<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/NCT02186886</url>
  </required_header>
  <id_info>
    <org_study_id>50831-PIMS-Golimumab-UC</org_study_id>
    <nct_id>NCT02186886</nct_id>
  </id_info>
  <brief_title>Physiological Intermolecular Modification Spectroscopy (PIMS) in Ulcerative Colitis With Golimumab</brief_title>
  <official_title>Personalised Medicine: a Break Through Approach for Early Determination of Anti Tumor Necrosis Factor (TNF) Responders and Non Responders Among Patients With Ulcerative Colitis in a Prospective Study With Golimumab (Simponi)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kliniken im Naturpark Altmuehltal</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kliniken im Naturpark Altmuehltal</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim of this study is to determine wether the macromolecular spectral characteristic of&#xD;
      ulcerative colitis patients - measured by Physiological Intermolecular Modification&#xD;
      Spectroscopy (PIMS) - is a predictive factor for response to Simponi treatment&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is widely appreciated that almost all proteins and other biological macromolecular in vivo&#xD;
      exist, at least transiently, as components of structural and functional complexes. This&#xD;
      transient interaction in simple component solutions have been studied using well established&#xD;
      daylight light scattering (LS) method which reflects molecular oscillation (7-12). Protein&#xD;
      association, protein unfolding, protein aggregation and cellular crowding are known to affect&#xD;
      the normal function of cellular system (13-19). In many cases, the resulting small changes in&#xD;
      normal protein-protein intra- and intermolecular interactions are thought to lead to a&#xD;
      variety of human diseases (20, 21). Based on these and the acquired knowledge on LS, the&#xD;
      cutting edge technology, PIMS has been developed. PIMS is a label free technology that is&#xD;
      able to study protein-protein and protein-solvent interactions in multi-component solutions.&#xD;
      It provides individual real time dynamic fingerprint of total physiological macromolecular&#xD;
      assemblies in a tissue in presence and absence of exogenous molecules (drug or drug&#xD;
      candidate, peptide or protein).&#xD;
&#xD;
      This technology is based on dynamic molecular resonance of proteins and macromolecules.&#xD;
      Cellular extracts in physiological conditions are frozen at -37°C. Macromolecular spectra are&#xD;
      registered as the temperature within the sample raises from -37 to 37°C. This provides,&#xD;
      within the organ of interest, dynamic fingerprint of an individual entire macromolecular&#xD;
      assemblies. The present technology can therefore rapidly and specifically determine the&#xD;
      response of a tissue or cell when an exogenous molecule is administrated. It reflects patient&#xD;
      molecular capacity to respond to the drugs effect and allows to identifying different&#xD;
      subpopulations within a group in response to a specific treatment. It highlights the&#xD;
      responders from non-responders to a given treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2014</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2015</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical response</measure>
    <time_frame>Week 14</time_frame>
    <description>Reduction of partial Mayo Score &gt; 2 points versus baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Calprotectin stool levels</measure>
    <time_frame>Week 6</time_frame>
    <description>Change in calprotectin stool levels at week 6 versus baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Calprotectin stool levels</measure>
    <time_frame>Week 14</time_frame>
    <description>Change in calprotectin stool levels at week 14 versus baseline</description>
  </secondary_outcome>
  <other_outcome>
    <measure>molecular spectral range</measure>
    <time_frame>Week 14</time_frame>
    <description>Change in molecular spectral ranges versus baseline</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Ulcerative Colitis</condition>
  <arm_group>
    <arm_group_label>Golimumab</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Golimumab: Patients with body weight less than 80 kg initial dose of 200 mg, followed by 100 mg at week 2, then 50 mg every 4 weeks, thereafter // Patients with body weight greater than or equal to 80 kg initial dose of 200 mg, followed by 100 mg at week 2, then 100 mg every 4 weeks, thereafter</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Golimumab</intervention_name>
    <description>Physiological Intermolecular Modification Spectroscopy</description>
    <arm_group_label>Golimumab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  moderate to severe active ulcerative colitis&#xD;
&#xD;
          -  qualified for initiating Golimumab therapy, i.e.inadequate response to conventional&#xD;
             therapy including corticosteroids and 6-mercaptopurine or azathioprine or intolerance&#xD;
             of medical contraindications to such therapies&#xD;
&#xD;
          -  must be able and willing to provide written informed consent&#xD;
&#xD;
          -  must have a negative tuberculosis screening or if inactive (latent) tuberculosis&#xD;
             diagnosed anti-tuberculosis therapy to be started before initiation of Golimumab&#xD;
             therapy in accordance with local recommendations&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cancer&#xD;
&#xD;
