<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03299335</url>
  </required_header>
  <id_info>
    <org_study_id>16-AOI-05</org_study_id>
    <nct_id>NCT03299335</nct_id>
  </id_info>
  <brief_title>Molecular Profile of the Evolution of Inclusion Body Myositis</brief_title>
  <acronym>IBM-RNAseq</acronym>
  <official_title>Molecular Profile of the Evolution of Inclusion Body Myositis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Nice</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Nice</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims at assessing the gene expression in the muscles of patients suffering from&#xD;
      sporadic Inclusion Body Myositis (sIBM) at various stages of the disease, by comparison with&#xD;
      muscles of control subject. The investigators use the RNA-seq technique to analyze the gene&#xD;
      expression levels and potential alternate transcripts, including long non-coding RNAs&#xD;
      (lncRNAs), in muscle tissue samples. The gene expression profiles will point to the genes of&#xD;
      interest that can then become the object of future studies, in which epigenetic changes of&#xD;
      these genes will be explored further. The value of those possible biomarkers will be&#xD;
      assessed. The investigators will also evaluate the correlation between the gene expression&#xD;
      profile, the degree of functional impairment, the histological picture and the presence or&#xD;
      absence of autoantibodies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sporadic inclusion body myositis (sIBM) is a myopathy that usually does not become apparent&#xD;
      before the age of 50 to 60. The disease is characterized by a progressive weakening of the&#xD;
      muscles, including the finger flexors of the hand and proximal leg muscles. Swallowing&#xD;
      problems are often observed. Muscular biopsy also reveals a combination of inflammatory,&#xD;
      mitochondrial and myodegenerative signs. What triggers the disease has not yet been&#xD;
      established, although two hypotheses are currently being explored: auto-immune and&#xD;
      degeneration etiologies. Histological inflammatory hallmarks, the presence of sIMB-specific&#xD;
      antibodies and the concomitance of other autoimmune pathologies point to the autoimmune&#xD;
      hypothesis. On the other hand, immunosuppressive drugs only have a positive effect in a&#xD;
      limited number of cases. The degenerative hypothesis is supported by the presence of rimmed&#xD;
      vacuoles and protein aggregates (inclusion bodies) in the myocytes. The presence of&#xD;
      mitochondrial anomalies can enhance protein aggregation that in turn can worsen mitochondrial&#xD;
      changes.&#xD;
&#xD;
      Many genetic studies have been carried out to assess a potential genetic link in the sIBM.&#xD;
      However, only connections to a number of HLA alleles and haplotypes have been found. In the&#xD;
      present study, the investigators propose to evaluate gene expression in the muscular tissue&#xD;
      by high-throughput RNA-sequencing (RNA-seq) in order to increase our knowledge of the sIMB&#xD;
      pathophysiology. The RNA-seq technique can not only identify transcripted genes in a given&#xD;
      tissue, but also discover unreported alternate or new transcripts, including long non-coding&#xD;
      RNAs (lncRNAs). Indeed, lncRNAs play an important role in regulating gene networks, in&#xD;
      particular in contributing to the setup and maintenance of epigenetic marks. The RNAseq&#xD;
      approach will allow the investigators to assess the perturbations in the gene expression&#xD;
      profiles and lncRNAs involved in the onset of the disease, by comparing the profiles obtained&#xD;
      from patients at various stages of the disease and control subjects.&#xD;
&#xD;
      This study aims at assessing the gene expression in the muscles of patients suffering from&#xD;
      sporadic Inclusion Body Myositis (sIBM) at various stages of the disease, by comparison with&#xD;
      muscles of control subject. The investigators use the RNA-seq technique to analyze the gene&#xD;
      expression levels and potential alternate transcripts, including long non-coding RNAs&#xD;
      (lncRNAs), in muscle tissue samples. The gene expression profiles will point to the genes of&#xD;
      interest that can then become the object of future studies, in which epigenetic changes of&#xD;
      these genes will be explored further. The value of those possible biomarkers will be&#xD;
      assessed. The investigators will also evaluate the correlation between the gene expression&#xD;
      profile, the degree of functional impairment, the histological picture and the presence or&#xD;
      absence of autoantibodies.&#xD;
&#xD;
      The study is interventional with no immediate benefits to the patient. RNAseq will be&#xD;
