MedPath

A Phase 3, Multi Site, Randomized, Double Blind, Placebo Controlled Study Of The Efficacy And Safety Comparing CP- 690,550 And Etanercept In Subjects With Moderate To Severe Chronic Plaque Psoriasis

Phase 3
Completed
Conditions
Psoriasis
Interventions
Biological: Etanercept 50 mg
Other: Placebo
Registration Number
NCT01241591
Lead Sponsor
Pfizer
Brief Summary

To evaluate the efficacy of CP-690,550 as compared to etanercept and the safety of CP-690,550 for treatment of moderate to severe chronic plaque psoriasis.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1101
Inclusion Criteria
  • Have had a diagnosis of plaque type psoriasis (psoriasis vulgaris);
  • Have plaque-type psoriasis covering at least 10% of total body surface area
  • Considered by dermatologist investigator to be a candidate for systemic therapy or phototherapy of psoriasis
Exclusion Criteria
  • Non-plaque or drug induced forms of psoriasis
  • Cannot discontinue current systemic and/or topical therapies for the treatment of psoriasis
  • Cannot discontinue phototherapy
  • Any uncontrolled significant medical condition

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
CP 690,550 5 mg BID+Placebo BIWCP 690,550 5 mg-
CP 690,550 10 mg BID+Placebo BIWCP 690,550 10 mg-
Placebo BID+Etanercept 50 mg BIWEtanercept 50 mg-
Placebo BID+Placebo BIWPlacebo-
Primary Outcome Measures
NameTimeMethod
Percentage of Participants With a Physician's Global Assessment (PGA) Response of "Clear" or "Almost Clear" at Week 12Week 12

The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 to 4). The severity scores are summed and averaged after which the total average is rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).

Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12Week 12

The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75 percent (%) reduction in PASI relative to baseline/Day 1.

Secondary Outcome Measures
NameTimeMethod
Percentage of Participants With a PGA Response of "Clear" or "Almost Clear" During the 12-Week Double-Blind TreatmentWeeks 2, 4, and 8

The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 to 4). The severity scores are summed and averaged after which the total average is rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response is defined as 0 (clear) or 1 (almost clear).

Percentage of Participants in Each PGA Category During the 12-Week Double-Blind TreatmentBaseline and Weeks 2, 4, 8, and 12

The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 to 4). The severity scores are summed and averaged after which the total average is rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe).

Percentage of Participants With a PASI75 Response During the 12-Week Double-Blind TreatmentWeeks 2, 4, and 8

The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75% reduction in PASI relative to baseline/Day 1.

Mean PASI Score During the 12-Week Double-Blind TreatmentBaseline and Weeks 2, 4, 8, and 12

Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section\*area score\*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis.

Mean Change From Baseline in PASI Score During the 12-Week Double-Blind TreatmentWeeks 2, 4, 8, and 12

Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section\*area score\*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis.

Mean PASI Component Scores by Body Region During the 12-Week Double Blind TreatmentBaseline and Weeks 2, 4, 8, and 12

Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section\*area score\*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis.

Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind TreatmentWeeks 2, 4, 8, and 12

Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section\*area score\*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis.

Percentage of Participants Who Achieved a 50% Reduction in PASI Relative to Baseline (PASI50) During the 12-Week Double-Blind TreatmentWeeks 2, 4, 8, and 12

PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0; higher scores represent greater severity of psoriasis.

Median Time to PASI50 Response During the 12-Week Double-Blind TreatmentBaseline up to Week 12
Percentage of Participants Who Achieved a 90% Reduction in PASI Relative to Baseline (PASI90) During the 12-Week Double-Blind TreatmentWeeks 2, 4, 8, and 12

PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0; higher scores represent greater severity of psoriasis.

Median Time to Achieve PASI75 Response During the 12-Week Double-Blind TreatmentBaseline up to Week 12
Mean Percentage of Total Psoriatic BSA During the 12-Week Double-Blind TreatmentBaseline and Weeks 2, 4, 8, and 12

Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The % surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.

Mean Percent Change From Baseline in Total Psoriatic BSA During the 12-Week Double-Blind TreatmentWeeks 2, 4, 8, and 12

Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant(fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.

Percentage of Participants With a PASI Score Greater Than or Equal to (≥)125% of the Baseline PASI Score During the 12-Week Double-Blind TreatmentWeeks 2, 4, 8, and 12
Mean Itch Severity Item (ISI) Score During the 12-Week Double-Blind TreatmentBaseline, Weeks 2, 4, 8, and 12

ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends.

