Clinical Effectiveness and Impact on Health-related Quality of Life in Peruvian Patients With Psoriasis After 16 Weeks of Adalimumab Therapy

This study has been terminated.
(This study was prematurely terminated due to low enrollment)
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01156532
First received: July 1, 2010
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

Recently, adalimumab has been authorized for active psoriasis in Peru and local experience is very low. The aim of this study is to obtain Peruvian data of clinical effectiveness; and impact in the health related quality of life with the use of Adalimumab in psoriatic patients complying with the dosing and monitoring recommendations of the local approved label.


Condition
Moderate to Severe Psoriasis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study; Clinical Effectiveness and Impact on Health-related Quality of Life in Peruvian Patients With Psoriasis After 16 Weeks of Adalimumab Therapy

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Proportion of patients reaching a Psoriasis Area and Severity Index score of 75 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Patients reaching a minimal important difference (MID) Dermatology Life Quality Index score [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Important difference (MID) Dermatology Life Quality Index score between 2.3-5


Secondary Outcome Measures:
  • Proportion of patients reaching a Euro Quality of Life -5 Dimensions index score increasing (improvement) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Mean increasing of at least 0.2

  • Serious Adverse Events [ Time Frame: Since enrollment until 70 days after the last study adalimumab dose ] [ Designated as safety issue: Yes ]
    Serious adverse events; including occurrence of Tuberculosis, opportunistic infection and cancer

  • Adherence of adalimumab treatment [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Participants whose percentages of missed dose are < 20%, are considered as "compliant"


Enrollment: 30
Study Start Date: November 2010
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Psoriatic patients with adalimumab treatment
Participant with moderate to severe chronic plaque Psoriasis defined as Psoriasis Area and Severity Index ≥ 10 and Body surface area ≥ 10% with or without psoriatic arthritis, who have adalimumab therapy indication because are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.

  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

Patients with moderate to severe psoriasis who receive adalimumab therapy according to habitual clinical practice, at Peruvian hospitals/clinics

Criteria

Inclusion Criteria:

  • Participant moderate to severe chronic plaque Psoriasis defined as Psoriasis Area and Severity Index ≥ 10 and Body surface area ≥ 10% with or without psoriatic arthritis, who have adalimumab therapy indication because are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate
  • Patient is capable of and willing to give written informed consent and to comply with the requirements of the study protocol

Exclusion Criteria:

  • Participants should not be enrolled if they cannot be treated in accordance with the local product label
  • Participants enrolled into another study or clinical trial
  • History of Hepatitis B infection
  • History of neurologic symptoms suggestive of central nervous system demyelinating disease
  • History of cancer or lymphoproliferative disease (other than successfully treated non-melanoma skin cancer or localized carcinoma in situ of the cervix)
  • Active Tuberculosis infection before initiating adalimumab treatment or latent Tuberculosis infection not able to take complete prophylactic treatment
  • Pregnant or lactating female, demonstrated by a pregnancy test before entering the study and willing to use a contraceptive method
  • Use of another anti- Tumoral Necrosis Factor previously
  • History of Congestive Heart Failure
  • Any other condition that according to the criteria of the participating investigator represents an obstacle for study conduction and/or subjects patients to an unacceptable risk
  • Participants with active infection including chronic or localized infections until infections are controlled
  • History of sensitive to latex
  • Participants who will receive concomitant phototherapy and systemic therapy during Humira therapy
  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: NCT01156532

Locations
Peru
Site Reference ID/Investigator# 35783
Lima, Peru
Site Reference ID/Investigator# 56700
Lima, Peru
Site Reference ID/Investigator# 43147
Trujillo, Peru
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Oscar E Guerra, MD AbbVie
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01156532     History of Changes
Other Study ID Numbers: P12-261
Study First Received: July 1, 2010
Last Updated: January 28, 2014
Health Authority: Peru: Ethics Committee

Keywords provided by AbbVie:
adalimumab therapy
Psoriasis
observational study

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Adalimumab
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 19, 2014