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

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ClinicalTrials.gov Identifier: NCT01156532
Recruitment Status : Terminated (This study was prematurely terminated due to low enrollment and not for safety reasons.)
First Posted : July 5, 2010
Results First Posted : August 25, 2014
Last Update Posted : August 25, 2014
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Tracking Information
First Submitted Date July 1, 2010
First Posted Date July 5, 2010
Results First Submitted Date August 8, 2014
Results First Posted Date August 25, 2014
Last Update Posted Date August 25, 2014
Study Start Date November 2010
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 8, 2014)
  • Percentage of Participants Reaching a Psoriasis Area and Severity Index 75 (PASI-75) Response [ Time Frame: Baseline to Week 16 ]
    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 ]
    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.
Original Primary Outcome Measures
 (submitted: July 1, 2010)
  • Proportion of patients reaching a Psoriasis Area and Severity Index score of 75 [ Time Frame: 16 weeks ]
  • Patients reaching a minimal important difference (MID) Dermatology Life Quality Index score [ Time Frame: 16 weeks ]
    Important difference (MID) Dermatology Life Quality Index score between 2.3-5
Change History Complete list of historical versions of study NCT01156532 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 8, 2014)
  • European Quality of Life 5 Dimensions (EQ-5D) Index Score at Baseline and Week 16 [ Time Frame: Baseline, Week 16 ]
    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). ]
    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 ]
    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 ]
    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 ]
    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.
Original Secondary Outcome Measures
 (submitted: July 1, 2010)
  • Proportion of patients reaching a Euro Quality of Life -5 Dimensions index score increasing (improvement) [ Time Frame: 16 weeks ]
    Mean increasing of at least 0.2
  • Serious Adverse Events [ Time Frame: Since enrollment until 70 days after the last study adalimumab dose ]
    Serious adverse events; including occurrence of Tuberculosis, opportunistic infection and cancer
  • Adherence of adalimumab treatment [ Time Frame: 16 weeks ]
    Participants whose percentages of missed dose are < 20%, are considered as "compliant"
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical Effectiveness and Impact on Health-related Quality of Life in Peruvian Patients With Psoriasis After 16 Weeks of Adalimumab Therapy
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
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Moderate to Severe Psoriasis
Intervention Not Provided
Study 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: January 28, 2014)
30
Original Estimated Enrollment
 (submitted: July 1, 2010)
75
Actual Study Completion Date August 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Peru
Removed Location Countries  
 
Administrative Information
NCT Number NCT01156532
Other Study ID Numbers P12-261
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party AbbVie ( AbbVie (prior sponsor, Abbott) )
Study Sponsor AbbVie (prior sponsor, Abbott)
Collaborators Not Provided
Investigators
Study Director: Manuel Uribe, MD AbbVie
PRS Account AbbVie
Verification Date August 2014