Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Photographic Library of Moderate to Severe Psoriasis Subjects Treated With Infliximab (Study P05047) (PHODYPSO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00749398
First received: September 5, 2008
Last updated: August 12, 2014
Last verified: August 2014

September 5, 2008
August 12, 2014
September 2007
September 2010   (final data collection date for primary outcome measure)
  • Static Photographic Physician Global Assessment (PGA) Score as Assessed by Two Dermatologists [ Time Frame: Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6) ] [ Designated as safety issue: No ]
    Digital pictures of each participant's whole body were taken at each visit. Static PGA was assessed by two dermatologists on the basis of these pictures at a single point in time. The mean of the two readings from the dermatologists was used. Static PGA score ranged from 0 (no psoriasis) to 5 (extreme psoriasis). The higher the number, the more severe the psoriasis was.
  • Dynamic Photographic PGA Score as Assessed by Two Dermatologists [ Time Frame: Week 0 (Visit 1), Week 14 (Visit 4), Week 30 (Visit 6) ] [ Designated as safety issue: No ]
    The dynamic PGA score resulted from the comparison of two sets of pictures/visits. The dynamic PGA was scored twice, at the middle and at the end of the observation period (comparison between picture sets of Week 0 (Visit 1) and Week 14 (Visit 4) visits and comparison between picture sets of Week 0 (Visit 1) and Week 30 (Visit 6) visits. Dynamic PGA was assessed by two dermatologists and the mean of the two readings was used. Clinical improvement was measured with a 10 centimeter (cm)-visual analogue scale (VAS) ranging from 0 (no improvement) to 10 (disappearance of lesions).
To yield visual evidence of the visible clinical benefits achieved with Remicade on psoriasis lesions documenting both improvement phase of lesions and maintenance phase. [ Time Frame: Digital pictures are taken at each visit : Week 0, Week 2, Week 6, Week 14, Week 22, Week 30 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00749398 on ClinicalTrials.gov Archive Site
  • Static PGA Score as Assessed by the Investigator [ Time Frame: Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6) ] [ Designated as safety issue: No ]
    Static PGA was assessed at each visit by the investigator. Static PGA score ranged from 0 (no psoriasis) to 5 (extreme psoriasis). The higher the number, the more severe the psoriasis was.
  • Dynamic PGA Score as Assessed by the Investigator [ Time Frame: Week 0 (Visit 1), Week 14 (Visit 4), Week 30 (Visit 6) ] [ Designated as safety issue: No ]
    The dynamic PGA was scored twice, at the middle and at the end of the observation period. Clinical improvement from Baseline (Visit 1) was evaluated with a 10 cm-VAS ranging from 0 (no improvement) to 10 (disappearance of lesions) at the Week 14 (Visit 4) and Week 30 (Visit 6) visits.
  • Percent Body Surface Area (BSA) Involved With Psoriasis [ Time Frame: Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5),Week 30 (Visit 6) ] [ Designated as safety issue: No ]
  • Psoriasis Area and Severity Index (PASI) Score [ Time Frame: Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6) ] [ Designated as safety issue: No ]
    PASI ranged from 0 (no symptoms) to 72 (very marked symptoms) and assessed 3 clinical signs within each area (head, arms, trunk, and legs): erythema (redness), induration (thickness), and desquamation (scaling).
  • Nail Psoriasis Severity Index (NAPSI) Score [ Time Frame: Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6) ] [ Designated as safety issue: No ]
    The nail was divided with imaginary horizontal and longitudinal lines into quadrants. Each nail was given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. Each nail was evaluated, and the sum of all the nails was the total NAPSI score. The sum of the scores from all nails ranged from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails).
  • Static PGA Score as Assessed by the Participant [ Time Frame: Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6) ] [ Designated as safety issue: No ]
    Participants assessed their psoriasis at Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), and Week 30 (Visit 6) according to the Static PGA score, which ranged from 0 (no psoriasis) to 5 (extreme psoriasis). The higher the number, the more severe the psoriasis was.
  • Dynamic PGA Score as Assessed by the Participant [ Time Frame: Week 0 (Visit 1), Week 14 (Visit 4), Week 30 (Visit 6) ] [ Designated as safety issue: No ]
    The dynamic PGA was scored twice, at the middle and at the end of the observation period. Clinical improvement from Baseline (Visit 1) was evaluated with a 10 cm-VAS ranging from 0 (no improvement) to 10 (disappearance of lesions) at the Week 14 (Visit 4) and Week 30 (Visit 6) visits.
  • Dermatology Life Quality Index (DLQI) Score [ Time Frame: Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6) ] [ Designated as safety issue: No ]
    DLQI ranged from 0 (no effect on participant's life) to 30 (extremely large effect on participant's life) and was computed by summing the score (each ranging from 0 to 3) of each of a 10-item questionnaire.
  • Number of Participants With Satisfactory Health Status [ Time Frame: Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6) ] [ Designated as safety issue: No ]
    Participant's opinion on his/her health status, as assessed by the following question: "Think about all the ways your psoriasis is affecting you, do you consider that your current status is satisfactory? (Yes/No)"
  • To describe the evolution of psoriasis lesion pictures in parallel with the investigator clinical assessments. [ Time Frame: Evolution from baseline at Week 14 and Week 30 of the physician assessments. ] [ Designated as safety issue: No ]
  • To describe the evolution of psoriasis lesion pictures in parallel with the patient assessment. [ Time Frame: Evolution from baseline at Week 14 and Week 30 of the patient assessments. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Photographic Library of Moderate to Severe Psoriasis Subjects Treated With Infliximab (Study P05047)
Atlas of the Evolution of Psoriasis Lesions Under Remicade® : A Dynamic Standardized Photographic Library of Moderate to Severe Psoriasis Subjects Treated With Infliximab

This is a national, multi-center, observational, prospective photographic atlas study in subjects who are treated with infliximab for moderate-to-severe psoriasis in daily clinic according to local country regulations and reimbursement.

Subjects will enter this study using a non-probability sampling method.

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

Participation to the observational study will be proposed to Dermatology departments by the medical department of the sponsor. Subjects with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label will be asked to participate.

Psoriasis
Biological: Infliximab
According to local country regulations.
Other Names:
  • Remicade
  • SCH 215596
Infliximab
Subjects with moderate-to-severe psoriasis who are treated with infliximab in daily clinics according to local country regulations and reimbursements.
Intervention: Biological: Infliximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
133
September 2010
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female, age >=18 with moderate-to-severe psoriasis.
  • Patient for whom the physician has decided to initiate psoriasis treatment with infliximab in accordance with the terms of the European labeling.
  • Patient must demonstrate his/her willingness to participate in the observational study by signing a written consent.

Exclusion Criteria:

  • Patient unable to understand and answer a self administered questionnaire.
  • No specific non-inclusion criteria will be applied to eligible patients.
  • Contradiction and/or Precaution listed in the Summary of Product Characteristics.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00749398
P05047
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
August 2014

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