Mean Change From Baseline in ISI Score During the 12-Week Double-Blind TreatmentWeeks 2, 4, 8, and 12

ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends.

Percentage of Participants Achieving an ISI Score of 0 During the 12-Week Double-Blind TreatmentWeeks 2, 4, 8, and 12

ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends.

Mean Dermatology Life Quality Index (DLQI) Score During the 12-Week Double-Blind TreatmentBaseline and Weeks 4 and 12

The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.

Mean Change From Baseline in DLQI Score During the 12-Week Double-Blind TreatmentWeeks 4 and 12

The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.

Mean DLQI Subscale Scores During the 12-Week Double-Blind TreatmentBaseline and Weeks 4 and 12

The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3).

Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind TreatmentWeeks 4 and 12

The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3). The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.

Percentage of Participants Achieving DLQI Response ≥5 During the 12-Week Double-Blind TreatmentWeeks 4 and 12

The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.

Percentage of Participants Achieving DLQI Response ≤1 During the 12-Week Double-Blind TreatmentWeeks 4 and 12

The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.

Mean SF-36 Domain Scores at Baseline and Week 12Baseline and Week 12

The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores indicate a better health related quality of life.

Mean Change From Baseline in SF-36 MCS and PCS ScoresWeek 12

The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score\*10) plus 50. Higher scores indicate a better health related quality of life.

Mean Change From Baseline in SF-36 Domain ScoresWeek 12

The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores indicate a better health related quality of life.

Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind TreatmentBaseline and Weeks 2, 4, and 8

The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear; 1=almost clear; 2=mild; 3=moderate; 4=severe).

Percentage of Participants With a PtGA Response During the 12-Week Double-Blind TreatmentWeeks 2, 4, 8, and 12

The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear; 1=almost clear; 2=mild; 3=moderate; 4=severe). Response defined as score of 0 or 1.

Median Time to DLQI ResponseWeeks 4 and 12

The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. DLQI Response was defined as a 5-point reduction in the total DLQI score.

Mean Short Form 36 (SF-36) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores at Baseline and Week 12Baseline and Week 12

The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score\*10) plus 50. Higher scores indicate a better health related quality of life.

Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind TreatmentWeek 12

The PSSM is a single, 7 point item that evaluates overall participant satisfaction with the study treatment. Response options range from "very dissatisfied" to "very satisfied" with the study medication.

Percentage of Participants Achieving PSSM Response of 'Very Satisfied' or 'Somewhat Satisfied' at Week 12Week 12

The PSSM is a single, 7 point item that evaluates overall participant satisfaction with the study treatment. Response options range from "very dissatisfied" to "very satisfied" with the study medication.

Mean European Quality of Life 5 Dimension (EQ-5D) Health State Utility Score During the 12-Week Double-Blind TreatmentBaseline and Week 12

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

Least Squares (LS) Mean Change From Baseline in EQ-5D Health State Utility Score During the 12-Week Double-Blind TreatmentWeek 12

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

Mean EQ-5D Visual Analog Score (VAS) During the 12-Week Double-Blind TreatmentBaseline and Week 12

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

Mean Change From Baseline in EQ-5D VAS at Week 12Week 12

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

Dimension Health State EQ-5D Score During the 12-Week Double-Blind TreatmentBaseline and Week 12

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The score for each of the 5 dimensions can range from 1 to 3; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed").

Mean Change From Baseline in EQ-5D Dimension Health State Score at Week 12Week 12

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The score for each of the 5 dimensions can range from 1 to 3; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed").

Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind TreatmentBaseline (BL) and Week 12

The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use (interactions with healthcare providers such as general practitioners \[GPs\], primary care physicians \[PCPs\], or family medicine physicians \[FMP\], emergency room visits, and hospitalizations), and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work.

Percentage of Participants Reporting Healthcare Resource Use Events During the 12-Week Double-Blind TreatmentWeek 12
Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on WorkBaseline and Week 12

Psoriasis Health Care Resource Utilization Questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The questionnaire assesses employment status of participant (employed: yes or no) and if currently employed it asks the participant if they were absent or on sick leave from work due to psoriasis; if unemployed it asks the participant if the unemployment is due to psoriasis.

Percentage of Participants Reporting Work-Impacted Events During the 12-Week Double-Blind TreatmentWeek 12

Psoriasis Health Care Resource Utilization Questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work.

