このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

An Open-Label, Prospective Study to Assess the Safety and Effectiveness of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in the Russian Federation

2014年9月22日 更新者：AbbVie (prior sponsor, Abbott)

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

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.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (実際)

50

段階

  • フェーズ 4

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

  • ロシア連邦
      • Ekaterinburg、ロシア連邦、620076
        • Site Reference ID/Investigator# 67547
      • Kazan、ロシア連邦、420012
        • Site Reference ID/Investigator# 78433
      • Moscow、ロシア連邦、107076
        • Site Reference ID/Investigator# 67542
      • Saratov、ロシア連邦、410028
        • Site Reference ID/Investigator# 67546
      • Smolensk、ロシア連邦、214018
        • Site Reference ID/Investigator# 78417
      • St. Petersburg、ロシア連邦、190013
        • Site Reference ID/Investigator# 78413
      • St. Petersburg、ロシア連邦、194044
        • Site Reference ID/Investigator# 67545

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:

A patient will be eligible for study participation if he/she meets the following criteria:

  1. Male and female patients ≥ 18 years of age.
  2. 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.
  3. Stable plaque psoriasis for at least 2 months before Screening and Baseline visits as determined by patient interview of his/her medical history.
  4. Moderate to severe plaque psoriasis defined by ≥ 10% Body Surface Area (BSA) involvement at the Baseline visit.
  5. PASI (Psoriasis Area and Severity Index) score ≥ 10 at the Baseline visit.

Exclusion Criteria:

  1. Diagnosis of erythrodermic psoriasis, pustular psoriasis, medication induced or medication-exacerbated psoriasis or new onset of guttate psoriasis.
  2. Diagnosis of other active skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with evaluation of psoriasis.

  3. 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.
  4. Patient who cannot avoid UVB (Ultraviolet-B) phototherapy for at least 14 days prior to the Baseline (Week 0) visit and during the study.
  5. 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.

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
他の：Adalimumab
Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
生物学的：アダリムマブ
他の名前：
  • ABT-D2E7
  • フミラ

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
Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 24
時間枠：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.
Baseline and Week 24

二次結果の測定

結果測定
メジャーの説明
時間枠
Percentage of Participants Achieving a Physician's Global Assessment of Clear
時間枠：Weeks 2, 4, 8, 12, 16 and 24

The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the qualified investigator's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:

  • 0: No evidence of scaling, erythema, or plaque elevation, overall score of cleared;
  • 1: Occasional fine scale over <5% of lesions, faint erythema, minimal plaque elevation, overall score of minimal;
  • 2: Fine scale dominates, light red coloration, mild plaque elevation, overall score of mild;
  • 3: Course scale dominates, moderate red coloration, moderate plaque elevation, overall score of moderate;
  • 4: Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation, overall score of marked;
  • 5: Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation, overall score of severe.

The percentage of participants achieving a PGA score of clear (0) is reported.
Weeks 2, 4, 8, 12, 16 and 24
Percentage of Participants Achieving a Physician's Global Assessment of Clear or Minimal
時間枠：Weeks 2, 4, 8, 12, 16 and 24

The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the qualified investigator's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:

  • 0: No evidence of scaling, erythema, or plaque elevation, overall score of cleared;
  • 1: Occasional fine scale over <5% of lesions, faint erythema, minimal plaque elevation, overall score of minimal;
  • 2: Fine scale dominates, light red coloration, mild plaque elevation, overall score of mild;
  • 3: Course scale dominates, moderate red coloration, moderate plaque elevation, overall score of moderate;
  • 4: Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation, overall score of marked;
  • 5: Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation, overall score of severe.

The percentage of participants achieving a PGA score of clear (0) or minimal (1) is reported.
Weeks 2, 4, 8, 12, 16 and 24
Percentage of Participants Achieving a One Grade Improvement in Physician's Global Assessment (PGA)
時間枠：Baseline and Weeks 2, 4, 8, 12, 16 and 24

The PGA is a 6-point scale used to measure the severity of disease at the time of the qualified investigator's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:

  • 0: No evidence of scaling, erythema, or plaque elevation, overall score of cleared;
  • 1: Occasional fine scale over <5% of lesions, faint erythema, minimal plaque elevation, overall score of minimal;
  • 2: Fine scale dominates, light red coloration, mild plaque elevation, overall score of mild;
  • 3: Course scale dominates, moderate red coloration, moderate plaque elevation, overall score of moderate;
  • 4: Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation, overall score of marked;
  • 5: Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation, overall score of severe.