      performed in both a group of sIBM patients (at early and late stages) and a group of control&#xD;
      subjects.&#xD;
&#xD;
      Patients suffering from sIMB will be recruited on the basis of the ENMC 2011 diagnostic&#xD;
      criteria. Predominant inflammatory changes (T-cell inflammatory infiltrate, expression of HLA&#xD;
      class I antigens) without a degenerative affection (rimmed vacuoles, endomysial fibrosis,&#xD;
      protein accumulation) will allow for a classification in the &quot;early sIMB&quot; group. Muscle&#xD;
      biopsies of control subjects are part of a proprietary collection of the Neurology Department&#xD;
      declared to the Nice University Hospital administration; they are selected from biopsies&#xD;
      devoid of anomalies among subjects matching the ages of the sIMB patients. A physical&#xD;
      examination and a venipuncture will be performed on patients in order to assess the absence&#xD;
      or presence of anti-cN-1A antibodies, a new marker of sIMB. Control subjects will undergo a&#xD;
      physical exam and a creatine kinase dosage. Tissue muscle has been collected beforehand in&#xD;
      the frame of the routine diagnostic procedure for both patients and control subjects.&#xD;
&#xD;
      Expression profiles will be obtained by RNAseq from 15 muscle biopsies. Three groups of&#xD;
      samples will be compared: 5 from early-stage sIMB patients, 5 from late-stage sIMB patients&#xD;
      and 5 from control subjects.&#xD;
&#xD;
      In addition to known expression modifications of genes involved in the inflammatory response,&#xD;
      in particular at early stages of the sIMB, or of genes involved in autophagy processes, at&#xD;
      late stages of the disease where muscle degeneration is advanced, this study will allow&#xD;
      identifying lncRNA potentially involved in the sIMB. Inasmuch as lncRNA are crucial for the&#xD;
      regulation of cell differentiation and ageing processes at the epigenetic level, this pilot&#xD;
      study will make possible to identify a group of genes of particular relevance, thus enabling&#xD;
      further research on epigenetic regulation. Furthermore, a delayed gene expression, as is the&#xD;
      case with lncRNA in early-stage sIMB patients, compared to lncRNA in late-stages disease&#xD;
      patients, may prove a biomarker for evolution, and serve as a beneficial tool for monitoring&#xD;
      sIMB in therapeutic trials to come.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2018</start_date>
  <completion_date type="Actual">February 7, 2020</completion_date>
  <primary_completion_date type="Actual">February 7, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>sIBM gene expression profile</measure>
    <time_frame>at 12 Months</time_frame>
    <description>The expression of different genes in muscle tissue will be evaluated by RNA-seq and will allow to establish the IBM gene expression profile</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>CPK level</measure>
    <time_frame>at 12 Months</time_frame>
    <description>The CPK level will be evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of cN-1A antibodies.</measure>
    <time_frame>at 12 Months</time_frame>
    <description>Presence or absence of cN-1A antibodies will be evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IWCI score</measure>
    <time_frame>at 12 Months</time_frame>
    <description>The IWCI score will be evaluated.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Inclusion Body Myositis</condition>
  <arm_group>
    <arm_group_label>Early-stage sIMB patients</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Late-stage sIMB patients</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control subjects</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood collection</intervention_name>
    <description>assay of CPK and anti-cN-1A antibodies</description>
    <arm_group_label>Control subjects</arm_group_label>
    <arm_group_label>Early-stage sIMB patients</arm_group_label>
    <arm_group_label>Late-stage sIMB patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria (early-stage sIBM patients):&#xD;
&#xD;
          -  Patient suffering from sIMB according to the ENMC 2011 criteria: &quot;sIMB defined on&#xD;
             histological and clinical features&quot; with, on the inclusion visit day:&#xD;
&#xD;
               -  duration of the disease &gt; 12 months;&#xD;
&#xD;
               -  onset of the disease &gt; 45 years;&#xD;
&#xD;
               -  quadriceps weakness ≥ hip flexors and/or fingers flexors weakness &gt; shoulder&#xD;
                  abductors;&#xD;
&#xD;
               -  CPK ≤ 15 x ULN.&#xD;
&#xD;
          -  Patient with available biopsy showing alterations compatible with an inflammatory&#xD;
             myopathy (endomysial inflammatory infiltrate, overexpression of HLA class I), but not&#xD;
