Effectiveness of Adalimumab in Moderate to Severe Plaque Psoriasis Patients With Distinct Co-morbidities

NCT01401452 | Completed Results

• 1 other identifier: P12-770
• Study Type: observational
• Target: 246
• Locations: 0 countries
• Sites: N/A

Brief Summary

This multicenter, post marketing observational study (PMOS) was designed to evaluate the effectiveness of adalimumab over a period of 9 months as determined by the Psoriasis Area and Severity Index (PASI) in participants with moderate to severe plaque psoriasis with distinct co-morbidities. Secondary objectives of this study were to measure changes in psychological health via the Dermatology Life Quality Index (DLQI); changes in comorbidities with respect to gender; changes in quality of life using the Short Form Health Survey (SF-36); and evaluation of Minimal Clinically Important Differences (MCID).

Conditions

Moderate to Severe Plaque Psoriasis

Keywords

Monoclonals; Moderate to severe plaque psoriasis; Psoriasis Area & Severity Index (PASI); Adalimumab; Biological disease modifying anti-rheumatic drugs (BDMARD); Co-morbidities; Antibodies; Disease Life Quality Index (DLQI)

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Months 1, 3, 6, and 9

  The percentage of participants with a ≥ 75% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.

  Baseline, Months 1, 3, 6, and 9

Secondary Outcomes (8)

• Mean Dermatology Life Quality Index (DLQI) Scores

  Baseline, Months 1, 3, 6, and 9

• Percentage of Participants Achieving a Psoriasis Area and Severity Index 50 (PASI 50) Response at Months 1, 3, 6, and 9

  Baseline, Months 1, 3, 6, and 9

• Percentage of Participants Achieving a Psoriasis Area and Severity Index 90 (PASI 90) Response at Months 1, 3, 6, and 9

  Baseline, Months 1, 3, 6, and 9

• Percentage of Participants Achieving a Psoriasis Area and Severity Index 100 (PASI 100) Response at Months 1, 3, 6, and 9

  Baseline, Months 1, 3, 6, and 9

• Mean Health Assessment Questionnaire Short Form 36 (SF-36) Physical Component Summary (PCS) Scores at 1, 3, 6, and 9 Months

  Baseline, Months 1, 3, 6, and 9

Study Arms (1)

Participants with psoriasis and at least one co-morbid disease

Participants with moderate to severe plaque psoriasis with at least one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression

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

Hospital, Dermatology

You may qualify if:

• Participants for whom adalimumab therapy is indicated and has been prescribed according to the product label and who meet the following criteria:
• Participant age ≥ 18 years
• Participants with moderate to severe plaque psoriasis participants who have at last one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression (diagnosed by a medical specialist for psychology, neurology, or psychiatry)
• Adalimumab naïve participants with moderate to severe plaque psoriasis after unsatisfactory response, non tolerability, or contraindication of systemic therapies such as ciclosporin, methotrexate or PUVA ( psoralen + UVA) or after biological disease modifying anti-rheumatic drugs (bDMARDs) failure (e.g.: infliximab, etanercept or ustekinumab)
• Participants of each country must fulfill any local treatment recommendation for use of bDMARD in psoriasis in their respective country. For Austria: participants must fulfill Austrian Treatment Recommendations for use of bDMARD in psoriasis (Chest X-ray and IGRA\* interferon gamma release assay or PPD-skin test negative for tuberculosis)
• Participant is willing to give informed consent to anonymous data collection and their forwarding to AbbVie as well as to informed consent if required in different countries.
• Participant must be able and willing to self-administer adalimumab injections or have a qualified person available to administer Humira® syringe or Humira® Pen injections

You may not qualify if:

• The following participants will not be included in this observational study:
• Participants who meet contraindications as outlined in the latest version of the Humira syringe® Summary of Product Characteristics (SPC) and Humira Pen® SPC
• Participants participating in another study program or clinical trial
• Participants who have been treated with Humira® before

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead
• Raffeiner GmbH: collaborator

Related Links

• Related Info

Results Point of Contact

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

800-633-9110

Study Officials

• AbbVie Inc

  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, 2011
• First Posted: July 25, 2011
• Study Start: August 1, 2011
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: October 4, 2017
• Results First Posted: October 4, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share