The percentage of participants achieving a shift from Baseline to a less severe category is reported.
Baseline and Weeks 2, 4, 8, 12, 16 and 24
Percentage of Participants Achieving a PASI 50 Response
時間枠：Baseline and Weeks 2, 4, 8, 12, 16, and 24
The percentage of participants with a ≥ 50% 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.
Baseline and Weeks 2, 4, 8, 12, 16, and 24
Percentage of Participants Achieving a PASI 75 Response
時間枠：Baseline and Weeks 2, 4, 8, 12, and 16
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.
Baseline and Weeks 2, 4, 8, 12, and 16
Percentage of Participants Achieving a PASI 90 Response
時間枠：Baseline and Weeks 2, 4, 8, 12, 16, and 24
The percentage of participants with a ≥ 90% 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.
Baseline and Weeks 2, 4, 8, 12, 16, and 24
Percentage of Participants Achieving a PASI 100 Response
時間枠：Baseline and Weeks 2, 4, 8, 12, 16, and 24
The percentage of participants with a 100% 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.
Baseline and Weeks 2, 4, 8, 12, 16, and 24
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
時間枠：Baseline and Weeks 2, 4, 8, 12, 16, and 24

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.

Change from Baseline is presented as a percentage of the Baseline value: Post-baseline value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement.
Baseline and Weeks 2, 4, 8, 12, 16, and 24
Percent Change From Baseline in Dermatology Life Quality Index (DLQI)
時間枠：Baseline and Weeks 8, 12, and 24
The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. Change from Baseline is presented as a percentage of the Baseline value: Post-baseline value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement.
Baseline and Weeks 8, 12, and 24
Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI)
時間枠：Baseline and Week 24

NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The most affected fingernail was determined at Baseline and used for the analysis.

Nail matrix psoriasis consists of any of the following: pitting, leukonychia, red spots in the lunula, or nail plate crumbling. Nail bed psoriasis is the presence or absence of onycholysis, splinter hemorrhages, oil drop (salman patch) discoloration or nail bed hyperkeratosis. Scoring for each is based on the following scale:

  • 0 = none;
  • 1 = present in 1/4 nail quadrants;
  • 2 = present in 2/4 nail quadrants;
  • 3 = present in 3/4 nail quadrants;
  • 4 = present in 4/4 nail quadrants.

The sum of these two scores is the total score for the nail, and ranges from 0 (no nail psoriasis) to 8 (psoriasis in 4/4 nail quadrants). Change from Baseline is presented as a percentage of the Baseline value, calculated as: Week 24 value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement.
Baseline and Week 24

