A Study to Evaluate Ustekinumab in Patients With Plaque Psoriasis in Asia-Pacific Countries (MARCOPOLO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pte Ltd
ClinicalTrials.gov Identifier:
NCT01677598
First received: August 30, 2012
Last updated: February 5, 2014
Last verified: February 2014

August 30, 2012
February 5, 2014
December 2011
November 2013   (final data collection date for primary outcome measure)
Number of psoriasis patients who use ustekinumab with label-recommended interval or other/missed dose interval [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
Number of psoriasis patients who use ustekinumab with label-recommended interval or other/missed dose interval will be assessed at Weeks 0, 16, 28, 52.
Same as current
Complete list of historical versions of study NCT01677598 on ClinicalTrials.gov Archive Site
  • Epidemiologic characteristics of the psoriasis population [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
    Epidemiologic characteristics of the psoriasis patients (sex, age, race, weight height, and peak disease level) will be determined.
  • Change from baseline (Week 0) in Psoriasis Area and Severity Index (PASI) score at Weeks 16, 28 and 52 [ Time Frame: Baseline (Week 0), Weeks 16, 28 and 52 ] [ Designated as safety issue: No ]
    The PASI is a physician-administered assessment tool used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease).
  • Change from baseline (Week 0) in Nail Psoriasis Severity Index (NAPSI) score at Weeks 16, 28, and 52 [ Time Frame: Baseline, Weeks 16, 28 and 52 ] [ Designated as safety issue: No ]
    NAPSI is used for assessing and grading the severity of nail psoriasis. Each nail is divided with imaginary horizontal and longitudinal lines into quadrants. Each nail is given a score for nail matrix psoriasis (0 to 4) and nail bed psoriasis (0 to 4) depending on the presence of any of the features of nail psoriasis in the 4 quadrants as: 0 (none), 1 (present in 1/4 nail), 2 (2/4), 3 (3/4), and 4 (4/4). Each nail gets a matrix score and a nail bed score, the total of which is the score for that nail (0 to 8). Each nail is evaluated, and the sum of all the nails is the total NAPSI score. The sum of the scores from all nails is 0 to 160 (Both finger and toe nails are included). Higher scores indicate worsening.
  • Change from baseline in EuroQol 5 Dimensional Questionnaire (EQ-5D) index score and EQ visual analog scale (VAS) at Weeks 16, 28, and 52 [ Time Frame: Baseline, Weeks 16, 28 and 52 ] [ Designated as safety issue: No ]
    The EQ-5D (EuroQol Group) is a validated generic measure of quality of life which usually requires less than 1 minute to complete (eg, the questionnaire may have questions about mobility, self care, usual activities, pain/discomfort and anxiety/depression.
  • Change from baseline (Week 0) in Dermatology Life Quality Index (DLQI) score [ Time Frame: Baseline, Weeks 16, 28 and 52 ] [ Designated as safety issue: No ]
    The DLQI is a patient-completed 10-item questionnaire that, in addition to evaluating overall quality of life, can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The aim of this questionnaire is to measure how much your skin problem has affected your life over the last week. For each of 10 questions patient has to select one of the following options: very much, a lot, a little, not at all.
  • Change from baseline (Week 0) in Patient Benefit Index (PBI) score at Weeks 16, 28, and 52 [ Time Frame: Baseline, Weeks 16, 28 and 52 ] [ Designated as safety issue: No ]
    The PBI is a patient-defined benefit assessment tool. Patients select personally relevant treatment goals from a standardized list of benefits called the Patient Needs Questionnaire. An evaluation of those treatment goals assessed by the patient is captured on the Patient Benefit Questionnaire. The PBI is calculated from the sum of the benefit items weighted by their respective relevance divided by the number of relevant items. Values between 0 (no benefit) and 4 (maximal patient-defined benefit) are possible.
  • Number of patients achieving PASI 50, 75, and 90 response (ie, at least 50%, 75% and 90% improvement in PASI) [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
    Number of patients achieving PASI 50, 75, and 90 response (ie, at least 50%, 75% and 90% improvement in PASI) will be evaluated at Weeks 16, 28, and 52.
  • Number of patients achieving a DLQI improvement (reduction) of greater than or equal to 5 points [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
    Number of patients achieving a DLQI improvement (reduction) of greater than or equal to 5 points will be evaluated at Weeks 16, 28, and 52.
  • Number of patients achieving a score of 0 or 1 in DLQI [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
    Number of patients achieving a score of 0 or 1 in DLQI will be evaluated at Weeks 16, 28, and 52.
  • Number of patients achieving an improvement in PBI [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
    Number of patients achieving an improvement in PBI will be evaluated at Weeks 16, 28, and 52.
  • Number of patients with comorbidities (obesity, hypertension, diabetes, dyslipidemia, and heart disease) [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
    Number of patients with comorbidities (obesity, hypertension, diabetes, dyslipidemia, and heart disease) will be evaluated at baseline, Weeks 16, 28, and 52.
  • Health Economics/Medical Resource Utilization Questionnaire (HE/MRU) [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
    Health economic impact using the HE/MRU questionnaire will be assessed at baseline, Weeks 16, 28 and 52. Patients will be asked to complete a HE/MRU questionnaire to collect information on demographics, medical insurances, and use of biologic agents and phototherapy. Sections 1 and 2 are completed by the patient. Sections 3 and 4 are completed by the physician.
  • Change from baseline in productivity VAS at Weeks 16, 28, and 52 [ Time Frame: Baseline, Weeks 16, 28 and 52 ] [ Designated as safety issue: No ]
