A Multi-center, Randomized, Vehicle-Controlled Study to Assess the Efficacy and Safety of Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment (BELIEVE)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 730
- 主要终点
- Percentage of Participants Who Achieve a PASI75 Response at Week 16 Compared With Baseline (Week 0)
研究概览
简要总结
The objective of this study is to assess the efficacy and safety of adalimumab in combination with topical psoriasis treatment, calcipotriol/betamethasone, vs. adalimumab in combination with matching vehicle in subjects with moderate to severe chronic plaque psoriasis.
详细描述
Additional information regarding sponsors: Abbott GmbH & Co. KG is sponsor for EU member states. Abbott US is sponsor for non-EU member states.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Subject is >= 18 years of age
- •Subject had a clinical diagnosis of chronic plaque psoriasis for at least 6 months, and has moderate to severe plaque psoriasis
- •Subject must have been treated and failed to respond to, or has a contraindication to, or is intolerant to at least two different systemic therapies, one of which must be cyclosporine, or methotrexate or oral PUVA
- •Subject is judged to be in generally good health as determined by the principal investigator
排除标准
- •Subject has previous exposure to adalimumab
- •Subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot avoid UVB or PUVA phototherapy
- •Subject is taking or requires oral or injectible corticosteroids
- •Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, medication-induced or medication-exacerbated psoriasis or new onset guttate psoriasis
- •Subject considered by the investigator, for any reason, to be an unsuitable candidate
- •Female subject who is pregnant or breast-feeding or considering becoming pregnant
- •Subject has a calcium metabolism disorder
研究组 & 干预措施
adalimumab + calcipotriol/betamethasone
adalimumab + calcipotriol/betamethasone ointment
干预措施: Calcipotriol/Betamethasone Ointment (Drug)
adalimumab + placebo
adalimumab + placebo (vehicle ointment)
干预措施: adalimumab (Biological)
adalimumab + placebo
adalimumab + placebo (vehicle ointment)
干预措施: placebo (vehicle ointment) (Drug)
adalimumab + calcipotriol/betamethasone
adalimumab + calcipotriol/betamethasone ointment
干预措施: adalimumab (Biological)
结局指标
主要结局
Percentage of Participants Who Achieve a PASI75 Response at Week 16 Compared With Baseline (Week 0)
时间窗: Week 0 and Week 16
PASI75 is defined as at least a 75% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. Positive percent decreases indicate improvement, with best improvement being 100%. The outcome measure is the percentage of participants who had at least a 75% PASI score decrease.
次要结局
- Percentage of Participants With a PASI50 Response at Week 16 Compared With Baseline (Week 0)(Week 0 and Week 16)
- Percentage of Participants With a PASI90 Response at Week 16 Compared With Baseline (Week 0)(Week 0 and Week 16)
- Percentage of Participants With a PASI100 Response at Week 16 Compared With Baseline (Week 0)(Week 0 and Week 16)
- Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 2(Week 2)
- Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 4(Week 4)
- Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 8(Week 8)
- Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 12(Week 12)
- Percentage of Participants Achieving a Physicians Global Assessment (PGA) Response of Clear or Minimal at Week 16(Week 16)
- Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16 Compared With Baseline (Week 0)(Week 0 and Week 16)
- Percent Change in the Dermatology Life Quality Index (DLQI) Total Score at Week 2 Compared With Baseline (Week 0)(Week 0 and Week 2)
- Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 4 Compared With Baseline (Week 0)(Week 0 and Week 4)
- Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 8 Compared With Baseline (Week 0)(Week 0 and Week 8)
- Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 12 Compared With Baseline (Week 0)(Week 0 and Week 12)
- Percent Change in Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) at Week 16 Compared With Baseline (Week 0)(Week 0 and Week 16)
- Percent Change in Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) at Week 8 Compared With Baseline (Week 0)(Week 0 and Week 8)