             specific to sIMB, in particular with no associated degenerative and/or mitochondrial&#xD;
             pathologies (protein aggregates: amyloid, p62, SMI-31, TDP-43; 15-18nm filaments;&#xD;
             ragged red fibers; COX negative fibers).&#xD;
&#xD;
          -  Patient whose sIMB diagnosis has been histologically confirmed with a second muscle&#xD;
             biopsy showing the typical histological hallmarks (endomysial inflammatory infiltrate,&#xD;
             overexpression of HLA class I and an associated degenerative and/or mitochondrial&#xD;
             pathology).&#xD;
&#xD;
          -  Patient who gave his consent for the use of the biological material from the muscle&#xD;
             biopsy at the time of the diagnosis.&#xD;
&#xD;
          -  Patient affiliated to a social security regimen.&#xD;
&#xD;
          -  Signed and written informed consent.&#xD;
&#xD;
        Exclusion Criteria (early-stage sIBM patients):&#xD;
&#xD;
          -  Patient with a known medical record that could significantly influence the results of&#xD;
             the study: auto-immune disease with conjunctive tissue inflammation (overlap myositis,&#xD;
             rheumatoid arthritis, lupus, vasculitis, spondylarthritis, scleroderma, psoriatic&#xD;
             arthritis), disease causing nerve-damage (Parkinson's disease, Alzheimer's disease,&#xD;
             amyotrophic lateral sclerosis), auto-immune neuropathy (chronic polyradiculoneuritis&#xD;
             and variants (multifocal motor neuropathy with conduction blocks, anti-MAG&#xD;
             neuropathy)).&#xD;
&#xD;
          -  Presence of the following histological characteristics in the muscle biopsy pointing&#xD;
             to degenerative and/or mitochondrial pathologies: protein aggregates (amyloid, p62,&#xD;
             SM-31, TDP-43), 15-18nm filaments, ragged red fibers or fibers with decreased COX&#xD;
             activity.&#xD;
&#xD;
          -  Patient who received one of the following treatments, prior to the first muscle&#xD;
             biopsy:&#xD;
&#xD;
               -  anti-inflammatory drugs in the past week;&#xD;
&#xD;
               -  corticotherapy in the past month;&#xD;
&#xD;
               -  immunosuppressive agents in the past 3 months;&#xD;
&#xD;
               -  other treatments: chloridin, amiodarone, colchicine, vincristine in the past 6&#xD;
                  months.&#xD;
&#xD;
          -  Patient under curators or guardianship.&#xD;
&#xD;
          -  Pregnant woman.&#xD;
&#xD;
        Inclusion Criteria (late-stage sIMB patients):&#xD;
&#xD;
          -  Patient suffering from sIMB according to the ENMC 2011 criteria: &quot;sIMB defined on&#xD;
             histological and clinical features&quot; with, on the inclusion visit day:&#xD;
&#xD;
               -  duration of the disease &gt; 12 months;&#xD;
&#xD;
               -  onset of the disease &gt; 45 years;&#xD;
&#xD;
               -  quadriceps weakness ≥ hip flexors and/or fingers flexors weakness &gt; shoulder&#xD;
                  abductors;&#xD;
&#xD;
               -  CPK ≤ 15 x ULN.&#xD;
&#xD;
          -  Patient whose sIMB diagnosis has been histologically confirmed with a muscle biopsy&#xD;
             featuring the following characteristics: endomysial inflammatory infiltrate, rimmed&#xD;
             vacuoles and protein aggregates (amyloid, p62, SM-31, TDP-43) or presence of 15-18nm&#xD;
             filaments.&#xD;
&#xD;
          -  Patient who gave his consent for the use of the biological material from the muscle&#xD;
             biopsy at the time of the diagnosis.&#xD;
&#xD;
          -  Patient affiliated to a social security regimen.&#xD;
&#xD;
          -  Signed and written informed consent.&#xD;
&#xD;
        Non-inclusion criteria (late-stage sIMB patients):&#xD;
&#xD;
          -  Patient with a known medical record that could significantly influence the results of&#xD;
             the study: auto-immune disease with conjunctive tissue inflammation (overlap myositis,&#xD;
             rheumatoid arthritis, lupus, vasculitis, spondylarthritis, scleroderma, psoriatic&#xD;
             arthritis), disease causing nerve-damage (Parkinson's disease, Alzheimer's disease,&#xD;
             amyotrophic lateral sclerosis), auto-immune neuropathy (chronic polyradiculoneuritis&#xD;
             and variants (multifocal motor neuropathy with conduction blocks, anti-MAG&#xD;
             neuropathy)).&#xD;
&#xD;
          -  Patient who received one of the following treatments, prior to the muscle biopsy that&#xD;
             confirmed the diagnosis:&#xD;
&#xD;
               -  anti-inflammatory drugs in the past week;&#xD;
&#xD;
               -  corticotherapy in the past month;&#xD;
&#xD;
               -  immunosuppressive agents in the past 3 months;&#xD;
&#xD;
               -  other treatments: chloridin, amiodarone, colchicine, vincristine in the past 6&#xD;