    A 10 cm VAS will be used to assess work, school, or at home productivity. Patients will be asked to put a single vertical line across the horizontal line at the spot that they feel best reflects the answer to the question, "How much has your disease affected your daily productivity at work, school or at home in the past 4 weeks?" The score will be recorded as a measurement of the placement of the patient's mark on a 10 cm scale.
  • Epidemiologic characteristics of the psoriasis population [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
    Epidemiologic characteristics of the psoriasis patients (sex, age, race, weight height, and peak disease level) will be determined.
  • Change from baseline (Week 0) in Psoriasis Area and Severity Index (PASI) score at Weeks 16, 28 and 52 [ Time Frame: Baseline (Week 0), Weeks 16, 28 and 52 ] [ Designated as safety issue: No ]
    The PASI is a physician-administered assessment tool used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease).
  • Change from baseline (Week 0) in Nail Psoriasis Severity Index (NAPSI) score at Weeks 16, 28, and 52 [ Time Frame: Baseline, Weeks 16, 28 and 52 ] [ Designated as safety issue: No ]
    This tool is used for assessing and grading the severity of nail psoriasis. A nail representing worst nail psoriasis is graded for nail matrix psoriasis and nail bed psoriasis. The sum of these 2 scores is the total NAPSI score. Nail matrix psoriasis consists of: pitting, leukonychia, red spots in the lunula, and nail plate crumbling and is scored as: 0 (none), 1 (present in 1/4 nail), 2 (2/4), 3 (3/4), and 4 (4/4). Nail bed psoriasis consists of: onycholysis, splinter hemorrhages, oil drop discoloration, and nail bed hyperkeratosis. Scoring for nail bed psoriasis is same as above.
  • Change from baseline in EuroQol 5 Dimensional Questionnaire (EQ-5D) index score and EQ visual analog scale (VAS) at Weeks 16, 28, and 52 [ Time Frame: Baseline, Weeks 16, 28 and 52 ] [ Designated as safety issue: No ]
    The EQ-5D (EuroQol Group) is a validated generic measure of quality of life which usually requires less than 1 minute to complete (eg, the questionnaire may have questions about mobility, self care, usual activities, pain/discomfort and anxiety/depression.
  • Change from baseline (Week 0) in Dermatology Life Quality Index (DLQI) score [ Time Frame: Baseline, Weeks 16, 28 and 52 ] [ Designated as safety issue: No ]
    The DLQI is a patient-completed 10-item questionnaire that, in addition to evaluating overall quality of life, can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The aim of this questionnaire is to measure how much your skin problem has affected your life over the last week. For each of 10 questions patient has to select one of the following options: very much, a lot, a little, not at all.
  • Change from baseline (Week 0) in Patient Benefit Index (PBI) score at Weeks 16, 28, and 52 [ Time Frame: Baseline, Weeks 16, 28 and 52 ] [ Designated as safety issue: No ]
    The PBI is a patient-defined benefit assessment tool. Patients select personally relevant treatment goals from a standardized list of benefits called the Patient Needs Questionnaire. An evaluation of those treatment goals assessed by the patient is captured on the Patient Benefit Questionnaire. The PBI is calculated from the sum of the benefit items weighted by their respective relevance divided by the number of relevant items. Values between 0 (no benefit) and 4 (maximal patient-defined benefit) are possible.
  • Number of patients achieving PASI 50, 75, and 90 response (ie, at least 50%, 75% and 90% improvement in PASI) [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
    Number of patients achieving PASI 50, 75, and 90 response (ie, at least 50%, 75% and 90% improvement in PASI) will be evaluated at Weeks 16, 28, and 52.
  • Number of patients achieving a DLQI improvement (reduction) of greater than or equal to 5 points [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
    Number of patients achieving a DLQI improvement (reduction) of greater than or equal to 5 points will be evaluated at Weeks 16, 28, and 52.
  • Number of patients achieving a score of 0 or 1 in DLQI [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
    Number of patients achieving a score of 0 or 1 in DLQI will be evaluated at Weeks 16, 28, and 52.
  • Number of patients achieving an improvement in PBI [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
    Number of patients achieving an improvement in PBI will be evaluated at Weeks 16, 28, and 52.
  • Number of patients with comorbidities (obesity, hypertension, diabetes, dyslipidemia, and heart disease) [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
    Number of patients with comorbidities (obesity, hypertension, diabetes, dyslipidemia, and heart disease) will be evaluated at baseline, Weeks 16, 28, and 52.
  • Health Economics/Medical Resource Utilization Questionnaire (HE/MRU) [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
    Health economic impact using the HE/MRU questionnaire will be assessed at baseline, Weeks 16, 28 and 52. Patients will be asked to complete a HE/MRU questionnaire to collect information on demographics, medical insurances, and use of biologic agents and phototherapy. Sections 1 and 2 are completed by the patient. Sections 3 and 4 are completed by the physician.
  • Change from baseline in productivity VAS at Weeks 16, 28, and 52 [ Time Frame: Baseline, Weeks 16, 28 and 52 ] [ Designated as safety issue: No ]
    A 10 cm VAS will be used to assess work, school, or at home productivity. Patients will be asked to put a single vertical line across the horizontal line at the spot that they feel best reflects the answer to the question, "How much has your disease affected your daily productivity at work, school or at home in the past 4 weeks?" The score will be recorded as a measurement of the placement of the patient's mark on a 10 cm scale.
Not Provided
Not Provided
 
