This study proposes to compare 2 different methods for managing a subject with psoriasis who has achieved good disease control, as defined by a clinical response with a Physician Global Assessment (PGA) inferior or equal to 1 at the screening visit, on etanercept treatment. The first method involves stopping etanercept treatment on entry into the study, with the option to reinitiate etanercept at 50 mg once weekly after medical review and agreement between the subject and the investigator. The second method involves continuing on etanercept at 25 mg once weekly, with the option to increase the dose to 50 mg once weekly after medical review and agreement between the subject and the investigator. Subjects will be randomized into one of these two study arms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
174
etanercept 50 mg once weekly as requested.
etanercept 25 mg or 50 mg as requested.
Centre Hopitalier St Jacques (Place St Jacques)
Besançon, France
CHU Dupuytren
Limoges, France
Service de Chirurgie Infantile
Lyon, France
C.H.U Nantes
Nantes, France
CHU de l Archet
Nice, France
Hopital Saint Louis
Paris, France
Time-Normalized Area Under Curve (AUC) of Physician Global Assessment (PGA) of Psoriasis Score at Week 52
PGA psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration and scaling across all psoriatic lesions. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). 'Clear' and "Almost clear' includes all participants who were scored as a 0 or 1. For participants who discontinued the study before week 52, the final PGA score was carried forward to the remaining time points before calculating the 52-week AUC. The AUC was calculated on the PGA score profile with the method of trapeziums from baseline visit to visit 52. The time-normalized AUC is defined as the ratio between AUC and the expected treatment period (days): AUC/ 52 weeks\*7days + 1.
Time frame: Week 52
Time-Normalized Area Under Curve (AUC) of Dermatology Life Quality Index (DLQI) at Week 52
DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).
Time frame: Week 52
Patient Psoriasis Satisfaction Questionnaire (PSSQ): The Overall Appearance of Skin, at Baseline, Before Retreatment, and at the End of Retreatment
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).
Time frame: Baseline to Week 52
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Flaking Skin, at Baseline, Before Retreatment, and at the End of Retreatment
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).
Time frame: Baseline to Week 52
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Redness of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).
Time frame: Baseline to Week 52
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Tightness of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).
Time frame: Baseline to Week 52
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Bleeding of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).
Time frame: Baseline to Week 52
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Burning Sensation in the Skin, at Baseline, Before Retreatment, and at the End of Retreatment
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).
Time frame: Baseline to Week 52
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Skin Pain, at Baseline, Before Retreatment, and at the End of Retreatment
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).
Time frame: Baseline to Week 52
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Joint Pain, at Baseline, Before Retreatment, and at the End of Retreatment
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).
Time frame: Baseline to Week 52
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Your Comfort Level With Your Personal Appearance, at Baseline, Before Retreatment, and at the End of Retreatment
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).
Time frame: Baseline to Week 52
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Anxiety, at Baseline, Before Retreatment, and at the End of Retreatment
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).
Time frame: Baseline to Week 52
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Depression, at Baseline, Before Retreatment, and at the End of Retreatment
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).
Time frame: Baseline to Week 52
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Fatigue, at Baseline, Before Retreatment, and at the End of Retreatment
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).
Time frame: Baseline to Week 52
Patient Psoriasis Satisfaction Questionnaire (PSSQ): How Others Respond to Your Personal Appearance at Work/School, at Baseline, Before Retreatment, and at the End of Retreatment
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).
Time frame: Baseline to Week 52
Patient Psoriasis Satisfaction Questionnaire (PSSQ): How Your Skin Affects Your Social and Leisure Activities, at Baseline, Before Retreatment, and at the End of Retreatment
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).
Time frame: Baseline to Week 52
Patient Psoriasis Satisfaction Questionnaire (PSSQ): How Satisfied Were You With Your Psoriasis Treatment in General? at Baseline, Before Retreatment, and at the End of Retreatment
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).
Time frame: Baseline to Week 52
Patient Psoriasis Satisfaction Questionnaire (PSSQ): I Would Like to Continue With my Current Psoriasis Treatment, at Baseline, Before Retreatment, and at the End of Retreatment
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).
Time frame: Baseline to Week 52
Physician Global Assessment (PGA) of Disease Activity at Week 52
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).
Time frame: Week 52
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Centre Hospitalier Lyon Sud
Pierre-Bénite, France
CHU de Poitiers
Poitiers, France
C.H.U de Reims
Reims, France
Hôpital Purpan
Toulouse, France
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