Observational Study to Estimate the Effectiveness of NCT02239666

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT02239666
Other study ID #	20120363
Secondary ID
Status	Completed
Phase	N/A
First received	September 11, 2014
Last updated	August 2, 2017
Start date	March 1, 2014
Est. completion date	January 5, 2017

Study information
Verified date	August 2017
Source	AstraZeneca
Contact	n/a
Is FDA regulated	No
Health authority
Study type	Observational

Clinical Trial Summary

To estimate the real-world effectiveness of approved biologics in subjects with moderate-to-severe plaque psoriasis who are either starting or switching biologic medication.

Description:

Plaque psoriasis is a chronic skin disease affecting 1-3% of US and European populations and severely impairs quality of life. Four biologics are authorized in Europe and the US for treatment of patients with moderate to severe psoriasis. Because complete skin clearance is rare with these agents, the treatment goal adopted by regulatory and reimbursement agencies is the proportion of patients achieving at least a 75% reduction from the subject's baseline PASI (Psoriasis Area and Severity Index) score or similarly, a sPGA [static Physician's Global Assessment) score of 0 or 1. Specifically, this study will provide information on the effectiveness of approved biologics as they are used in clinical practice. This information is currently not consistently available from other sources, including existing psoriasis patient registries.

Study Hypothesis: This study will estimate in each country the proportion of biologic treatment-naïve and biologic treatment-switching psoriasis subjects in the real-world having total clearance at 6 months after initiating a biologic.

The study population will include up to approximately 300 adults in each of up to 6 participating countries who have been diagnosed by their physicians with moderate to severe plaque psoriasis, and are initiating biologic therapy(biologic treatment-naïve or biologic treatment-switching) for plaque psoriasis.

Summary of Subject Eligibility Criteria: aged 18 or over; diagnosed with moderate to severe plaque psoriasis; initiating a biologic approved for psoriasis at study entry; able to fill out questionnaires; provided written informed consent; and not participating in a clinical trial utilizing an investigational agent in the 3 months prior to the first biologic dose.

Assessments: Skin clearance is the primary indicator of treatment effectiveness, and will be measured using the physician-reported PASI and sPGA. Other assessments will be by the following patient questionnaires: psoriasis symptom inventory (PSI), the dermatology life quality index (DLQI), the static patient's global assessment ( sPtGA), treatment satisfaction and global health status.

All subjects will be initiating biologic therapy at study entry. Therapy discontinuations, switches, and dosing changes during follow-up will be reported by the site and summarized.

Follow-up continues for approximately 12 months after first dose or until the subject is lost to follow-up or withdraws from the study (for any reason including death), whichever comes first. Where appropriate, data will be obtained for each subject during mandatory visits at 6 months (± 6 weeks) and 12 months (± 6 weeks) after first biologic dose, and at routine visits that occur during the follow-up period. To the extent possible data will also be collected at other usual care visits that occur during follow-up.

Recruitment information / eligibility
Status	Completed
Enrollment	899
Est. completion date	January 5, 2017
Est. primary completion date	January 5, 2017
Accepts healthy volunteers	No
Gender	All
Age group	18 Years to 100 Years
Eligibility	Inclusion Criteria: - subjects who are greater than or equal to 18 YO diagnosed with moderate to severe plaque psoriasis - subjects who will be initiating therapy with a biologic approved for moderate to severe psoriasis either for the first time (biologic treatment naive) or in course of switching to a different biologic agent - subject who is able to complete questionnaires - subject able to provide written informed consent Exclusion Criteria: - subjects who are participating in a clinical trial utilizing an investigational agent in the 3 months prior to the first biologic dose on study

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• NIS
This is a non-interventional study (NIS) of usual care over the 12 months following initiation of biologic therapy.

