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Study to Assess the Immunogenicity, Safety, and Efficacy of High Capacity Process Etanercept in Rheumatoid Arthritis Subjects

2017年5月10日 更新者：Pfizer

A Single-arm, Open-label Study To Assess The Immunogenicity, Safety, And Efficacy Of Etanercept Manufactured Using The High Capacity Process Administered To Subjects With Rheumatoid Arthritis

Open-label immunogenicity, safety and efficacy study of etanercept manufactured using the high capacity process. Descriptive results will be provided however a formal hypothesis will not be tested in this trial.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

188

段階

  • フェーズ 3

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

  • ギリシャ
      • Thessaloniki、ギリシャ、56429
        • Rheumatology Unit
    • Achaia
      • Rion Patras、Achaia、ギリシャ、26500
        • Rheumatology department
    • Crete
      • Heraklion、Crete、ギリシャ、71110
        • University Hospital of Heraklion
  • クロアチア
      • Rijeka、クロアチア、51000
        • CHC Rijeka
      • Zagreb、クロアチア、10000
        • Medicinski Centar Kuna Peric
  • スロバキア
      • Bratislava、スロバキア、841 04
        • Reumatologicka ambulancia
      • Dunajska Streda、スロバキア、929 01
        • AAGS, s.r.o.
      • Poprad、スロバキア、058 01
        • Reumatologicka ambulancia, MUDr. Zuzana Cizmarikova, s.r.o.
      • Rimavska Sobota、スロバキア、979 01
        • Reumex S.R.O.
      • Trnava、スロバキア、917 01
        • REUMA-GLOBAL s.r.o.
      • Zilina、スロバキア、010 01
        • Reumatologicka ambulancia
  • セルビア
    • Beograd
      • Belgrade、Beograd、セルビア、11000
        • Institute of Rheumatology
  • ドイツ
      • Berlin、ドイツ、14059
        • Schlosspark-Klinik, Innere Medizin II, Rheumatologie
      • Hannover、ドイツ、30625
        • Medizinische Hochschule Hannover
      • Vogelsang-Gommern、ドイツ、39245
        • Immunologisches Zentrum Vogelsang-Gommern GmbH
    • Hessen
      • Frankfurt/Main、Hessen、ドイツ、60528
        • Centrum für innovative Diagnostik und Therapie
    • Nordrhein-westfalen
      • Ratingen、Nordrhein-westfalen、ドイツ、40882
        • Rheumaforschung - Studienambulanz Dr. Wassenberg
  • ハンガリー
      • Budapest、ハンガリー、1036
        • Qualiclinic Kft.
      • Kistarcsa、ハンガリー、2143
        • Pest Megyei Flor Ferenc Korhaz
      • Nyiregyhaza、ハンガリー、4400
        • Szabolcs-Szatmar-Bereg megyei
  • ブルガリア
      • Plovdiv、ブルガリア、4000
        • MHAT Plovdiv
      • Sofia、ブルガリア、1431
        • DCC "Aleksandrovska" EOOD
      • Sofia、ブルガリア、1612
        • UMHAT "Sv. Ivan Rilski" EAD, Sofia
      • Stara Zagora、ブルガリア、6000
        • Medical Center - "New rehabilitation center" EOOD
  • ポーランド
      • Krakow、ポーランド、31-501
        • Krakowskie Centrum Medyczne sp. Z.O.O
      • Nadarzyn、ポーランド、05-830
        • NZOZ Lecznica MAK-MED s.c.
      • Poznan、ポーランド、61-397
        • Prywatna Praktyka Lekarska Prof. UM dr hab.med. Pawel Hrycaj
      • Warszawa、ポーランド、02-691
        • Reumatika-Centrum Reumatologii
  • 南アフリカ
    • Cape Town
      • Panorama、Cape Town、南アフリカ、7500
        • Panorama Medical Centre
    • Johannesburg
      • Parktown、Johannesburg、南アフリカ、2193
        • Wits Clinical Research CMJAH Clinical Trial Site
    • Kwazulu-natal
      • Durban/Berea、Kwazulu-natal、南アフリカ、4001
        • St. Augustines Hospital

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:

  • Moderate to severe active disease with presence of at least 4 tender joints and 4 swollen joints.
  • Either the patient or a designee must be capable of administering the subcutaneous injection of study drug.

