The Effects of Infliximab Versus Methotrexate in the Treatment of Moderate to Severe Psoriasis (Study P04271AM2)(COMPLETED)
2017年4月4日 更新者:Merck Sharp & Dohme LLC
An Open-Label, Randomized Efficacy and Safety Study of Infliximab Versus Methotrexate in the Treatment of Moderate to Severe Psoriasis
This is a Phase 3b, randomized, parallel-group, multicenter, active-controlled, open-label study of the efficacy and safety of infliximab compared with methotrexate (MTX) in the treatment of moderate to severe psoriasis in adults who were diagnosed with moderate to severe plaque-type psoriasis for at least 6 months prior to screening (subjects with concurrent psoriatic arthritis may also be enrolled).
調査の概要
研究の種類
介入
入学 (実際)
868
段階
- フェーズ 3
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~75年 (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:
- Adult male and female subjects (>= 18 to 75 years of age) with a diagnosis of moderate to severe plaque-type psoriasis for at least 6 months prior to study screening (subjects with concurrent psoriatic arthritis may also be enrolled).
- Subjects must be eligible for phototherapy or systemic therapy for their psoriasis and must have a Baseline Psoriasis Area and Severity Index (PASI) score of 12 or greater and have at least 10% of their total body surface area (BSA) involved at Baseline.
- Subjects must agree to avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during the study.
- Subjects must also meet the tuberculosis (TB) eligibility assessment and screening criteria as follows: Have no history of latent or active TB prior to screening; have no signs or symptoms suggestive of active TB upon medical history and/or physical examination; have had no recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB prior to or simultaneously with the first administration of study medication; within 1 month prior to the first administration of study medication, either have negative diagnostic TB test results (defined as 2 negative tuberculin skin tests) OR have a newly identified positive diagnostic TB test result (defined as at least 1 positive tuberculin skin tests) during screening in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated either prior to or simultaneously with the first administration of study medication.
- Subjects must have had a chest x-ray (posterior-anterior and lateral) within 3 months prior to Screening with no evidence of malignancy, infection, fibrosis, or current or old active TB.
- Specific parameters must also be met with regard to screening laboratory test results and liver enzymes in order to be eligible to participate in the study.
Exclusion Criteria:
- Subjects who have non-plaque forms of psoriasis, current drug-induced psoriasis, are pregnant, nursing, or planning pregnancy;
- Subjects previously treated with MTX or infliximab; subjects who are taking specific drugs within the specified time frame prior to Baseline as follows: any therapeutic agent targeted at reducing tumor necrosis factor (TNF) or any biologic, live virus or bacterial vaccinations within 3 months; any systemic medications or treatments that could affect psoriasis or PASI evaluations, or any systemic immunosuppressants or lithium within 4 weeks; any topical medications or treatments that could affect psoriasis or PASI evaluations within 2 weeks. The only allowed topical treatments for psoriasis are shampoos (containing tar or salicylic acid only) and topical moisturizers. Subjects should not use these topical agents during the morning prior to a study visit. Non-medicated shampoos may be used on the morning of a visit.
- Subjects with poor health, including concomitant congestive heart failure (CHF); history of chronic or recurrent infectious disease, as specified; human immunodeficiency virus, hepatitis B, or hepatitis C; demyelinating disease or symptoms suggestive of multiple sclerosis or optic neuritis; systemic lupus erythematosus; or who have had serious infections (eg, hepatitis, pneumonia, or pyelonephritis], or who have been hospitalized or received IV antibiotics, or who had an opportunistic infection (eg, cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB), or a transplanted organ within specified time frames; or other conditions as specified in the protocol.
- Subjects who have used any investigational drugs within 4 weeks of Screening, who are participating in other clinical studies, staff or family members of study staff are excluded from participation in the study.
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:ランダム化
- 介入モデル:並列代入
- 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 |
---|---|
アクティブコンパレータ:メトトレキサート
|
Methotrexate will be supplied as 2.5 mg tablets.
Subjects are to take 15 mg/week orally for the first 6 weeks of the study.
Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week.
If subjects randomized to MTX 15 mg/week experience a <25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week.
Subjects will be treated for 22 weeks.
他の名前:
|
実験的:インフリキシマブ
|
The infliximab dose will be prepared according to the subject's weight (5 mg/kg).
Each intravenous (IV) infusion will be administered over a period of not less than 2 hours.
The infusion must be given via a separate line using the administration set with a 1.2 micron filter.
Subjects will be infused at Weeks 0, 2, 6, 14, and 22.
他の名前:
|
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 |
---|---|---|
Psoriasis Area and Severity Index 75 (PASI75) Response at Week 16.
時間枠:16 weeks
|
PASI75 response is defined as the proportion of participants who achieved at least a 75% improvement in PASI score from Baseline.
|
16 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
PASI75 Response at Week 26
時間枠:26 weeks
|
PASI75 response is defined as the proportion of participants who achieved at least a 75% improvement in PASI score from Baseline.
|
26 weeks
|
Proportion of Participants Who Achieved a Physician's Global Assessment (PGA) Score of Cleared or Minimal at Week 16
時間枠:16 weeks
|
PGA is assessed relative to baseline condition and is defined as: clear (100% clear; some residual pinkness or pigmentation: Wornoff's ring may be present), excellent/minimal (75-99% clearing; marked improvement: nearly normal skin texture; some erythema may be present), good (50-74% clearing; moderate improvement: plaque has cleared to point of small scattered papules with normal intervening epidermis), fair (25-49% clearing; slight improvement: decrease in scaling and softening of plaque), poor (0-24% clearing; little or no change in scaling, erythema, or plaque elevation), or worse (worse).
|
16 weeks
|
Proportion of Participants Who Achieved a PGA Score of Cleared or Minimal at Week 26
時間枠:26 weeks
|
PGA is assessed relative to baseline condition and is defined as: clear (100% clear; some residual pinkness or pigmentation: Wornoff's ring may be present), excellent/minimal (75-99% clearing; marked improvement: nearly normal skin texture; some erythema may be present), good (50-74% clearing; moderate improvement: plaque has cleared to point of small scattered papules with normal intervening epidermis), fair (25-49% clearing; slight improvement: decrease in scaling and softening of plaque), poor (0-24% clearing; little or no change in scaling, erythema, or plaque elevation), or worse (worse).
|
26 weeks
|
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スポンサー
出版物と役立つリンク
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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 (実際)
2005年9月1日
一次修了 (実際)
2008年6月1日
研究の完了 (実際)
2008年6月1日
試験登録日
最初に提出
2005年11月8日
QC基準を満たした最初の提出物
2005年11月8日
最初の投稿 (見積もり)
2005年11月10日
学習記録の更新
投稿された最後の更新 (実際)
2017年5月10日
QC基準を満たした最後の更新が送信されました
2017年4月4日
最終確認日
2017年4月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- P04271
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
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infliximabの臨床試験
-
Onze Lieve Vrouwe GasthuisSanteonわからない