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An Global Comparative Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis

2016年1月12日 更新者：Hoffmann-La Roche

A Global Comparative Observational Study In Rheumatoid Arthritis (RA) Patients Who Are Treated With A TNF Inhibitor Or Tocilizumab As The First Biologic Therapy

This prospective, multi-center, observational study will assess the efficacy and safety of treatment in patients who are treated with a TNF Inhibitor or RoActemra/Actemra (tocilizumab) as the first biologic therapy. Data will be collected for 52 weeks.

調査の概要

状態

完了

条件

研究の種類

観察的

入学 (実際)

1225

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

  • アルゼンチン
      • Catamarca Capital、アルゼンチン、4700
      • Mendoza、アルゼンチン、5500
      • Mendoza、アルゼンチン、5501
      • Rosario、アルゼンチン、S2000PBJ
  • イギリス
      • Barnsley、イギリス、S75 2EP
      • Basildon、イギリス、SS16 5NL
      • Basingstoke、イギリス、RG24 9NA
      • Brighton、イギリス、BN2 5BE
      • Cannock、イギリス、WS11 5XY
      • Cardiff、イギリス、CF14 4XW
      • Chertsey、イギリス、KT16 0PZ
      • Crawley、イギリス、RH11 7DH
      • Darlington、イギリス、DL3 6HX
      • Enfield、イギリス、EN2 8JL
      • Grimsby、イギリス、DN33 2BA
      • Guildford、イギリス、GU2 7XX
      • Ipswich、イギリス、IP4 5PD
      • Kettering、イギリス、NN16 8UZ
      • Lancaster、イギリス、LA1 4RP
      • Leeds、イギリス、LS7 4SA
      • Llandudno、イギリス、LL30 1LB
      • London、イギリス、W6 8RF
      • London、イギリス、SW17 0QT
      • London、イギリス、SE18 4QH
      • Luton、イギリス、LU4 0DZ
      • Maidstone、イギリス、ME16 9QQ
      • Margate、イギリス、CT9 4AN
      • North Shields、イギリス、NE29 8NH
      • Oswestry、イギリス、SY10 7AG
      • Plymouth、イギリス、PL6 8DH
      • Portsmouth、イギリス、PO6 3LY
      • Reading、イギリス、RG1 5AN
      • Rhyl、イギリス、LL18 5UJ
      • Romford、イギリス、RM7 0AG
      • Sheffield、イギリス、S10 2JF
      • Stockport、イギリス、SK2 7JE
      • Sunderland、イギリス、SR4 7TP
      • Swindon、イギリス、SN3 6BB
      • Torquay、イギリス、TQ2 7AA
      • Warrington、イギリス、WA5 1QG
      • Wirral、イギリス、CH49 5PE
      • Wolverhampton、イギリス、WV10 0QP
      • Wrightington、イギリス、WN6 9EP
  • イタリア
    • Abruzzo
      • Coppito、Abruzzo、イタリア、67100
      • Pescara、Abruzzo、イタリア、65100
    • Calabria
      • Reggio Calabria、Calabria、イタリア、89133
    • Campania
      • Avellino、Campania、イタリア、83100
      • Napoli、Campania、イタリア、80131
      • Napoli、Campania、イタリア、80144
      • Salerno、Campania、イタリア、84131
    • Friuli-Venezia Giulia
      • Udine、Friuli-Venezia Giulia、イタリア、33100
    • Lazio
      • Roma、Lazio、イタリア、00133
      • Roma、Lazio、イタリア、00189
    • Liguria
      • Arenzano、Liguria、イタリア、16011
    • Lombardia
      • Brescia、Lombardia、イタリア、25123
      • Legnano、Lombardia、イタリア、20025
      • Milano、Lombardia、イタリア、20157
      • Milano、Lombardia、イタリア、20162
    • Marche
      • Jesi Ancona、Marche、イタリア、60035
    • Molise
      • Agnone、Molise、イタリア、86081
    • Piemonte
      • Torino、Piemonte、イタリア、10126
      • Torino、Piemonte、イタリア、10128
    • Puglia
      • Brindisi、Puglia、イタリア、72100
