A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque Psoriasis (IXORA-S)
A 52-Week Multicenter, Randomized, Blinded, Parallel-Group Study Comparing the Efficacy and Safety of Ixekizumab to Ustekinumab in Patients With Moderate-to-Severe Plaque Psoriasis
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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Dundee、イギリス、DD1 9SY
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Salford、イギリス、M6 8HD
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Catania、イタリア、95125
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Pisa、イタリア、56100
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Nijmegen、オランダ、6525 GL
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Wein、オーストリア、1090
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Calgary、カナダ、T3A 2N1
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Edmonton、カナダ、T5K 1X3
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Mississauga、カナダ、L5H 1GO
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North Bay、カナダ、P1B 3Z7
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St. John's、カナダ、A1A4Y3
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Toronto、カナダ、M3H 5Y8
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Genève、スイス、1211
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Lausanne、スイス、1011
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Zürich、スイス、8091
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Malmö、スウェーデン、20502
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Stockholm、スウェーデン、SE-118 83
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Badalona、スペイン、08916
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Barcelona、スペイン、08041
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Madrid、スペイン、28041
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Madrid、スペイン、28031
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Sevilla、スペイン、41071
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Frankfurt am Main、ドイツ、60590
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Giessen、ドイツ、35390
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Hamburg、ドイツ、20354
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Heidelberg、ドイツ、69120
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Kiel、ドイツ、24148
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Lübeck、ドイツ、23538
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München、ドイツ、80802
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Tübingen、ドイツ、72076
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Witten、ドイツ、58453
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Budapest、ハンガリー、1135
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Kecskemet、ハンガリー、6000
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Szeged、ハンガリー、6720
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Szolnok、ハンガリー、5000
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Marseille、フランス、13008
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Martigues、フランス、13500
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Nice、フランス、06202
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Rouen、フランス、76031
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Toulouse、フランス、31059
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Brussels、ベルギー、1200
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Gent、ベルギー、9000
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Bialystok、ポーランド、15-351
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Lodz、ポーランド、90-265
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Swidnik、ポーランド、21-040
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Warsaw、ポーランド、01-142
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Warsaw、ポーランド、01-518
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Warszawa、ポーランド、02-507
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Chronic plaque psoriasis for at least 6 months before baseline
- Failure, contraindication, or intolerability to at least 1 systemic therapy (including cyclosporine, methotrexate, or phototherapy)
- Psoriasis Area Severity Index (PASI) score at least 10 at screening and at baseline
- Participant must agree to use reliable method of birth control during the study; women must continue using birth control for at least 15 weeks after stopping treatment
Exclusion Criteria:
- Predominant pattern of pustular, erythrodermic, and/or guttate forms of psoriasis
- History of drug-induced psoriasis
- Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks before baseline and during the study
- Have received systemic nonbiologic psoriasis therapy or phototherapy within 4 weeks of baseline, or have had topical psoriasis treatment within the 2 weeks of baseline
- Concurrent or recent use of any biologic agent within the following washout periods: etanercept <28 days; infliximab, adalimumab, or alefacept <60 days; golimumab <90 days; rituximab <12 months; or any other biologic agent <5 half-lives prior to baseline
- Have prior use of ustekinumab, or have any condition or contraindication to ustekinumab that would preclude the participant from participating in this protocol
- Have previously completed or withdrawn from this study, participated in any other study with ixekizumab, have participated in any study investigating other interleukin (IL)-17 or IL-12/23 antagonists, or have received treatment with other IL-17 or IL-12/23 antagonists
- Have had a live vaccination within 12 weeks of baseline, or intend to have a live vaccination during the course of the study or within 15 weeks of completing treatment in this study
- Have had a vaccination with Bacillus Calmette-Guérin (BCG) within 12 months of baseline or intend to have vaccination with BCG during the course of the study or within 12 months of completing treatment in this study
- Have a known allergy or hypersensitivity to latex
- Have had any major surgery within 8 weeks of baseline or will require such during the study
- Have active or history of malignant disease within 5 years prior to baseline
- Significant uncontrolled disorder
- Ongoing infection or serious infection within 12 weeks of baseline; serious bone or joint infection within 24 weeks of baseline
- Are women who are lactating or breast-feeding
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ：Ustekinumab
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40.
Placebo for ixekizumab injections will be used for blinding.
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管理SC
管理SC
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実験的：Ixekizumab
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12.
After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52.Placebo for ustekinumab injections will be used for blinding.
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管理SC
他の名前：
管理SC
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline
時間枠：Week 12
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The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs).
For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement).
Each area is scored by itself and the scores were then combined for the final PASI.
Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)].
Overall scores range from 0 (no Ps) to 72 (the most severe disease).
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Week 12
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Percentage of Participants With a ≥75% Improvement in PASI (PASI 75) From Baseline
時間枠：Week 12
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The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs).
For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement).
Each area is scored by itself and the scores then combined for the final PASI.
Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)].
Overall scores range from 0 (no Ps) to 72 (the most severe disease).
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Week 12
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Percentage of Participants With a 100% Improvement of PASI (PASI 100) From Baseline
時間枠：Week 12
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The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs).
For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement).
Each area is scored by itself and the scores were then combined for the final PASI.
Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)].
Overall scores range from 0 (no Ps) to 72 (the most severe disease).
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Week 12
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Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1) With at Least a 2-Point Improvement From Baseline
時間枠：Week 12
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The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point.
Lesions were categorized by descriptions for induration, erythema, and scaling.
Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe).
An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline.
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Week 12
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Percentage of Participants With a sPGA (0) Remission
時間枠：Week 12
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The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point.
Lesions were categorized by descriptions for induration, erythema, and scaling.
Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe).
An sPGA assessed as 0, indicates complete resolution of plaque Ps.
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Week 12
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Change From Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis
時間枠：Baseline, Week 12
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The percentage involvement of psoriasis on each participant's body surface area was assessed by the investigator on a scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand including palm, fingers and thumb. ANCOVA model with modified baseline observation carried forward (mBOCF) was used to produce Least Square (LS) mean with baseline, treatment group, region weight group as fixed effects. |
Baseline, Week 12
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Change From Baseline in Palmoplantar Psoriasis Severity Index (PPASI) Total Score
時間枠：Baseline, Week 12
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The Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 (no Ps) to 72. (the most severe disease) The PPASI was only assessed if participants have palmoplantar psoriasis at baseline. ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects. |
Baseline, Week 12
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Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Total Score
時間枠：Baseline, Week 12
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The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total score ranging from 0 (less severity) to 72 (more severity). ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects. |
Baseline, Week 12
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Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Total Score
時間枠：Baseline, Week 12
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NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail(fn) Ps. This scale is used to evaluate severity of fn bed Ps & fn matrix Ps by area of involvement in the fn unit. fn is divided with imaginary horizontal & longitudinal lines into quadrants. Each fn is given a score for fn bed Ps 0(none) to 4(Ps in 4 quadrants of the fn) & fn matrix Ps 0(none) to 4(Ps in 4 quadrants in matrix), depending on presence (score of 1) or absence (score of 0) of any of the features of fn bed or matrix Ps in each quadrant.NAPSI score of a fn is sum of scores in fn bed & fn matrix from each quadrant (maximum of 8). Each fn is evaluated, then the sum of all fn equals the total NAPSI score with a range from range 0 to 80. Higher scores indicate more severe ps. ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects. |
Baseline, Week 12
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Change From Baseline in Itch Numeric Rating Scale (NRS)
時間枠：Baseline, Week 12
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The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 (no itch) and 10 (worst itch imaginable). Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours. ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects. |
Baseline, Week 12
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Change From Baseline on the Skin Pain Visual Analog Scale (VAS) (0,100)
時間枠：Baseline, Week 12
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Skin Pain VAS is a participant administered scale designed to measure skin pain from psoriasis using a 100-millimeter (mm) horizontal VAS. Overall severity of a participant's skin pain from psoriasis at the present time is indicated by placing a single mark on the horizontal scale (0 = no skin pain; 100 = severe skin pain). ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects. |
Baseline, Week 12
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Percentage of Participants With Dermatology Life Quality Index (DLQI) (0,1)
時間枠：Week 12
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The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment.
Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0."
Totals range from 0 to 30 (less to more impairment).
A score of 0 or 1 indicates no impact of disease on a participants quality of life.
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Week 12
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Change From Baseline on the Hospital Anxiety and Depression Scale (HADS) Depression Subscale
時間枠：Baseline, Week 12
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The HADS is a participant-rated instrument used to assess both anxiety and depression. This instrument consists of 14 items questionnaire, each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal. ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects. |
Baseline, Week 12
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Change From Baseline on the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale.
