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

NCT01156532 | Terminated Results

• 1 other identifier: P12-261
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 3

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.

Conditions

Moderate to Severe Psoriasis

Keywords

adalimumab therapy; Psoriasis; observational study

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Reaching a Psoriasis Area and Severity Index 75 (PASI-75) Response

  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.

  Baseline to Week 16

• Percentage of Participants Reaching a Minimal Important Difference (MID) in the Dermatology Life Quality Index (DLQI) Score

  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.

  Baseline to Week 16

Secondary Outcomes (5)

• European Quality of Life 5 Dimensions (EQ-5D) Index Score at Baseline and Week 16

  Baseline, Week 16

• Number of Participants With Serious Adverse Events (SAEs)

  From the time of informed consent until 70 days (5 half-lives) after the last dose of study drug (treatment was 16 weeks).

• Adherence to Adalimumab Treatment

  up to 16 weeks

• Mean Psoriasis Area and Severity Index (PASI) Score Over Time

  Baseline, Week 4, Week 8, Week 16

• Mean Dermatology Life Quality Index (DLQI) Score Over Time

  Baseline, Week 4, Week 8, Week 16

Study Arms (1)

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (3)

Site Reference ID/Investigator# 35783

Lima, Peru

Location

Site Reference ID/Investigator# 56700

Lima, Peru

Location

Site Reference ID/Investigator# 43147

Trujillo, Peru

Location

Related Links

• Related Info

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Although a sample of 75 participants was originally planned, only 30 participants were enrolled in this study. The limited sample size can result in a potential sampling bias that cannot be tested.

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie (prior sponsor, Abbott)

800-633-9110

Study Officials

• Manuel Uribe, MD

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2010
• First Posted: July 5, 2010
• Study Start: November 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: August 25, 2014
• Results First Posted: August 25, 2014

Record last verified: 2014-08

Locations

PE (3)