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OpenTrials
Completed

NCT Number: NCT04428411

Study To Evaluate The Impact Of Difficult To Treat Sites On Biological Response In Moderate-To-Severe Plaque Psoriasis(PsO).

This study is to evaluate available local data in Iraq patients with moderate-to-severe plaque psoriasis on Enbrel treatment with regards to efficacy, treatment for PsO who have difficult to treat sites at presentation.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer

Baghdad, Iraq

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Moderate-to-severe plaque psoriasis patients whom have been receiving etanercept for at least 1 year duration.
  • Have difficult to treat sites at presentation.
  • Age ≥18 years.
  • No history of using other biological treatments, other than etanercept for the treatment of moderate-to-severe PsO.

Exclusion criteria

  • Etanercept use for treatment of moderate-to-severe PsO less than 1 year duration.
  • Previous use of another biological treatment for treatment of moderate-to-severe PsO.

Treatment and study plan

Enbrel

Drug

As provided in real world practice

Primary outcomes

  1. Mean Change From Baseline in Percent Body Surface Area (BSA) Score at Month 4

    Time frame: Baseline (pre-treatment), Month 4 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)

    Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area of a body region was counted. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint equal to (=) 10 percent (%) for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%. Higher % BSA = greater severity of psoriasis. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.

  2. Mean Change From Baseline in Percent Body Surface Area (BSA) Score at Month 12

    Time frame: Baseline (pre-treatment), Month 12 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)

    Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area of a body region was counted. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint = 10 % for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%. Higher % BSA = greater severity of psoriasis. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.

  3. Mean Change From Baseline in Percent Body Surface Area (BSA) Score at Last Visit

    Time frame: Baseline (pre-treatment), Last Visit (any time after 12 months till maximum of approximately 5 years) (from the data retrieved and observed in approximately 1.8 months of this study)

    Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area of a body region was counted. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint = 10 % for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%. Higher % BSA = greater severity of psoriasis. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.

  4. Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 4

    Time frame: Baseline (pre-treatment), Month 4 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)

    DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.

  5. Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 12

    Time frame: Baseline (pre-treatment), Month 12 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)

    DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.

  6. Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Last Visit

    Time frame: Baseline (pre-treatment), Last Visit (any time after 12 months till maximum of approximately 5 years) (from the data retrieved and observed in approximately 1.8 months of this study)

    DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.

  7. Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Month 4

    Time frame: Baseline (pre-treatment), Month 4 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)

    The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 (no disease) to 72.0 (maximum disease), with higher scores representing greater severity of psoriasis. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.

  8. Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Month 12

    Time frame: Baseline (pre-treatment), Month 12 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)

    The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 (no disease) to 72.0 (maximum disease), with higher scores representing greater severity of psoriasis. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.

  9. Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Last Visit

    Time frame: Baseline (pre-treatment), Last Visit (any time after 12 months till maximum of approximately 5 years) (from the data retrieved and observed in approximately 1.8 months of this study)

    The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 (no disease) to 72.0 (maximum disease), with higher scores representing greater severity of psoriasis. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.

Secondary outcomes

  1. Percent Body Surface Area (BSA) Score at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to Treatment

    Time frame: Baseline (pre-treatment), Month 4, 12 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)

    Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area of a body region was counted. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint = 10 percent (%) for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%. Higher % BSA = greater severity of psoriasis. This outcome measure evaluated comparison between participants adherent and not adherent to treatment.

  2. Dermatology Life Quality Index (DLQI) Score at Baseline, Month 4 and Month 12 in Participants Adherent and Not Adherent to Treatment

    Time frame: Baseline (pre-treatment), Month 4, 12 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)

    DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. This outcome measure evaluated comparison between participants adherent and not adherent to treatment.

  3. Psoriasis Area and Severity Index (PASI) Score at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to Treatment

    Time frame: Baseline (pre-treatment), Month 4, 12 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)

    The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 (no disease) to 72.0 (maximum disease), with higher scores representing greater severity of psoriasis. This outcome measure evaluated comparison between participants adherent and not adherent to treatment.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

The Impact of Difficult to Treat Sites on Biological Treatment Response in Patients With Moderate-to-Severe Plaque Psoriasis

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 11, 2020
Registry last updated
Oct 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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