<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/NCT03006198</url>
  </required_header>
  <id_info>
    <org_study_id>CR106936</org_study_id>
    <secondary_id>C0168ARA4017</secondary_id>
    <nct_id>NCT03006198</nct_id>
  </id_info>
  <brief_title>Tracking Biologics Along the Silk Road</brief_title>
  <acronym>HARIR</acronym>
  <official_title>Tracking Biologics Along the Silk Road</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Pharmaceutica N.V., Belgium</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Pharmaceutica N.V., Belgium</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to explore and describe the disease characteristics, treatment&#xD;
      and outcomes of participants with rheumatoid arthritis, ankylosing spondylitis, psoriatic&#xD;
      arthritis, Crohn's Disease or ulcerative colitis as the major disease treated with REMICADE,&#xD;
      SIMPONI or STELARA in clinical practice in the emerging regions of North Africa, the Middle&#xD;
      East, and Western Asia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 4, 2016</start_date>
  <completion_date type="Actual">December 1, 2018</completion_date>
  <primary_completion_date type="Actual">December 1, 2018</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>Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response</measure>
    <time_frame>Year 2/early withdrawal</time_frame>
    <description>The ACR 20 Response is defined as greater than or equal to (&gt;=) 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and &gt;=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Response</measure>
    <time_frame>Year 2/early withdrawal</time_frame>
    <description>The ACR 50 Response is defined as &gt;=50 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and &gt;=50 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI and serum CRP.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Achieving American College of Rheumatology (ACR) 70 Response</measure>
    <time_frame>Year 2/early withdrawal</time_frame>
    <description>The ACR 70 Response is defined as &gt;=70 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and &gt;=70 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI and CRP.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) 20 Response</measure>
    <time_frame>Year 2/early withdrawal</time_frame>
    <description>The ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants in 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20 percent improvement from baseline and an absolute change &gt;= 10 units on a 0-10 scale (0=no disease activity; 10=high disease activity) for &gt;= 3 domains, and no worsening in remaining domain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Achieving ASAS 40 Response</measure>
    <time_frame>Year 2/early withdrawal</time_frame>
    <description>The ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants in 4 domains: participant global assessment of disease activity, pain, function, inflammation. The ASAS 40 = 40 percent improvement from baseline and an absolute change &gt;= 20 units on a 0-10 scale (0=no disease activity, 10=high disease activity) for &gt;= 3 domains, and no worsening in remaining domain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Achieving ASAS 5/6 Response</measure>
    <time_frame>Year 2/early withdrawal</time_frame>
    <description>ASAS 5/6 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined timeframe at least 20 percent improvement in score in at least 5 of a conventional set of 6 clinical domains relevant to AS and no worsening in the remaining domain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Clinical Response as Assessed by Crohn's Disease Activity Index (CDAI)</measure>
    <time_frame>Year 2/early withdrawal</time_frame>
    <description>The CDAI will be assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being. The last 4 variables are scored over 7 days by the participant on a diary card. Clinical response defined as reduction of greater than or equal to 70 points and/or 25 percent from baseline in CDAI.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Clinical Remission as Assessed by CDAI</measure>
    <time_frame>Year 2/early withdrawal</time_frame>
    <description>The CDAI will be assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being. The last 4 variables are scored over 7 days by the participant on a diary card. Remission will be defined as CDAI less than (&lt;) 150 points.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score for Crohn's Disease</measure>
    <time_frame>Baseline, Year 2/early withdrawal</time_frame>
    <description>The IBDQ is a 32-item questionnaire used to assess quality of life in participants with inflammatory bowel diseases. Each question has graded responses from 1 (worst situation) to 7 (best situation). Total score ranges from 32 (worst) to 224 (best). Higher scores indicate better quality of life.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Clinical Response as Assessed by Mayo Score</measure>
    <time_frame>Year 2/early withdrawal</time_frame>
    <description>Clinical response is defined as a decrease from baseline in the Mayo score by greater than or equal to 30 percent and &gt;= 3 points, and a decrease from baseline in the rectal bleeding sub score to 0 or 1. The Mayo score consists of 4 sub scores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score is calculated as the sum of 4 sub scores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe. Higher scores indicate worsening of the disease.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Clinical Remission as Assessed by Mayo Score</measure>
    <time_frame>Year 2/early withdrawal</time_frame>
    <description>Clinical remission is defined as a Mayo score less than or equal to 2 points, with no individual sub score greater than 1. The Mayo score consists of 4 sub scores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score is calculated as the sum of 4 sub scores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe. Higher scores indicate worsening of the disease.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score for Ulcerative Colitis</measure>
    <time_frame>Year 2/early withdrawal</time_frame>
    <description>The IBDQ is a 32-item questionnaire used to assess quality of life in participants with inflammatory bowel diseases. Each question has graded responses from 1 (worst situation) to 7 (best situation). Total score ranges from 32 (worst) to 224 (best). Higher scores indicate better quality of life.</description>
  </primary_outcome>
  <number_of_groups>5</number_of_groups>
  <enrollment type="Actual">140</enrollment>
