Special Investigation in Patients With Psoriasis Vulgaris and Psoriatic Arthritis (All Patients Investigation)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01155570
First received: June 30, 2010
Last updated: September 30, 2013
Last verified: September 2013
  Purpose

The survey will be conducted with regard to the following aspects of treatment with Humira (adalimumab) in patients with psoriasis vulgaris and psoriatic arthritis receiving this drug:

  • unknown adverse drug reactions, especially clinically significant adverse reactions
  • incidence and conditions of occurrence of adverse reactions in the clinical setting
  • factors that may affect the safety and effectiveness of Humira.

Condition
Psoriasis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Investigation (All Cases Investigation in Patients With Psoriasis Vulgaris and Psoriatic Arthritis)

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Serious Adverse Drug Reactions (SADRs), Deaths, and Discontinuations Due to AEs [ Time Frame: From study registration through Week 24 ] [ Designated as safety issue: Yes ]
    This study was mandated by the Japanese government as an approval condition for Humira in Japan; therefore, definitions of adverse events and seriousness criteria were applicable as specified in the Japanese local standard operating procedures, based on local Japanese regulations. ADRs were defined as adverse events for which the causal relationship with Humira was other than "not related" (ie, "probable," "possible," or "unclear"). The count of participants with AEs presented in this table includes serious and nonserious AEs. The count of participants with discontinuations due to AEs includes those who discontinued due to an AE plus other reasons. Please see Safety section for further details regarding adverse events.

  • Physician's Global Assessment at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

    The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:

    • 0 / Clear (plaque elevation=none, scaling=none, erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration);
    • 1 / Minimal (plaque elevation=possible but difficult to ascertain whether there is a slight elevation above normal skin, scaling=surface dryness with some white coloration, erythema=up to moderate);
    • 2 / Mild (plaque elevation=slight, scaling=fine, erythema=up to moderate);
    • 3 / Moderate (plaque elevation=moderate, scaling=coarser, erythema=moderate);
    • 4 / Severe (plaque elevation=marked, scaling=coarse, erythema=severe);
    • 5 / Very Severe (plaque elevation=very marked, scaling=very coarse, erythema=very severe).

  • Physician's Global Assessment At Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

    The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:

    • 0 / Clear (plaque elevation=none, scaling=none, erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration);
    • 1 / Minimal (plaque elevation=possible but difficult to ascertain whether there is a slight elevation above normal skin, scaling=surface dryness with some white coloration, erythema=up to moderate);
    • 2 / Mild (plaque elevation=slight, scaling=fine, erythema=up to moderate);
    • 3 / Moderate (plaque elevation=moderate, scaling=coarser, erythema=moderate);
    • 4 / Severe (plaque elevation=marked, scaling=coarse, erythema=severe);
    • 5 / Very Severe (plaque elevation=very marked, scaling=very coarse, erythema=very severe).

  • Physician's Global Assessment at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]

    The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:

    • 0 / Clear (plaque elevation=none, scaling=none, erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration);
    • 1 / Minimal (plaque elevation=possible but difficult to ascertain whether there is a slight elevation above normal skin, scaling=surface dryness with some white coloration, erythema=up to moderate);
    • 2 / Mild (plaque elevation=slight, scaling=fine, erythema=up to moderate);
    • 3 / Moderate (plaque elevation=moderate, scaling=coarser, erythema=moderate);
    • 4 / Severe (plaque elevation=marked, scaling=coarse, erythema=severe);
    • 5 / Very Severe (plaque elevation=very marked, scaling=very coarse, erythema=very severe).

  • Physician's Global Assessment at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

    The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:

    • 0 / Clear (plaque elevation=none, scaling=none, erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration);
    • 1 / Minimal (plaque elevation=possible but difficult to ascertain whether there is a slight elevation above normal skin, scaling=surface dryness with some white coloration, erythema=up to moderate);
    • 2 / Mild (plaque elevation=slight, scaling=fine, erythema=up to moderate);
    • 3 / Moderate (plaque elevation=moderate, scaling=coarser, erythema=moderate);
    • 4 / Severe (plaque elevation=marked, scaling=coarse, erythema=severe);
    • 5 / Very Severe (plaque elevation=very marked, scaling=very coarse, erythema=very severe).