Locations
Country	Name	City	State
France	Research Site	Angers
France	Research Site	Argenteuil
France	Research Site	Besancon Cedex
France	Research Site	Bordeaux
France	Research Site	Brest Cedex
France	Research Site	Chambray les Tours
France	Research Site	Le Mans Cedex 9
France	Research Site	Limoges
France	Research Site	Lyon Cedex 03
France	Research Site	Nice
France	Research Site	Pierre-Benite cedex
France	Research Site	Poitiers
France	Research Site	Reims cedex
France	Research Site	Rennes Cedex 9
France	Research Site	Saint Priest en Jarez
France	Research Site	Toulouse Cedex 9
France	Research Site	Vandoeuvre les Nancy
Germany	Research Site	Bergen auf Rügen
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Bonn
Germany	Research Site	Buxtehude
Germany	Research Site	Dülmen
Germany	Research Site	Erlangen
Germany	Research Site	Eschweiler
Germany	Research Site	Friedrichshafen
Germany	Research Site	Gelsenkirchen-Feldmark
Germany	Research Site	Greifswald
Germany	Research Site	Hamburg
Germany	Research Site	Hamburg
Germany	Research Site	München
Germany	Research Site	Münster
Germany	Research Site	Osnabrück
Germany	Research Site	Potsdam
Germany	Research Site	Quedlinburg
Germany	Research Site	Selters
Germany	Research Site	Simmern
Italy	Research Site	Ancona
Italy	Research Site	Bergamo
Italy	Research Site	Bologna
Italy	Research Site	Brescia
Italy	Research Site	Cagliari
Italy	Research Site	Genova
Italy	Research Site	Milano
Italy	Research Site	Milano
Italy	Research Site	Modena
Italy	Research Site	Pavia
Italy	Research Site	Perugia
Italy	Research Site	Roma
Italy	Research Site	Roma (RM)
Italy	Research Site	Rome
Italy	Research Site	Siena
Italy	Research Site	Verona
United Kingdom	Research Site	Airdrie
United Kingdom	Research Site	Cardiff
United Kingdom	Research Site	Christchurch, Dorset
United Kingdom	Research Site	Dundee
United Kingdom	Research Site	Durham
United Kingdom	Research Site	Exeter
United Kingdom	Research Site	Lincoln
United Kingdom	Research Site	London
United Kingdom	Research Site	Nottingham
United Kingdom	Research Site	Poole
United Kingdom	Research Site	Portsmouth
United Kingdom	Research Site	Redhill
United Kingdom	Research Site	Scunthorpe
United Kingdom	Research Site	Stourbridge
United Kingdom	Research Site	Wolverhampton
United States	Research Site	Alpharetta	Georgia
United States	Research Site	Aurora	Colorado
United States	Research Site	Aventura	Florida
United States	Research Site	Bakersfield	California
United States	Research Site	Birmingham	Alabama
United States	Research Site	Bridgeport	West Virginia
United States	Research Site	Burbank	California
United States	Research Site	Carmel	Indiana
United States	Research Site	Clarkston	Michigan
United States	Research Site	Dallas	Texas
United States	Research Site	East Windsor	New Jersey
United States	Research Site	Gahanna	Ohio
United States	Research Site	Hot Springs	Arkansas
United States	Research Site	Houston	Texas
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Irvine	California
United States	Research Site	Louisville	Kentucky
United States	Research Site	Macon	Georgia
United States	Research Site	New York	New York
United States	Research Site	Norfolk	Virginia
United States	Research Site	Overland Park	Kansas
United States	Research Site	Owensboro	Kentucky
United States	Research Site	Pembroke Pines	Florida
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Portland	Oregon
United States	Research Site	Roanoke	Virginia
United States	Research Site	Rochester	New York
United States	Research Site	Rogers	Arkansas
United States	Research Site	Sacramento	California
United States	Research Site	Saint Louis	Missouri
United States	Research Site	San Antonio	Texas
United States	Research Site	Sandy Springs	Georgia
United States	Research Site	Seattle	Washington
United States	Research Site	Silver Spring	Maryland
United States	Research Site	Warren	Ohio
United States	Research Site	West Jordan	Utah

Sponsors *(1)*
Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States, France, Germany, Italy, United Kingdom,