Mean Psoriasis Quality of Life 12 (PQOL-12) Score During the 12-Week Double-Blind TreatmentBaseline and Week 12

The PQOL-12 is a 12-item questionnaire; 8 of the items on the Koo-Menter Psoriasis Index 12-item Quality of Life Questionnaire (PQOL-12) focus on emotional issues associated with psoriasis (self conscious, helpless, embarrassed, ability to enjoy life). The last 4 items deal with physical symptoms (pain or soreness, itch, physical irritation) and choice of clothing. The recall period is over the past month. The questions are answered on a scale from 0 to 10 with 0 being best and 10 being worst. Scores from each question are summed to give a total score (range 0 -120); higher scores indicate greater impairment to quality of life.

Mean Change From Baseline in PQOL-12 Score During the 12-Week Double-Blind TreatmentWeek 12

The PQOL-12 is a 12-item questionnaire; 8 of the items on the PQOL-12) focus on emotional issues associated with psoriasis (self conscious, helpless, embarrassed, ability to enjoy life). The last 4 items deal with physical symptoms (pain or soreness, itch, physical irritation) and choice of clothing. The recall period is over the past month. The questions are answered on a scale from 0 to 10 with 0 being best and 10 being worst. Scores from each question are summed to give a total score (range 0 -120); higher scores indicate greater impairment to quality of life.

Trial Locations

Locations (120)

Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhuegel

🇦🇹

Wien, Austria

Cliniques universitaires Saint-Luc

🇧🇪

Bruxelles, Belgium

Department for skin and venerial diseases, Clinical Center University of Sarajevo

🇧🇦

Sarajevo, Bosnia and Herzegovina

Universitetska Mnogoprofilna Bolnitsa Za Aktivno Lechenie- Dr Georgi Stranski- Pleven

🇧🇬

Pleven, Bulgaria

Mnogoprofilna Bolnitsa Za Aktivno Lechenie- Tokuda Bolnitsa Sofia- Sofia

🇧🇬

Sofia, Bulgaria

Universitetska mnogoprofilna bolnitsa za aktivno lechenie- Alexandrovska- Sofia

🇧🇬

Sofia, Bulgaria

Tsentar za kozhno-venericheski zaboliavania" EOOD

🇧🇬

Sofia, Bulgaria

Dermatovenerological Clinic, University hospital center "Sestre milosrdnice"

🇭🇷

Zagreb, Croatia

Amphia Hospital Location Molengracht / Department Dermatology

🇳🇱

Breda, Netherlands

Solumed S.C.

🇵🇱

Poznan, Poland

Dermatovenerologic dispensary #10 of Vyborg region

🇷🇺

Saint-Petersburg, Russian Federation

State Research Center of Dermatovenerology, Department of clinical dermatology

🇷🇺

Moscow, Russian Federation

State Research Center of Dermatovenerology, Department of dermatology

🇷🇺

Moscow, Russian Federation

North-Western State Medical University I.I. Mechnikov, Dermatovenerology Department

🇷🇺

Saint-Petersburg, Russian Federation

Clinical hospital of emergency care N.V. Soloviev

🇷🇺

Yaroslavl, Russian Federation

Dermatologicka klinika SZU, Fakultna nemocnica s poliklinikou F.D. Roosevelta

🇸🇰

Banska Bystrica, Slovakia

Centro de Investigaciones Dermatologicas

🇦🇷

Ciudad Autonoma de Buenos Aires, Argentina

IMAI (Instituto Medico de Asistencia e Investigaciones)

🇦🇷

Ciudad Autonoma de Buenos Aires, Argentina

MBAL na Voennomeditsinska akademia- Sofia

🇧🇬

Sofia, Bulgaria

Reumalab S.A.S.

🇨🇴

Medellin, Antioquia, Colombia

Centro Integral de Reumatología del Caribe Circaribe S.A

🇨🇴

Barranquilla, Atlantico, Colombia

Hudklinikken Herning

🇩🇰

Herning, Denmark

Hopital Ambroise Pare, Service de Dermatologie

🇫🇷

Boulogne, France

Hopital Fournier

🇫🇷

NANCY Cédex, France

CHU de NICE - Hôpital de l'Archet II

🇫🇷

Nice, France

CHU de Nantes - Hotel Dieu

🇫🇷

Nantes Cedex 1, France

Hopital Saint-Louis

🇫🇷

Paris, France

Charite - Universitaetsmedizin Berlin

🇩🇪

Berlin, Germany

Hopital Nord

🇫🇷

Saint Priest En Jarez, France

Hopital Robert Debre

🇫🇷

Reims, France

Hôpital Larrey

🇫🇷

Toulouse cedex 9, France

Hautklinik der Ruprecht-Karls-Universitaet Heidelberg

🇩🇪

Heidelberg, Germany

Klinikum der Johann Wolfgang Goethe Universitaet

🇩🇪

Frankfurt/Main, Germany

Universitaetsklinikum Hamburg-Eppendorf

🇩🇪

Hamburg, Germany

Dres. med. Bredlich/PD Rosenbach/Thiele

🇩🇪

Osnabrueck, Germany

Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum/Bor- es Nemikortani Klinika

