xml: <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/NCT05973370</url>
    </required_header>
    <id_info>
      <org_study_id>Effect of UDCA on Rheumatoid</org_study_id>
      <nct_id>NCT05973370</nct_id>
    </id_info>
    <brief_title>Evaluating the Effect of Ursodeoxycholic Acid in Patients With Rheumatoid Arthritis</brief_title>
    <official_title>Evaluating the Effect of Ursodeoxycholic Acid in Patients With Rheumatoid Arthritis in Egypt</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tanta University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tanta University</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>
        The purpose of this study is to investigate the potential therapeutic effects of the&#xD;
        secondary bile acid ursodeoxycholic acid (UDCA) on synovial inflammation and disease activity&#xD;
        when administered as add-on treatments to the current DMARDs treatments for rheumatoid&#xD;
        arthritis patients with variant disease activity.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is a randomized, open-labeled, controlled prospective study to evaluate the&#xD;
        potential therapeutic effects of the secondary bile acid ursodeoxycholic acid (UDCA) on&#xD;
        synovial inflammation and disease activity when administered as add-on treatments to the&#xD;
        current DMARDs treatments for rheumatoid arthritis patients with variant disease activity.&#xD;
        The study population will be rheumatoid arthritis patients attending the Physical Medicine,&#xD;
        Rheumatology and Rehabilitation Department at Menoufia University Hospital, Menoufia, Egypt.&#xD;
        A total of 60 rheumatoid arthritis patients who will meet the inclusion criteria will be&#xD;
        enrolled in this study. The 60 participants will be divided into 30 rheumatoid arthritis&#xD;
        patients who will receive placebo + the current DMARDs treatments of rheumatoid arthritis for&#xD;
        24 weeks and serve as the control group, and 30 rheumatoid arthritis patients who will&#xD;
        receive DMARDs + ursodeoxycholic acid (UDCA) 500 mg/day for 24 weeks. Clinical Examinations&#xD;
        and laboratory parameters will be performed and measured at the beginning of the study, 12&#xD;
        weeks and 24 weeks after randomization to evaluate the efficacy of and UDCA in the treatment&#xD;
        of rheumatoid arthritis.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 1, 2023</start_date>
    <completion_date type="Anticipated">October 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">July 30, 2023</primary_completion_date>
    <phase>Phase 2</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 study is a randomized controlled prospective study</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Changes from Baseline in DAS28-CRP activity Score</measure>
      <time_frame>Baseline, after 12 weeks, after 24 weeks</time_frame>
      <description>To evaluate the effect of the use of digoxin and UDCA as an add-on therapy in patients with rheumatoid arthritis by evaluating the change from baseline in the clinical findings as measured by Clinical Disease activity score 28 (DAS28-CRP) scores. A lower DAS28-CRP score from Baseline would mean improvement in disease activity and an increase in DAS28-CRP score from Baseline would mean an increase in disease activity or a worsening in disease activity.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in ACR 20, ACR 50, ACR 70 response criteria</measure>
      <time_frame>Baseline, after 12 weeks, after 24 weeks</time_frame>
      <description>The American College of Rheumatology (ACR) response criteria criteria (ACR20, ACR50, ACR70) for rheumatoid arthritis (RA) have been widely adopted as measures of medication efficacy in clinical trials. The ACR20 response has been the preferred endpoint for clinical trials because it is the response shown to discriminate optimally between active treatment and placebo while identifying few placebo-treated patients as improved</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Changes from baseline Measurement of inflammatory markers (IL-17A, IL-23, HIF-1α, VEGF) at 12 and 24 weeks</measure>
      <time_frame>Baseline, after 12 weeks, after 24 weeks</time_frame>
      <description>Serum IL-17A, IL-23, VEGF and HIF-1α levels (pg/ml) will be measured by means of the human enzyme-linked immunosorbent assay (ELISA) technique according to the manufacturer's protocol.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Numbers of participants with treatment-related adverse events</measure>
      <time_frame>Baseline, after 12 weeks, after 24 weeks</time_frame>