      • Martina Franca、Puglia、イタリア、74015
      • San Cesario Di Lecce、Puglia、イタリア、73016
    • Sicilia
      • Catania、Sicilia、イタリア、95124
    • Toscana
      • Prato、Toscana、イタリア、59100
    • Umbria
      • Perugia、Umbria、イタリア、06122
  • ウクライナ
      • Donetsk、ウクライナ、83045
      • Kharkiv、ウクライナ、61052
      • Kmelnytskyy、ウクライナ、29000
      • Kyiv、ウクライナ、02125
      • Kyiv、ウクライナ、03151
      • Kyiv、ウクライナ、1023
      • Odesa、ウクライナ、65026
      • Uzhgorod、ウクライナ、88000
      • Zaporizhzhya、ウクライナ、69600
  • ウルグアイ
      • Montevideo、ウルグアイ、11000
      • Montevideo、ウルグアイ、11800
  • エクアドル
      • Cuenca、エクアドル
      • Esmeraldas、エクアドル、EC080150
      • Guayaquil、エクアドル、EC090114
      • Portoviejo、エクアドル
      • Quito、エクアドル、005932
      • Quito、エクアドル、EC170135
      • Quito、エクアドル、EC170412
  • ギリシャ
      • Athens、ギリシャ、11527
      • Athens、ギリシャ、155 62
      • Patra、ギリシャ、26335
      • Thessaloniki、ギリシャ、56429
      • Thessaloniki、ギリシャ、544 65
  • グアテマラ
      • Ciudad de Guatemala、グアテマラ
  • コロンビア
      • Barranquilla、コロンビア
      • Bogota、コロンビア
      • Bucaramanga、コロンビア
      • Medellin、コロンビア
  • スイス
      • Aarau、スイス、5000
      • Basel、スイス、4031
      • Chur、スイス、7000
      • St. Gallen、スイス、9007
  • スペイン
      • Madrid、スペイン、28006
      • Madrid、スペイン、28905
      • Madrid、スペイン、28007
    • Madrid
      • Fuenlabrada、Madrid、スペイン、28942
      • San Sebastian de los Reyes、Madrid、スペイン、28702
  • ドイツ
      • Aachen、ドイツ、52064
      • Bad Aibling、ドイツ、83043
      • Bad Neuenahr-Ahrweiler、ドイツ、53474
      • Bayreuth、ドイツ、95445
      • Berlin、ドイツ、13055
      • Dresden、ドイツ、01109
      • Erfurt、ドイツ、99096
      • Erlangen、ドイツ、91056
      • Fulda、ドイツ、36043
      • Hamburg、ドイツ、22767
      • Hamburg、ドイツ、22147
      • Heidelberg、ドイツ、69121
      • Herne、ドイツ、44652
      • Köln、ドイツ、50937
      • Ludwigsfelde、ドイツ、14974
      • München、ドイツ、81541
      • München、ドイツ、80639
      • Passau、ドイツ、94032
      • Rostock、ドイツ、18059
      • Stuttgart、ドイツ、70178
      • Traunstein、ドイツ、83278
      • Wuppertal、ドイツ、42105
  • パナマ
      • Panama City、パナマ、32400
  • ベルギー
      • AYE、ベルギー、6900
      • Aalst、ベルギー、9300
      • Assebroek、ベルギー、8310
      • Bruxelles、ベルギー、1050
      • Bruxelles、ベルギー、1000
      • Edegem、ベルギー、2650
      • Genk、ベルギー、3600
      • Gent、ベルギー、9000
      • Godinne、ベルギー、5530
      • Heusy、ベルギー、4802
      • Liège、ベルギー、4000
      • Oostende、ベルギー、8400
      • Verviers、ベルギー、4800
      • Westmalle、ベルギー、2390
  • ポルトガル
      • Almada、ポルトガル、2801-951
      • Amadora、ポルトガル、2720-276
      • Lisboa、ポルトガル、1649-035
      • Lisboa、ポルトガル、1069-166
      • Porto、ポルトガル、4200-319
      • Porto、ポルトガル、4099-001
      • Vila Nova de Gaia、ポルトガル、4400-129
  • メキシコ
      • Guadalajara、メキシコ、44650
      • Guadalajara、メキシコ、44600
      • Guadalajara、メキシコ、45040
      • Mexicali、メキシコ、21100
      • Mexico Ctiy、メキシコ、07760

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

サンプリング方法

確率サンプル

調査対象母集団

Adult patients with rheumatoid arthritis

説明

Inclusion Criteria:

