<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/NCT04404517</url>
  </required_header>
  <id_info>
    <org_study_id>IntnsificADA</org_study_id>
    <nct_id>NCT04404517</nct_id>
  </id_info>
  <brief_title>Correlation of Serum Adalimumab Levels at an Administration of 40 mg Weekly vs 80 mg Every Two Weeks</brief_title>
  <acronym>IntnsificADA</acronym>
  <official_title>Correlation of Serum Adalimumab Levels at an Administration of 40 mg Weekly vs 80 mg Every Two Weeks</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitario La Paz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Universitario La Paz</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      RCT to evaluate possible pharmacokinetic differences between the two current regimes of&#xD;
      intensified adalimumab administration.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      IBD patients in need of intensified adalimumab treatment will be randomized to receive 40mg&#xD;
      sc weekly or 80mg sc every two weeks, and after 6 weeks of treatment each of the groups will&#xD;
      be allocated to the other dosing regime. Adalimumab blood levels and other features such as&#xD;
      specific drug antibodies and disease activity parameters will be compared between both&#xD;
      groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 1, 2019</start_date>
  <completion_date type="Anticipated">October 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2021</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adalimumab trough level</measure>
    <time_frame>12 weeks</time_frame>
    <description>Drug levels will be measured during 12 weeks of treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Antibodies to Adalimumab (ADA)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Antibodies to Adalimumab will be tested for 12 weeks of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical response for Ulcerative Colitis</measure>
    <time_frame>12 weeks</time_frame>
    <description>Simple Clinical Colitis Activity Index (SCCAI) (for UC) refers to disease symptoms during the previous week. It is composed of six domains. After recording, the clinician-based SCCAI is able to categorize two types of patients: patients with inactive disease (SCCAI&lt;5) and patients with active disease (SCCAI≥5).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical response for Ulcerative colitis</measure>
    <time_frame>12 weeks</time_frame>
    <description>Truelove Index (for UC), is composed of 6 variables. Clinical remission was defined as 1 or 2 stools per day without blood, absence of fever or tachycardia, a normal hemoglobin or &quot;returning towards normal,&quot; a normal ESR or &quot;returning towards normal,&quot; and gaining weight.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical response for Crohn´s Disease</measure>
    <time_frame>12 weeks</time_frame>
    <description>Harvey-Bradshaw Index (for CD) considers five parameters. For each parameter a specific score is assigned. A score below 5 is considered as clinical remission. A reduction of 3 points is considered as relevant to define clinical response.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fecal calprotectin</measure>
    <time_frame>12 weeks</time_frame>
    <description>Fecal calprotectin levels will be tested during the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood acute phase reactants</measure>
    <time_frame>12 weeks</time_frame>
    <description>Blood acute phase reactants will be tested during the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QOL</measure>
    <time_frame>12 weeks</time_frame>
    <description>Quality of life will be analysed using the Inflammatory Bowel Disease Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Satisfaction</measure>
    <time_frame>12 weeks</time_frame>
    <description>Treatment Satisfaction Questionnaire for Medication (TSQM)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Inflammatory Bowel Diseases</condition>
  <arm_group>
    <arm_group_label>40mg1w</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Adalimumab at an administration of 40 mg weekly for 6 weeks, followed by Adalimumab at an administration of 80 mg every two weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>80mg2w</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Adalimumab at an administration of 80 mg every two weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Adalimumab</intervention_name>
    <description>Monoclonal antibody used in IBD treatment</description>
    <arm_group_label>40mg1w</arm_group_label>
    <arm_group_label>80mg2w</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients &gt; 18y&#xD;
&#xD;
          -  Intensified adalimumab regime at least 4 weeks prior to enrollment.&#xD;
&#xD;
          -  Immunosuppressants are allowed if a stable dose for &gt; 12w is maintained.&#xD;
&#xD;
          -  Corticosteroids are allowed if they were initiated prior to enrollment and a stable&#xD;
             dose is maintained.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients unable to understand study protocol, study procedures or not capacitated to&#xD;
             give informed consent.&#xD;
&#xD;
          -  Pregnant or lactating women.&#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>Maria Dolores Martin Arranz, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Hospital Universitario La Paz. IdiPaz. Universidad Autónoma de Madrid.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Eduardo Martin Arranz, PhD</last_name>
    <phone>+34912071350</phone>
    <email>emarranz@salud.madrid.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital Universitario La Paz</name>
      <address>
        <city>Madrid</city>
        <state>Madrd</state>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eduardo Martin Arranz, PhD</last_name>
      <phone>+34912071350</phone>
      <email>emarranz@salud.madrid.org</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>September 16, 2019</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>July 22, 2021</last_update_submitted>
  <last_update_submitted_qc>July 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Universitario La Paz</investigator_affiliation>
    <investigator_full_name>María Dolores Martín Arranz, PhD</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <keyword>AntiTNF</keyword>
  <keyword>Inflammatory Bowel Diseases</keyword>
  <keyword>Adalimumab</keyword>
  <keyword>Therapeutic drug monitoring</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intestinal Diseases</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adalimumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04404517
org study id: IntnsificADA
nct id: NCT04404517
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
RCT to evaluate possible pharmacokinetic differences between the two current regimes of
      intensified adalimumab administration.
