<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/NCT04424303</url>
  </required_header>
  <id_info>
    <org_study_id>A3921360</org_study_id>
    <secondary_id>TOFAst study</secondary_id>
    <nct_id>NCT04424303</nct_id>
  </id_info>
  <brief_title>Tofacitinib in Adult Patients With Moderate to Severe Ulcerative Colitis</brief_title>
  <acronym>TOFAST</acronym>
  <official_title>Evaluation of the Clinical Benefit of ToFAcitinib Treatment in Patients With Moderate to Severe Ulcerative Colitis Under Real-life Conditions of Use: TOFAst Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an observational prospective study with two years of follow-up, designed to evaluate&#xD;
      the effectiveness of tofacitinib in patients with moderate to severe ulcerative colitis in&#xD;
      French clinical practice&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 4, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2026</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2026</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients with clinical benefit 2 years after initiation of tofacitinib treatment.</measure>
    <time_frame>Week 104</time_frame>
    <description>The definition of clinical benefit is independent of the discontinuation or not of tofacitinib treatment during the observation period.&#xD;
Clinical benefit at 2 years is defined as a modified partial Mayo Score of 0 or 1 with rectal bleeding subscore of 0 and stool frequency subscore of 0 or 1&#xD;
-Patients who died or who had a colectomy or used another biologic/anti-JAK/immunosuppressant will be considered to be non-responders, as well as patients who used:&#xD;
More than one oral or topical corticosteroid with systemic effects for UC for more than three months during the first 18 months&#xD;
Oral corticosteroids for UC, between 18 and 24 months (whatever the duration of treatment),</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with clinical benefit of tofacitinib at 2 years, for those still receiving tofacitinib at 2 years.</measure>
    <time_frame>week 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Predictors of the clinical benefit at 2 years identified from the available baseline data</measure>
    <time_frame>Week 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients in clinical remission and still receiving tofacitinib</measure>
    <time_frame>Week 52</time_frame>
    <description>Clinical remission is defined as partial Mayo score (PMS) &lt;2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients in clinical remission without corticosteroids (oral or topical with systemic effects for UC) at 1 year</measure>
    <time_frame>Week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with short-term clinical response for patients still treated with tofacitinib</measure>
    <time_frame>Approximately week 8 and 16</time_frame>
    <description>Clinical response is defined as a reduction in partial Mayo score ≥ 3 points and ≥ 30% with respect to baseline, with a concomitant reduction in rectal bleeding sub-score ≥ 1 point (absolute sub-score of 0 or 1).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with biological response during the observation period</measure>
    <time_frame>Week 104</time_frame>
    <description>Biological response is defined as 50% reduction in the initial value of CRP or Fecal Calprotectine (FCP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with mucosal healing during the observation period</measure>
    <time_frame>Week 52</time_frame>
    <description>Mucosal healing is defined as endoscopic subscore of 0 or 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients in sustained clinical remission</measure>
    <time_frame>Week 52 and 104</time_frame>
    <description>Clinical remission is defined as partial Mayo score (PMS) &lt;2 at 52 and 104 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to loss of response to tofacitinib treatment in patients after dose reduction to 5 mg BID at the end of induction</measure>
    <time_frame>Week 8, 16, 24, 72, 52 and 104</time_frame>
    <description>The clinical loss of response is defined by a recrudescence of the symptoms that lead to a systemic therapeutic intervention (return to previous dose of tofacitinib or corticosteroid therapy, or an immunosuppressant or biologic/other anti-JAK)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with extraintestinal manifestations at each visit</measure>
    <time_frame>Week 8, 16, 24, 72, 52, 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with a colectomy during study follow-up and time of occurrence</measure>
    <time_frame>Week 8, 16, 24, 72,52 and 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characteristics of patients and UC, on the basis of all the data collected at baseline</measure>
    <time_frame>Week 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of the changes in the rectal bleeding and stool frequency subscores during the first 2 weeks after initiation of tofacitinib therapy</measure>
    <time_frame>14 weeks</time_frame>
    <description>(self-assessment by patients)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in patient quality-of-life evaluated from the SIBDQ questionnaire between baseline and 1 year, baseline and 2 years, and between 1 and 2 years</measure>
    <time_frame>Week 52, Week 52 to week 104 and week 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in adherence to tofacitinib treatment during each visit</measure>
    <time_frame>Week 8, 16, 24, 72, 52, 104</time_frame>
    <description>Using MARS questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with serious and non-serious adverse events.</measure>
    <time_frame>Week 8, 16, 24,72,52 and 104</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">280</enrollment>
  <condition>Ulcerative Colitis</condition>
  <arm_group>
    <arm_group_label>Patients prescribed tofacitinib</arm_group_label>
    <description>Patients with a confirmed diagnosis of moderate to severe ulcerative colitis initiating tofacitinib as per the French summary of product characteristics (SmPC).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tofacitinib</intervention_name>
    <description>Observational study</description>
    <arm_group_label>Patients prescribed tofacitinib</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients with moderate to severe Ulcerative Colitis initiating tofacitinib treatment&#xD;
        as per the French Summary of product characteristics (SmPC)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients of 18 years old or above&#xD;
&#xD;
          -  Patients with confirmed diagnosis of moderate to severe ulcerative colitis&#xD;