Exclusion Criteria:

  • Prior treatment with etanercept.
  • Presence of active infection or active or untreated tuberculosis.

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：ETN 50mg QW
生物学的：etanercept
50mg subcutaneous, once weekly, 24 weeks

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 With Positive Etanercept Anti-Drug Antibody (ADA) Status at Week 12
時間枠：Week 12
Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized.
Week 12
Percentage of Participants With Positive Etanercept Anti-Drug Antibody Status at Week 24
時間枠：Week 24
Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized.
Week 24
Percentage of Participants With Positive Etanercept Anti-Drug Antibody Status: Throughout Study Treatment
時間枠：Baseline up to Week 24
Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized.
Baseline up to 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 With Positive Etanercept Neutralizing Anti-Drug Antibody Status: Throughout Study Treatment
時間枠：Baseline (Day 1) up to Week 24
Percentage of participants with positive Etanercept neutralizing anti-drug antibodies were summarized.
Baseline (Day 1) up to Week 24
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
時間枠：Baseline (Day 1) up to Week 28 (Follow-up)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.
Baseline (Day 1) up to Week 28 (Follow-up)
Number of Participants With Investigator-Identified Serious Infections
時間枠：Baseline (Day 1) up to Week 28 (Follow-up)
Infection was considered as serious by investigator for any of the following outcomes: death; life-threatening; required initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity or congenital anomaly/birth defect.
Baseline (Day 1) up to Week 28 (Follow-up)
Number of Participants With Injection Site Reactions
時間枠：Baseline (Day 1) up to Week 28 (Follow-up)
Injection site reactions included injection site erythema, swelling, pain and warmth.
Baseline (Day 1) up to Week 28 (Follow-up)
Number of Participants With Grade 3 and 4 Clinical Laboratory Abnormalities
時間枠：Baseline (Day 1) up to Week 28 (Follow-up)
Laboratory abnormalities(national cancer institute toxicity criteria version 4.0),Grade 3:neutrophil (greater than or equal to[>=]0.5,less than[<]1.0 10^9/L),lymphocyte (<0.5 10^9/L),hemoglobin (Hb) (<80,>=65 gram per liter [g/L]),platelet(<50.0,>=25.0 10^9/L),white blood count(WBC) (<2.0, >=1.0 10^9/L);alkaline phosphatase (AP),aspartate aminotransferase(AST),alanine aminotransferase(ALT) (greater than[>]5.0*upper range [UR], <=20.0*UR unit per liter[U/L]);bilirubin(>1.5*UR, less than or equal to[<=]3.0*UR micromole per liter[mcmol/L]);creatinine(>3.0*UR, <=6.0*UR mcmol/L);albumin (<20.0 g/L),urea(>3.0*UR, <=4.0*UR g/L);potassium (K)-high,low (>6.0,<=7.0or<3.0,>=2.5 mcmol/L); sodium(Na)-high,low(>155, <=160 or <130, >=120 mcmol/L)and Grade 4: neutrophil(<0.5 10^9/L),Hb (<65 g/L);platelet (<25.0 10^9/L); WBC(<1.0 10^9/L);AP,AST,ALT(>20.0*UR U/L);bilirubin(>3.0*UR mcmol/L);creatinine (>6.0*UR mcmol/L);urea (>4.0*UR g/L);K-high,low (>7.0or<2.5 mcmol/L);Na-high, low (>160or<120 mcmol/L).
Baseline (Day 1) up to Week 28 (Follow-up)
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response
時間枠：Week 4, 12, 24
ACR20 responder: participants with 20 percent (%) improvement in tender and swollen 28-joint counts and 20% improvement in at least 3 of the 5 measures: participant global assessment of arthritis (PtGA), physician global assessment of arthritis (PGA), participant pain visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI) and C-reactive protein. PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PGA: physician judged participant's overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. Pain-VAS: participant assessed arthritis pain by 100 millimeter (mm) VAS, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability. Percentage of participants with ACR20 response were reported.
Week 4, 12, 24
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
時間枠：Week 4, 12, 24