その他の成果指標

結果測定
メジャーの説明
時間枠
Change From Baseline in Hemoglobin
時間枠：Baseline and Week 24 (or Early Termination Visit)
Safety variables included laboratory data, vital signs and adverse events.
Baseline and Week 24 (or Early Termination Visit)
Change From Baseline in Hematocrit
時間枠：Baseline and Week 24 (or Early Termination Visit)
Safety variables included laboratory data, vital signs and adverse events. The hematocrit measures the volume of red blood cells compared to the total blood volume (red blood cells and plasma).
Baseline and Week 24 (or Early Termination Visit)
Change From Baseline in Red Blood Cell Count
時間枠：Baseline and Week 24 (or Early Termination Visit)
Safety variables included laboratory data, vital signs and adverse events.
Baseline and Week 24 (or Early Termination Visit)
Change From Baseline in Blood Cell Counts
時間枠：Baseline and Week 24 (or Early Termination Visit)
Safety variables included laboratory data, vital signs and adverse events.
Baseline and Week 24 (or Early Termination Visit)
Change From Baseline in Erythrocyte Sedimentation Rate
時間枠：Baseline and Week 24 (or Early Termination Visit)
Safety variables included laboratory data, vital signs and adverse events.
Baseline and Week 24 (or Early Termination Visit)
Change From Baseline in Alanine Aminotransferase
時間枠：Baseline and Week 24 (or Early Termination Visit)
Safety variables included laboratory data, vital signs and adverse events.
Baseline and Week 24 (or Early Termination Visit)
Change From Baseline in Aspartate Aminotransferase
時間枠：Baseline and Week 24 (or Early Termination Visit)
Safety variables included laboratory data, vital signs and adverse events.
Baseline and Week 24 (or Early Termination Visit)
Change From Baseline in Alkaline Phosphatase
時間枠：Baseline and Week 24 (or Early Termination Visit)
Safety variables included laboratory data, vital signs and adverse events.
Baseline and Week 24 (or Early Termination Visit)
Change From Baseline in Total Bilirubin
時間枠：Baseline and Week 24 (or Early Termination Visit)
Safety variables included laboratory data, vital signs and adverse events.
Baseline and Week 24 (or Early Termination Visit)
Change From Baseline in Creatinine
時間枠：Baseline and Week 24 (or Early Termination Visit)
Safety variables included laboratory data, vital signs and adverse events.
Baseline and Week 24 (or Early Termination Visit)
Change From Baseline in Blood Urea Nitrogen (BUN)
時間枠：Baseline and Week 24 (or Early Termination Visit)
Safety variables included laboratory data, vital signs and adverse events.
Baseline and Week 24 (or Early Termination Visit)
Change From Baseline in Uric Acid
時間枠：Baseline and Week 24 (or Early Termination Visit)
Safety variables included laboratory data, vital signs and adverse events.
Baseline and Week 24 (or Early Termination Visit)
Change From Baseline in Inorganic Phosphate
時間枠：Baseline and Week 24 (or Early Termination Visit)
Safety variables included laboratory data, vital signs and adverse events.
Baseline and Week 24 (or Early Termination Visit)
Change From Baseline in Calcium, Sodium and Potassium
時間枠：Baseline and Week 24 (or Early Termination Visit)
Safety variables included laboratory data, vital signs and adverse events.
Baseline and Week 24 (or Early Termination Visit)
Change From Baseline in Glucose
時間枠：Baseline and Week 24 (or Early Termination Visit)
Safety variables included laboratory data, vital signs and adverse events.
Baseline and Week 24 (or Early Termination Visit)
Change From Baseline in Albumin
時間枠：Baseline and Week 24 (or Early Termination Visit)
Safety variables included laboratory data, vital signs and adverse events.
Baseline and Week 24 (or Early Termination Visit)
Change From Baseline in Total Protein
時間枠：Baseline and Week 24 (or Early Termination Visit)
Safety variables included laboratory data, vital signs and adverse events.
Baseline and Week 24 (or Early Termination Visit)
Change From Baseline in Cholesterol
時間枠：Baseline and Week 24 (or Early Termination Visit)
Safety variables included laboratory data, vital signs and adverse events.
Baseline and Week 24 (or Early Termination Visit)
Change From Baseline in Triglycerides
時間枠：Baseline and Week 24 (or Early Termination Visit)
Safety variables included laboratory data, vital signs and adverse events.
Baseline and Week 24 (or Early Termination Visit)
Change From Baseline in High Sensitivity C-reactive Protein (hsCRP)
時間枠：Baseline and Week 24 (or Early Termination Visit)
Safety variables included laboratory data, vital signs and adverse events.
Baseline and Week 24 (or Early Termination Visit)
Change From Baseline in Urine pH
時間枠：Baseline and Week 24 (or Early Termination Visit)
Safety variables included laboratory data, vital signs and adverse events.
Baseline and Week 24 (or Early Termination Visit)
Change From Baseline in Urine Specific Gravity
時間枠：Baseline and Week 24 (or Early Termination Visit)
Safety variables included laboratory data, vital signs and adverse events. Specific gravity is a measure of the amount of material dissolved in the urine. Specific gravity is the ratio of the density (mass of a unit volume) of a substance to the density (mass of the same unit volume) of a reference substance.
Baseline and Week 24 (or Early Termination Visit)
Change From Baseline in Blood Pressure
時間枠：Baseline and Week 24 (or Early Termination Visit)
Safety variables included laboratory data, vital signs and adverse events.
Baseline and Week 24 (or Early Termination Visit)
Change From Baseline in Pulse
時間枠：Baseline and Week 24 (or Early Termination Visit)
Safety variables included laboratory data, vital signs and adverse events.
Baseline and Week 24 (or Early Termination Visit)
Change From Baseline in Respiratory Rate
時間枠：Baseline and Week 24 (or Early Termination Visit)
Safety variables included laboratory data, vital signs and adverse events.
Baseline and Week 24 (or Early Termination Visit)
Change From Baseline in Weight
時間枠：Baseline and Week 24 (or Early Termination Visit)
Safety variables included laboratory data, vital signs and adverse events.
Baseline and Week 24 (or Early Termination Visit)
Change From Baseline in Body Temperature
時間枠：Baseline and Week 24 (or Early Termination Visit)
Safety variables included laboratory data, vital signs and adverse events.
Baseline and Week 24 (or Early Termination Visit)
Number of Participants With Adverse Events (AEs)
時間枠：From the first dose of study drug until 70 days after the last dose (up to 33 weeks).

An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment.

The investigator rated the severity of each AE as either:

Mild: The AE is transient and easily tolerated; Moderate: The AE causes the participant discomfort and interrupts usual activities.

Severe: The AE causes considerable interference with usual activities and may be incapacitating or life-threatening.

A serious adverse event (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome.

Drug-related AEs are those assessed by the investigator as either probably or possibly related.

Other malignancy excludes lymphoma, hepatosplenic T-cell lymphoma (HSTCL), leukemia, non-melanoma skin cancer (NMSC), and melanoma.
From the first dose of study drug until 70 days after the last dose (up to 33 weeks).

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

AbbVie (prior sponsor, Abbott)

捜査官

  • スタディディレクター：Martin Okun, 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

2012年5月1日

一次修了 (実際)

2013年9月1日

研究の完了 (実際)

2013年9月1日

試験登録日

最初に提出

2012年5月7日

QC基準を満たした最初の提出物

2012年7月17日

最初の投稿 (見積もり)

2012年7月19日

学習記録の更新

投稿された最後の更新 (見積もり)

2014年10月1日

QC基準を満たした最後の更新が送信されました

2014年9月22日

最終確認日

2014年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • M13-279

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。

類似の治験を検索

スポンサーと協力者

医学的状態

薬物療法

CROs by country

CROs in Zimbabwe

条件

まれな病気

薬物療法

ダイエットサプリメント

スポンサー/協力者

場所

購読する