&#xD;
          -  Patients for whom gastroenterologist decides to initiate treatment with tofacitinib as&#xD;
             per the French SmPC&#xD;
&#xD;
          -  Patients informed about the study procedures and receiving an information letter&#xD;
             signed by the investigator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have already received tofacitinib treatment before baseline&#xD;
&#xD;
          -  Patients that fulfill any of the contrindications according to the latest version of&#xD;
             the SmPC&#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>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <phone>1-800-718-1021</phone>
    <email>ClinicalTrials.gov_Inquiries@pfizer.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Clinique de l Europe</name>
      <address>
        <city>Amiens</city>
        <zip>80090</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hopital Sud</name>
      <address>
        <city>Amiens</city>
        <zip>80480</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hopital Jean Minjoz</name>
      <address>
        <city>Besancon</city>
        <zip>25003</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Cahors</name>
      <address>
        <city>Cahors</city>
        <zip>46005</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Infirmerie Protestante de Lyon</name>
      <address>
        <city>Caluire</city>
        <zip>69300</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hopital Trousseau</name>
      <address>
        <city>Chambray Les Tours</city>
        <zip>37171</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hopital D'Estaing</name>
      <address>
        <city>Clermont Ferrand</city>
        <zip>63100</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Aphp - Hopital Beaujon</name>
      <address>
        <city>Clichy Cedex</city>
        <zip>92118</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ch Dunkerque</name>
      <address>
        <city>Dunkerque</city>
        <zip>59385</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hopital Albert Michallon</name>
      <address>
        <city>La Tronche</city>
        <zip>38700</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ch Bicetre</name>
      <address>
        <city>Le Kremlin Bicetre</city>
        <zip>94275</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CH Le Mans</name>
      <address>
        <city>Le Mans</city>
        <zip>72037</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ch Emile Roux</name>
      <address>
        <city>Le Puy En Velay</city>
        <zip>43012</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hopital Claude Huriez</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ch Saint Joseph Saint Luc</name>
      <address>
        <city>Lyon</city>
        <zip>69365</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ch Montfermeil</name>
      <address>
        <city>Montfermeil</city>
        <zip>93370</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hopital Saint Eloi</name>
      <address>
        <city>Montpellier Cedex 5</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinique Beau Soleil</name>
      <address>
        <city>Montpellier</city>
        <zip>34070</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Chu Nantes</name>
      <address>
        <city>Nantes</city>
        <zip>44004</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinique Jules Verne</name>
      <address>
        <city>Nantes</city>
        <zip>44014</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hopital de L'Archet</name>
      <address>
        <city>Nice</city>
        <zip>06202</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hopital Caremeau</name>
      <address>
        <city>Nimes</city>
        <zip>30029</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Aphp - Hopital Saint Louis</name>
      <address>
        <city>Paris Cedex 10</city>
        <zip>75466</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hopital Europeen Georges Pompidou</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Groupe Hospitalier Saint Joseph</name>
      <address>
        <city>Paris</city>
        <zip>75674</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Chu Bichat Claude Bernard</name>
      <address>
        <city>Paris</city>
        <zip>75877</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Chu de Bordeaux - Hopital Haut Leveque</name>
      <address>
        <city>Pessac</city>
        <zip>33600</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHU LYON</name>
      <address>
        <city>Pierre Benite</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ch Annecy Genevois</name>
      <address>
        <city>Pringy</city>
        <zip>74374</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Chu Rennes</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hopital Nord</name>
      <address>
        <city>St Priest En Jarez Cedex</city>
        <zip>42277</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinique Pasteur</name>
      <address>
        <city>Toulouse</city>
        <zip>31076</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ch Valence</name>
      <address>
        <city>Valence</city>
        <zip>26953</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ch Valenciennes</name>
      <address>
        <city>Valenciennes</city>
        <zip>59322</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>https://pmiform.com/clinical-trial-info-request?StudyID=A3921360</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>September 15, 2023</last_update_submitted>
  <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ulcerative Colitis, Tofacitinib, France, Real world data</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>Tofacitinib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</ipd_description>
  </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/NCT04424303
org study id: A3921360
secondary id: TOFAst study
nct id: NCT04424303
lead sponsor: 
has dmc: No
This is an observational prospective study with two years of follow-up, designed to evaluate
      the effectiveness of tofacitinib in patients with moderate to severe ulcerative colitis in
      French clinical practice
observational model: Cohort
time perspective: Prospective
measure: Proportion of patients with clinical benefit 2 years after initiation of tofacitinib treatment.
time frame: Week 104
description: The definition of clinical benefit is independent of the discontinuation or not of tofacitinib treatment during the observation period.