🇭🇺

Debrecen, Hungary

Eberhard-Karls-Universitaet Tuebingen

🇩🇪

Tuebingen, Germany

SZTE Szentgyorgyi Albert Klinikai Kozpont/Borgyogyaszati es Allergologiai Klinika

🇭🇺

Szeged, Hungary

Academic Medical Centre (AMC)

🇳🇱

Amsterdam, Noord Holland, Netherlands

NZOZ Osteo-Medic s.c. Artur Racewicz, Jerzy Supronik

🇵🇱

Bialystok, Poland

Erasmus MC

🇳🇱

Rotterdam, Netherlands

Ryazan regional clinical dermatovenerologic dispensary

🇷🇺

Ryazan, Russian Federation

Korolev Dermatovenerologic Dispensary

🇷🇺

Korolev, Moscow Region, Russian Federation

Rostov-on-Don regional dermatovenerologic dispensary

🇷🇺

Rostov-on-Don, Russian Federation

Clinic of dermatovenerologic diseases

🇷🇺

Saratov, Russian Federation

Smolensk State Medical Academy

🇷🇺

Smolensk, Russian Federation

Narodny ustav reumatickych chorob

🇸🇰

Piestany, Slovakia

Hospital Universitario de La Princesa

🇪🇸

Madrid, Spain

Hospital Puerta de Hierro Majadahonda

🇪🇸

Majadahonda, Madrid, Spain

Falu lasarett, Hudkliniken

🇸🇪

Falun, Sweden

Hospital Universitario Fundacion Alcorcon

🇪🇸

Alcorcon, Madrid, Spain

Hospital General Universitario de Alicante

🇪🇸

Alicante, Spain

Mersin University Medical Faculty

🇹🇷

Akdeniz, Mersin, Turkey

Dokuz Eylul Universitesi Tip Fakultesi Dermatoloji Anabilim Dali

🇹🇷

Izmir, Turkey

Bispebjerg Hospital, University of Copenhagen

🇩🇰

Copenhagen NV, Denmark

Hermelinen Forskning AB

🇸🇪

Lulea, Sweden

Nemocnice Ceske Budejovice, a.s.

🇨🇿

Ceske Budejovice, Czechia

FN Kradec Kralove

🇨🇿

Hradec Kralove, Czechia

Fakultni nemocnice Plzen

🇨🇿

Plzen - Bory, Czechia

Kralska zdravotni

🇨🇿

Usti nad Labem, Czechia

Kozni ordinace

🇨🇿

Praha 1, Czechia

Universitair Ziekenhuis Gent

🇧🇪

Gent, Belgium

Riesgo de Fractura S.A.

🇨🇴

Bogota, Cundinamarca, Colombia

CHG Le Mans

🇫🇷

Le Mans, Cedex 09, France

Medicity S.A.S

🇨🇴

Bucaramanga, Santander, Colombia

LKH Feldkirch Abteilung fuer Dermatologie und Venerologie

🇦🇹

Feldkirch, Austria

LKH Innsbruck Universitaetsklinik fuer Dermatologie und Venerologie

🇦🇹

Innsbruck, Austria

LKH Salzburg, Landesklinik fuer Dermatologie

🇦🇹

Salzburg, Austria

Clinica Davila

🇨🇱

Santiago, Rm 8431657, RM, Chile

Clinica Dermovein S.A.

🇨🇱

Santiago, Chile

Department of Dermatovenerology, University Hospital Center Osijek

🇭🇷

Osijek, Croatia

Centro de Especialidades Dermatologicas

🇨🇱

Vina del Mar, V Region, Chile

Centro de Investigacion Clinica de la Universidad del Rosario

🇨🇴

Bogota, Cundinamarca, Colombia

CHU de Besancon - Hopital Saint Jacques

🇫🇷

Besancon, France

Kralska zdravotni a.s., Masarykovy nemocnice o.z.

