Phase 4
Completed N=174
Study Comparing 2 Different Strategies For Management of Subjects With Plaque Psoriasis Who Have Responded to Etanercept
Source: ClinicalTrials.gov NCT00992394 ↗Enrolled (actual)
174
Serious AEs
5.9%
Results posted
Jan 2016
Primary outcomePrimary: Time-Normalized Area Under Curve (AUC) of Physician Global Assessment (PGA) of Psoriasis Score at Week 52 — 1.64; 1.33 Units on a scale
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time-Normalized Area Under Curve (AUC) of Physician Global Assessment (PGA) of Psoriasis Score at Week 52 |
1.64; 1.33 | — |
| SECONDARY Time-Normalized Area Under Curve (AUC) of Dermatology Life Quality Index (DLQI) at Week 52 |
4.07; 2.96 | — |
| SECONDARY Patient Psoriasis Satisfaction Questionnaire (PSSQ): The Overall Appearance of Skin, at Baseline, Before Retreatment, and at the End of Retreatment |
66; 67; 15; 5; 31; 12 | — |
| SECONDARY Patient Psoriasis Satisfaction Questionnaire (PSSQ): Flaking Skin, at Baseline, Before Retreatment, and at the End of Retreatment |
60; 59; 12; 4; 26; 11 | — |
| SECONDARY Patient Psoriasis Satisfaction Questionnaire (PSSQ): Redness of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment |
62; 59; 14; 4; 27; 10 | — |
| SECONDARY Patient Psoriasis Satisfaction Questionnaire (PSSQ): Tightness of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment |
61; 54; 17; 5; 30; 9 | — |
| SECONDARY Patient Psoriasis Satisfaction Questionnaire (PSSQ): Bleeding of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment |
45; 37; 17; 11; 22; 10 | — |
| SECONDARY Patient Psoriasis Satisfaction Questionnaire (PSSQ): Burning Sensation in the Skin, at Baseline, Before Retreatment, and at the End of Retreatment |
51; 39; 14; 6; 23; 8 | — |
| SECONDARY Patient Psoriasis Satisfaction Questionnaire (PSSQ): Skin Pain, at Baseline, Before Retreatment, and at the End of Retreatment |
47; 44; 13; 7; 24; 8 | — |
| SECONDARY Patient Psoriasis Satisfaction Questionnaire (PSSQ): Joint Pain, at Baseline, Before Retreatment, and at the End of Retreatment |
33; 23; 7; 7; 14; 7 | — |
| SECONDARY Patient Psoriasis Satisfaction Questionnaire (PSSQ): Your Comfort Level With Your Personal Appearance, at Baseline, Before Retreatment, and at the End of Retreatment |
64; 58; 17; 6; 35; 8 | — |
| SECONDARY Patient Psoriasis Satisfaction Questionnaire (PSSQ): Anxiety, at Baseline, Before Retreatment, and at the End of Retreatment |
43; 36; 13; 6; 17; 5 | — |
| SECONDARY Patient Psoriasis Satisfaction Questionnaire (PSSQ): Depression, at Baseline, Before Retreatment, and at the End of Retreatment |
39; 31; 15; 5; 17; 3 | — |
| SECONDARY Patient Psoriasis Satisfaction Questionnaire (PSSQ): Fatigue, at Baseline, Before Retreatment, and at the End of Retreatment |
44; 43; 13; 7; 20; 6 | — |
| SECONDARY 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 |
50; 48; 20; 7; 28; 9 | — |
| SECONDARY Patient Psoriasis Satisfaction Questionnaire (PSSQ): How Your Skin Affects Your Social and Leisure Activities, at Baseline, Before Retreatment, and at the End of Retreatment |
56; 45; 23; 9; 29; 8 | — |
| SECONDARY 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 |
84; 79; 30; 13; 39; 17 | — |
| SECONDARY 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 |
82; 78; 34; 16; 41; 18 | — |
| SECONDARY Physician Global Assessment (PGA) of Disease Activity at Week 52 |
1.8; 1.4 | — |
Eligibility Criteria
Inclusion Criteria
- Eighteen (18) years of age or older at the time of consent.
- Previously treated with etanercept for chronic plaque psoriasis for at least 12 weeks prior to the screening visit and received a total weekly dose of 50 mg per week for at least the 6 weeks preceding the day of the screening visit
- Having shown clinical response with a PGA inferior or equal to 1 at the screening visit.
- PGA inferior or equal to 1 at the baseline visit.
Exclusion Criteria
- Evidence of skin conditions (eg, eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis.
- Evidence of active or previously known medical history of inflammatory arthritis (eg, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis).
- Any biologics other than etanercept within the 20 weeks prior to the screening visit.
Data sourced from ClinicalTrials.gov (NCT00992394). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.