  • Adult patients, >/=18 years of age
  • Diagnosis of rheumatoid arthritis
  • Non-respondent or intolerant to non-biologic disease-modifying anti-rheumatic drug (DMARD) therapy
  • Patient has been prescribed a first biologic therapy up to 6 weeks prior to the inclusion visit, irrespective of the treatment prescribed

Exclusion Criteria:

  • Patients whose first biologic therapy is given as part of a clinical trial studying rheumatoid arthritis (RA) treatment
  • Patients who are receiving or have received experimental DMARDs as part of a clinical trial studying RA treatment in the last 12 months
  • Patients whose first biologic is rituximab, abatacept or anakinra.
  • Patients who have received any biologic therapy for more than 6 weeks prior to the inclusion visit

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

コホートと介入

グループ/コホート
コホート

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
Mean Change From Baseline in Calculated Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 24
時間枠：Baseline and Week 24
Disease activity score based on 28 joint counts (DAS28) is a composite measure of disease severity and it incorporates four specific measures of disease: swollen joint count (SJC) of 28 joints, tender joint count (TJC) of 28 joints, Patient's Global Assessment of Disease Activity by visual analogue scale (VAS), and acute-phase inflammatory marker [erythrocyte sedimentation rate (ESR) in millimeter/hour (mm/h), or C-reactive protein (CRP) in milligram/liter (mg/L)]. For the purposes of this study, ESR was used whenever possible to calculate the DAS28 (DAS28-ESR). Higher the scores, greater is the disease activity. A DAS28 score of less than or equal to (</=) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.
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
Mean Change From Baseline in Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 52
時間枠：Baseline and Week 52
Disease activity score based on 28 joint counts (DAS28) is a composite measure of disease severity and it incorporates four specific measures of disease: swollen joint count (SJC) of 28 joints, tender joint count (TJC) of 28 joints, Patient's Global Assessment of Disease Activity by visual analogue scale (VAS), and acute-phase inflammatory marker (ESR in mm/h, or CRP in mg/L). For the purposes of this study, ESR was used whenever possible to calculate the DAS28 (DAS28-ESR). Higher the scores, greater is the disease activity. A DAS28 score of </= 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.
Baseline and Week 52
Mean Change From Baseline in Erythrocyte Sedimentation Rate
時間枠：Baseline, Week 24, Week 52
Blood samples were collected for ESR, which is an acute phase reactant and a measure of inflammation. BL = baseline.
Baseline, Week 24, Week 52
Mean Change From Baseline in C-reactive Protein
時間枠：Baseline, Week 24, Week 52
Blood samples were collected for C-reactive protein (CRP). CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as RA.
Baseline, Week 24, Week 52
Mean Change From Baseline in Swollen Joint Count
時間枠：Baseline, Week 24, Week 52
A swollen joint count (SJC) is the most specific clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue. Twenty-eight joints were assessed for swelling. Joints were classified as swollen (1)/ not swollen (0) giving a total possible SJC score of 0 to 28.
Baseline, Week 24, Week 52
Mean Change From Baseline in Tender Joint Count
時間枠：Baseline, Week 24, Week 52
A tender joint count (TJC) is the most specific clinical method to quantify abnormalities in participants with RA. It is associated with the level of pain. Twenty-eight joints were assessed for tenderness. Joints were classified as tender (1)/not tender (0) giving a total possible TJC score of 0 to 28.
Baseline, Week 24, Week 52
Mean Change From Baseline in Clinical Disease Activity Index and Simplified Disease Activity Index Score
時間枠：Baseline, Week 24, Week 52
Clinical Disease Activity Index (CDAI) was calculated as the sum of the following parameters: SJC + TJC + VAS Patient Global Assessment of Disease Activity + VAS Physician Global Assessment of Disease Activity. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity'. CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. Simplified Disease Activity Index (SDAI) was calculated as the sum of the following parameters: SJC +TJC + Patient Global Assessment of Disease Activity + Physician Global Assessment of Disease Activity + CRP. SDAI scores ranged from 0 to 86, with higher scores also indicating increased disease activity.
Baseline, Week 24, Week 52
Mean Change From Baseline in Physician Global Assessment Score
時間枠：Baseline, Week 24, Week 52