                  months.&#xD;
&#xD;
          -  Patient under curators or guardianship.&#xD;
&#xD;
          -  Pregnant woman.&#xD;
&#xD;
        Inclusion Criteria (control subjects):&#xD;
&#xD;
          -  Signed and written informed consent for the use of muscle tissue used collected for&#xD;
             the diagnosis of a CPK elevation and/or myopathy and/or myalgias.&#xD;
&#xD;
          -  No signs of muscular weakness at the time of the muscle biopsy.&#xD;
&#xD;
          -  Age &gt; 45, correlated to the age of sIMB patients, allowing for the constitution of a&#xD;
             homogeneous group compared to sIMB patients.&#xD;
&#xD;
          -  Patient affiliated to a social security regimen.&#xD;
&#xD;
          -  Signed and written informed consent.&#xD;
&#xD;
        Non-inclusion criteria (control subjects):&#xD;
&#xD;
          -  Subject with a muscle biopsy showing signs of inflammation and/or vacuoles and/or&#xD;
             dystrophy.&#xD;
&#xD;
          -  Subject with a known medical record that could significantly influence the results of&#xD;
             the study: auto-immune disease with conjunctive tissue inflammation (overlap myositis,&#xD;
             rheumatoid arthritis, lupus, vasculitis, spondylarthritis, scleroderma, psoriatic&#xD;
             arthritis), disease causing nerve-damage (Parkinson's disease, Alzheimer's disease,&#xD;
             amyotrophic lateral sclerosis), auto-immune neuropathy (chronic polyradiculoneuritis&#xD;
             and variants (multifocal motor neuropathy with conduction blocks, anti-MAG&#xD;
             neuropathy)).&#xD;
&#xD;
          -  Subject with a confirmed sIMB diagnosis.&#xD;
&#xD;
          -  Patient who received one of the following treatments, prior to the muscle biopsy that&#xD;
             confirmed the diagnosis:&#xD;
&#xD;
               -  anti-inflammatory drugs in the past week;&#xD;
&#xD;
               -  corticotherapy in the past month;&#xD;
&#xD;
               -  immunosuppressive agents in the past 3 months;&#xD;
&#xD;
               -  other treatments: chloridin, amiodarone, colchicine, vincristine in the past 6&#xD;
                  months.&#xD;
&#xD;
          -  Patient under curators or guardianship.&#xD;
&#xD;
          -  Pregnant woman.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hôpital Pasteur 2 - Service Système Nerveux Périphérique, Muscle et SLA</name>
      <address>
        <city>Nice</city>
        <zip>06001</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>March 21, 2023</last_update_submitted>
  <last_update_submitted_qc>March 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myositis</mesh_term>
    <mesh_term>Myositis, Inclusion Body</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03299335
org study id: 16-AOI-05
nct id: NCT03299335
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims at assessing the gene expression in the muscles of patients suffering from
      sporadic Inclusion Body Myositis (sIBM) at various stages of the disease, by comparison with
      muscles of control subject. The investigators use the RNA-seq technique to analyze the gene
      expression levels and potential alternate transcripts, including long non-coding RNAs
      (lncRNAs), in muscle tissue samples. The gene expression profiles will point to the genes of
      interest that can then become the object of future studies, in which epigenetic changes of
      these genes will be explored further. The value of those possible biomarkers will be
      assessed. The investigators will also evaluate the correlation between the gene expression
      profile, the degree of functional impairment, the histological picture and the presence or
      absence of autoantibodies.
Sporadic inclusion body myositis (sIBM) is a myopathy that usually does not become apparent
      before the age of 50 to 60. The disease is characterized by a progressive weakening of the
      muscles, including the finger flexors of the hand and proximal leg muscles. Swallowing
      problems are often observed. Muscular biopsy also reveals a combination of inflammatory,
      mitochondrial and myodegenerative signs. What triggers the disease has not yet been
      established, although two hypotheses are currently being explored: auto-immune and
      degeneration etiologies. Histological inflammatory hallmarks, the presence of sIMB-specific
      antibodies and the concomitance of other autoimmune pathologies point to the autoimmune
      hypothesis. On the other hand, immunosuppressive drugs only have a positive effect in a
      limited number of cases. The degenerative hypothesis is supported by the presence of rimmed
      vacuoles and protein aggregates (inclusion bodies) in the myocytes. The presence of
      mitochondrial anomalies can enhance protein aggregation that in turn can worsen mitochondrial
      changes.

