<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/NCT02256462</url>
  </required_header>
  <id_info>
    <org_study_id>PAILOT</org_study_id>
    <nct_id>NCT02256462</nct_id>
  </id_info>
  <brief_title>Pediatric Crohn's Disease AdalImumab Level-based Optimization Treatment (PAILOT) Trial</brief_title>
  <official_title>Pediatric Crohn's Disease AdalImumab Level-based Optimization Treatment (PAILOT) Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Schneider Children's Medical Center, Israel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Schneider Children's Medical Center, Israel</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objectives: To examine the effect of drug level-based personalized treatment of adalimumab in&#xD;
      children with Crohn's disease. Design: A prospective, randomized, open label study. Setting:&#xD;
      Pediatric gastroenterology centers. Participants: Children 6 year to 17 years who are&#xD;
      diagnosed with CD and are planned to receive adalimumab treatment. Main outcome measures:&#xD;
      Pediatric Crohn's Activity Index (PCDAI) at 48 and 72 weeks. Secondary outcome measures:&#xD;
      Corticosteroids free remission rates and on adalimumab at 48 and 72 weeks. The effect of&#xD;
      routine adalimumab drug monitoring-based treatment on trough levels and anti-adalimumab&#xD;
      antibodies during therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The efficacy of adalimumab in inducing and maintaining remission in both adults and children&#xD;
      with moderate-to-severe Crohn's Disease has been demonstrated in multiple clinical trials.&#xD;
      Despite efforts to optimize treatment, approximately 40% of patients who initially respond to&#xD;
      anti-TNF ultimately lose response. Measurement of adalimumab (ADA) drug levels and antibodies&#xD;
      to adalimumab (ATAs) in patients has been shown to assist decision making in patients who&#xD;
      have lost response during the course of treatment. This approach is based on the observations&#xD;
      showing that higher ADA concentrations are associated with higher treatment efficacy and that&#xD;
      loss of response is primarily attributed to either undetectable drug levels or to the&#xD;
      presence of high titers of ATAs. Existing data is mostly based on retrospective cohort&#xD;
      studies, nevertheless, the concept of routine therapeutic drug monitoring in-order to improve&#xD;
      efficacy is still evolving. Recently, preliminary results of the Trough level Adapted&#xD;
      infliXImab Treatment (TAXIT) study, performed in adult IBD patients, have failed to&#xD;
      demonstrate superiority of level-based treatment over clinically-based treatment regarding&#xD;
      rates of response over time. Nevertheless, it is premature to conclude that patients do not&#xD;
      benefit from a tailored approach as the reported abstract did not stratify patients according&#xD;
      to type of disease (CD vs. ulcerative colitis) and as some significant advantages such as&#xD;
      reduced rate of antibodies and reduction of CRP were described in the level-based arm.&#xD;
      Anti-TNF treatment in pediatric patients may differ from adults due to a higher risk for&#xD;
      developing the rare hepatosplenic T cell lymphomas (HSCTL) in young males treated with&#xD;
      combination therapy including thiopurines and anti-TNF agents. Concomitant therapy (using&#xD;
      immunomodulators, mainly azathioprine) which has demonstrated superiority over mono-therapy&#xD;
      has become a standard of care in moderate to severe CD in adults. In-view of the concerns of&#xD;
      pediatric gastroenterologist from concomitant therapy-induced adverse events the option to&#xD;
      improve efficacy of mono-therapy by guiding it according to drug monitoring is further&#xD;
      appealing. Therefore, our aim is to assess the efficacy of routine therapeutic drug&#xD;
      monitoring based treatment in pediatric CD patients in a prospective randomized control&#xD;
      trial. We hope that this study will further contribute to the understanding of the potential&#xD;
      benefits of therapeutic drug monitoring based management in pediatric patients treated with&#xD;
      anti-TNF agents.Hypothesis:&#xD;
&#xD;
      We hypothesize that by routine measuring of ADA trough levels and ATAs titers we will achieve&#xD;
      higher and stable trough levels resulting in greater corticosteroid free remission rates and&#xD;
      decreased LOR rates. We assume that this will be associated with lower frequencies of ATAs.&#xD;
      We further assume that the intervention will reduce the need for alteration of treatment&#xD;
      schemes by adding immunomodulators or by switching treatment within class or out of class.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      This is ADA therapy optimization study in patients starting or receiving ADA due to active&#xD;
      disease.&#xD;
&#xD;
        1. Primary Efficacy Objective: To evaluate the effect of routine ADA drug monitoring-based&#xD;
           treatment, in comparison to clinically-based monitoring on disease activity.&#xD;
&#xD;
