Efficacy and Safety of Etanercept 50 mg Once Weekly Plus As Needed Topical Agent in Moderate to Severe Plaque Psoriasis (REFINE)
2017년 2월 7일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
310
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Quebec, 캐나다, G1V 4X7
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Quebec, 캐나다, G1J 1X7
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Alberta
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Calgary, Alberta, 캐나다, T2G 1B1
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British Columbia
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Surrey, British Columbia, 캐나다, V3R 6A7
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Vancouver, British Columbia, 캐나다, V5Z 4E8
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Manitoba
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Winnipeg, Manitoba, 캐나다, R3C 0N2
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New Brunswick
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Moncton, New Brunswick, 캐나다, E1C 8X3
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, 캐나다, A1A 5E8
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St. John's, Newfoundland and Labrador, 캐나다, A1C 2H5
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Nova Scotia
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Halifax, Nova Scotia, 캐나다, B3H 1Z4
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Ontario
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Courtice, Ontario, 캐나다, L1E 3C3
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Markham, Ontario, 캐나다, L3P 1A8
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Mississauga, Ontario, 캐나다, L5H 1G9
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North Bay, Ontario, 캐나다, P1B 3Z7
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Peterborough, Ontario, 캐나다, K9J 1Z2
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Richmond Hill, Ontario, 캐나다, L4B 1A5
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Sudbury, Ontario, 캐나다, P3C 1X8
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Toronto, Ontario, 캐나다, M3H 5Y8
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Toronto, Ontario, 캐나다, M4V 1R1
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Waterloo, Ontario, 캐나다, N2J 1C4
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Windsor, Ontario, 캐나다, N8W 5L7
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Quebec
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Montreal, Quebec, 캐나다, H2K 4L5
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Montreal, Quebec, 캐나다, H3Z 2S6
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Saint-Hyacinthe, Quebec, 캐나다, J2S 6L6
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: 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
다른 이름들:
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실험적: 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
다른 이름들:
Topical agents prescribed at the discretion of the Principal Investigator and were are limited to the following:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Percent Change in Psoriasis Area and Severity Index (PASI) From Week 12 to Week 24
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Percent Change in PASI From Week 12 to Weeks 16 and 20
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2011년 4월 1일
기본 완료 (실제)
2012년 12월 1일
연구 완료 (실제)
2013년 5월 1일
연구 등록 날짜
최초 제출
2011년 2월 24일
QC 기준을 충족하는 최초 제출
2011년 3월 10일
처음 게시됨 (추정)
2011년 3월 11일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 3월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 2월 7일
마지막으로 확인됨
2017년 2월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 20090647
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
etanercept에 대한 임상 시험
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Sunshine Guojian Pharmaceutical (Shanghai) Co.,...완전한
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Amgen완전한관절염, 류마티스; 관절염, 건선미국, 푸에르토 리코
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Nanfang Hospital of Southern Medical University알려지지 않은
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Duke UniversityNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)빼는