The Physician's Global Assessment of disease activity was assessed using a 0 to 100 millimeter (mm) horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). Change from baseline = scores at observation minus score at baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Baseline, Week 24, Week 52
Loss of Efficacy or Development of Intolerance to Biologic Therapy
時間枠：Up to Week 52
Events that are clearly consistent with the expected pattern of progression of the underlying disease may contribute to lack of efficacy. Lack of efficacy was one of the reasons for termination of biology therapy. The number of participants showing lack of efficacy to biologic therapy is presented.
Up to Week 52
Proportion of Participants Who Terminated Biologic Treatment
時間枠：Up to Week 52
The proportion of participants who discontinued biologic treatment was compared between tocilizumab-treated and TNF inhibitor-treated participants.
Up to Week 52
Reasons for Treatment Discontinuation
時間枠：Up to Week 52
The reasons for discontinuation of tocilizumab or TNF inhibitor is presented.
Up to Week 52
Cumulative Number of Participants Who Discontinued Biologic Therapy at the End of Each Study Period
時間枠：Up to end of treatment
The total number of participants who discontinued biologic therapy at the end of each study period (Week 0 - 24, Week 24 - 52, Week 52 - 57 and Week 57 - end of treatment) is presented. Participants who did not have a biologic therapy discontinuation or discontinued before having one, were considered as 'censored' at the date study termination.
Up to end of treatment
Number of Participants of Infusion Reactions or Injection Site Reactions During the Study Following the Start of the First Biologic Therapy
時間枠：Up to Week 52
An infusion reaction was defined as an adverse event (AE) occurring during and within 24 hours after the infusion, which may include hypersensitivity reactions or anaphylactic reactions. Injection site reactions were included in the summaries for infusion reactions.
Up to Week 52
Number of Participants With Adverse Events, Serious Adverse Events and Non-serious Adverse Events
時間枠：Up to Week 52
An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
Up to Week 52
Number of Participants With Serious and Non-serious Adverse Events of Special Interest, Including Infections, During the Study
時間枠：Up to Week 52
Adverse events of special interest (AESI) for this study included: infections (including opportunistic infections), myocardial infarction/acute coronary syndrome, gastrointestinal perforation and related events, malignancies, anaphylaxis / hypersensitivity reactions, demyelinating disorders, stroke, bleeding events and hepatic events. Based on seriousness criteria, they were categorized as serious and non-serious adverse events of special interest.
Up to Week 52
Mean Change From Baseline in Health Assessment Questionnaire Disability Index Score
時間枠：Baseline, Week 24, Week 52
The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation.
Baseline, Week 24, Week 52
Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Score
時間枠：Baseline, Week 24, Week 52
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant's health status.
Baseline, Week 24, Week 52
Mean Change From Baseline in Visual Analogue Scale Pain Score
時間枠：Baseline, Week 24, Week 52
VAS is a 100 mm scale. Intensity of pain range: 0 mm=no pain to 100 mm=worst possible pain. Change from baseline =scores at observation minus score at baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Baseline, Week 24, Week 52
Shift From Baseline in Morning Stiffness
時間枠：Baseline, Week 24, Week 52
Shift tables presenting the number of participants in each bivariate category Week (W) 0 versus Week 24 and Week 52, with regards to morning stiffness at the different time points, was presented for each treatment arm. For participants who experienced joint stiffness while waking up in the morning, duration of morning stiffness was categorized as follows: Less than 30 minutes (min), Between 30 and 60 minutes, Between 60 and 120 minutes, Between 120 to 240 minutes, More than 240 minutes and the whole day. Baseline = BL
Baseline, Week 24, Week 52
Change From Baseline in Patient Global Assessment of Disease Activity
時間枠：Baseline, Week 24, Week 52
The patient's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative change from Baseline indicated improvement.
Baseline, Week 24, Week 52

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

Hoffmann-La Roche

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

2012年2月1日

一次修了 (実際)

2015年2月1日

研究の完了 (実際)

2015年2月1日

試験登録日

最初に提出

2012年2月28日

QC基準を満たした最初の提出物

2012年2月28日

最初の投稿 (見積もり)

2012年3月5日

学習記録の更新

投稿された最後の更新 (見積もり)

2016年2月10日

QC基準を満たした最後の更新が送信されました

2016年1月12日

最終確認日

2016年1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

  • MA27950

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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