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 and not for safety reasons.)
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01156532
First received: July 1, 2010
Last updated: August 8, 2014
Last verified: August 2014
  Purpose

Adalimumab has recently 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 on health-related quality of life with the use of adalimumab in participants with chronic plaque psoriasis 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:
  • Percentage of Participants Reaching a Psoriasis Area and Severity Index 75 (PASI-75) Response [ Time Frame: Baseline to 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). PASI-75 responders are the participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The mean PASI improvement was calculated using a linear regression model.

  • Percentage of Participants Reaching a Minimal Important Difference (MID) in the Dermatology Life Quality Index (DLQI) Score [ Time Frame: Baseline to 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, a little, 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. MID for the DLQI was defined as a score decrease from baseline of 2.3 to 5. The mean DLQI improvement was calculated using a linear regression model.


Secondary Outcome Measures:
  • European Quality of Life 5 Dimensions (EQ-5D) Index Score at Baseline and Week 16 [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    EQ-5D is a self-reported health outcome which measures mobility, self-care, usual activities, pain discomfort, anxiety, and depression. An overall score is derived that measures from -0.59 (worst) to +1 (best). Improvement was defined as a mean score increase of at least 0.2.

  • Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: From the time of informed consent until 70 days (5 half-lives) after the last dose of study drug (treatment was 16 weeks). ] [ Designated as safety issue: Yes ]
    An adverse event was considered an SAE if it met any of the following criteria: death of the participant; life-threatening event; hospitalization; prolongation of hospitalization; congenital anomaly; persistent or significant disability/incapacity; an important medical event requiring medical or surgical intervention to prevent serious outcome; spontaneous or elective abortion. SAEs included the occurrence of tuberculosis, opportunistic infection, and malignancy.

  • Adherence to Adalimumab Treatment [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]
    Adherence was measured by how many times a participant had a discontinuation (i.e., missed a study dose) during the 16 weeks of treatment.

  • Mean Psoriasis Area and Severity Index (PASI) Score Over Time [ Time Frame: Baseline, Week 4, Week 8, 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). The mean PASI improvement was calculated using a linear regression model.

  • Mean Dermatology Life Quality Index (DLQI) Score Over Time [ Time Frame: Baseline, Week 4, Week 8, Week 16 ] [ Designated as safety issue: No ]
    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, a little, 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. The mean DLQI improvement was calculated using a linear regression model.


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
Adalimumab Treatment in Participants with Psoriasis
Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they 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

Participants with moderate to severe psoriasis who receive adalimumab therapy according to standard clinical practice at Peruvian hospitals/clinics.

Criteria

Inclusion Criteria:

  • Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate
  • Participant 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 participants to an unacceptable risk
  • Participants with active infection including chronic or localized infections until infections are controlled
  • History of sensitivity to latex
  • Participants who will receive concomitant phototherapy and systemic therapy during adalimumab 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: Manuel Uribe, 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
Results First Received: August 8, 2014
Last Updated: August 8, 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 28, 2014