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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: January 2, 2013
Last verified: January 2013
History of Changes
  Purpose

The survey will be conducted with regard to the following aspects of treatment with Humira 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:

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Evaluation of adverse event [ Time Frame: at week 24 ] [ Designated as safety issue: Yes ]
    Occurrence of adverse event (yes or no), nature of adverse events, date of onset, seriousness,clinical course of adverse events, outcome, measures, causal relationship between the event and Humira

  • Physician's Global Assessment [ Time Frame: at week 4 ] [ Designated as safety issue: No ]
  • Physician's Global Assessment [ Time Frame: at week 8 ] [ Designated as safety issue: No ]
  • Physician's Global Assessment [ Time Frame: at week 16 ] [ Designated as safety issue: No ]
  • Physician's Global Assessment [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
  • Psoriasis Severity Index [ Time Frame: at week 16 ] [ Designated as safety issue: No ]
  • Psoriasis Severity Index [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
  • Dermatology Life Quality Index [ Time Frame: at week 16 ] [ Designated as safety issue: No ]
  • Dermatology Life Quality Index [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
  • Pain evaluated using visual analog scale [ Time Frame: at week 4 ] [ Designated as safety issue: No ]
  • Pain evaluated using visual analog scale [ Time Frame: at week 16 ] [ Designated as safety issue: No ]
  • Pain evaluated using visual analog scale [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
  • Improvement rating on the basis of Disease Activity Score28 [ Time Frame: at week 4 ] [ Designated as safety issue: No ]
  • Improvement rating on the basis of Disease Activity Score28 [ Time Frame: at week 16 ] [ Designated as safety issue: No ]
  • Improvement rating on the basis of Disease Activity Score28 [ Time Frame: at week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effectiveness evaluation by the investigator [ Time Frame: at week 24 ] [ Designated as safety issue: No ]

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
Those with an exposure

  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.

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

Exclusion Criteria:

Contraindications according to the Package Insert

  • Patients who have serious infections
  • Patients who have tuberculosis
  • Patients with a history of hypersensitivity to any ingredient of Humira
  • Patients who have demyelinating disease or with a history of demyelinating disease
  • Patients who have congestive cardiac failure
  Contacts and Locations
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 Abbvie GK
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

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
Last Updated: January 2, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by AbbVie:
Psoriasis

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

ClinicalTrials.gov processed this record on May 19, 2013