Study of Adalimumab in Subjects With Moderate to Severe Chronic Hidradenitis Suppurativa
2011年4月14日 更新者：Abbott
A Phase 2 Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Hidradenitis Suppurativa
This study will investigate how well adalimumab works in people with hidradenitis suppurativa (HS) in the short and long term.
調査の概要
詳細な説明
This Phase 2 randomized, double-blind, placebo-controlled multicenter study consists of 2 treatment periods: a 16-week double-blind, placebo-controlled period (Period 1: Weeks 0 through the end of Week 15) followed by a 36-week open-label period (Period 2: Weeks 16 through 52).
Participants are randomized in a 1:1:1 ratio based on Hurley Stage as stratification factor to receive adalimumab 40 mg every week (qwk), adalimumab 40 mg every other week (eow), or matching placebo during Period 1.
During Period 2, participants receive open-label adalimumab 40 mg eow with the option to escalate to 40 mg weekly dosing at Week 28 or Week 31 if the participant has a Physician's Global Assessment of moderate disease or worse (score of greater than or equal to 3).
The primary objective of the study is to determine the clinical efficacy and safety of participants with moderate to severe chronic hidradenitis suppurativa (HS) after 16 weeks of treatment.
The secondary objective is to evaluate the maintenance of efficacy and continued safety of adalimumab for an additional 36 weeks of treatment.
(Note: Hurley Stage is a classification system for skin involvement that is largely based on the presence and extent of abscess formation accompanied by scarring and sinus tracts.
Hurley Stages are I [abscess formation without scarring and sinus tracts], II [widely separated recurrent abscesses with scarring and sinus tracts], and III [multiple interconnected abscesses and sinus tracts across entire area].
Randomization in this study was performed using stratification by Hurley Stage [III versus (I or II).)
At the present time, Period 1 double-blind data only is provided; additional information will be provided when analysis of open-label Period 2 is completed.
研究の種類
介入
入学 (実際)
154
段階
- フェーズ2
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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Alabama
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Birmingham、Alabama、アメリカ、35205
- Site Ref # / Investigator 19062
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California
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Bakerfield、California、アメリカ、93309
- Site Ref # / Investigator 18201
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Los Angeles、California、アメリカ、90045
- Site Ref # / Investigator 18467
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San Diego、California、アメリカ、92103
- Site Ref # / Investigator 18207
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Florida
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Miami、Florida、アメリカ、33136
- Site Ref # / Investigator 18204
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Georgia
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Atlanta、Georgia、アメリカ、30327
- Site Ref # / Investigator 18209
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Illinois
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Skokie、Illinois、アメリカ、60077
- Site Ref # / Investigator 18202
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Indiana
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Evansville、Indiana、アメリカ、47714
- Site Ref # / Investigator 18211
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Massachusetts
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Boston、Massachusetts、アメリカ、02111
- Site Ref # / Investigator 18203
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Boston、Massachusetts、アメリカ、02114
- Site Ref # / Investigator 18210
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Missouri
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St Louis、Missouri、アメリカ、63104
- Site Ref # / Investigator 18461
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Nebraska
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Omaha、Nebraska、アメリカ、68144
- Site Ref # / Investigator 18466
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New York
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New York、New York、アメリカ、10016
- Site Ref # / Investigator 19141
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New York、New York、アメリカ、10019
- Site Ref # / Investigator 18208
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North Carolina
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Winston-Salem、North Carolina、アメリカ、27103
- Site Ref # / Investigator 19001
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Pennsylvania
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Hershey、Pennsylvania、アメリカ、17033
- Site Ref # / Investigator 18981
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Philadelphia、Pennsylvania、アメリカ、19104
- Site Ref # / Investigator 18464
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Texas
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Dallas、Texas、アメリカ、75246-1613
- Site Ref # / Investigator 19061
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San Antonio、Texas、アメリカ、78258
- Site Ref # / Investigator 18463
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Virginia
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Norfolk、Virginia、アメリカ、23507
- Site Ref # / Investigator 18206
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Amsterdam、オランダ、1105 AZ
- Site Ref # / Investigator 18470
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Rotterdam、オランダ、3015 CA
- Site Ref # / Investigator 18468
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Copenhagen NV、デンマーク、2400
- Site Ref # / Investigator 18683
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Roskilde、デンマーク、4000
- Site Ref # / Investigator 18684
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Dessau、ドイツ、06847
- Site Ref # / Investigator 18471
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Kiel、ドイツ、24105
- Site Ref # / Investigator 18469
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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
説明
Inclusion Criteria:
- Adults with stable, moderate to severe hidradenitis suppurativa
- Negative Chest X-ray and PPD test at Screening. If participant has had a past ulcerative reaction to PPD placement and/or chest X-ray consistent with prior tuberculosis exposure, the participant must initiate, or have documented completion of, a course of anti-tuberculosis therapy.