  <condition>Arthritis, Rheumatoid; Spondylitis, Ankylosing; Arthritis, Psoriatic; Colitis, Ulcerative</condition>
  <arm_group>
    <arm_group_label>Cohort 1: Rheumatoid Arthritis</arm_group_label>
    <description>Participants with Rheumatoid arthritis as the major disease treated with REMICADE, SIMPONI or STELARA in clinical practice in the emerging regions of North Africa, the Middle East, and Western Asia will be observed for disease characteristics, treatment and outcomes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2: Ankylosing Spondylitis</arm_group_label>
    <description>Participants with Ankylosing spondylitis as the major disease treated with REMICADE, SIMPONI or STELARA in clinical practice in the emerging regions of North Africa, the Middle East, and Western Asia will be observed for disease characteristics, treatment and outcomes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3: Psoriatic Arthritis</arm_group_label>
    <description>Participants with Psoriatic arthritis as the major disease treated with REMICADE, SIMPONI or STELARA in clinical practice in the emerging regions of North Africa, the Middle East, and Western Asia will be observed for disease characteristics, treatment and outcomes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 4: Crohn's Disease</arm_group_label>
    <description>Participants with Crohn's disease as the major disease treated with REMICADE, SIMPONI or STELARA in clinical practice in the emerging regions of North Africa, the Middle East, and Western Asia will be observed for disease characteristics, treatment and outcomes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 5: Ulcerative Colitis</arm_group_label>
    <description>Participants with Ulcerative colitis as the major disease treated with REMICADE, SIMPONI or STELARA in clinical practice in the emerging regions of North Africa, the Middle East, and Western Asia will be observed for disease characteristics, treatment and outcomes.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Participants with confirmed diagnosis of rheumatoid arthritis, ankylosing spondylitis,&#xD;
        psoriatic arthritis, Crohn's Disease, or ulcerative colitis as their major disease for&#xD;
        which they will be treated with REMICADE, SIMPONI, or STELARA within clinical practice.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant must have a confirmed diagnosis of rheumatoid arthritis, ankylosing&#xD;
             spondylitis, psoriatic arthritis, Crohn's Disease, or ulcerative colitis. A&#xD;
             participant can be included for one disease only; participants with multiple diagnoses&#xD;
             should be included for their major disease only&#xD;
&#xD;
          -  Initiation of treatment with REMICADE, SIMPONI, or STELARA should be planned at the&#xD;
             time of enrollment into this observational study (such treatment should be started&#xD;
             within 30 days of enrollment)&#xD;
&#xD;
          -  Participant must be either treatment-naïve to biologics or have been treated with no&#xD;
             more than 2 different biologic agents before enrollment&#xD;
&#xD;
          -  Participant must sign a participation agreement/informed consent form (ICF) allowing&#xD;
             data collection and source data verification in accordance with local requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participant who have previously received treatment with REMICADE, SIMPONI, or STELARA&#xD;
             must not be enrolled if they start the same therapy a second time&#xD;
&#xD;
          -  Participant has received an investigational drug (including investigational vaccines)&#xD;
             or used an invasive investigational medical device within 30 days before baseline data&#xD;
             collection&#xD;
&#xD;
          -  Participant is currently enrolled in an investigational study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janssen Pharmaceutica N.V., Belgium Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Pharmaceutica N.V., Belgium</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Alger</city>
        <country>Algeria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Alexandria</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hawalli Area</city>
        <country>Kuwait</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kuwait</city>
        <country>Kuwait</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Doha</city>
        <country>Qatar</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Makkah</city>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Riyadh</city>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Algeria</country>
    <country>Egypt</country>
    <country>Kuwait</country>
    <country>Qatar</country>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>January 9, 2019</last_update_submitted>
  <last_update_submitted_qc>January 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spondylitis</mesh_term>
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
    <mesh_term>Arthritis, Psoriatic</mesh_term>
    <mesh_term>Spondylitis, Ankylosing</mesh_term>
    <mesh_term>Colitis, Ulcerative</mesh_term>
  </condition_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/NCT03006198
org study id: CR106936
secondary id: C0168ARA4017
nct id: NCT03006198
lead sponsor: 
has dmc: No
is fda regulated drug: No
The objective of this study is to explore and describe the disease characteristics, treatment
      and outcomes of participants with rheumatoid arthritis, ankylosing spondylitis, psoriatic
      arthritis, Crohn's Disease or ulcerative colitis as the major disease treated with REMICADE,
      SIMPONI or STELARA in clinical practice in the emerging regions of North Africa, the Middle
      East, and Western Asia.
observational model: Cohort
time perspective: Prospective
measure: Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response
time frame: Year 2/early withdrawal
description: The ACR 20 Response is defined as greater than or equal to (>=) 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).
measure: Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Response
time frame: Year 2/early withdrawal
description: The ACR 50 Response is defined as >=50 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=50 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI and serum CRP.
measure: Percentage of Participants Achieving American College of Rheumatology (ACR) 70 Response
time frame: Year 2/early withdrawal
description: The ACR 70 Response is defined as >=70 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=70 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI and CRP.
