyelinating Polyradiculoneuropathy, Autoimmune Diseases, Clarkson Syndrome, Muscular Autoimmune Disorders
- Being tested
- IVIg
- Keywords
- Transcriptome analysis, peripheral blood, chronic inflammatory demyelinating polyradiculoneuropathy, auto immune diseases, IVIg
- Medical subject headings
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVIgDrug
| Study group | Role | What they receive |
|---|---|---|
| IVIg | Experimental | Not described Receives: Drug: IVIg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene expression profile
Change of the gene expression profile of a peripheral blood sample collected. just before IVIg administration (T1), and 3 weeks after IVIg treatment (T2)
Measured: 3 weeks
Secondary outcomes (2)
Gene expression profile in each lymphocytary sub-group
Change of the gene expression profile of a peripheral blood sample collected. just before IVIg administration (T1), and 3 weeks after IVIg treatment (T2), in each lymphocytary sub-group : CD3+CD4+, CD3+CD8+, CD4+FoxP3+, CD4+CD25+
Measured: 3 weeks
IgG
To measure IgG in a peripheral blood sample at T1 and T2 time
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionJan 2018
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Inflammatory Demyelinating PolyradiculoneuropathyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karine Viala, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02404298
- Sponsor's protocol ID
- P111122
- Acronym
- PHARMACOPID
- Status last verified
- May 2018
- First submitted
- 6 Feb 2015
- Last updated
- 4 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of the Mechanisms of Action of Intravenous Immunoglobulins in CIDP by Analysis of the Genetic Expression Profile in Blood Mononuclear Cells
- ClinicalTrials.gov ID
- NCT02404298
- Acronym / sponsor ID
- PHARMACOPID / P111122
- Conditions
- Chronic Inflammatory Demyelinating Polyradiculoneuropathy, Autoimmune Diseases, Clarkson Syndrome, Muscular Autoimmune Disorders
- Keywords
- Transcriptome analysis, peripheral blood, chronic inflammatory demyelinating polyradiculoneuropathy, auto immune diseases, IVIg
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Sep 2018 (estimated)
- First posted
- 31 Mar 2015 (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.
Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is an immune-mediated disorder of peripheral nerves. Intravenous immunoglobulins (IVIg) are a first line therapy for CIDP. The investigators used a transcriptomic approach to compare the gene expression profiles in the peripheral blood of patients having a CIDP or autoimmune diseases, before and after IVIg treatment, in order to identify their mechanism of action in this condition, to lead to a better understanding of CIDP pathophysiology, and potentially determine factors associated with the response to the treatment.
Detailed description
We study the change of the:
- gene profile on transcriptome analysis of peripheral blood
- T cell repertory
- igG dosage
- immunological profile
Before IVIG (T1 time) and and 3 weeks after IVIg treatment (T2 time). On a population of patients having: CIDP, autoimmune muscular disease, Clarkson syndrome, or autoimmune diseases.
We also search for polymorphism of FCgammareceptor, TKPC et CASP3 genes in CIDP patients
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IVIg | Experimental | Drug: IVIg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years old
- Obtained informed consent
- Patient having a definite or probable CIDP according to EFNS/PNS criteria or atypical CIDP corresponding to patients having the EFNS/PNS clinical criteria and at least two EFNS/PNS supportive criteria
- Or
- Patient having a muscular autoimmune disease, or a Clarkson syndrome or other autoimmune disease
Key exclusion criteria (2 listed)
- pregnancy
- breastfeeding
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 |
|---|---|---|
| IVIg | Drug | IVIg |
Primary outcome
Gene expression profile
Time frame: 3 weeks
Change of the gene expression profile of a peripheral blood sample collected. just before IVIg administration (T1), and 3 weeks after IVIg treatment (T2)
2 secondary outcomes
Gene expression profile in each lymphocytary sub-group
Time frame: 3 weeks
IgG
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2018.
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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.
Karine Viala, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IVIg in people with Chronic Inflammatory Demyelinating Polyradiculoneuropathy and Autoimmune Diseases, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 4 Jun 2018. 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 France. 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.
Are results available for this study?
Results are not available in the source record.
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?
Gene expression profile (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2018; AzTrials last refreshed its copy on 26 Oct 2026.