時間枠：Baseline, Week 12
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The HADS is a participant-rated instrument used to assess both anxiety and depression. This instrument consists of 14 items questionnaire, each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal. ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects. |
Baseline, Week 12
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Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score;
時間枠：Baseline, Week 12
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The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. Items from 8 domains contribute to the PCS. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. SF-36 acute version was used, which has a 1 week recall period. ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects. |
Baseline, Week 12
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Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) Score
時間枠：Baseline, Week 12
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The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. Items from 8 domains contribute to the PCS. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. SF-36 acute version was used, which has a 1 week recall period. ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects. |
Baseline, Week 12
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Change From Baseline on Patient Global Assessment of Disease Severity (PatGA)
時間枠：Baseline, Week 12
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The Patient Global Assessment of Disease Severity is a single-item participant-reported outcome measure on which participants are asked to rate the severity of their psoriasis "today" from 0 (Clear) = no psoriasis, to 5 (Severe) = the worst their psoriasis has ever been. ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects. |
Baseline, Week 12
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Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) "Bolt On" Psoriasis (PSO) -Index
時間枠：Baseline, Week 12
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The European Quality of Life - 5 Dimensions 5 Level (EQ-5D-5L) is a standardized measure of health status used to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L consists of a descriptive system of the respondent's health which comprises the following 5 dimensions: 1) mobility 2) self-care 3) usual activities 4) pain/discomfort 5) anxiety/depression. The Bolt On PSO is an addition to the EQ-5D-5L that consists of 2 dimensions specific to psoriatic disease: 6) skin irritation (itching) and 7) self-confidence. Index scores for the Bolt On PSO range from 0.0042 to 1.0 (worse to better health). ANCOVA model was used to produce LS mean with baseline, treatment group, region weight group as fixed effects. |
Baseline, Week 12
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Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) VAS
時間枠：Baseline, Week 12
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The EQ-5D 5L is a standardized measure of health status that includes a descriptive system of the respondent's health and a rating of his/her current health state using a 0 (worst health imaginable)- to 100 (best health imaginable)-millimeter (mm) Visual Analog Scale (VAS).
ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.
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Baseline, Week 12
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Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) United Kingdom(UK) Population-based Index Score
時間枠：Baseline, Week 12
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The EQ-5D-5L descriptive system comprises 5 dimensions, each with 5 levels. The EQ-5D-5L health states were converted into a single summary index by applying a crosswalk using a UK Population value set to each of the levels in each dimension. This produced patient-level index scores between -0.594 and 1.0 (worse to better health). ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects. |
Baseline, Week 12
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Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Absenteeism
時間枠：Baseline, Week 12
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The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work & WPAI-PSO absenteeism score is derived from these questions. Each WPAI score is expressed as an impairment percentage (0-100), with higher scores representing greater impairment (worse outcomes). ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects. |
Baseline, Week 12
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Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Presenteeism
時間枠：Baseline, Week 12
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The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work & WPAI-PSO Presenteeism score is derived from these questions. each WPAI score is expressed as an impairment percentage (0-100), with higher scores representing greater impairment (worse outcomes). ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects. |
Baseline, Week 12
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Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Work Impairment Score.
時間枠：Baseline, Week 12
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The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work & WPAI-PSO work impairment score is derived from these questions. each WPAI score is expressed as an impairment percentage (0-100), with higher scores representing greater impairment (worse outcomes). ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects. |
Baseline, Week 12
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Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Impairment in Activities Performed Outside of Work
時間枠：Baseline, Week 12
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The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work & WPAI-PSO impairment in activities performed outside of work score is derived from these questions. each WPAI score is expressed as an impairment percentage (0-100), with higher scores representing greater impairment (worse outcomes). ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects. |
Baseline, Week 12
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協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- Elewski BE, Blauvelt A, Gallo G, Wolf E, McKean-Matthews M, Burge R, Merola JF, Gottlieb AB, Guenther LC. Simultaneous Nail and Skin Clearance in Ixekizumab Head-to-Head Trials for Moderate-to-Severe Psoriasis and Psoriatic Arthritis. Dermatol Ther (Heidelb). 2022 Apr;12(4):911-920. doi: 10.1007/s13555-022-00704-2. Epub 2022 Mar 13.
- Wasel N, Thaci D, French LE, Conrad C, Dutronc Y, Gallo G, Berggren L, Lacour JP. Ixekizumab and Ustekinumab Efficacy in Nail Psoriasis in Patients with Moderate-to-Severe Psoriasis: 52-Week Results from a Phase 3, Head-to-Head Study (IXORA-S). Dermatol Ther (Heidelb). 2020 Aug;10(4):663-670. doi: 10.1007/s13555-020-00383-x. Epub 2020 May 15.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 16012
- I1F-MC-RHBS (その他の識別子：Eli Lilly and Company)
- 2015-000892-28 (EudraCT番号)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- 研究プロトコル
- 統計分析計画 (SAP)
- 臨床試験報告書（CSR）
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国で製造され、米国から輸出された製品。
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