Randomised, Open-label Preliminary Study to Assess the Effects of 2 Regimens of Etanercept on Nail and Skin Symptoms in Patients With Nail Psoriasis and Plaque Psoriasis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 136
- 主要终点
- Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail
研究概览
简要总结
The purpose of this study is to evaluate if Etanercept administered at a higher initial dose provides greater improvement in nail and skin psoriasis symptoms than a regimen with a lower initial dose.
详细描述
This study will assess the effects of the 2 Etanercept regimens on fingernail psoriasis over 24 weeks among patients with both skin and fingernail symptoms who have previously failed at least one therapy for nail psoriasis. The endpoint of 24 weeks was chosen to allow sufficient time for normal nail growth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Active, stable plaque psoriasis defined by the following criteria:
- •Body surface area (BSA) ≥ 10 % at screening and baseline
- •Or, PASI >10 at screening and baseline
- •Or, PGA of Psoriasis status of moderate or worse (moderate, marked, or severe) at screening and baseline
- •Or, DLQI > 10 at baseline
- •Active fingernail psoriasis defined as target fingernail NAPSI ≥ 2 and overall NAPSI > 14 - Target nail is defined as the nail with the highest nail score (matrix+bed scores) at baseline. Should more than one fingernail have the same score, the target fingernail will be chosen by the investigator.
- •Failure of at least one systemic psoriasis therapy for nail psoriasis
- •Eligible to receive biologic therapy for psoriasis in accordance to local guidelines
排除标准
- •Evidence of Skin conditions other than psoriasis
- •Psoralen plus ultraviolet radiation (PUVA), cyclosporine, alefacept, methotrexate, acitretin, or any other systemic anti-psoriasis therapy within 28 days of study drug initiation
- •Prior exposure to any TNF-inhibitor. Prior exposure to efalizumab
研究组 & 干预措施
1
etanercept 50 mg SC injection twice weekly for 12 weeks reducing to etanercept 50 mg once weekly to week 24
干预措施: etanercept (Drug)
2
etanercept 50 mg SC once weekly for the complete 24 week treatment period
干预措施: etanercept (Drug)
结局指标
主要结局
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail
时间窗: Baseline, Week 24
Target fingernail (highest matrix + bed scores at baseline) divided with imaginary lines into quadrants and graded for nail matrix and nail bed psoriasis. Sum of scores = total score for that nail (0-8). Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present in 1/4 nail), 2 (present in 2/4 nail), 3 (present in 3/4 nail), 4 (present in 4/4 nail). Higher scores = more severe psoriasis.
次要结局
- Change From Baseline in Overall Nail Psoriasis Severity Index (NAPSI) Score(Baseline, Week 24)
- Percent of Participants Who Achieved a 50% Improvement in the Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail at Week 12 and Week 24(Week 12, Week 24)
- Percent of Participants Who Achieved a 75% Improvement in the Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail at Week 12 and Week 24(Week 12, Week 24)
- Percent of Participants Who Achieved a 50% Improvement in the Nail Psoriasis Severity Index (NAPSI) for Overall NAPSI Score at Week 12 and Week 24(Week 12, Week 24)
- Percent of Participants Who Achieved a 75% Improvement in the Nail Psoriasis Severity Index (NAPSI) for Overall NAPSI Score at Week 12 and Week 24(Week 12, Week 24)
- Change From Baseline in the Psoriasis Area and Severity Index (PASI) Score(Baseline, Week 24)
- Percent of Participants Achieving a 50% Improvement in the Psoriasis Area and Severity Index (PASI) Score at Week 12 and Week 24(Week 12 , Week 24)
- Percent of Participants Achieving a 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score at Week 12 and Week 24(Week 12 , Week 24)
- Change From Baseline in Physician Global Assessment (PGA) of Psoriasis(Baseline, Week 24)
- Percent of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear or Almost Clear(Baseline, Week 24 or Early Termination)
- Percent of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Mild or Better(Baseline, Week 24 or Early Termination)
- Change From Baseline in the Dermatology Life Quality Index (DLQI)(Baseline, Week 24)
- Change From Baseline in Physician Assessment of Nail Psoriasis Activity Visual Analog Scale (VAS)(Baseline, Week 24)
- Change From Baseline in Patient Assessment of Nail Psoriasis Activity Visual Analog Scale (VAS)(Baseline, Week 24)
- Change From Baseline in Physician Fingernail Grading Assessment Total Score(Baseline, Week 24)