<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/NCT03757364</url>
  </required_header>
  <id_info>
    <org_study_id>UWM/Ps-ENTH.2018/001</org_study_id>
    <nct_id>NCT03757364</nct_id>
  </id_info>
  <brief_title>Methotrexate in the Treatment of Distal Interphalangeal Joint Extensor Tendon Enthesopathy in Nail Psoriasis</brief_title>
  <official_title>Effect of Methotrexate in the Treatment of Distal Interphalangeal Joint Extensor Tendon Enthesopathy in Patients With Nail Psoriasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ryszard Górecki</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Warmia and Mazury</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary aim of the study is to assess the effect of methotrexate on the development of&#xD;
      distal interphalangeal joint extensor tendon enthesopathy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nail psoriasis is one of the risk factors for psoriatic arthritis (PsA), especially with&#xD;
      distal interphalangeal joints affected. Nail changes in psoriasis have been observed in&#xD;
      10-55% of patients, and the nail psoriasis-related inflammation can spread to adjacent&#xD;
      structures, including DIP joints and digital extensor tendons. Enthesopathies are among the&#xD;
      characteristic features of psoriatic arthritis. In everyday practice, assessment of psoriatic&#xD;
      changes in nails is based mainly on clinical indices, such as nail psoriasis severity index&#xD;
      (NAPSI) and modified NAPSI (mNAPSI), while imaging examinations, such as ultrasonography are&#xD;
      performed much less frequently.&#xD;
&#xD;
      The findings of this study may assess the reasonableness of systemic treatment of nail&#xD;
      psoriasis in patients without arthritis as enthesopathy prevention as well as the usability&#xD;
      of US nail examinations in Ps and PsA patients in assessment of morphological changes and a&#xD;
      response to treatment.&#xD;
&#xD;
      A US examination of nails and distal interphalangeal joint extensor tendons are conducted in&#xD;
      all of the patients twice at an interval of six months. The examination is conducted by a&#xD;
      rheumatologist experienced in ultrasound examinations of the skeletal and muscular system. An&#xD;
      assessment of the nails, extensor tendons and DIP joints is made by placing the head on the&#xD;
      dorsal side. In order to avoid pressure on surface tissues, an appropriate amount of gel&#xD;
      without gel pads was used. The intensified blood flow, made visible by the PD technique, is&#xD;
      confirmed by pulsed wave Doppler spectrum. The nail thickness is measured as the maximum&#xD;
      distance between the dorsal and ventral nail plates. The nail bed thickness is measured as&#xD;
      the distance between the ventral plate and the bone margin of the distal phalanx. The nail&#xD;
      matrix thickness is measured at the proximal end of the nail bed.&#xD;
&#xD;
      The study was approved by the Bioethics Committee of the Warmia and Mazury Chamber of&#xD;
      Physicians The study are conducted according to the Good Clinical Practice guidelines. Each&#xD;
      participant signs an informed consent and be coded with unique ID.&#xD;
&#xD;
      Results of analyses will be saved by indexing with ID code only, personal data with&#xD;
      individual IDs will be saved in additional file. All hard copy will be archived in secure&#xD;
      room with coded electronic key.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 7, 2018</start_date>
  <completion_date type="Actual">September 30, 2018</completion_date>
  <primary_completion_date type="Actual">September 30, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Effect of Methotrexate on Distal Interphalangeal Joint Extensor Tendon Enthesopathy</measure>
    <time_frame>6 months</time_frame>
    <description>Ultrasonographic assessment of the effect of methotrexate on the development of distal interphalangeal joint extensor tendon enthesopathy in patients with nail psoriasis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect of Methotrexate on Morphological Changes in Psoriatic Nails</measure>
    <time_frame>6 months</time_frame>
    <description>Ultrasonographic assessment of the effect of methotrexate on morphological changes in psoriatic nails</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">32</enrollment>
  <condition>Nail Psoriasis</condition>
  <arm_group>
    <arm_group_label>19 patients with Ps</arm_group_label>
    <description>19 patients with Ps with psoriatic changes in nails treated at the Dermatological Clinic in Olsztyn and the Clinic of Dermatology, Sexually Transmitted Diseases and Clinical Immunology of the University of Warmia and Mazury in Olsztyn, in whom a US examination revealed DIP joint extensor tendon enthesopathy who were started on methotrexate during the study and the treatment continued for 6 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>13 patients with PsA</arm_group_label>