  • Psoriasis Area and Severity Index (PASI) at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).

  • Psoriasis Area and Severity Index (PASI) at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).

  • Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 16 [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
    PASI75 is defined as at least a 75% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score.

  • Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    PASI75 is defined as at least a 75% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 24 PASI score) divided by Week 0 PASI score.

  • Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16 [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
    PASI90 is defined as at least a 90% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score.

  • Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI90) Response at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    PASI90 is defined as at least a 90% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 24 PASI score) divided by Week 0 PASI score.

  • Dermatology Life Quality Index at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot (score of 2), a little (score of 1), or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired.

  • Dermatology Life Quality Index at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot (score of 2), a little (score of 1), or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired.

  • Pain Visual Analog Scale (VAS) at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Participants assessed their pain due to psoriatic arthritis in the past week, on a single-line Visual Analog Scale (VAS) from 0 (no pain) to 100 (pain as bad as it could be).

  • Pain Visual Analog Scale (VAS) at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    Participants assessed their pain due to psoriatic arthritis in the past week, on a single-line Visual Analog Scale (VAS) from 0 (no pain) to 100 (pain as bad as it could be).

  • Pain Visual Analog Scale (VAS) at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Participants assessed their pain due to psoriatic arthritis in the past week, on a single-line Visual Analog Scale (VAS) from 0 (no pain) to 100 (pain as bad as it could be).

  • Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    DAS28-4 (ESR) is calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR), and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity.

  • Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    DAS28-4 (ESR) is calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR), and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity.

  • Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    DAS28-4 (ESR) is calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR), and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity.

  • Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP]) at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    DAS28-4 (CRP) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein (CRP) level, and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity.

  • Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP]) at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    DAS28-4 (CRP) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein (CRP) level, and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity.

  • Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP]) at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    DAS28-4 (CRP) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein (CRP) level, and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity.


Secondary Outcome Measures:
  • Physician's Overall Response Rating At Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    Overall response rating, according to investigator's subjective clinical opinion. The level of overall improvement rating was categorized as "markedly improved," "improved," "not changed," or "not assessable," comparing clinical conditions at Week 24 or at discontinuation with Baseline conditions.


Enrollment: 752
Study Start Date: February 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Humira
Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.

Detailed Description:

This study was non-interventional, open-labeled, all-cases, central registration method, post marketing observational study in which Humira was prescribed for patients with psoriasis vulgaris and/or psoriatic arthritis in routine medical practice.

When investigators prescribed Humira to an eligible patient who provided informed consent, they filled out a registration form and send it to the registration center via postal mail. At the end of the 24-week observation period, an investigator filled out a case report form for each patient to describe the findings during the study period, and provided the completed form to medical representatives. Even if Humira treatment was for any reason discontinued, the investigators followed each such participant for 24 weeks after the first administration of Humira, and filled out a case report form for the participant at the end of the 24-week period.

Some participants entered this study from study NCT00647400 (M04-702), a Phase III extension study of Humira (adalimumab) in Japan.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients who receive Humira for the treatment of psoriasis vulgaris or psoriatic arthritis

Criteria

Inclusion Criteria:

All patients who receive Humira for the treatment of psoriasis vulgaris or psoriatic arthritis not responding to conventional treatment will be evaluated. Eligible patients should be

  • those not responding to at least one type of conventional systemic treatment (including ultraviolet therapy) who have skin lesions involving 10% of body surface area or
  • patients with intractable eruptions of joint signs/symptoms.

Exclusion Criteria:

Contraindications according to the Package Insert include patients who have any of the following:

  • serious infections
  • tuberculosis
  • a history of hypersensitivity to any ingredient of Humira
  • demyelinating disease or a history of demyelinating disease
  • congestive cardiac failure.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01155570

  Show 634 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Yuji Yamaguchi, MD Abbvie GK
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01155570     History of Changes
Other Study ID Numbers: P12-077
Study First Received: June 30, 2010
Results First Received: July 23, 2013
Last Updated: September 30, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by AbbVie:
Psoriasis

Additional relevant MeSH terms:
Psoriasis
Arthritis, Psoriatic
Skin Diseases, Papulosquamous
Skin Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases

ClinicalTrials.gov processed this record on September 30, 2014