🇨🇿

Usti nad Labem, Czechia

C.H.U. de Poitiers

🇫🇷

Poitiers, France

Universitaetsklinikum Erlangen Hautklinik im Internistischen Zentrum

🇩🇪

Erlangen, Germany

Department of Dermatology, Aarhus University Hospital

🇩🇰

Aarhus C, Denmark

Hospital Clinico Universidad de Chile, Departamento Dermatologia

🇨🇱

Santiago, Chile

Department of dermatovenerology, University Hospital Center Zagreb

🇭🇷

Zagreb, Croatia

Chu Morvan

🇫🇷

BREST Cédex, France

Centre Hospitalier Lyon Sud

🇫🇷

Pierre-Benite, France

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KoeR

🇩🇪

Mainz, Germany

Hautzentrum Duelmen

🇩🇪

Duelmen, Germany

Universitaets- Hautklinik Koeln

🇩🇪

Koeln, Germany

Universitaetsklinik Carl Gustav Carus

🇩🇪

Dresden, Germany

Klinika Dermatologii, Wenerologii i Alergologii, Uniwersyteckie Centrum Kliniczne

🇵🇱

Gdansk, Poland

Hopital Dupuytren

🇫🇷

Limoges, France

Hôpital de Brabois / Bâtiment Philippe Canton

🇫🇷

Vandoeuvre-les-Nancy, France

Hautarztpraxis

🇩🇪

Witten, Germany

Dres.Kirsten Prepeneit und Volker Streit

🇩🇪

Buchholz, Germany

Krakowskie Centrum Medyczne NZOZ

🇵🇱

Krakow, Poland

Technische Universitaet Muenchen

🇩🇪

Muenchen, Germany

Miskolci Semmelweis Ignac Korhaz-Rendelointezet/Borgyogyaszat

🇭🇺

Miskolc, Hungary

ALLERGO-DERM BAKOS Kft.

🇭🇺

Szolnok, Hungary

Hautarztpraxis Dres. Scholz, Sebastian, Schilling

🇩🇪

Mahlow, Germany

Dermatology Department

🇮🇱

Afula, Israel

PT & R

🇳🇱

Beek, Netherlands

Synexus Magyarorszag Kft.

🇭🇺

Budapest, Hungary

Severance Hospital, Yonsei University College of Medicine/Department of Dermatology

🇰🇷

Seoul, Korea, Republic of

Samsung Medical Center / Department of Dermatology

🇰🇷

Gangnam-Gu, Seoul, Korea, Republic of

Novum Instytut Dermatologii Leczniczej i Estetycznej

🇵🇱

Opole, Poland

DOST-Dermatovenerologicke oddelenie sanatorneho typu, SANARE, spol. s r.o.

🇸🇰

Svidnik, Slovakia

Whipps Cross University Hospital

🇬🇧

London, Leytonstone, United Kingdom

Dermatovenerologic dispensary #7

🇷🇺

Moscow, Russian Federation

Military medical academy S.M. Kirov

🇷🇺

Saint-Petersburg, Russian Federation

Kantonsspital St. Gallen

🇨🇭

St. Gallen, Switzerland

Gazi University Medical Faculty

🇹🇷

Besevler, Ankara, Turkey

Skanes Universitetssjukhus i Malmo, Hudkliniken

🇸🇪

Malmo, Sweden

Karolinska Universitetssjukhuset Solna

🇸🇪

Stockholm, Sweden

National Skin Centre

🇸🇬

Singapore, Singapore

Changi General Hospital

🇸🇬

Singapore, Singapore

Hospital 12 de Octubre

🇪🇸

Madrid, Spain

Leicester Royal Infirmary, Balmoral building, Clinic 3, Dermatology

🇬🇧

Leicester, United Kingdom

Istanbul university Istanbul Medical Faculty

🇹🇷

Capa, Istanbul, Turkey

Consorcio Hospital General Universitario de Valencia

🇪🇸

Valencia, Spain

T.C. Saglik Bakanligi Marmara Universitesi Egitim ve Arastirma Hastanesi Dermatoloji Anabilim Dali

🇹🇷

Pendik, Istanbul, Turkey

Sodersjukhuset, Hudkliniken

🇸🇪

Stockholm, Sweden

Hôpital Bichat

🇫🇷

Paris, France

The University of Hong Kong (HKU)-Queen Mary Hospital (QMH)

🇭🇰

Hong Kong, Hong Kong

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