    <description>13 patients with PsA with psoriatic changes in nails treated at the Dermatological Clinic in Olsztyn and the Clinic of Dermatology, Sexually Transmitted Diseases and Clinical Immunology of the University of Warmia and Mazury in Olsztyn, in whom a US examination revealed DIP joint extensor tendon enthesopathy who were started on methotrexate during the study and the treatment continued for 6 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methotrexate</intervention_name>
    <description>Methotrexate in the treatment of distal interphalangeal joint extensor tendon enthesopathy in patients with nail psoriasis</description>
    <arm_group_label>13 patients with PsA</arm_group_label>
    <arm_group_label>19 patients with Ps</arm_group_label>
    <other_name>Methotrexate Ebeve, Metex,</other_name>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood probes for laboratory test&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with psoriatic changes in nails with distal interphalangeal extensor tendon&#xD;
        enthesopathy in ultrasound examination&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with psoriatic changes in nails treated at the Rheumatological Clinic in&#xD;
             Olsztyn and the Clinic of Dermatology, Sexually Transmitted Diseases and Clinical&#xD;
             Immunology of the University of Warmia and Mazury in Olsztyn, in whom a US examination&#xD;
             revealed DIP joint extensor tendon enthesopathy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with osteoarthritis of hands, those who work hard physically and&#xD;
             those with changes in nails other than caused by psoriasis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>34 Years</minimum_age>
    <maximum_age>57 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Magdalena Krajewska-Włodarczyk, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Warmia and Mazury</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Warmia and Mazury</name>
      <address>
        <city>Olsztyn</city>
        <state>Warminsko-mazurskie</state>
        <zip>10-900</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/30271786</url>
    <description>Ultrasound Assessment of Changes in Nails in Psoriasis and Psoriatic Arthritis</description>
  </link>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/19060455</url>
    <description>The link between psoriasis and arthritis</description>
  </link>
  <reference>
    <citation>Krajewska-Wlodarczyk M, Owczarczyk-Saczonek A, Placek W, Wojtkiewicz M, Wiktorowicz A, Wojtkiewicz J. Ultrasound Assessment of Changes in Nails in Psoriasis and Psoriatic Arthritis. Biomed Res Int. 2018 Sep 9;2018:8251097. doi: 10.1155/2018/8251097. eCollection 2018.</citation>
    <PMID>30271786</PMID>
  </reference>
  <reference>
    <citation>McGonagle D, Tan AL, Benjamin M. The nail as a musculoskeletal appendage--implications for an improved understanding of the link between psoriasis and arthritis. Dermatology. 2009;218(2):97-102. doi: 10.1159/000182250. Epub 2008 Dec 6.</citation>
    <PMID>19060455</PMID>
  </reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 25, 2018</study_first_submitted>
  <study_first_submitted_qc>November 25, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>November 25, 2018</last_update_submitted>
  <last_update_submitted_qc>November 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Warmia and Mazury</investigator_affiliation>
    <investigator_full_name>Ryszard Górecki</investigator_full_name>
    <investigator_title>Head of Collegium Medicum, Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Distal Interphalangeal Joint Extensor Tendon Enthesopathy</keyword>
  <keyword>Nail Psoriasis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Enthesopathy</mesh_term>
    <mesh_term>Psoriasis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methotrexate</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/NCT03757364
org study id: UWM/Ps-ENTH.2018/001
nct id: NCT03757364
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The primary aim of the study is to assess the effect of methotrexate on the development of
      distal interphalangeal joint extensor tendon enthesopathy.
Nail psoriasis is one of the risk factors for psoriatic arthritis (PsA), especially with
      distal interphalangeal joints affected. Nail changes in psoriasis have been observed in
      10-55% of patients, and the nail psoriasis-related inflammation can spread to adjacent
      structures, including DIP joints and digital extensor tendons. Enthesopathies are among the
      characteristic features of psoriatic arthritis. In everyday practice, assessment of psoriatic
      changes in nails is based mainly on clinical indices, such as nail psoriasis severity index
      (NAPSI) and modified NAPSI (mNAPSI), while imaging examinations, such as ultrasonography are
      performed much less frequently.

      The findings of this study may assess the reasonableness of systemic treatment of nail
      psoriasis in patients without arthritis as enthesopathy prevention as well as the usability
      of US nail examinations in Ps and PsA patients in assessment of morphological changes and a
      response to treatment.