      <description>The adverse events in each group will be observed and documented during the whole procedure to show the safety of the treatment.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Rheumatoid Arthritis</condition>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Participants in this arm will receive Placebo with the current DMARDs treatments for rheumatoid arthritis for 24 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Ursodeoxycholic acid (UDCA)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants in this arm will receive ursodeoxycholic acid (UDCA) 500 mg/day + DMARDs for 24 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo will be administered to the control group for 24 weeks as an add-on treatment to the current DMARDs treatments for rheumatoid arthritis.</description>
      <arm_group_label>Control</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ursodeoxycholic acid (UDCA) 500 mg</intervention_name>
      <description>All subjects will receive Ursodeoxycholic acid (UDCA) administered at 500 mg/day for 24 weeks as an addon treatment to the current DMARDs treatments for rheumatoid arthritis.</description>
      <arm_group_label>Ursodeoxycholic acid (UDCA)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosed with rheumatoid arthritis according to the ACR/EULAR 2010 criteria.&#xD;
  &#xD;
            -  Having active rheumatoid arthritis disease activity (the 28-joint disease activity&#xD;
               score [DAS28] according to the CRP formula &gt; 2.6).&#xD;
  &#xD;
            -  Aged between 18 and 80 years.&#xD;
  &#xD;
            -  With clear consciousness and able to cooperate with this study.&#xD;
  &#xD;
            -  Personal willingness and ability to comply with the study follow-up schedule and other&#xD;
               requirements of the study protocol.&#xD;
  &#xD;
            -  Both male and female will be included&#xD;
  &#xD;
            -  All patients receiving non-biological drugs will be also included.&#xD;
  &#xD;
            -  Sign an informed consent for the clinical study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant or planning to be pregnant and breast-feeding women&#xD;
  &#xD;
            -  Patients suffering from any chronic diseases&#xD;
  &#xD;
            -  Patients with other autoimmune diseases, such as systemic lupus erythematosus,&#xD;
               Sjogren's syndrome and mixed connective tissue disease.&#xD;
  &#xD;
            -  Patients who have a diagnosis of any other inflammatory arthritis (e.g., psoriatic&#xD;
               arthritis or ankylosing spondylitis).&#xD;
  &#xD;
            -  Patients with a history of, or suspected, demyelinating disease of the central nervous&#xD;
               system (e.g. multiple sclerosis or optic neuritis).&#xD;
  &#xD;
            -  Patients with a current or recent history of severe, progressive, and/or uncontrolled&#xD;
               renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac,&#xD;
               neurological, or cerebral disease.&#xD;
  &#xD;
            -  Patients treated with biological therapy such as TNF-α or IL-1β antagonists.&#xD;
  &#xD;
            -  Patients with infectious or inflammatory diseases, endocrine disorders, any past or&#xD;
               current psychiatric or neurological diseases.&#xD;
  &#xD;
            -  Patients with cardiovascular diseases such as arrhythmias and acute myocardial&#xD;
               infarction.&#xD;
  &#xD;
            -  Patients with electrolyte disturbances (such as hypokalemia, hypomagnesemia, and&#xD;
               hypercalcemia) could potentially elevate the risk of digoxin toxicity.&#xD;
  &#xD;
            -  Patients with clinically significant hepatic and renal dysfunction or impairment.&#xD;
  &#xD;
            -  Alcohol abuse&#xD;
  &#xD;
            -  Patients with evidence of viral (HBV or HCV), autoimmune hepatitis, and decompensated&#xD;
               liver disease.&#xD;
  &#xD;
            -  Patients with cancer currently diagnosed or in medical history, if no recovery was&#xD;
               achieved.&#xD;
  &#xD;
            -  Patients who are allergic to Ursodeoxycholic acid (UDCA)&#xD;
  &#xD;
            -  Patients who are unconscious and unable to complete the study.&#xD;
  &#xD;
            -  Patients with acute inflammation of the gall bladder or the biliary tract, frequent&#xD;
               episodes of biliary colic, and impaired contractility of the gall bladder, will be&#xD;
               excluded.&#xD;
  &#xD;
            -  Patients with cholestasis, primary biliary cirrhosis, or biliary obstruction will also&#xD;
               be excluded.&#xD;
  &#xD;
            -  Patients who have received an organ transplant.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Nageh Ahmed El-Mahdy, Professor</last_name>
      <role>Study Chair</role>
