A Study to Evaluate Raptiva in Subjects With Chronic Moderate or Worse Plaque Psoriasis Who Have Had an Inadequate Response to an Anti-TNF Agent
2015年7月1日 更新者:Genentech, Inc.
A Phase IV Open-Label Study to Evaluate the Efficacy and Safety of 1.0 mg/kg Raptiva (Efalizumab) in Adult Subjects With Chronic Moderate or Worse Plaque Psoriasis Who Have Had an Inadequate Response to an Anti-TNF Agent
This is a Phase IV open-label study to evaluate the efficacy and safety of SC efalizumab in adult subjects (18 years of age and older) with chronic moderate or worse plaque psoriasis who have had an inadequate response to treatment with an anti-TNF agent.
The study will consist of a screening period, a treatment period, and an observation period.
All subjects will begin in the screening period (the length of which is dependent on the previous anti-TNF agent treatment).
Approximately 100 eligible subjects will receive treatment from Day 0 through Day 168.
調査の概要
研究の種類
介入
入学 (実際)
73
段階
- フェーズ 4
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
説明
Inclusion Criteria:
- Have chronic (6 months or greater) moderate or worse plaque psoriasis
- Have had an inadequate response to at least 12 weeks of treatment with an anti-TNF agent, where an inadequate response is defined as: PGA ratings of moderate (3), severe (4), or very severe (5), and BSA involvement of 5% or greater
- Be a candidate for systemic therapy or phototherapy in the opinion of the investigator
- Be naive to efalizumab treatment
- Weigh no more than 200 kg
- For women of childbearing potential, use a method of contraception acceptable to the investigator to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of their participation in the study and for 6 weeks after the last dose of efalizumab
Exclusion Criteria:
- Have a history of psoriatic arthritis that meets one of the following criteria: Is not controlled with non-steroidal anti-inflammatory drugs (NSAIDs);Requires the use of disease modifying antirheumatic drugs (DMARDs), including biologics while enrolled in the study; Please note that if, following enrollment, a subject requires treatment with a DMARD, study drug treatment should be discontinued and the subject should be moved into the observation period of the study. The subject should have the observation period assessments performed at the appropriate intervals as per the protocol
- Have a history of hypersensitivity to efalizumab or any of its components
- Are using any excluded therapy
- Are currently abusing alcohol or illegal drugs
- Have a history of or an ongoing uncontrolled serious bacterial, viral, fungal, or atypical mycobacterial infection. This includes diagnoses that required more than 2 weeks of therapy, such as endocarditis and osteomyelitis, which have been treated in the past 6 months. In addition, if the subject is currently receiving antibiotics, antivirals, or antifungals for an infection or for suppression or prophylaxis for any diagnosis, the subject will be excluded.
- Have any history of opportunistic infections (e.g., systemic fungal infections, parasites)
- Are seropositive for hepatitis B antigen, hepatitis C antibody, or human immunodeficiency virus (HIV). Subjects will undergo testing during screening, and any subjects who are seropositive for hepatitis B antigen, hepatitis C antibody, or HIV will be excluded.
- Have a history of active tuberculosis or are currently undergoing treatment for tuberculosis. A purified protein derivative (PPD) test will be performed at the screening visit. Subjects with a positive PPD test (not due to BCG vaccination) or chest x-ray will be excluded.
- Have the presence or history of malignancy, including lymphoproliferative disorders. Subjects with a history of fully resolved basal or squamous cell skin cancer may be enrolled.
- Are pregnant or lactating women
- Have a diagnosis of hepatic cirrhosis, regardless of cause or severity
- Have a history of thrombocytopenia
- Have a history of clinically significant hemolytic or unexplained anemia
- Have been exposed to any experimental drugs or treatments within 30 days or 5 half-lives, whichever is longer, prior to the screening visit
- Have had any previous exposure to efalizumab
- Have been vaccinated with a live virus or live bacteria within the 14 days prior to the first dose of efalizumab
- Have any medical condition that, in the judgment of the investigator, would jeopardize the subject's safety following exposure to study drug or would significantly interfere with the subject's ability to comply with the provisions of this protocol
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
- 主な目的:処理
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:1
|
皮下反復投与量
|
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 |
---|---|---|
Proportion of Subjects With a Physician's Global Assessment (PGA) Rating of Clear (0), Almost Clear (1), or Mild (2)
時間枠:Day 84
|
The PGA scale used in this study was: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe
|
Day 84
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Proportion of Subjects With a PGA Rating of Clear (0), Almost Clear (1), or Mild (2)
時間枠:Day 168
|
The PGA scale used in this study was: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe
|
Day 168
|
Proportion of Subjects With a PGA Rating of Clear (0) or Almost Clear (1)
時間枠:Day 84
|
The PGA scale used in this study was: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe
|
Day 84
|
Proportion of Subjects With a PGA Rating of Clear (0) or Almost Clear (1)
時間枠:Day 168
|
The PGA scale used in this study was: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe
|
Day 168
|
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。
スポンサー
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
2006年5月1日
一次修了 (実際)
2008年2月1日
試験登録日
最初に提出
2006年6月13日
QC基準を満たした最初の提出物
2006年6月13日
最初の投稿 (見積もり)
2006年6月15日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年7月23日
QC基準を満たした最後の更新が送信されました
2015年7月1日
最終確認日
2009年4月1日
詳しくは
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