- Ability to administer subcutaneous injections
- General good health otherwise
Exclusion Criteria:
- Prior anti-TNF therapy
- Unstable antibiotic therapy for HS
- Required medication washouts for other HS treatments
- Prior exposure to Tysabri® (natalizumab);
- Recent infection requiring treatment
- Significant medical events or conditions that may put patients at risk for participation
- Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study;
- History of cancer, except successfully treated skin cancer
- Recent history of drug or alcohol abuse
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：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Adalimumab 40 mg qwk
Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
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Subcutaneous injection using prefilled syringe containing adalimumab 40 mg in 0.8 milliliters
他の名前：
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実験的：Adalimumab 40 mg eow
Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
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Subcutaneous injection using prefilled syringe containing adalimumab 40 mg in 0.8 milliliters
他の名前：
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プラセボコンパレーター：Placebo
Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
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Subcutaneous injection using prefilled syringe containing 0.8 milliliters
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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 Achieving Clinical Response at Week 16
時間枠：Baseline, Week 16
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Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline.
PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).
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Baseline, 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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Percent Change From Baseline in Number of All Inflammatory Nodules and Plaques at Week 16
時間枠：Baseline, Week 16
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Includes inflammatory nodules that are tender, erythematous, and have diameters less than 5 cm and includes plaques that have diameters greater than or equal to 5 cm.
Range for percent change is negative infinity to infinity.
Negative percent changes from Baseline indicate improvement.
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Baseline, Week 16
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Percentage of Participants Achieving Clinical Response at Week 2
時間枠：Baseline, Week 2
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Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline.
PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).
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Baseline, Week 2
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Percentage of Participants Achieving Clinical Response at Week 4
時間枠：Baseline, Week 4
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Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline.
PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).
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Baseline, Week 4
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Percentage of Participants Achieving Clinical Response at Week 8
時間枠：Baseline, Week 8
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Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline.
PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).
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Baseline, Week 8
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Percentage of Participants Achieving Clinical Response at Week 12
時間枠：Baseline, Week 12
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Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline.
PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).
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Baseline, Week 12
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Change From Baseline in Modified Sartorius Scale at Week 16
時間枠：Baseline, Week 16
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The Modified Sartorius Scale reflects changes in hidradenitis suppurative symptoms, namely the number of lesions (abscesses, nodules, and fistulas) and the longest distance between lesions.
A total score is derived based on assessments at up to 8 distinct anatomical regions and ranges from 5 to indefinite.
Smaller numbers are better scores and indicate less lesion involvement, thus decreases (negative changes) from baseline indicate improvement in severity of disease.
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Baseline, Week 16
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Change From Baseline in Modified Sartorius Scale at Week 52
時間枠：Baseline, Week 52
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The Modified Sartorius Scale reflects changes in hidradenitis suppurative symptoms, namely the number of lesions (abscesses, nodules, and fistulas) and the longest distance between lesions.
A total score is derived based on assessments at up to 8 distinct anatomical regions and ranges from 5 to indefinite.
Smaller numbers are better scores and indicate less lesion involvement, thus decreases (negative changes) from baseline indicate improvement in severity of disease.
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Baseline, Week 52
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Percent Change From Baseline in Number of All Inflammatory Nodules and Plaques at Week 52
時間枠：Baseline, Week 52
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Includes inflammatory nodules that are tender, erythematous, and have diameters less than 5 cm and includes plaques that have diameters greater than or equal to 5 cm.
Range for percent change is negative infinity to infinity.
Negative percent changes from Baseline indicate improvement.
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Baseline, Week 52
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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。
スポンサー
捜査官
- スタディディレクター：Martin Okun, MD, PhD、Abbott
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。
一般刊行物
- Ryan C, Sobell JM, Leonardi CL, Lynde CW, Karunaratne M, Valdecantos WC, Hendrickson BA. Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis. Am J Clin Dermatol. 2018 Jun;19(3):437-447. doi: 10.1007/s40257-017-0341-6.
- Scheinfeld N, Sundaram M, Teixeira H, Gu Y, Okun M. Reduction in pain scores and improvement in depressive symptoms in patients with hidradenitis suppurativa treated with adalimumab in a phase 2, randomized, placebo-controlled trial. Dermatol Online J. 2016 Mar 16;22(3):13030/qt38x5922j.
- Kimball AB, Kerdel F, Adams D, Mrowietz U, Gelfand JM, Gniadecki R, Prens EP, Schlessinger J, Zouboulis CC, van der Zee HH, Rosenfeld M, Mulani P, Gu Y, Paulson S, Okun M, Jemec GB. Adalimumab for the treatment of moderate to severe Hidradenitis suppurativa: a parallel randomized trial. Ann Intern Med. 2012 Dec 18;157(12):846-55. doi: 10.7326/0003-4819-157-12-201212180-00004.
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
2009年4月1日
一次修了 (実際)
2010年3月1日
研究の完了 (実際)
2010年11月1日
試験登録日
最初に提出
2009年4月30日
QC基準を満たした最初の提出物
2009年6月10日
最初の投稿 (見積もり)
2009年6月11日
学習記録の更新
投稿された最後の更新 (見積もり)
2011年5月9日
QC基準を満たした最後の更新が送信されました
2011年4月14日
最終確認日
2011年4月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。