IBD patients in need of intensified adalimumab treatment will be randomized to receive 40mg
      sc weekly or 80mg sc every two weeks, and after 6 weeks of treatment each of the groups will
      be allocated to the other dosing regime. Adalimumab blood levels and other features such as
      specific drug antibodies and disease activity parameters will be compared between both
      groups.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Adalimumab trough level
time frame: 12 weeks
description: Drug levels will be measured during 12 weeks of treatment
measure: Antibodies to Adalimumab (ADA)
time frame: 12 weeks
description: Antibodies to Adalimumab will be tested for 12 weeks of treatment
measure: Clinical response for Ulcerative Colitis
time frame: 12 weeks
description: Simple Clinical Colitis Activity Index (SCCAI) (for UC) refers to disease symptoms during the previous week. It is composed of six domains. After recording, the clinician-based SCCAI is able to categorize two types of patients: patients with inactive disease (SCCAI<5) and patients with active disease (SCCAI≥5).
measure: Clinical response for Ulcerative colitis
time frame: 12 weeks
description: Truelove Index (for UC), is composed of 6 variables. Clinical remission was defined as 1 or 2 stools per day without blood, absence of fever or tachycardia, a normal hemoglobin or "returning towards normal," a normal ESR or "returning towards normal," and gaining weight.
measure: Clinical response for Crohn´s Disease
time frame: 12 weeks
description: Harvey-Bradshaw Index (for CD) considers five parameters. For each parameter a specific score is assigned. A score below 5 is considered as clinical remission. A reduction of 3 points is considered as relevant to define clinical response.
measure: Fecal calprotectin
time frame: 12 weeks
description: Fecal calprotectin levels will be tested during the study
measure: Blood acute phase reactants
time frame: 12 weeks
description: Blood acute phase reactants will be tested during the study
measure: QOL
time frame: 12 weeks
description: Quality of life will be analysed using the Inflammatory Bowel Disease Questionnaire
measure: Treatment Satisfaction
time frame: 12 weeks
description: Treatment Satisfaction Questionnaire for Medication (TSQM)
arm group label: 40mg1w
arm group type: Active Comparator
description: Adalimumab at an administration of 40 mg weekly for 6 weeks, followed by Adalimumab at an administration of 80 mg every two weeks
arm group label: 80mg2w
arm group type: Active Comparator
description: Adalimumab at an administration of 80 mg every two weeks
intervention type: Drug
intervention name: Adalimumab
description: Monoclonal antibody used in IBD treatment
arm group label: 40mg1w
arm group label: 80mg2w
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Maria Dolores Martin Arranz, PhD
role: Study Director
affiliation: Hospital Universitario La Paz. IdiPaz. Universidad Autónoma de Madrid.
last name: Eduardo Martin Arranz, PhD
phone: +34912071350
email: emarranz@salud.madrid.org
facility: 
status: Recruiting
contact: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital Universitario La Paz
investigator full name: María Dolores Martín Arranz, PhD
investigator title: Director
mesh term: Intestinal Diseases
mesh term: Inflammatory Bowel Diseases
mesh term: Adalimumab
sharing ipd: No