<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/NCT03804723</url>
  </required_header>
  <id_info>
    <org_study_id>001</org_study_id>
    <nct_id>NCT03804723</nct_id>
  </id_info>
  <brief_title>Glucocorticoids Withdrawal in Early Systemic Lupus Erythematosus</brief_title>
  <official_title>Glucocorticoids Withdrawal in Early Systemic Lupus Erythematosus: a Randomized Placebo-controlled Equivalence Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pisa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pisa</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a 36 months, randomized, double-blind, placebo-controlled, parallel-groups,&#xD;
      equivalence multicenter trial in patients with inactive Systemic Lupus Erythematosus to&#xD;
      evaluate if low disease activity can be sustained with withdrawal of glucocorticoids in&#xD;
      patients on stable clinical remission or low disease activity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 2019</start_date>
  <completion_date type="Anticipated">September 2023</completion_date>
  <primary_completion_date type="Anticipated">June 2022</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>This is a 36 month, randomized, double-blind, placebo-controlled, parallel-groups, equivalence multicenter trial in patients with inactive SLE to evaluate if low disease activity can be sustained with withdrawal of glucocorticoids</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>disease flare</measure>
    <time_frame>35 months</time_frame>
    <description>The primary endpoint is the proportion of patients who will experience a disease during the follow-up period in the groups given prednisone 5 mg or placebo in the double-blind period.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">321</enrollment>
  <condition>Systemic Lupus Erythematosus</condition>
  <condition>Glucocorticoids</condition>
  <condition>Therapy Withdrawal</condition>
  <arm_group>
    <arm_group_label>GC withdrawal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>non GC withdrawal</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>oral Prednisone 5mg</intervention_name>
    <description>patients randomized to this arm will stop prednisone 5 mg</description>
    <arm_group_label>GC withdrawal</arm_group_label>
    <arm_group_label>non GC withdrawal</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of SLE according to the EULAR/ACR criteria within three years from screening&#xD;
             visit&#xD;
&#xD;
          -  Ability to understand the purpose and risks of the study and provide signed and dated&#xD;
             informed consent and authorization to use protected health information in accordance&#xD;
             with national subject privacy regulations&#xD;
&#xD;
          -  Aged 18 to 75 years old, inclusive, at the time of informed consent&#xD;
&#xD;
          -  Documented diagnosis of SLE according to the current ACR criteria&#xD;
&#xD;
          -  Stable immunosuppressive treatment for SLE for a minimum of one year/six months&#xD;
&#xD;
          -  Stable treatment with antimalarials for a minimum of 3 months&#xD;
&#xD;
          -  stable (lasting for at least 6 months) low disease activity&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Disease activity (non LLDAS) within 6 months prior to screening&#xD;
&#xD;
          -  Concomitant ongoing conditions (e.g. asthma, Crohn's disease) that require treatment&#xD;
             with systemic GC (excluding topical or inhaled GC).&#xD;
&#xD;
          -  Unwillingness or inability to comply with the requirements of this protocol, including&#xD;
             the presence of any condition (physical, mental, social) likely to affect the subject&#xD;
             returning for follow-up visits on schedule&#xD;
&#xD;
          -  Nursing mothers, pregnant women or women planning to become pregnant during the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Marta Mosca, MD</last_name>
    <phone>050992519</phone>
    <email>marta.mosca@med.inipi.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Chiara Tani, MD</last_name>
    <email>chiara.tani@ao-pisa.toscana.it</email>
  </overall_contact_backup>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>January 16, 2019</last_update_submitted>
  <last_update_submitted_qc>January 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pisa</investigator_affiliation>
    <investigator_full_name>Marta Mosca</investigator_full_name>
    <investigator_title>Assistant Professor of Rheumatology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lupus Erythematosus, Systemic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prednisone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03804723
org study id: 001
nct id: NCT03804723
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is a 36 months, randomized, double-blind, placebo-controlled, parallel-groups,
      equivalence multicenter trial in patients with inactive Systemic Lupus Erythematosus to
      evaluate if low disease activity can be sustained with withdrawal of glucocorticoids in
      patients on stable clinical remission or low disease activity.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a 36 month, randomized, double-blind, placebo-controlled, parallel-groups, equivalence multicenter trial in patients with inactive SLE to evaluate if low disease activity can be sustained with withdrawal of glucocorticoids
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: disease flare
time frame: 35 months
description: The primary endpoint is the proportion of patients who will experience a disease during the follow-up period in the groups given prednisone 5 mg or placebo in the double-blind period.
arm group label: GC withdrawal
arm group type: Experimental
arm group label: non GC withdrawal
arm group type: Placebo Comparator
intervention type: Drug
intervention name: oral Prednisone 5mg
description: patients randomized to this arm will stop prednisone 5 mg
arm group label: GC withdrawal
arm group label: non GC withdrawal
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Marta Mosca, MD
phone: 050992519
email: marta.mosca@med.inipi.it
last name: Chiara Tani, MD
email: chiara.tani@ao-pisa.toscana.it
responsible party type: Principal Investigator
investigator affiliation: University of Pisa
investigator full name: Marta Mosca
investigator title: Assistant Professor of Rheumatology
mesh term: Lupus Erythematosus, Systemic
mesh term: Prednisone
sharing ipd: Undecided