An Open-Label, Prospective Study to Assess the Safety and Effectiveness of Adalimumab (Humira®) in Patients With Moderate to Severe Plaque Psoriasis in the Russian Federation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 14
- 主要终点
- Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 24
研究概览
简要总结
This is an open-label study designed to establish the safety and effectiveness of adalimumab in the treatment of moderate to severe plaque psoriasis after 24 weeks of treatment.
详细描述
During the treatment period, participants will receive an initial adalimumab 80 milligram (mg) subcutaneous (sc) dose, followed by adalimumab 40 mg sc every other week starting one week after initial dose. Safety and effectiveness assessments will be completed at Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 and Week 24. Participants may discontinue adalimumab treatment at any time during study participation. Participants that end study participation early will have a Premature Discontinuation visit. All participants who do not initiate commercial Humira® will have a follow-up phone call 70 days after the last administration of study drug to obtain information on any new or ongoing Adverse Events (AEs). The 70-day follow-up phone call will not be required for any participant that initiates adalimumab therapy not supplied in the context of the clinical trial after the end of study participation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •A patient will be eligible for study participation if he/she meets the following criteria:
- •Male and female patients ≥ 18 years of age.
- •Clinical diagnosis of psoriasis for at least 6 months as determined by patient interview of his/her medical history and confirmation of diagnosis through physical examination by the investigator.
- •Stable plaque psoriasis for at least 2 months before Screening and Baseline visits as determined by patient interview of his/her medical history.
- •Moderate to severe plaque psoriasis defined by ≥ 10% Body Surface Area (BSA) involvement at the Baseline visit.
- •PASI (Psoriasis Area and Severity Index) score ≥ 10 at the Baseline visit.
排除标准
- •Diagnosis of erythrodermic psoriasis, pustular psoriasis, medication induced or medication-exacerbated psoriasis or new onset of guttate psoriasis.
- •Diagnosis of other active skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with evaluation of psoriasis.
- •Patient who cannot discontinue topical therapies for the treatment of psoriasis such as corticosteroids, vitamin D analogs, or retinoids at least 14 days prior to the Baseline (Week 0) visit and during the study. Participants are allowed to use:
- •Shampoos that contain no corticosteroid;
- •Bland (without beta or alpha hydroxy acids or containing no psoriasis treatment) emollients;
- •Low potency topical corticosteroids on the palms, soles, face, inframammary area, and groin only.
- •Patient who cannot avoid UVB (Ultraviolet-B) phototherapy for at least 14 days prior to the Baseline (Week 0) visit and during the study.
- •Patient who cannot avoid PUVA (psoralen + ultraviolet A) phototherapy for at least 28 days prior to the Baseline (Week 0) visit and during the study.
结局指标
主要结局
Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 24
时间窗: Baseline and Week 24
The percentage of participants with a ≥ 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (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.
次要结局
- Percentage of Participants Achieving a Physician's Global Assessment of Clear(Weeks 2, 4, 8, 12, 16 and 24)
- Percentage of Participants Achieving a Physician's Global Assessment of Clear or Minimal(Weeks 2, 4, 8, 12, 16 and 24)
- Percentage of Participants Achieving a One Grade Improvement in Physician's Global Assessment (PGA)(Baseline and Weeks 2, 4, 8, 12, 16 and 24)
- Percentage of Participants Achieving a PASI 50 Response(Baseline and Weeks 2, 4, 8, 12, 16, and 24)
- Percentage of Participants Achieving a PASI 75 Response(Baseline and Weeks 2, 4, 8, 12, and 16)
- Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI)(Baseline and Week 24)
- Percentage of Participants Achieving a PASI 90 Response(Baseline and Weeks 2, 4, 8, 12, 16, and 24)
- Percentage of Participants Achieving a PASI 100 Response(Baseline and Weeks 2, 4, 8, 12, 16, and 24)
- Percent Change From Baseline in Dermatology Life Quality Index (DLQI)(Baseline and Weeks 8, 12, and 24)
- Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score(Baseline and Weeks 2, 4, 8, 12, 16, and 24)