Outcome
Type	Measure	Description	Time frame
Primary	PASI100	Physician-completed Psoriasis Area and Severity Index (PASI) measuring for each study subject average redness, thickness and scaliness of plaque psoriasis regions, weighted by area of involvement in each of four regions (head and neck, upper extremities, trunk, lower extremities). PASI100 represents a 100% improvement from baseline, that is, complete clearance. A static, or one-off, PASI (sPASI) score of 0 is equivalent to PASI100	6 months
Secondary	PASI100 (or sPASI=0)	Physician-completed Psoriasis Area and Severity Index (PASI) measuring for each study subject average redness, thickness and scaliness of plaque psoriasis regions, weighted by area of involvement in each of four regions (head and neck, upper extremities, trunk, lower extremities). PASI100 represents a 100% improvement from baseline, that is, complete clearance. A static, or one-off, PASI (sPASI) score of 0 is equivalent to PASI100	12 months
Secondary	PASI100 (or sPASI=0)	Physician-completed Psoriasis Area and Severity Index (PASI) measuring for each study subject average redness, thickness and scaliness of plaque psoriasis regions, weighted by area of involvement in each of four regions (head and neck, upper extremities, trunk, lower extremities). PASI100 represents a 100% improvement from baseline, that is, complete clearance. A static, or one-off, PASI (sPASI) score of 0 is equivalent to PASI100	6 months and 12 months
Secondary	sPGA=0	Physician-completed static Patient Global Assessment (sPGA) is a one-off assessment of severity of psoriasis on 6-point scale ranging from 0 (clear; no psoriasis) to 6 (very severe).	6 months and 12 months
Secondary	Psoriasis Symptom Inventory (PSI) responders	A PSI responder is defined as a total PSI score less than or equal to 8, with no single item score more than 1	6 months and 12 months
Secondary	sPGA=0 or 1	Physician-completed static Patient Global Assessment (sPGA) is a one-off assessment of severity of psoriasis on 6-point scale ranging from 0 (clear; no psoriasis) to 6 (very severe).	6 months and 12 months
Secondary	PSI=0	Psoriasis Symptom Inventory (patient questionnaire) score of 0	6 months and 12 months
Secondary	Dermatology Life Quality Index (DLQI) =0	Measures functional disability of subjects with dermatological disorders. A self-administered 10-item questionnaire containing 6 functional scales (symptoms/feelings, sleep, leisure/daily activities, school/holidays, personal relationship and treatment).	6 months and 12 months
Secondary	Static Patient Global Assessment (sPtGA)	Patient assessment of the severity of their psoriasis on a 6-point scale ranging from 0 (clear; no psoriasis) to 6 (very severe).	6 months and 12 months
Secondary	Percent PASI improvement (or sPASI scores)	Physician-completed Psoriasis Area and Severity Index (PASI) measuring for each study subject average redness, thickness and scaliness of plaque psoriasis regions, weighted by area of involvement in each of four regions (head and neck, upper extremities, trunk, lower extremities). PASI score given represents a the percent improvement from baseline assessment. A static, or one-off, PASI (sPASI) score of 0 is equivalent to PASI100	6 months and 12 months

See also
Status	Clinical Trial	Phase
Completed	`NCT01194219` - Study to Evaluate Safety and Effectiveness of Oral Apremilast (CC-10004) in Patients With Moderate to Severe Plaque Psoriasis	Phase 3
Recruiting	`NCT06030076` - A Study to Assess the Effects of Switching From a Biologic Treatment to Tildrakizumab Using Patient-reported Outcomes in Adult Participants With Moderate to Severe Plaque Psoriasis
Completed	`NCT04263610` - Efficacy and Safety of Tildrakizumab in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Who Are Non-Responders to Dimethyl Fumarate Therapy	Phase 4
Completed	`NCT02601469` - Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS in Patients With Plaque Psoriasis	Phase 2
Completed	`NCT05600036` - A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Plaque Psoriasis	Phase 2
Completed	`NCT05375955` - A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis.	Phase 2
Completed	`NCT03614078` - A Study of PRCL-02 in Moderate to Severe Chronic Plaque Psoriasis	Phase 2
Not yet recruiting	`NCT05036889` - A 16-week Randomized Evaluation of the Impact of Mind.Px Application on Response to Biologic Treatment in Patients Suffering From Plaque Psoriasis Through Clinical Utility and Health Outcomes.	N/A
Completed	`NCT04603027` - A Phase 2 Study Investigating the Effect of EDP1815 in the Treatment of Mild to Moderate Plaque Psoriasis	Phase 2
Completed	`NCT03638258` - The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis	Phase 2
Completed	`NCT02881346` - Efficacy and Tolerability of Enstilar® in Daily Practice
Recruiting	`NCT02611349` - Study to Evaluate the Long-Term Safety of IDP-118 Lotion in the Treatment of Plaque Psoriasis	Phase 3
Completed	`NCT02251678` - Evaluate the Effect of Elimune Capsules	Phase 1
Completed	`NCT01987843` - Dose-finding Study of MT-1303 in Subjects With Moderate to Severe Chronic Plaque Psoriasis	Phase 2
Terminated	`NCT01708629` - Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects	Phase 3
Completed	`NCT01230138` - Pivotal Efficacy and Safety Registration Trial of FP187 in Moderate to Severe Plaque Psoriasis	Phase 2
Withdrawn	`NCT00747032` - To Demonstrate the Superior Efficacy of NYC 0462 Ointment Over That of the Placebo in the Treatment of Plaque Psoriasis	Phase 3
Completed	`NCT00581100` - Effects of Etanercept on Nail Psoriasis and Plaque Psoriasis	Phase 4
Suspended	`NCT01228656` - Effectiveness of Association Mometasone Furoate 0.1% and Salicylic Acid 5% Compared With Mometasone Furoate	Phase 2
Completed	`NCT00540618` - A Phase II Study of MEDI-507, Administered by Injection to Adults With Psoriasis	Phase 2

Observational Study to Estimate the Effectiveness of Biologics When Treating Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

Study information

Clinical Trial Summary

Description:

Recruitment information / eligibility

Study Design

Related Conditions & MeSH terms

Intervention

Locations

Sponsors (1)

Countries where clinical trial is conducted

Outcome

External Links