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Videocapillaroscopy Assessment During Systemic Agent Therapy in Psoriasis

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ClinicalTrials.gov Identifier: NCT02162472
Recruitment Status : Recruiting
First Posted : June 12, 2014
Last Update Posted : September 23, 2019
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Joaquin Brieva, Northwestern University

Tracking Information
First Submitted Date June 10, 2014
First Posted Date June 12, 2014
Last Update Posted Date September 23, 2019
Study Start Date July 2015
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 11, 2014)
Videocapillaroscopy assessment in psoriasis [ Time Frame: Week 0, 2, 4, 6, 8, 12, 16 and 24 ]
The primary objective is to determine if videocapillaroscopy could be used as an objective and reliable method to assess psoriasis severity and to document improvement during treatment by measuring changes in vascular features.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02162472 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Videocapillaroscopy Assessment During Systemic Agent Therapy in Psoriasis
Official Title Videocapillaroscopy Assessment During Systemic Agent Therapy in Patients With Psoriasis
Brief Summary The aim of this study is to determine if videocapillaroscopy could be used as an objective and reliable method to assess psoriasis severity and to document improvement during treatment by measuring changes in vascular features.
Detailed Description

This is a single-center, prospective, observational study that will recruit subjects from Northwestern University to examine the degree of improvement of psoriatic plaques during systemic therapy treatment. Thirty patients with a confirmed diagnosis of "active" psoriasis treated with a single systemic agent will be recruited from the Northwestern Medical Faculty Foundation Dermatology clinic. The study population will include 15 patients receiving adalimumab and 15 patients receiving methotrexate.

Eight visits will be completed for each subject: visit 0 (baseline) and visits 1-8 (week 2, 4, 6, 8, 12, 16 and 24). At the baseline visit, after informed consent is obtained, a capillaroscopic examination will be performed to assess for evidence of characteristic vascular alterations. If such changes are present, the remainder of the baseline visit will be completed. This includes gathering personal information (age, race, gender etc.), clinical history (time of first diagnosis, presentation site, treatment used, biopsy results if previously performed, etc.) and past medical history (including current and previous medications). At each of the subsequent visits (visit 1-8), any changes to medical history and/or medications will be obtained and recorded. At each of the eight visits, a dermatologic physical examination, including PASI and PGA scores will be performed.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Thirty patients with a confirmed diagnosis of "active" psoriasis treated with a single systemic agent will be recruited from the Northwestern Medical Faculty Foundation Dermatology clinic. The study population will include 15 patients receiving adalimumab and 15 patients receiving methotrexate.
Condition Psoriasis
Intervention Not Provided
Study Groups/Cohorts
  • Adalimumab
    Subjects will receive adalimumab as standard of care for psoriasis
  • Methotrexate
    Subjects will receive methotrexate as standard of care for psoriasis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 11, 2014)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Subjects with a clinical diagnosis of chronic active plaque psoriasis
  • Subjects eligible for systemic monotherapy (oral or biologic agents).
  • Subjects with evidence of characteristic vascular alterations on capillaroscopic examination.
  • Subjects who are able to complete the study visits and procedures, including completion of the DLQI questionnaire.
  • Subjects who are willing to have standardized digital photographs taken of 2 different target plaque lesions on the extremities.
  • Subjects who are willing to have videocapillaroscopic photographs taken of 2 different target plaque lesions as well as of 2 areas of uninvolved skin on the extremities.
  • Subjects who have had a "4 week" washout period if they have recently changed systemic psoriatic therapy.

Exclusion Criteria:

  • Those who do not fit the inclusion criteria.
  • Subjects who are unable to understand the protocol or give informed consent.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Beatrice Nardone, MD,PhD 312-503-5905 b-nardone@northwestern.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02162472
Other Study ID Numbers STU78102
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Joaquin Brieva, Northwestern University
Study Sponsor Northwestern University
Collaborators AbbVie
Investigators
Principal Investigator: Joaquin Brieva, MD Northwestern University
PRS Account Northwestern University
Verification Date September 2019