        2. Secondary Objective: To evaluate the effect of routine ADA drug monitoring-based&#xD;
           treatment on trough levels and ATAs during therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2015</start_date>
  <completion_date type="Actual">January 31, 2019</completion_date>
  <primary_completion_date type="Actual">January 31, 2019</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Loss of response (LOR) during treatment.</measure>
    <time_frame>Week 72</time_frame>
    <description>Patients with loss of response are defined as those with a good initial clinical response to anti-TNFα, with a later clinical and biochemical relapse defined as PCDAI≥10 (for patients in remission) or an increase of 15 points PCDAI from post induction baseline and CRP&gt; 0.5mg/dl and/or calprotectin&gt;150µgr/gr</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Corticosteroids free complete clinical remission, on ADA,</measure>
    <time_frame>48 and 72 weeks</time_frame>
    <description>Patients with PCDAI&lt;10, and quiescent disease by physician global assessment (PGA).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trough levels</measure>
    <time_frame>8, 16, 32, 48, 72 weeks</time_frame>
    <description>Mean adalimumab trough levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antibodies to adalimumab</measure>
    <time_frame>8, 16, 32, 48, 72 weeks</time_frame>
    <description>Presence of antibodies to adalimumab (ATAs)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anthropometric indices</measure>
    <time_frame>0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, weeks</time_frame>
    <description>Anthropometric indices (weight, height, BMI) and growth assessment during scheduled visits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory markers</measure>
    <time_frame>0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, weeks</time_frame>
    <description>Laboratory surrogate markers (CBC, ESR, CRP, albumin, fecal calprotectin) during scheduled visits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>4, 8, 16, 24, 32, 40, 48, 56, 64, 72, weeks</time_frame>
    <description>Medication associated adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The need for treatment modification during therapy</measure>
    <time_frame>Week 72</time_frame>
    <description>Addition of immunomodulator, switch within/out of class</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease activity defined by PCDAI</measure>
    <time_frame>48 and 72 weeks</time_frame>
    <description>Pediatric Crohn's Disease Activity Index</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">82</enrollment>
  <condition>Crohn's Disease</condition>
  <arm_group>
    <arm_group_label>Interventional</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adalimumab levels and antibodies will be obtained with every laboratory examination (every 2 months, except for the first 2 visits). Dose or interval adjustment will be performed as followed:when trough levels results taken prior to ADA injection are above 5 µg/ml no change in dosing is required. Detectable levels below 5 µg/ml will result in interval decrease to every week. If levels are still below 5 µg/ml dose will be increased to 40 mg (in patients receiving less than 40 mg). Undetectable levels below 0.3µg/ml will be followed by antibodies (ATAs) measurement. If ATAs are persistently above 8 µg/ml the patient will discontinue the study. If ATAs are below 8 µg/ml ADA intervals will be decreased to every week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clinical</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Adalimumab levels and antibodies will be requested based on physician judgment when there are signs of loss of response (LOR). Dose and interval adjustment will be performed according to clinical measures: Following physician decision trough levels and ATAs will be collected and further adjustment may be considered according to results. Interval adjustment will be performed as described for the interventional arm.&#xD;
LOR is defined as PCDAI equal or higher than 10 or CRP higher than 0.5 mg/dl (5mg/l) and/or Fecal calprotectin higher than 150 mcg/gr (If lower than 150 at randomization).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Adalimumab</intervention_name>
    <description>Eligible patients are those who are planned to start Adalimumab (ADA). Patients will be randomized at the first screening visits to either group 1 (interventional) or group 2 (clinical). Eligible patients, will start induction treatment (weeks 0,2) with ADA (&gt; 40kg 160/80/40 mg every 2 weeks or &lt; 40 kg 100/50/25 mg for m2 body surface area every 2 weeks). Interventions will start from the 4th injection for responding patients only (based on levels taken prior to the third injection). Responding patients will continue to the maintenance phase in which they will receive ADA every 2 weeks, either 40 mg or 25 mg/m2. At screening, and every 2 months all patients will be examined and have height, weight, PCDAI performed as well as comprehensive laboratory examinations.</description>
    <arm_group_label>Interventional</arm_group_label>
    <other_name>Humira</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Crohn's disease&#xD;