measure: Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) 20 Response
time frame: Year 2/early withdrawal
description: The ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants in 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20 percent improvement from baseline and an absolute change >= 10 units on a 0-10 scale (0=no disease activity; 10=high disease activity) for >= 3 domains, and no worsening in remaining domain.
measure: Percentage of Participants Achieving ASAS 40 Response
time frame: Year 2/early withdrawal
description: The ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants in 4 domains: participant global assessment of disease activity, pain, function, inflammation. The ASAS 40 = 40 percent improvement from baseline and an absolute change >= 20 units on a 0-10 scale (0=no disease activity, 10=high disease activity) for >= 3 domains, and no worsening in remaining domain.
measure: Percentage of Participants Achieving ASAS 5/6 Response
time frame: Year 2/early withdrawal
description: ASAS 5/6 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined timeframe at least 20 percent improvement in score in at least 5 of a conventional set of 6 clinical domains relevant to AS and no worsening in the remaining domain.
measure: Number of Participants With Clinical Response as Assessed by Crohn's Disease Activity Index (CDAI)
time frame: Year 2/early withdrawal
description: The CDAI will be assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being. The last 4 variables are scored over 7 days by the participant on a diary card. Clinical response defined as reduction of greater than or equal to 70 points and/or 25 percent from baseline in CDAI.
measure: Number of Participants With Clinical Remission as Assessed by CDAI
time frame: Year 2/early withdrawal
description: The CDAI will be assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being. The last 4 variables are scored over 7 days by the participant on a diary card. Remission will be defined as CDAI less than (<) 150 points.
measure: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score for Crohn's Disease
time frame: Baseline, Year 2/early withdrawal
description: The IBDQ is a 32-item questionnaire used to assess quality of life in participants with inflammatory bowel diseases. Each question has graded responses from 1 (worst situation) to 7 (best situation). Total score ranges from 32 (worst) to 224 (best). Higher scores indicate better quality of life.
measure: Number of Participants With Clinical Response as Assessed by Mayo Score
time frame: Year 2/early withdrawal
description: Clinical response is defined as a decrease from baseline in the Mayo score by greater than or equal to 30 percent and >= 3 points, and a decrease from baseline in the rectal bleeding sub score to 0 or 1. The Mayo score consists of 4 sub scores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score is calculated as the sum of 4 sub scores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe. Higher scores indicate worsening of the disease.
measure: Number of Participants With Clinical Remission as Assessed by Mayo Score
time frame: Year 2/early withdrawal
description: Clinical remission is defined as a Mayo score less than or equal to 2 points, with no individual sub score greater than 1. The Mayo score consists of 4 sub scores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score is calculated as the sum of 4 sub scores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe. Higher scores indicate worsening of the disease.
measure: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score for Ulcerative Colitis
time frame: Year 2/early withdrawal
description: The IBDQ is a 32-item questionnaire used to assess quality of life in participants with inflammatory bowel diseases. Each question has graded responses from 1 (worst situation) to 7 (best situation). Total score ranges from 32 (worst) to 224 (best). Higher scores indicate better quality of life.
arm group label: Cohort 1: Rheumatoid Arthritis
description: Participants with Rheumatoid arthritis as the major disease treated with REMICADE, SIMPONI or STELARA in clinical practice in the emerging regions of North Africa, the Middle East, and Western Asia will be observed for disease characteristics, treatment and outcomes.
arm group label: Cohort 2: Ankylosing Spondylitis
description: Participants with Ankylosing spondylitis as the major disease treated with REMICADE, SIMPONI or STELARA in clinical practice in the emerging regions of North Africa, the Middle East, and Western Asia will be observed for disease characteristics, treatment and outcomes.
arm group label: Cohort 3: Psoriatic Arthritis
description: Participants with Psoriatic arthritis as the major disease treated with REMICADE, SIMPONI or STELARA in clinical practice in the emerging regions of North Africa, the Middle East, and Western Asia will be observed for disease characteristics, treatment and outcomes.
arm group label: Cohort 4: Crohn's Disease
description: Participants with Crohn's disease as the major disease treated with REMICADE, SIMPONI or STELARA in clinical practice in the emerging regions of North Africa, the Middle East, and Western Asia will be observed for disease characteristics, treatment and outcomes.
arm group label: Cohort 5: Ulcerative Colitis
description: Participants with Ulcerative colitis as the major disease treated with REMICADE, SIMPONI or STELARA in clinical practice in the emerging regions of North Africa, the Middle East, and Western Asia will be observed for disease characteristics, treatment and outcomes.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Janssen Pharmaceutica N.V., Belgium Clinical Trial
role: Study Director
affiliation: Janssen Pharmaceutica N.V., Belgium
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Algeria
country: Egypt
country: Kuwait
country: Qatar
country: Saudi Arabia
responsible party type: Sponsor
mesh term: Spondylitis
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
mesh term: Arthritis, Psoriatic
mesh term: Spondylitis, Ankylosing
mesh term: Colitis, Ulcerative