      <affiliation>Professor of Pharmacology and Toxicology Faculty of Pharmacy, Tanta University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Medhat Ismail Abdel Hamid, Professor</last_name>
      <role>Study Chair</role>
      <affiliation>Professor of Pharmacology and Toxicology Faculty of Medicine, Al-Azhar University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Dalia Salah Seif, Associate Professor</last_name>
      <role>Study Director</role>
      <affiliation>Associate Professor of Physical Medicine, Rheumatology and Rehabilitation Faculty of Medicine, Menoufyia University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Enass Yousef Osman, PHD</last_name>
      <role>Study Director</role>
      <affiliation>Lecturer of Pharmacology and toxicology, Faculty of Pharmacy, Tanta University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Mariam George Tadros Bolous, Master</last_name>
      <role>Principal Investigator</role>
      <affiliation>Assistant Lecturer of Clinical pharmacy, Faculty of Pharmacy, Sinai University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Mariam George Tadros, Master</last_name>
      <phone>+20 1503030620</phone>
      <email>mariam.tadros77@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Dalia Salah Seif, Associate Professor</last_name>
      <phone>+20 1008312704</phone>
      <email>sdalia30@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Menoufia University Hospital</name>
        <address>
          <city>Shibīn Al Kawm</city>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mariam George Tadros Bolous, Master Degree</last_name>
        <phone>+20 1503030620</phone>
        <email>mariam.tadros77@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Dalia Salah Seif, Associate Professor</last_name>
        <phone>+20 1008312704</phone>
        <email>sdalia30@gmail.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Kvien TK, Laing T, Mease P, Menard HA, Moreland LW, Naden RL, Pincus T, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovsky J, Wolfe F, Hawker G. 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010 Sep;62(9):2569-81. doi: 10.1002/art.27584.</citation>
      <PMID>20872595</PMID>
    </reference>
    <reference>
      <citation>Neogi T, Aletaha D, Silman AJ, Naden RL, Felson DT, Aggarwal R, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Khanna D, Kvien TK, Laing T, Liao K, Mease P, Menard HA, Moreland LW, Nair R, Pincus T, Ringold S, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovsky J, Wolfe F, Hawker G; American College of Rheumatology; European League Against Rheumatism. The 2010 American College of Rheumatology/European League Against Rheumatism classification criteria for rheumatoid arthritis: Phase 2 methodological report. Arthritis Rheum. 2010 Sep;62(9):2582-91. doi: 10.1002/art.27580.</citation>
      <PMID>20872596</PMID>
    </reference>
    <reference>
      <citation>Lee EJ, Kwon JE, Park MJ, Jung KA, Kim DS, Kim EK, Lee SH, Choi JY, Park SH, Cho ML. Ursodeoxycholic acid attenuates experimental autoimmune arthritis by targeting Th17 and inducing pAMPK and transcriptional corepressor SMILE. Immunol Lett. 2017 Aug;188:1-8. doi: 10.1016/j.imlet.2017.05.011. Epub 2017 May 21.</citation>
      <PMID>28539269</PMID>
    </reference>
    <reference>
      <citation>O'Dwyer AM, Lajczak NK, Keyes JA, Ward JB, Greene CM, Keely SJ. Ursodeoxycholic acid inhibits TNFalpha-induced IL-8 release from monocytes. Am J Physiol Gastrointest Liver Physiol. 2016 Aug 1;311(2):G334-41. doi: 10.1152/ajpgi.00406.2015. Epub 2016 Jun 23.</citation>
      <PMID>27340129</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Tanta University</investigator_affiliation>
      <investigator_full_name>Mariam George Tadros Bolous</investigator_full_name>
      <investigator_title>Assistant Lecturer of Clinical pharmacy, Faculty of Pharmacy, Sinai University</investigator_title>
    </responsible_party>
    <keyword>Rheumatoid arthritis</keyword>
    <keyword>Ursodeoxycholic acid</keyword>
    <keyword>Synovial inflammation</keyword>
    <keyword>Th17 cells</keyword>
    <keyword>Synovial hypoxia</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Arthritis</mesh_term>
      <mesh_term>Arthritis, Rheumatoid</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ursodeoxycholic Acid</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05973370
  org study id: Effect of UDCA on Rheumatoid
  nct id: NCT05973370
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to investigate the potential therapeutic effects of the
        secondary bile acid ursodeoxycholic acid (UDCA) on synovial inflammation and disease activity
        when administered as add-on treatments to the current DMARDs treatments for rheumatoid
        arthritis patients with variant disease activity.