A Study to Evaluate Ustekinumab in Patients With Plaque Psoriasis in Asia-Pacific Countries
A Study to Evaluate Ustekinumab in Clinical Practice in Patients With Plaque Psoriasis in Asia-Pacific Countries

The purpose of this study is to determine how patients use ustekinumab (label-recommended or other/missed dose interval) in Asia-Pacific countries.

This is an open-label (all people know the identity of the medication), multicenter, Phase 4, observational study (no study medication was administered during the study) designed to assess how patients will use ustekinumab (label-recommended or other/missed dose interval) in Asia-Pacific countries. The study will consist of 4 study visits which will take place over the duration of 1 year. At the first visit (ie, Week 0), eligibility for the study will be determined (it will be screening and baseline visit). At each subsequent visit (Weeks 16, 28, and 52), exposure to ustekinumab will be recorded, questionnaires for efficacy will be completed, and information about adverse events and concomitant medications will be collected. As many patient reported outcome questionnaires as possible will be administered, depending on the availability of validated translations. Safety will be assessed by monitoring of adverse events, vital signs and physical examination.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients at least 18 years of age with a diagnosis of plaque psoriasis, according to the dermatologists' clinical judgment

Plaque Psoriasis
Drug: No intervention
No intervention will be administered during study. This will be an observational study in patients using ustekinumab as label-recommended or other/missed dose interval in Asia-Pacific countries
Other Name: CNTO 1275
Patients with plaque psoriasis
Patients with plaque psoriasis using ustekinumab in Asia-Pacific countries.
Intervention: Drug: No intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
169
November 2013
November 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have a diagnosis of plaque psoriasis, according to the dermatologists' clinical judgment
  • Agree to initiate treatment with ustekinumab on the same day as enrollment into the study
  • Have not received anti-IL12/23 therapies within 6 months prior to enrollment into the study

Exclusion Criteria:

  • Has difficulty understanding questions posed by any of the questionnaires
  • Are currently participating in an investigational drug clinical study
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Indonesia,   Korea, Republic of,   Malaysia,   Singapore,   Taiwan
 
NCT01677598
CR100140, CNTO1275PSO4016
No
Johnson & Johnson Pte Ltd
Johnson & Johnson Pte Ltd
Not Provided
Study Director: Johnson & Johnson Pte Ltd Clinical Trial Johnson & Johnson Pte Ltd
Johnson & Johnson Pte Ltd
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP