Efficacy and Safety of Etanercept 50 mg Once Weekly Plus As Needed Topical Agent in Moderate to Severe Plaque Psoriasis (REFINE)
2017年2月7日 更新者：Amgen
A Randomized, Blinded Assessor Study to Evaluate the Efficacy and Safety of Etanercept 50 mg Once Weekly Plus As Needed Topical Agent Versus Etanercept 50 mg Twice Weekly in Subjects With Moderate to Severe Plaque Psoriasis
To estimate the difference in effectiveness between treatment with etanercept 50 mg twice weekly (BIW) and treatment with etanercept 50 mg once weekly (QW) plus an as needed (PRN) topical agent for 12 weeks in adults with moderate to severe plaque psoriasis.
調査の概要
詳細な説明
The recommended starting dose of etanercept for adult plaque psoriasis patients is a 50 mg dose given twice a week (BIW) for 3 months followed by a reduction to a maintenance dose of 50 mg once weekly (QW). While most patients with moderate to severe plaque psoriasis are managed satisfactorily on etanercept monotherapy, a proportion may require a modified or alternative treatment regimen (eg, to handle flares or loss of effect) at some point during their chronic management. Despite the clinical need, no published data from randomized controlled studies are currently available that demonstrate efficacy and safety of combined etanercept-based regimens in patients with plaque psoriasis.
The addition of an as-needed topical medication to the step-down dose of etanercept 50 mg once weekly administered after the initial 12 week period of 50 mg twice weekly may be a potential option for patients who may require adjunctive therapy. This study aimed to provide data on this treatment option by estimating the difference in mean percent change in Psoriasis Area and Severity Index (PASI) scores between step-down etanercept 50 mg once weekly supplemented with as-needed topical medication and continuous treatment with etanercept 50 mg twice weekly.
Eligible patients will be enrolled in the study and will receive etanercept 50 mg twice weekly for 12 weeks. After 12 weeks of etanercept treatment, participants will be randomized in a 1:1 ratio to 1 of 2 treatment groups.
研究の種類
介入
入学 (実際)
310
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Quebec、カナダ、G1V 4X7
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Quebec、カナダ、G1J 1X7
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Alberta
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Calgary、Alberta、カナダ、T2G 1B1
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British Columbia
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Surrey、British Columbia、カナダ、V3R 6A7
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Vancouver、British Columbia、カナダ、V5Z 4E8
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Manitoba
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Winnipeg、Manitoba、カナダ、R3C 0N2
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New Brunswick
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Moncton、New Brunswick、カナダ、E1C 8X3
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Newfoundland and Labrador
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St. John's、Newfoundland and Labrador、カナダ、A1A 5E8
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St. John's、Newfoundland and Labrador、カナダ、A1C 2H5
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Nova Scotia
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Halifax、Nova Scotia、カナダ、B3H 1Z4
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Ontario
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Courtice、Ontario、カナダ、L1E 3C3
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Markham、Ontario、カナダ、L3P 1A8
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Mississauga、Ontario、カナダ、L5H 1G9
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North Bay、Ontario、カナダ、P1B 3Z7
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Peterborough、Ontario、カナダ、K9J 1Z2
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Richmond Hill、Ontario、カナダ、L4B 1A5
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Sudbury、Ontario、カナダ、P3C 1X8
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Toronto、Ontario、カナダ、M3H 5Y8
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Toronto、Ontario、カナダ、M4V 1R1
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Waterloo、Ontario、カナダ、N2J 1C4
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Windsor、Ontario、カナダ、N8W 5L7
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Quebec
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Montreal、Quebec、カナダ、H2K 4L5
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Montreal、Quebec、カナダ、H3Z 2S6
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Saint-Hyacinthe、Quebec、カナダ、J2S 6L6
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Has had stable moderate to severe plaque psoriasis for at least 6 months (eg, no morphology changes or significant flares of disease activity in the opinion of the investigator).
- Has a body surface area (BSA) involvement ≥ 10% and Psoriasis Area and Severity Index (PASI) ≥ 10 at screening and at baseline.
- Is a candidate for systemic therapy or phototherapy in the opinion of the investigator.
- Other inclusion criteria may apply.