&#xD;
          2. Age 6-17 (inclusive)&#xD;
&#xD;
          3. Naïve to biologics&#xD;
&#xD;
          4. Informed consent&#xD;
&#xD;
          5. Neg. TB-Test, negative HBV- S Ag&#xD;
&#xD;
          6. Negative stool culture, parasites and clostridium toxin&#xD;
&#xD;
        Inclusion criteria Comments:&#xD;
&#xD;
          1. Patients receiving corticosteroids may be included if on taper-down scheduled to be&#xD;
             completed by week 10.&#xD;
&#xD;
          2. Partial enteral nutrition, accounting for less than 50% of daily required calories,&#xD;
             may be supplied as needed.&#xD;
&#xD;
          3. Patients receiving antibiotics must cease use of antibiotics within the 14 days of&#xD;
             receiving the first injection. Excluding immunomodulators (azathioprine/6MP and&#xD;
             methotrexate), any other targeted therapy for crohn's disease (i.e 5-ASA) must be&#xD;
             stopped prior to ADA first injection. Immunomodulators will be required to be stopped&#xD;
             either prior to first ADA injection or at 6 months following ADA initiation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnancy.&#xD;
&#xD;
          2. Renal Failure.&#xD;
&#xD;
          3. Current abscess or perforation of the bowel.&#xD;
&#xD;
          4. Small bowel obstruction within the last 6 months.&#xD;
&#xD;
          5. Fixed non inflammatory stricture with related symptoms.&#xD;
&#xD;
          6. Complicated or heavily draining perianal fistula (indolent non draining or minimally&#xD;
             draining fistula are not an exclusion criteria).&#xD;
&#xD;
          7. Prior treatment with infliximab or adalimumab.&#xD;
&#xD;
          8. Previous malignancy.&#xD;
&#xD;
          9. Sepsis or active bacterial infection.&#xD;
&#xD;
         10. Surgery related to Crohn's disease in the previous 8 weeks.&#xD;
&#xD;
         11. Positive Hepatitis B surface antigen or evidence for TB.&#xD;
&#xD;
         12. IBD unclassified.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Raanan Shamir, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Tel Aviv University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Schneider Children's Hospital</name>
      <address>
        <city>Petach Tikva</city>
        <zip>4920235</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <reference>
    <citation>Hanauer SB, Sandborn WJ, Rutgeerts P, Fedorak RN, Lukas M, MacIntosh D, Panaccione R, Wolf D, Pollack P. Human anti-tumor necrosis factor monoclonal antibody (adalimumab) in Crohn's disease: the CLASSIC-I trial. Gastroenterology. 2006 Feb;130(2):323-33; quiz 591. doi: 10.1053/j.gastro.2005.11.030.</citation>
    <PMID>16472588</PMID>
  </reference>
  <reference>
    <citation>Colombel JF, Sandborn WJ, Rutgeerts P, Enns R, Hanauer SB, Panaccione R, Schreiber S, Byczkowski D, Li J, Kent JD, Pollack PF. Adalimumab for maintenance of clinical response and remission in patients with Crohn's disease: the CHARM trial. Gastroenterology. 2007 Jan;132(1):52-65. doi: 10.1053/j.gastro.2006.11.041. Epub 2006 Nov 29.</citation>
    <PMID>17241859</PMID>
  </reference>
  <reference>
    <citation>Karmiris K, Paintaud G, Noman M, Magdelaine-Beuzelin C, Ferrante M, Degenne D, Claes K, Coopman T, Van Schuerbeek N, Van Assche G, Vermeire S, Rutgeerts P. Influence of trough serum levels and immunogenicity on long-term outcome of adalimumab therapy in Crohn's disease. Gastroenterology. 2009 Nov;137(5):1628-40. doi: 10.1053/j.gastro.2009.07.062. Epub 2009 Aug 5.</citation>
    <PMID>19664627</PMID>
  </reference>
  <reference>
    <citation>Paul S, Moreau AC, Del Tedesco E, Rinaudo M, Phelip JM, Genin C, Peyrin-Biroulet L, Roblin X. Pharmacokinetics of adalimumab in inflammatory bowel diseases: a systematic review and meta-analysis. Inflamm Bowel Dis. 2014 Jul;20(7):1288-95. doi: 10.1097/MIB.0000000000000037.</citation>
    <PMID>24831559</PMID>
  </reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>September 26, 2014</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2014</study_first_posted>
  <last_update_submitted>September 25, 2021</last_update_submitted>
  <last_update_submitted_qc>September 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Schneider Children's Medical Center, Israel</investigator_affiliation>
    <investigator_full_name>Amit Assa</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</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/NCT02256462
org study id: PAILOT
nct id: NCT02256462
lead sponsor: 
has dmc: No
Objectives: To examine the effect of drug level-based personalized treatment of adalimumab in
      children with Crohn's disease. Design: A prospective, randomized, open label study. Setting:
      Pediatric gastroenterology centers. Participants: Children 6 year to 17 years who are
      diagnosed with CD and are planned to receive adalimumab treatment. Main outcome measures:
      Pediatric Crohn's Activity Index (PCDAI) at 48 and 72 weeks. Secondary outcome measures:
      Corticosteroids free remission rates and on adalimumab at 48 and 72 weeks. The effect of
      routine adalimumab drug monitoring-based treatment on trough levels and anti-adalimumab
      antibodies during therapy.