  This study is a randomized, open-labeled, controlled prospective study to evaluate the
        potential therapeutic effects of the secondary bile acid ursodeoxycholic acid (UDCA) on
        synovial inflammation and disease activity when administered as add-on treatments to the
        current DMARDs treatments for rheumatoid arthritis patients with variant disease activity.
        The study population will be rheumatoid arthritis patients attending the Physical Medicine,
        Rheumatology and Rehabilitation Department at Menoufia University Hospital, Menoufia, Egypt.
        A total of 60 rheumatoid arthritis patients who will meet the inclusion criteria will be
        enrolled in this study. The 60 participants will be divided into 30 rheumatoid arthritis
        patients who will receive placebo + the current DMARDs treatments of rheumatoid arthritis for
        24 weeks and serve as the control group, and 30 rheumatoid arthritis patients who will
        receive DMARDs + ursodeoxycholic acid (UDCA) 500 mg/day for 24 weeks. Clinical Examinations
        and laboratory parameters will be performed and measured at the beginning of the study, 12
        weeks and 24 weeks after randomization to evaluate the efficacy of and UDCA in the treatment
        of rheumatoid arthritis.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This study is a randomized controlled prospective study
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Changes from Baseline in DAS28-CRP activity Score
  time frame: Baseline, after 12 weeks, after 24 weeks
  description: To evaluate the effect of the use of digoxin and UDCA as an add-on therapy in patients with rheumatoid arthritis by evaluating the change from baseline in the clinical findings as measured by Clinical Disease activity score 28 (DAS28-CRP) scores. A lower DAS28-CRP score from Baseline would mean improvement in disease activity and an increase in DAS28-CRP score from Baseline would mean an increase in disease activity or a worsening in disease activity.
  measure: Changes in ACR 20, ACR 50, ACR 70 response criteria
  time frame: Baseline, after 12 weeks, after 24 weeks
  description: The American College of Rheumatology (ACR) response criteria criteria (ACR20, ACR50, ACR70) for rheumatoid arthritis (RA) have been widely adopted as measures of medication efficacy in clinical trials. The ACR20 response has been the preferred endpoint for clinical trials because it is the response shown to discriminate optimally between active treatment and placebo while identifying few placebo-treated patients as improved
  measure: Changes from baseline Measurement of inflammatory markers (IL-17A, IL-23, HIF-1α, VEGF) at 12 and 24 weeks
  time frame: Baseline, after 12 weeks, after 24 weeks
  description: Serum IL-17A, IL-23, VEGF and HIF-1α levels (pg/ml) will be measured by means of the human enzyme-linked immunosorbent assay (ELISA) technique according to the manufacturer's protocol.
  measure: Numbers of participants with treatment-related adverse events
  time frame: Baseline, after 12 weeks, after 24 weeks
  description: The adverse events in each group will be observed and documented during the whole procedure to show the safety of the treatment.
  arm group label: Control
  arm group type: Placebo Comparator
  description: Participants in this arm will receive Placebo with the current DMARDs treatments for rheumatoid arthritis for 24 weeks.
  arm group label: Ursodeoxycholic acid (UDCA)
  arm group type: Active Comparator
  description: Participants in this arm will receive ursodeoxycholic acid (UDCA) 500 mg/day + DMARDs for 24 weeks.