      A US examination of nails and distal interphalangeal joint extensor tendons are conducted in
      all of the patients twice at an interval of six months. The examination is conducted by a
      rheumatologist experienced in ultrasound examinations of the skeletal and muscular system. An
      assessment of the nails, extensor tendons and DIP joints is made by placing the head on the
      dorsal side. In order to avoid pressure on surface tissues, an appropriate amount of gel
      without gel pads was used. The intensified blood flow, made visible by the PD technique, is
      confirmed by pulsed wave Doppler spectrum. The nail thickness is measured as the maximum
      distance between the dorsal and ventral nail plates. The nail bed thickness is measured as
      the distance between the ventral plate and the bone margin of the distal phalanx. The nail
      matrix thickness is measured at the proximal end of the nail bed.

      The study was approved by the Bioethics Committee of the Warmia and Mazury Chamber of
      Physicians The study are conducted according to the Good Clinical Practice guidelines. Each
      participant signs an informed consent and be coded with unique ID.

      Results of analyses will be saved by indexing with ID code only, personal data with
      individual IDs will be saved in additional file. All hard copy will be archived in secure
      room with coded electronic key.
observational model: Case-Control
time perspective: Retrospective
measure: Effect of Methotrexate on Distal Interphalangeal Joint Extensor Tendon Enthesopathy
time frame: 6 months
description: Ultrasonographic assessment of the effect of methotrexate on the development of distal interphalangeal joint extensor tendon enthesopathy in patients with nail psoriasis.
measure: Effect of Methotrexate on Morphological Changes in Psoriatic Nails
time frame: 6 months
description: Ultrasonographic assessment of the effect of methotrexate on morphological changes in psoriatic nails
arm group label: 19 patients with Ps
description: 19 patients with Ps with psoriatic changes in nails treated at the Dermatological Clinic in Olsztyn and the Clinic of Dermatology, Sexually Transmitted Diseases and Clinical Immunology of the University of Warmia and Mazury in Olsztyn, in whom a US examination revealed DIP joint extensor tendon enthesopathy who were started on methotrexate during the study and the treatment continued for 6 months
arm group label: 13 patients with PsA
description: 13 patients with PsA with psoriatic changes in nails treated at the Dermatological Clinic in Olsztyn and the Clinic of Dermatology, Sexually Transmitted Diseases and Clinical Immunology of the University of Warmia and Mazury in Olsztyn, in whom a US examination revealed DIP joint extensor tendon enthesopathy who were started on methotrexate during the study and the treatment continued for 6 months
intervention type: Drug
intervention name: Methotrexate
description: Methotrexate in the treatment of distal interphalangeal joint extensor tendon enthesopathy in patients with nail psoriasis
arm group label: 13 patients with PsA
arm group label: 19 patients with Ps
other name: Methotrexate Ebeve, Metex,
blood probes for laboratory test
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 34 Years
maximum age: 57 Years
healthy volunteers: No
last name: Magdalena Krajewska-Włodarczyk, PhD
role: Principal Investigator
affiliation: University of Warmia and Mazury
facility: 
country: Poland
url: https://www.ncbi.nlm.nih.gov/pubmed/30271786
description: Ultrasound Assessment of Changes in Nails in Psoriasis and Psoriatic Arthritis
url: https://www.ncbi.nlm.nih.gov/pubmed/19060455
description: The link between psoriasis and arthritis
citation: Krajewska-Wlodarczyk M, Owczarczyk-Saczonek A, Placek W, Wojtkiewicz M, Wiktorowicz A, Wojtkiewicz J. Ultrasound Assessment of Changes in Nails in Psoriasis and Psoriatic Arthritis. Biomed Res Int. 2018 Sep 9;2018:8251097. doi: 10.1155/2018/8251097. eCollection 2018.
PMID: 30271786
citation: McGonagle D, Tan AL, Benjamin M. The nail as a musculoskeletal appendage--implications for an improved understanding of the link between psoriasis and arthritis. Dermatology. 2009;218(2):97-102. doi: 10.1159/000182250. Epub 2008 Dec 6.
PMID: 19060455
responsible party type: Sponsor-Investigator
investigator affiliation: University of Warmia and Mazury
investigator full name: Ryszard Górecki
investigator title: Head of Collegium Medicum, Clinical Professor
mesh term: Enthesopathy
mesh term: Psoriasis
mesh term: Methotrexate
sharing ipd: No