Quality of Life in Adalimumab Treated Psoriasis Patients Failing Other Biologic Disease Modifying Anti-rheumatic Drugs

NCT01084668 | Completed Results

• 1 other identifier: P10-708
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 9

Brief Summary

The aim of this post-marketing observational study (PMOS) was to obtain further data on long-term safety, efficacy, and quality of life outcomes for adalimumab in routine clinical use in participants with moderate to severe chronic plaque psoriasis after unsustainable clinical response to other biologic disease modifying anti-rheumatic drugs (BDMARDs). There are few data so far showing the effects of switching from other BDMARDs to adalimumab in patients with moderate to severe chronic plaque psoriasis. This study was designed to evaluate the long-term effectiveness of adalimumab in participants with moderate to severe chronic plaque psoriasis using the Psoriasis Area and Severity Index (PASI) in participants previously treated with efalizumab, infliximab, or etanercept and who either never achieved satisfactory response, achieved satisfactory response initially but lost it over time, or discontinued treatment due to intolerance/side effect(s) or other reasons, for example after regular stop of etanercept.

Conditions

Psoriasis Chronic

Keywords

moderate to severe chronic plaque psoriasis; adalimumab; Psoriasis Area and Severity Index (PASI); Disease Life Quality Index (DLQI); Nail Psoriasis Severity Index (NAPSI); biologic disease modifying anti-rheumatic drug (BDMARD); antibodies; monoclonals

Outcome Measures

Primary Outcomes (2)

• Psoriasis Area and Severity Index (PASI) Score

  Psoriasis Area and Severity Index (PASI) score is based on assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).

  Inclusion visit (Week 0), Week 4, Week 36, Week 52

• Reduction in Psoriasis Area and Severity Index Score of at Least 75% (PASI75)

  PASI75 is the number of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 52 (final visit). PASI score is based on assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).

  Inclusion visit (Week 0) to Week 52

Secondary Outcomes (3)

• Dermatology Life Quality Index (DLQI) Score

  Inclusion visit (Week 0), Week 4, Week 36, Week 52

• Nail Psoriasis Severity Index (NAPSI) Score

  Inclusion visit (Week 0), Week 4, Week 36, and Week 52

• Tolerability and Safety Assessed by Collection and Classification of Adverse Reactions

  From the time of participant consent until 70 days after last dose of study drug

Study Arms (1)

Adalimumab

Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure

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:

• Patients for whom adalimumab therapy is indicated and has been prescribed according to the product label
• Patients aged 18 years and older
• Unsatisfactory response to prior BDMARDS (efalizumab, infliximab, etanercept) in patients with moderate to severe chronic plaque psoriasis or achievement of satisfactory response initially, but loss over time or discontinuation of treatment due to intolerance/side effects(s) or other reasons e.g. restart after regular stop of etanercept
• Patients must fulfill Austrian Treatment Recommendations for use of BDMARD in psoriasis (chest X-ray and purified protein derivative \[PPD\] skin test negative for tuberculosis)
• Patient is willing to consent to data being collected and provided to Abbott
• Patient must be able and willing to self-administer Pen injections or have a qualified person available to administer Pen injections

You may not qualify if:

• Patients who meet contraindications as outlined in the latest version of the Humira-Pen Summary of Product Characteristics (SPC)
• Patients who do not meet the criteria for the use of BDMARDs of the Austrian Treatment Recommendations
• Patients participating in another study or clinical trial

Sponsors & Collaborators

• Abbott: lead
• Assign Data Management and Biostatistics GmbH: collaborator

Study Sites (9)

Site Reference ID/Investigator# 27435

Feldkirch, 6807, Austria

Location

Site Reference ID/Investigator# 27436

Graz, 8010, Austria

Location

Site Reference ID/Investigator# 38445

Graz, 8036, Austria

Location

Site Reference ID/Investigator# 27443

Linz, 4020, Austria

Location

Site Reference ID/Investigator# 27442

Vienna, 1030, Austria

Location

Site Reference ID/Investigator# 27440

Vienna, 1130, Austria

Location

Site Reference ID/Investigator# 27437

Vienna, 1160, Austria

Location

Site Reference ID/Investigator# 27439

Vienna, A-1090, Austria

Location

Site Reference ID/Investigator# 23309

Wels, 4600, Austria

Location

Results Point of Contact

• Title: Global Medical Services
• Organization: Abbott

800-633-9110

Study Officials

• Astrid Dworan-Timler, MD

  Abbott Austria

  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: February 28, 2010
• First Posted: March 10, 2010
• Study Start: November 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: June 29, 2012
• Results First Posted: May 30, 2012

Record last verified: 2012-06

Locations

AU (9)