Clinical Effectiveness and Impact on Health-related Quality of Life in Peruvian Patients With Psoriasis After 16 Weeks of Adalimumab Therapy
2014年8月8日 更新者：AbbVie (prior sponsor, Abbott)
Observational Study; Clinical Effectiveness and Impact on Health-related Quality of Life in Peruvian Patients With Psoriasis After 16 Weeks of Adalimumab Therapy
Adalimumab has recently been authorized for active psoriasis in Peru and local experience is very low.
The aim of this study is to obtain Peruvian data of clinical effectiveness and impact on health-related quality of life with the use of adalimumab in participants with chronic plaque psoriasis complying with the dosing and monitoring recommendations of the local approved label.
調査の概要
状態
終了しました
条件
研究の種類
観察的
入学 (実際)
30
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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Lima、ペルー
- Site Reference ID/Investigator# 35783
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Lima、ペルー
- Site Reference ID/Investigator# 56700
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Trujillo、ペルー
- Site Reference ID/Investigator# 43147
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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
サンプリング方法
非確率サンプル
調査対象母集団
Participants with moderate to severe psoriasis who receive adalimumab therapy according to standard clinical practice at Peruvian hospitals/clinics.
説明
Inclusion Criteria:
- Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate
- Participant is capable of and willing to give written informed consent and to comply with the requirements of the study protocol
Exclusion Criteria:
- Participants should not be enrolled if they cannot be treated in accordance with the local product label
- Participants enrolled into another study or clinical trial
- History of hepatitis B infection
- History of neurologic symptoms suggestive of central nervous system demyelinating disease
- History of cancer or lymphoproliferative disease (other than successfully treated non-melanoma skin cancer or localized carcinoma in situ of the cervix)
- Active tuberculosis infection before initiating adalimumab treatment or latent tuberculosis infection not able to take complete prophylactic treatment
- Pregnant or lactating female, demonstrated by a pregnancy test before entering the study and willing to use a contraceptive method
- Use of another anti-tumoral necrosis factor previously
- History of congestive heart failure
- Any other condition that according to the criteria of the participating investigator represents an obstacle for study conduction and/or subjects participants to an unacceptable risk
- Participants with active infection including chronic or localized infections until infections are controlled
- History of sensitivity to latex
- Participants who will receive concomitant phototherapy and systemic therapy during adalimumab therapy
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
コホートと介入
グループ/コホート |
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Adalimumab Treatment in Participants with Psoriasis
Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
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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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Percentage of Participants Reaching a Psoriasis Area and Severity Index 75 (PASI-75) Response
時間枠：Baseline to Week 16
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PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination.
The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).
PASI-75 responders are the participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16.
The mean PASI improvement was calculated using a linear regression model.
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Baseline to Week 16
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Percentage of Participants Reaching a Minimal Important Difference (MID) in the Dermatology Life Quality Index (DLQI) Score
時間枠：Baseline to Week 16
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Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week.
Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0).
The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired.
MID for the DLQI was defined as a score decrease from baseline of 2.3 to 5. The mean DLQI improvement was calculated using a linear regression model.
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Baseline to Week 16
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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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European Quality of Life 5 Dimensions (EQ-5D) Index Score at Baseline and Week 16
時間枠：Baseline, Week 16
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EQ-5D is a self-reported health outcome which measures mobility, self-care, usual activities, pain discomfort, anxiety, and depression.
An overall score is derived that measures from -0.59 (worst) to +1 (best).
Improvement was defined as a mean score increase of at least 0.2.
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Baseline, Week 16
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Number of Participants With Serious Adverse Events (SAEs)
時間枠：From the time of informed consent until 70 days (5 half-lives) after the last dose of study drug (treatment was 16 weeks).
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An adverse event was considered an SAE if it met any of the following criteria: death of the participant; life-threatening event; hospitalization; prolongation of hospitalization; congenital anomaly; persistent or significant disability/incapacity; an important medical event requiring medical or surgical intervention to prevent serious outcome; spontaneous or elective abortion.
SAEs included the occurrence of tuberculosis, opportunistic infection, and malignancy.
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From the time of informed consent until 70 days (5 half-lives) after the last dose of study drug (treatment was 16 weeks).
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Adherence to Adalimumab Treatment
時間枠：up to 16 weeks
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Adherence was measured by how many times a participant had a discontinuation (i.e., missed a study dose) during the 16 weeks of treatment.
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up to 16 weeks
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Mean Psoriasis Area and Severity Index (PASI) Score Over Time
時間枠：Baseline, Week 4, Week 8, Week 16
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PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination.
The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).
The mean PASI improvement was calculated using a linear regression model.
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Baseline, Week 4, Week 8, Week 16
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Mean Dermatology Life Quality Index (DLQI) Score Over Time
時間枠：Baseline, Week 4, Week 8, Week 16
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DLQI score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week.
Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0).
The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired.
The mean DLQI improvement was calculated using a linear regression model.
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Baseline, Week 4, Week 8, Week 16
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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。
捜査官
- スタディディレクター：Manuel Uribe, MD、AbbVie
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。
便利なリンク
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
2010年11月1日
一次修了 (実際)
2013年8月1日
研究の完了 (実際)
2013年8月1日
試験登録日
最初に提出
2010年7月1日
QC基準を満たした最初の提出物
2010年7月1日
最初の投稿 (見積もり)
2010年7月5日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年8月25日
QC基準を満たした最後の更新が送信されました
2014年8月8日
最終確認日
2014年8月1日
詳しくは
本研究に関する用語
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