ACR50 responder: participants with 50% improvement in tender and swollen 28-joint counts and 50% improvement in at least 3 of the 5 measures: participant global assessment of arthritis (PtGA), physician global assessment of arthritis (PGA), participant pain visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI) and C-reactive protein. PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PGA: physician judged participant's overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. Pain-VAS: participant assessed arthritis pain by 100 millimeter (mm) VAS, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability. Percentage of participants with ACR50 response were reported.
Week 4, 12, 24
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
時間枠：Week 4, 12, 24
ACR70 responder: participants with 70% improvement in tender and swollen 28-joint counts and 70% improvement in at least 3 of the 5 measures: participant global assessment of arthritis (PtGA), physician global assessment of arthritis (PGA), participant pain visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI) and C-reactive protein. PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PGA: physician judged participant's overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. Pain-VAS: participant assessed arthritis pain by 100 millimeter (mm) VAS, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability. Percentage of participants with ACR70 response were reported.
Week 4, 12, 24
Change From Baseline in Disease Activity Scale Based on 28 Joint Count Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 4, 12 and 24
時間枠：Baseline, Week 4, 12, 24
DAS28: measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from number of swollen joints (SJC) and tender joints (TJC ) using the 28 joints count, erythrocyte sedimentation rate (millimeter per hour [mm/hour]) and participant's general health visual analog scale assessment (scores: 0 mm [very well] to 100 mm [extremely bad], higher scores indicate worse health condition). Total DAS28-4 (ESR) score: 0 (none) to 10 (extreme disease activity), higher scores indicate more disease activity. DAS28-4 (ESR) less than (<) 2.6= remission, <3.2= low disease activity, greater than or equal to (>=) 3.2 to 5.1= moderate disease activity and >5.1= high disease activity.
Baseline, Week 4, 12, 24
Change From Baseline in Disease Activity Scale Based on 28 Joint Count C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Week 4, 12 and 24
時間枠：Baseline, Week 4, 12, 24
DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated from the number of swollen joints and tender joints using the 28 joints count, C-Reactive protein (milligram per liter [mg/L]) and participant's general health visual analog scale assessment (scores ranging 0 mm [very well] to 100 mm [extremely bad], higher scores indicate worse health condition). Total DAS28-4 (CRP) score range: 0 (none) to 10 (extreme disease activity), higher scores indicate more disease activity. DAS28-4 (CRP) less than (<) 2.6= remission, <3.2= low disease activity, greater than or equal to (>=) 3.2 to 5.1= moderate disease activity and >5.1= high disease activity.
Baseline, Week 4, 12, 24
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 4, 12 and 24
時間枠：Baseline, Week 4, 12, 24
HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each item scored on 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0 (least difficulty) and 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities.
Baseline, Week 4, 12, 24

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

Pfizer

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

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

2015年4月1日

一次修了 (実際)

2016年5月1日

研究の完了 (実際)

2016年6月1日

試験登録日

最初に提出

2015年2月13日

QC基準を満たした最初の提出物

2015年2月26日

最初の投稿 (見積もり)

2015年3月4日

学習記録の更新

投稿された最後の更新 (実際)

2017年5月15日

QC基準を満たした最後の更新が送信されました

2017年5月10日

最終確認日

2017年3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

  • B1801359
  • 2013-004569-16 (EudraCT番号)

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。

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