Exclusion Criteria:
- Has active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit.
- Has evidence of skin conditions at the time of the screening visit (eg, eczema) that would interfere with evaluations of the effect of etanercept on psoriasis.
- Diagnosed with medication-induced or medication-exacerbated psoriasis.
- Significant concurrent medical conditions.
- Has any active localized infection; requiring local intervention or chronic or localized infections.
- Other exclusion criteria may apply.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：独身
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：Etanercept 50 mg BIW
Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg etanercept twice weekly for 12 weeks.
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Administered by subcutaneous injection
他の名前：
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実験的：Etanercept 50 mg QW + Topical
Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg etanercept once weekly plus as needed topical agents.
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Administered by subcutaneous injection
他の名前：
Topical agents prescribed at the discretion of the Principal Investigator and were are limited to the following:
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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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Percent Change in Psoriasis Area and Severity Index (PASI) From Week 12 to Week 24
時間枠：Week 12 and Week 24
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The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs.
The total PASI score ranges from 0 to 72.
The higher the total score, the more severe the disease.
Change from Week 12 to Week 24 is presented as a percentage of the Week 12 value: Week 12 value - Week 24 value / Week 12 value * 100 so that a positive change indicates improvement.
Change was adjusted for treatment using a mixed model.
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Week 12 and Week 24
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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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Percent Change in PASI From Week 12 to Weeks 16 and 20
時間枠：Week 12, Week 16 and Week 20
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The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs.
The total PASI score ranges from 0 to 72.
The higher the total score, the more severe the disease.
Change from Week 12 presented as a percentage of the Week 12 value: Week 12 value - postbaseline value / Week 12 value * 100, so that a positive change indicates improvement.
Change was adjusted for treatment using a mixed model.
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Week 12, Week 16 and Week 20
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Percent Change in PASI From Baseline to Weeks 12, 16, 20, and 24
時間枠：Baseline and Weeks 12, 16, 20, and 24
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The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs.
The total PASI score ranges from 0 to 72.
The higher the total score, the more severe the disease.
Change from Baseline is presented as a percentage of the Baseline value: Baseline value - postbaseline value / Baseline value * 100, so that a positive change indicates improvement.
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Baseline and Weeks 12, 16, 20, and 24
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Percentage of Participants With a PASI 50 Response
時間枠：Baseline and Weeks 12, 16, 20 and 24
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The percentage of participants with a 50% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline.
PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination.
The score ranges from 0 (best outcome) to 72 (worst outcome).
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Baseline and Weeks 12, 16, 20 and 24
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Percentage of Participants With a PASI 75 Response
時間枠：Baseline and Weeks 12, 16, 20 and 24
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The percentage of participants with a 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline.
PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination.
The score ranges from 0 (best outcome) to 72 (worst outcome).
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Baseline and Weeks 12, 16, 20 and 24
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Percentage of Participants With a PASI 90 Response
時間枠：Baseline and Weeks 12, 16, 20 and 24
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The percentage of participants with a 90% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline.
PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination.
The score ranges from 0 (best outcome) to 72 (worst outcome).
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Baseline and Weeks 12, 16, 20 and 24
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Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Psoriasis Score of 0 (Clear) or 1 (Almost Clear)
時間枠：Weeks 12, 16, 20, and 24
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The sPGA scale is completed by the same blinded assessor performing the PASI assessments and is designed to evaluate the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema.
The sPGA is assessed on a scale of 0 to 5 (0 = clear, 5 = severe).
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Weeks 12, 16, 20, and 24
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Percent Change in the Percentage of Body Surface Area (BSA) Involvement From Week 12 to Weeks 16, 20, and 24
時間枠：Weeks 12, 16, 20, and 24
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The percentage of body surface area involved with psoriasis was measured by the same blinded assessor performing the PASI assessments. Change from Week 12 is presented as a percentage of the Week 12 value: Week 12 value - postbaseline value / Week 12 value * 100, so that a positive change indicates improvement. Change was adjusted for treatment using a mixed model. |
Weeks 12, 16, 20, and 24
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Percent Change in the Percentage of Body Surface Area (BSA) Involvement From Baseline to Weeks 12, 16, 20, and 24
時間枠：Baseline and Weeks 12, 16, 20, and 24
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The percentage of body surface area involved with psoriasis was measured by the same blinded assessor performing the PASI assessments. Change from Baseline \ is presented as a percentage of the Baseline value: Baseline value - postbaseline value / Baseline value * 100, so that a positive change indicates improvement. |
Baseline and Weeks 12, 16, 20, and 24
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Change From Week 12 to Week 24 in Dermatology Quality of Life Index (DQLI) Total Score
時間枠：Week 12 and Week 24
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The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings.
Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30.
A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all.
Change from Week 12 to Week 24 is calculated as: Week 12 value - Week 24 value so that a positive change indicates improvement.
Change was adjusted for treatment using a mixed model.
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Week 12 and Week 24
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Change From Baseline to Weeks 12 and 24 in Dermatology Quality of Life Index (DQLI) Total Score
時間枠：Baseline and Week 12 and Week 24
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The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings.
Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30.
A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all.
Change from Baseline was calculated as Baseline value - postbaseline value so that a positive change indicates improvement.
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Baseline and Week 12 and Week 24
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Change in Treatment Satisfaction Questionnaire for Medications (TSQM) Scores From Week 12 to Week 24
時間枠：Week 12 and Week 24
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TSQM is a validated questionnaire consisting of 14 questions regarding a participant's perception of the level of satisfaction or dissatisfaction with the medication they are taking.
Four scales are generated: side effects, effectiveness, convenience, and global satisfaction.
Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied.
From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction.
Change was calculated as Week 24 - Week 12 so that a positive change indicates improvement over time.
Change was adjusted for treatment using a mixed model.
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Week 12 and Week 24
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Change in Treatment Satisfaction Questionnaire for Medications (TSQM) Scores From Baseline to Weeks 12 and 24
時間枠：Baseline and Weeks 12 and 24
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The TSQM is a validated questionnaire consisting of 14 questions regarding a participant's perception of the level of satisfaction or dissatisfaction with the medication they are taking.
Four scales are generated: side effects, effectiveness, convenience, and global satisfaction.
Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied.
From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction.
Change was calculated as postbaseline value - Baseline value so that a positive change indicates improvement.
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Baseline and Weeks 12 and 24
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Health Resource Utilization: Number of Participants With Visits to a Healthcare Provider
時間枠：Baseline and 24 weeks
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Participants completed a questionnaire to assess their health resource utilization (HRU) related to psoriasis.
To assess the number of visits to a healthcare provider, participants answered the following questions regarding the past 4 weeks: How many times have you been to any physician's office or urgent care clinic?
How many times have you seen a nurse practitioner, a physician assistant, a psychologist, a naturopath, an acupuncturist, a chiropractor, or other healthcare professional (HCP)?
The number of participants with one or more visits is reported.
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Baseline and 24 weeks
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Health Resource Utilization: Number of Participants With Home Healthcare Visits
時間枠：Baseline and 24 weeks
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Participants completed a questionnaire to assess their health resource utilization (HRU) related to psoriasis.
To assess the number of homecare visits, participants answered the following question regarding the past 4 weeks: How many times have you received care from a health professional in your home?
The number of participants with one or more visits is reported.
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Baseline and 24 weeks
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Health Resource Utilization: Number of Participants Requiring Paid Help With Chores
時間枠：Baseline and 24 weeks
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Participants completed a questionnaire to assess their health resource utilization (HRU) related to psoriasis.
To assess the number of participants who needed paid help with chores, participants answered the following question regarding the past 4 weeks: How many times have you paid someone to help you do chores around the house (cleaning, maintenance, lawn care)?
The number of participants who paid for help one or more times is reported.
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Baseline and 24 weeks
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Health Resource Utilization: Number of Participants Who Needed Friend or Family Care
時間枠：Baseline and 24 weeks
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Participants completed a questionnaire to assess their health resource utilization (HRU) related to psoriasis.
Participants answered the following question regarding the past 4 weeks: How many hours have you had a friend or family member take time off work to provide care or transportation?
The number of participants who had paid or non-paid help for one or more hours is reported.