      Many genetic studies have been carried out to assess a potential genetic link in the sIBM.
      However, only connections to a number of HLA alleles and haplotypes have been found. In the
      present study, the investigators propose to evaluate gene expression in the muscular tissue
      by high-throughput RNA-sequencing (RNA-seq) in order to increase our knowledge of the sIMB
      pathophysiology. The RNA-seq technique can not only identify transcripted genes in a given
      tissue, but also discover unreported alternate or new transcripts, including long non-coding
      RNAs (lncRNAs). Indeed, lncRNAs play an important role in regulating gene networks, in
      particular in contributing to the setup and maintenance of epigenetic marks. The RNAseq
      approach will allow the investigators to assess the perturbations in the gene expression
      profiles and lncRNAs involved in the onset of the disease, by comparing the profiles obtained
      from patients at various stages of the disease and control subjects.

      This study aims at assessing the gene expression in the muscles of patients suffering from
      sporadic Inclusion Body Myositis (sIBM) at various stages of the disease, by comparison with
      muscles of control subject. The investigators use the RNA-seq technique to analyze the gene
      expression levels and potential alternate transcripts, including long non-coding RNAs
      (lncRNAs), in muscle tissue samples. The gene expression profiles will point to the genes of
      interest that can then become the object of future studies, in which epigenetic changes of
      these genes will be explored further. The value of those possible biomarkers will be
      assessed. The investigators will also evaluate the correlation between the gene expression
      profile, the degree of functional impairment, the histological picture and the presence or
      absence of autoantibodies.

      The study is interventional with no immediate benefits to the patient. RNAseq will be
      performed in both a group of sIBM patients (at early and late stages) and a group of control
      subjects.

      Patients suffering from sIMB will be recruited on the basis of the ENMC 2011 diagnostic
      criteria. Predominant inflammatory changes (T-cell inflammatory infiltrate, expression of HLA
      class I antigens) without a degenerative affection (rimmed vacuoles, endomysial fibrosis,
      protein accumulation) will allow for a classification in the "early sIMB" group. Muscle
      biopsies of control subjects are part of a proprietary collection of the Neurology Department
      declared to the Nice University Hospital administration; they are selected from biopsies
      devoid of anomalies among subjects matching the ages of the sIMB patients. A physical
      examination and a venipuncture will be performed on patients in order to assess the absence
      or presence of anti-cN-1A antibodies, a new marker of sIMB. Control subjects will undergo a
      physical exam and a creatine kinase dosage. Tissue muscle has been collected beforehand in
      the frame of the routine diagnostic procedure for both patients and control subjects.

      Expression profiles will be obtained by RNAseq from 15 muscle biopsies. Three groups of
      samples will be compared: 5 from early-stage sIMB patients, 5 from late-stage sIMB patients
      and 5 from control subjects.

      In addition to known expression modifications of genes involved in the inflammatory response,
      in particular at early stages of the sIMB, or of genes involved in autophagy processes, at
      late stages of the disease where muscle degeneration is advanced, this study will allow
      identifying lncRNA potentially involved in the sIMB. Inasmuch as lncRNA are crucial for the
      regulation of cell differentiation and ageing processes at the epigenetic level, this pilot
      study will make possible to identify a group of genes of particular relevance, thus enabling
      further research on epigenetic regulation. Furthermore, a delayed gene expression, as is the
      case with lncRNA in early-stage sIMB patients, compared to lncRNA in late-stages disease
      patients, may prove a biomarker for evolution, and serve as a beneficial tool for monitoring
      sIMB in therapeutic trials to come.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: sIBM gene expression profile
time frame: at 12 Months
description: The expression of different genes in muscle tissue will be evaluated by RNA-seq and will allow to establish the IBM gene expression profile
measure: CPK level
time frame: at 12 Months
description: The CPK level will be evaluated.
measure: Rate of cN-1A antibodies.
time frame: at 12 Months
description: Presence or absence of cN-1A antibodies will be evaluated.
measure: IWCI score
time frame: at 12 Months
description: The IWCI score will be evaluated.
arm group label: Early-stage sIMB patients
arm group type: Other
arm group label: Late-stage sIMB patients
arm group type: Other
arm group label: Control subjects
arm group type: Other
intervention type: Other
intervention name: Blood collection
description: assay of CPK and anti-cN-1A antibodies
arm group label: Control subjects
arm group label: Early-stage sIMB patients
arm group label: Late-stage sIMB patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Myositis
mesh term: Myositis, Inclusion Body