The efficacy of adalimumab in inducing and maintaining remission in both adults and children
      with moderate-to-severe Crohn's Disease has been demonstrated in multiple clinical trials.
      Despite efforts to optimize treatment, approximately 40% of patients who initially respond to
      anti-TNF ultimately lose response. Measurement of adalimumab (ADA) drug levels and antibodies
      to adalimumab (ATAs) in patients has been shown to assist decision making in patients who
      have lost response during the course of treatment. This approach is based on the observations
      showing that higher ADA concentrations are associated with higher treatment efficacy and that
      loss of response is primarily attributed to either undetectable drug levels or to the
      presence of high titers of ATAs. Existing data is mostly based on retrospective cohort
      studies, nevertheless, the concept of routine therapeutic drug monitoring in-order to improve
      efficacy is still evolving. Recently, preliminary results of the Trough level Adapted
      infliXImab Treatment (TAXIT) study, performed in adult IBD patients, have failed to
      demonstrate superiority of level-based treatment over clinically-based treatment regarding
      rates of response over time. Nevertheless, it is premature to conclude that patients do not
      benefit from a tailored approach as the reported abstract did not stratify patients according
      to type of disease (CD vs. ulcerative colitis) and as some significant advantages such as
      reduced rate of antibodies and reduction of CRP were described in the level-based arm.
      Anti-TNF treatment in pediatric patients may differ from adults due to a higher risk for
      developing the rare hepatosplenic T cell lymphomas (HSCTL) in young males treated with
      combination therapy including thiopurines and anti-TNF agents. Concomitant therapy (using
      immunomodulators, mainly azathioprine) which has demonstrated superiority over mono-therapy
      has become a standard of care in moderate to severe CD in adults. In-view of the concerns of
      pediatric gastroenterologist from concomitant therapy-induced adverse events the option to
      improve efficacy of mono-therapy by guiding it according to drug monitoring is further
      appealing. Therefore, our aim is to assess the efficacy of routine therapeutic drug
      monitoring based treatment in pediatric CD patients in a prospective randomized control
      trial. We hope that this study will further contribute to the understanding of the potential
      benefits of therapeutic drug monitoring based management in pediatric patients treated with
      anti-TNF agents.Hypothesis:

      We hypothesize that by routine measuring of ADA trough levels and ATAs titers we will achieve
      higher and stable trough levels resulting in greater corticosteroid free remission rates and
      decreased LOR rates. We assume that this will be associated with lower frequencies of ATAs.
      We further assume that the intervention will reduce the need for alteration of treatment
      schemes by adding immunomodulators or by switching treatment within class or out of class.

      Objectives:

      This is ADA therapy optimization study in patients starting or receiving ADA due to active
      disease.

        1. Primary Efficacy Objective: To evaluate the effect of routine ADA drug monitoring-based
           treatment, in comparison to clinically-based monitoring on disease activity.

        2. Secondary Objective: To evaluate the effect of routine ADA drug monitoring-based
           treatment on trough levels and ATAs during therapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Loss of response (LOR) during treatment.
time frame: Week 72
description: Patients with loss of response are defined as those with a good initial clinical response to anti-TNFα, with a later clinical and biochemical relapse defined as PCDAI≥10 (for patients in remission) or an increase of 15 points PCDAI from post induction baseline and CRP> 0.5mg/dl and/or calprotectin>150µgr/gr
measure: Corticosteroids free complete clinical remission, on ADA,
time frame: 48 and 72 weeks
description: Patients with PCDAI<10, and quiescent disease by physician global assessment (PGA).