Clinical benefit at 2 years is defined as a modified partial Mayo Score of 0 or 1 with rectal bleeding subscore of 0 and stool frequency subscore of 0 or 1
-Patients who died or who had a colectomy or used another biologic/anti-JAK/immunosuppressant will be considered to be non-responders, as well as patients who used:
More than one oral or topical corticosteroid with systemic effects for UC for more than three months during the first 18 months
Oral corticosteroids for UC, between 18 and 24 months (whatever the duration of treatment),
measure: Proportion of patients with clinical benefit of tofacitinib at 2 years, for those still receiving tofacitinib at 2 years.
time frame: week 104
measure: Predictors of the clinical benefit at 2 years identified from the available baseline data
time frame: Week 104
measure: Proportion of patients in clinical remission and still receiving tofacitinib
time frame: Week 52
description: Clinical remission is defined as partial Mayo score (PMS) <2
measure: Proportion of patients in clinical remission without corticosteroids (oral or topical with systemic effects for UC) at 1 year
time frame: Week 52
measure: Proportion of patients with short-term clinical response for patients still treated with tofacitinib
time frame: Approximately week 8 and 16
description: Clinical response is defined as a reduction in partial Mayo score ≥ 3 points and ≥ 30% with respect to baseline, with a concomitant reduction in rectal bleeding sub-score ≥ 1 point (absolute sub-score of 0 or 1).
measure: Proportion of patients with biological response during the observation period
time frame: Week 104
description: Biological response is defined as 50% reduction in the initial value of CRP or Fecal Calprotectine (FCP)
measure: Proportion of patients with mucosal healing during the observation period
time frame: Week 52
description: Mucosal healing is defined as endoscopic subscore of 0 or 1
measure: Proportion of patients in sustained clinical remission
time frame: Week 52 and 104
description: Clinical remission is defined as partial Mayo score (PMS) <2 at 52 and 104 weeks
measure: Time to loss of response to tofacitinib treatment in patients after dose reduction to 5 mg BID at the end of induction
time frame: Week 8, 16, 24, 72, 52 and 104
description: The clinical loss of response is defined by a recrudescence of the symptoms that lead to a systemic therapeutic intervention (return to previous dose of tofacitinib or corticosteroid therapy, or an immunosuppressant or biologic/other anti-JAK)
measure: Proportion of patients with extraintestinal manifestations at each visit
time frame: Week 8, 16, 24, 72, 52, 104
measure: Proportion of patients with a colectomy during study follow-up and time of occurrence
time frame: Week 8, 16, 24, 72,52 and 104
measure: Characteristics of patients and UC, on the basis of all the data collected at baseline
time frame: Week 104
measure: Description of the changes in the rectal bleeding and stool frequency subscores during the first 2 weeks after initiation of tofacitinib therapy
time frame: 14 weeks
description: (self-assessment by patients)
measure: Change in patient quality-of-life evaluated from the SIBDQ questionnaire between baseline and 1 year, baseline and 2 years, and between 1 and 2 years
time frame: Week 52, Week 52 to week 104 and week 104
measure: Change in adherence to tofacitinib treatment during each visit
time frame: Week 8, 16, 24, 72, 52, 104
description: Using MARS questionnaire
measure: Proportion of patients with serious and non-serious adverse events.
time frame: Week 8, 16, 24,72,52 and 104
arm group label: Patients prescribed tofacitinib
description: Patients with a confirmed diagnosis of moderate to severe ulcerative colitis initiating tofacitinib as per the French summary of product characteristics (SmPC).
intervention type: Drug
intervention name: Tofacitinib
description: Observational study
arm group label: Patients prescribed tofacitinib
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
last name: Pfizer CT.gov Call Center
phone: 1-800-718-1021
email: ClinicalTrials.gov_Inquiries@pfizer.com
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: France
url: https://pmiform.com/clinical-trial-info-request?StudyID=A3921360
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Colitis
mesh term: Colitis, Ulcerative
mesh term: Ulcer
mesh term: Tofacitinib
sharing ipd: No
ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.