  intervention type: Drug
  intervention name: Placebo
  description: Placebo will be administered to the control group for 24 weeks as an add-on treatment to the current DMARDs treatments for rheumatoid arthritis.
  arm group label: Control
  intervention type: Drug
  intervention name: Ursodeoxycholic acid (UDCA) 500 mg
  description: All subjects will receive Ursodeoxycholic acid (UDCA) administered at 500 mg/day for 24 weeks as an addon treatment to the current DMARDs treatments for rheumatoid arthritis.
  arm group label: Ursodeoxycholic acid (UDCA)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Nageh Ahmed El-Mahdy, Professor
  role: Study Chair
  affiliation: Professor of Pharmacology and Toxicology Faculty of Pharmacy, Tanta University
  last name: Medhat Ismail Abdel Hamid, Professor
  role: Study Chair
  affiliation: Professor of Pharmacology and Toxicology Faculty of Medicine, Al-Azhar University
  last name: Dalia Salah Seif, Associate Professor
  role: Study Director
  affiliation: Associate Professor of Physical Medicine, Rheumatology and Rehabilitation Faculty of Medicine, Menoufyia University
  last name: Enass Yousef Osman, PHD
  role: Study Director
  affiliation: Lecturer of Pharmacology and toxicology, Faculty of Pharmacy, Tanta University
  last name: Mariam George Tadros Bolous, Master
  role: Principal Investigator
  affiliation: Assistant Lecturer of Clinical pharmacy, Faculty of Pharmacy, Sinai University
  last name: Mariam George Tadros, Master
  phone: +20 1503030620
  email: mariam.tadros77@gmail.com
  last name: Dalia Salah Seif, Associate Professor
  phone: +20 1008312704
  email: sdalia30@gmail.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Egypt
  citation: Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Kvien TK, Laing T, Mease P, Menard HA, Moreland LW, Naden RL, Pincus T, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovsky J, Wolfe F, Hawker G. 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010 Sep;62(9):2569-81. doi: 10.1002/art.27584.
  PMID: 20872595
  citation: Neogi T, Aletaha D, Silman AJ, Naden RL, Felson DT, Aggarwal R, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Khanna D, Kvien TK, Laing T, Liao K, Mease P, Menard HA, Moreland LW, Nair R, Pincus T, Ringold S, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovsky J, Wolfe F, Hawker G; American College of Rheumatology; European League Against Rheumatism. The 2010 American College of Rheumatology/European League Against Rheumatism classification criteria for rheumatoid arthritis: Phase 2 methodological report. Arthritis Rheum. 2010 Sep;62(9):2582-91. doi: 10.1002/art.27580.
  PMID: 20872596
  citation: Lee EJ, Kwon JE, Park MJ, Jung KA, Kim DS, Kim EK, Lee SH, Choi JY, Park SH, Cho ML. Ursodeoxycholic acid attenuates experimental autoimmune arthritis by targeting Th17 and inducing pAMPK and transcriptional corepressor SMILE. Immunol Lett. 2017 Aug;188:1-8. doi: 10.1016/j.imlet.2017.05.011. Epub 2017 May 21.
  PMID: 28539269
  citation: O'Dwyer AM, Lajczak NK, Keyes JA, Ward JB, Greene CM, Keely SJ. Ursodeoxycholic acid inhibits TNFalpha-induced IL-8 release from monocytes. Am J Physiol Gastrointest Liver Physiol. 2016 Aug 1;311(2):G334-41. doi: 10.1152/ajpgi.00406.2015. Epub 2016 Jun 23.
  PMID: 27340129
  responsible party type: Principal Investigator
  investigator affiliation: Tanta University
  investigator full name: Mariam George Tadros Bolous
  investigator title: Assistant Lecturer of Clinical pharmacy, Faculty of Pharmacy, Sinai University
  mesh term: Arthritis
  mesh term: Arthritis, Rheumatoid
  mesh term: Ursodeoxycholic Acid