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Baseline and 24 weeks
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Health Resource Utilization: Out of Pocket Expenses
時間枠：Baseline and 24 weeks
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Participants completed a questionnaire to assess their health resource utilization (HRU) related to psoriasis.
To assess out of pocket expenses, participants answered the following question regarding the past 4 weeks: Not counting study mandated visits, what out-of-pocket expenses did you spend for the management of psoriasis (i.e.
costs due to travelling to doctor appointment, hospital or clinic parking costs, alternative medications)?
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Baseline and 24 weeks
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Health Resource Utilization: Employment Status
時間枠：Baseline and 24 weeks
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Participants completed a questionnaire to assess their health resource utilization (HRU) related to psoriasis.
Participants were asked their employment status at Baseline and at Week 24.
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Baseline and 24 weeks
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Health Resource Utilization: Productivity While Working
時間枠：Baseline and 24 weeks
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Participants who were employed were asked: How much did your psoriasis affect your productivity while you were working?
Possible responses were: a) A great deal; b) Quite a bit; c) Somewhat; d) Minimally; e) Not at all.
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Baseline and 24 weeks
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Health Resource Utilization: Number of Participants With Missed Hours From Work
時間枠：Baseline and 24 weeks
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Participants who were employed answered the following question regarding the past 4 weeks: How many hours per week did you miss from work because of your psoriasis?
The number of participants with one or more missed hours of work per week is reported.
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Baseline and 24 weeks
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Health Resource Utilization: Ability to Perform Daily Activities
時間枠：Baseline and 24 weeks
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Participants were asked: How much did your psoriasis affect your ability to do your daily activities or household chores?
Possible answers were: a) A great deal; b) Quite a bit; c) Somewhat; d) Minimally; e) Not at all.
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Baseline and 24 weeks
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Number of Participants With Adverse Events
時間枠：32 weeks
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An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant.
A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal, • life threatening, • requires in-patient hospitalization or prolongation of existing hospitalization, • results in persistent or significant disability/incapacity, • congenital anomaly/birth defect, and/or • other significant medical hazard.
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32 weeks
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Papp KA, Barber K, Bissonnette R, Bourcier M, Lynde CW, Poulin Y, Shelton J, Garces K, Toole J, Poulin-Costello M. Improvements in patient-reported outcomes in patients with psoriasis receiving etanercept plus topical therapies: results from REFINE. J Eur Acad Dermatol Venereol. 2015 Aug;29(8):1555-61. doi: 10.1111/jdv.12934. Epub 2015 Jan 21.
- Papp KA, Barber K, Bissonnette R, Bourcier M, Lynde CW, Poulin Y, Shelton J, Toole J, Vieira A, Poulin-Costello M. A Randomized, blinded assessor study to Evaluate the efFIcacy and safety of etanercept 50 mg once weekly plus as Needed topical agent vs. Etanercept 50 mg twice weekly in patients with moderate to severe plaque psoriasis (REFINE). J Eur Acad Dermatol Venereol. 2015 Feb;29(2):361-366. doi: 10.1111/jdv.12555. Epub 2014 Jul 1.
- Gooderham MJ, Poulin-Costello M, Shelton J, Bayan N, Papp KA. Predictors of Topical Use in Psoriasis Patients in the REFINE Study. J Cutan Med Surg. 2016 Mar-Apr;20(2):106-12. doi: 10.1177/1203475415604322. Epub 2015 Sep 1.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2011年4月1日
一次修了 (実際)
2012年12月1日
研究の完了 (実際)
2013年5月1日
試験登録日
最初に提出
2011年2月24日
QC基準を満たした最初の提出物
2011年3月10日
最初の投稿 (見積もり)
2011年3月11日
学習記録の更新
投稿された最後の更新 (実際)
2017年3月15日
QC基準を満たした最後の更新が送信されました
2017年2月7日
最終確認日
2017年2月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
etanerceptの臨床試験
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First Affiliated Hospital of Zhejiang UniversityTongji Hospital; Ruijin Hospital; The First Affiliated Hospital of Zhengzhou University; The Children... と他の協力者募集
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All India Institute of Medical Sciences, New Delhi完了
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mAbxience Research S.L.完了