measure: Trough levels
time frame: 8, 16, 32, 48, 72 weeks
description: Mean adalimumab trough levels
measure: Antibodies to adalimumab
time frame: 8, 16, 32, 48, 72 weeks
description: Presence of antibodies to adalimumab (ATAs)
measure: Anthropometric indices
time frame: 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, weeks
description: Anthropometric indices (weight, height, BMI) and growth assessment during scheduled visits
measure: Laboratory markers
time frame: 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, weeks
description: Laboratory surrogate markers (CBC, ESR, CRP, albumin, fecal calprotectin) during scheduled visits
measure: Adverse events
time frame: 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, weeks
description: Medication associated adverse events
measure: The need for treatment modification during therapy
time frame: Week 72
description: Addition of immunomodulator, switch within/out of class
measure: Disease activity defined by PCDAI
time frame: 48 and 72 weeks
description: Pediatric Crohn's Disease Activity Index
arm group label: Interventional
arm group type: Experimental
description: Adalimumab levels and antibodies will be obtained with every laboratory examination (every 2 months, except for the first 2 visits). Dose or interval adjustment will be performed as followed:when trough levels results taken prior to ADA injection are above 5 µg/ml no change in dosing is required. Detectable levels below 5 µg/ml will result in interval decrease to every week. If levels are still below 5 µg/ml dose will be increased to 40 mg (in patients receiving less than 40 mg). Undetectable levels below 0.3µg/ml will be followed by antibodies (ATAs) measurement. If ATAs are persistently above 8 µg/ml the patient will discontinue the study. If ATAs are below 8 µg/ml ADA intervals will be decreased to every week.
arm group label: Clinical
arm group type: No Intervention
description: Adalimumab levels and antibodies will be requested based on physician judgment when there are signs of loss of response (LOR). Dose and interval adjustment will be performed according to clinical measures: Following physician decision trough levels and ATAs will be collected and further adjustment may be considered according to results. Interval adjustment will be performed as described for the interventional arm.
LOR is defined as PCDAI equal or higher than 10 or CRP higher than 0.5 mg/dl (5mg/l) and/or Fecal calprotectin higher than 150 mcg/gr (If lower than 150 at randomization).
intervention type: Drug
intervention name: Adalimumab
description: Eligible patients are those who are planned to start Adalimumab (ADA). Patients will be randomized at the first screening visits to either group 1 (interventional) or group 2 (clinical). Eligible patients, will start induction treatment (weeks 0,2) with ADA (> 40kg 160/80/40 mg every 2 weeks or < 40 kg 100/50/25 mg for m2 body surface area every 2 weeks). Interventions will start from the 4th injection for responding patients only (based on levels taken prior to the third injection). Responding patients will continue to the maintenance phase in which they will receive ADA every 2 weeks, either 40 mg or 25 mg/m2. At screening, and every 2 months all patients will be examined and have height, weight, PCDAI performed as well as comprehensive laboratory examinations.
arm group label: Interventional
other name: Humira
criteria: 
gender: All
minimum age: 6 Years
maximum age: 17 Years
healthy volunteers: No
last name: Raanan Shamir, MD
role: Study Chair
affiliation: Tel Aviv University
facility: 
country: Israel
citation: Hanauer SB, Sandborn WJ, Rutgeerts P, Fedorak RN, Lukas M, MacIntosh D, Panaccione R, Wolf D, Pollack P. Human anti-tumor necrosis factor monoclonal antibody (adalimumab) in Crohn's disease: the CLASSIC-I trial. Gastroenterology. 2006 Feb;130(2):323-33; quiz 591. doi: 10.1053/j.gastro.2005.11.030.
PMID: 16472588
citation: Colombel JF, Sandborn WJ, Rutgeerts P, Enns R, Hanauer SB, Panaccione R, Schreiber S, Byczkowski D, Li J, Kent JD, Pollack PF. Adalimumab for maintenance of clinical response and remission in patients with Crohn's disease: the CHARM trial. Gastroenterology. 2007 Jan;132(1):52-65. doi: 10.1053/j.gastro.2006.11.041. Epub 2006 Nov 29.
PMID: 17241859
citation: Karmiris K, Paintaud G, Noman M, Magdelaine-Beuzelin C, Ferrante M, Degenne D, Claes K, Coopman T, Van Schuerbeek N, Van Assche G, Vermeire S, Rutgeerts P. Influence of trough serum levels and immunogenicity on long-term outcome of adalimumab therapy in Crohn's disease. Gastroenterology. 2009 Nov;137(5):1628-40. doi: 10.1053/j.gastro.2009.07.062. Epub 2009 Aug 5.
PMID: 19664627
citation: Paul S, Moreau AC, Del Tedesco E, Rinaudo M, Phelip JM, Genin C, Peyrin-Biroulet L, Roblin X. Pharmacokinetics of adalimumab in inflammatory bowel diseases: a systematic review and meta-analysis. Inflamm Bowel Dis. 2014 Jul;20(7):1288-95. doi: 10.1097/MIB.0000000000000037.
PMID: 24831559
responsible party type: Principal Investigator
investigator affiliation: Schneider Children's Medical Center, Israel
investigator full name: Amit Assa
investigator title: Dr
mesh term: Crohn Disease
mesh term: Adalimumab
sharing ipd: No