          -  type one diabetes&#xD;
&#xD;
          -  current infection and/or inflammation other than related to ulcerative colitis&#xD;
&#xD;
          -  autoimmune diseases&#xD;
&#xD;
          -  any contraindications stated by Golimumab product label&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthias G Breidert, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Naturpark Kliniken Altmuehltal</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Matthias G Breidert, MD</last_name>
    <phone>+49845671</phone>
    <phone_ext>431</phone_ext>
    <email>matthias.breidert@klinik-koesching.de</email>
  </overall_contact>
  <location>
    <facility>
      <name>Kliniken im Naturpark Altmuehltal; Klinik Koesching</name>
      <address>
        <city>Kosching</city>
        <zip>85092</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Matthias G Breidert, MD</last_name>
      <phone>+49845671</phone>
      <phone_ext>431</phone_ext>
      <email>matthias.breidert@klinik-koesching.de</email>
    </contact>
    <investigator>
      <last_name>Matthias G Breidert, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 1, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>July 9, 2014</last_update_submitted>
  <last_update_submitted_qc>July 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 10, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ulcerative Colitis</keyword>
  <keyword>Golimumab</keyword>
  <keyword>Physiological Intermolecular Modification Spectroscopy</keyword>
  <keyword>PIMS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colitis</mesh_term>
    <mesh_term>Colitis, Ulcerative</mesh_term>
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Golimumab</mesh_term>
  </intervention_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/NCT02186886
org study id: 50831-PIMS-Golimumab-UC
nct id: NCT02186886
lead sponsor: 
has dmc: No
Aim of this study is to determine wether the macromolecular spectral characteristic of
      ulcerative colitis patients - measured by Physiological Intermolecular Modification
      Spectroscopy (PIMS) - is a predictive factor for response to Simponi treatment
It is widely appreciated that almost all proteins and other biological macromolecular in vivo
      exist, at least transiently, as components of structural and functional complexes. This
      transient interaction in simple component solutions have been studied using well established
      daylight light scattering (LS) method which reflects molecular oscillation (7-12). Protein
      association, protein unfolding, protein aggregation and cellular crowding are known to affect
      the normal function of cellular system (13-19). In many cases, the resulting small changes in
      normal protein-protein intra- and intermolecular interactions are thought to lead to a
      variety of human diseases (20, 21). Based on these and the acquired knowledge on LS, the
      cutting edge technology, PIMS has been developed. PIMS is a label free technology that is
      able to study protein-protein and protein-solvent interactions in multi-component solutions.
      It provides individual real time dynamic fingerprint of total physiological macromolecular
      assemblies in a tissue in presence and absence of exogenous molecules (drug or drug
      candidate, peptide or protein).

      This technology is based on dynamic molecular resonance of proteins and macromolecules.
      Cellular extracts in physiological conditions are frozen at -37°C. Macromolecular spectra are
      registered as the temperature within the sample raises from -37 to 37°C. This provides,
      within the organ of interest, dynamic fingerprint of an individual entire macromolecular
      assemblies. The present technology can therefore rapidly and specifically determine the
      response of a tissue or cell when an exogenous molecule is administrated. It reflects patient
      molecular capacity to respond to the drugs effect and allows to identifying different
      subpopulations within a group in response to a specific treatment. It highlights the
      responders from non-responders to a given treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Clinical response
time frame: Week 14
description: Reduction of partial Mayo Score > 2 points versus baseline
measure: Calprotectin stool levels
time frame: Week 6
description: Change in calprotectin stool levels at week 6 versus baseline
measure: Calprotectin stool levels
time frame: Week 14
description: Change in calprotectin stool levels at week 14 versus baseline
measure: molecular spectral range
time frame: Week 14
description: Change in molecular spectral ranges versus baseline
arm group label: Golimumab
arm group type: Other
description: Golimumab: Patients with body weight less than 80 kg initial dose of 200 mg, followed by 100 mg at week 2, then 50 mg every 4 weeks, thereafter // Patients with body weight greater than or equal to 80 kg initial dose of 200 mg, followed by 100 mg at week 2, then 100 mg every 4 weeks, thereafter
intervention type: Drug
intervention name: Golimumab
description: Physiological Intermolecular Modification Spectroscopy
arm group label: Golimumab
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Matthias G Breidert, MD
role: Principal Investigator
affiliation: Naturpark Kliniken Altmuehltal
last name: Matthias G Breidert, MD
phone: +49845671
phone ext: 431
email: matthias.breidert@klinik-koesching.de
facility: 
status: Recruiting
contact: 
investigator: 
country: Germany
responsible party type: Sponsor
mesh term: Colitis
mesh term: Colitis, Ulcerative
mesh term: Ulcer
mesh term: Golimumab