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A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor

2016年6月30日 更新者：Hoffmann-La Roche

An Open-label Study to Evaluate the Safety of MabThera, and Its Effect on Treatment Response, in Patients With Rheumatoid Arthritis Following Inadequate Response to a Single Anti-TNF Agent

This study will evaluate the efficacy and safety of MabThera in patients with active rheumatoid arthritis who have had an inadequate response to one prior anti-TNF alpha inhibitor. MabThera-naive patients will be stratified into 3 arms, according to previous inadequate response to a)etanercept, b)infliximab or c)adalimumab. Patients will be treated with MabThera (1g infusion) on day 1 and day 15, and will continue their basic methotrexate therapy. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.

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)

302

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

  • ドイツ
      • Bad Abbach、ドイツ、93077
      • Bad Aibling、ドイツ、83043
      • Bad Bramstedt、ドイツ、24576
      • Bamberg、ドイツ、96047
      • Berlin、ドイツ、10117
      • Berlin、ドイツ、12200
      • Berlin、ドイツ、13125
      • Berlin、ドイツ、13589
      • Berlin、ドイツ、13055
      • Berlin、ドイツ、14163
      • Bonn、ドイツ、53111
      • Bremen、ドイツ、28199
      • Cuxhaven、ドイツ、27476
      • Damp、ドイツ、24351
      • Donaueschingen、ドイツ、78166
      • Dresden、ドイツ、01109
      • Düsseldorf、ドイツ、40225
      • Düsseldorf、ドイツ、40211
      • Erfurt、ドイツ、99096
      • Erlangen、ドイツ、91054
      • Erlangen、ドイツ、91056
      • Essen、ドイツ、45326
      • Essen、ドイツ、45239
      • Frankfurt Am Main、ドイツ、60590
      • Freiburg、ドイツ、79106
      • Fulda、ドイツ、36039
      • GIEßEN、ドイツ、35392
      • Gommern、ドイツ、39245
      • Göttingen、ドイツ、37075
      • Hagen、ドイツ、58135
      • Halle、ドイツ、06120
      • Hamburg、ドイツ、22081
      • Hannover、ドイツ、30625
      • Hannover、ドイツ、30159
      • Heidelberg、ドイツ、69120
      • Herne、ドイツ、44652
      • Hofheim、ドイツ、65719
      • Homburg/saar、ドイツ、66424
      • Jena、ドイツ、07743
      • Karlsruhe、ドイツ、76135
      • Köln、ドイツ、50924
      • Ludwigshafen、ドイツ、67063
      • Mainz、ドイツ、55131
      • Mainz、ドイツ、55122
      • Mittelherwigsdorf、ドイツ、02763
      • Muenchen、ドイツ、80336
      • Mönchengladbach、ドイツ、41061
      • München、ドイツ、81541
      • München、ドイツ、80335
      • Münster、ドイツ、48149
      • Naunhof、ドイツ、04683
      • Oldenburg、ドイツ、26121
      • Osnabrück、ドイツ、49074
      • Pirna、ドイツ、01796
      • Ratingen、ドイツ、40882
      • Rostock、ドイツ、18059
      • Schwerte、ドイツ、58239
      • Sendenhorst、ドイツ、48324
      • Stuttgart、ドイツ、70178
      • Treuenbrietzen、ドイツ、14929
      • Trier、ドイツ、54292
      • Tübingen、ドイツ、72076
      • ULM、ドイツ、89081
      • Wiesbaden、ドイツ、65191
      • Wiesbaden、ドイツ、65189
      • Wuerzburg、ドイツ、97080
      • Wuppertal、ドイツ、42105
      • Würselen、ドイツ、52146
      • Zeven、ドイツ、27404

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 patients, 18-75 years of age;
  • rheumatoid arthritis for >=6 months;
  • previous inadequate response to a single anti-TNF alpha inhibitor;
  • methotrexate at a stable dose range 7.5-25 mg/week.

Exclusion Criteria:

  • other chronic inflammatory articular disease or systemic autoimmune disease;
  • previous treatment with MabThera or intolerance to MabThera;
  • corticosteroids>=10 mg/day prednisolone within last 2 weeks, or corticosteroids at unstable doses within last 2 weeks;

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：MabThera (Rituximab)
薬：rituximab [MabThera]
1 g was given by intravenous infusion on Days 1 and 15

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
Change From Baseline to Week 24 in Disease Activity Score Based on 28-Joint Count (DAS28)
時間枠：Week 24
The DAS28 consists of swollen joint count (SJC) and tender joint count (TJC) measurements, the erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hr), and the Patient's Global Assessment of Disease Activity (participant-ated rheumatoid arthritis [RA] activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.
Week 24

二次結果の測定

結果測定
メジャーの説明
時間枠
DAS28 Score
時間枠：Screening and Weeks 8, 16, and 24
The DAS28 consists of SJC and TJC measurements, the ESR in mm/hr, and the Patient's Global Assessment of Disease Activity (participant-rated RA assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
Screening and Weeks 8, 16, and 24
Percentage of Participants With European League Against Rheumatism (EULAR) Response of Good or Moderate
時間枠：Weeks 8, 16, and 24
The DAS28-based EULAR response criteria were used to measure individual responses as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders experienced a change from baseline of >1.2 with a DAS28 score ≤3.2 and moderate responders experienced a change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or a change from baseline >0.6 to ≤1.2 with a DAS28 score of ≤5.1.
Weeks 8, 16, and 24
Percentage of Participants With Low Disease Activity (DAS28 ≤3.2) at Week 24
時間枠：Week 24
Percentage of participants with low disease activity defined as DAS28 ≤3.2 at follow-up Week 24. The DAS28 consists of SJC and TJC measurements, the ESR in mm/hr, and the Patient's Global Assessment of Disease Activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity).
Week 24
Percentage of Participants Achieving Remission (DAS28 <2.6) at Week 24
時間枠：Week 24
Percentage of participants with remission defined as DAS28 <2.6 at follow-up Week 24. The DAS28 consists of SJC and TJC measurements, the ESR in mm/hr, and the Patient's Global Assessment of Disease Activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
Week 24
Percentage of Participants Achieving a Response By EULAR Category
時間枠：Weeks 8, 16, and 24
Percentage of participants achieving a response by EULAR category, including 'moderate', 'good', or no response at follow-up Weeks 8, 16, and 24. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline >1.2 with a DAS28 score ≤ 3.2; moderate responders had a change from baseline >1.2 with a DAS28 score of >3.2 to ≤5.1 or a change from baseline >0.6 to ≤1.2 with a DAS28 score of ≤5.1; non-responders had a change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with a DAS28 score of >5.1.
Weeks 8, 16, and 24
Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
時間枠：Screening and Weeks 8, 16, and 24
The HAQ-DI score consists of questions referring to 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. For each of the categories, participants reported the amount of difficulty they had in performing 2 or 3 specific sub-category items. The standard disability score was calculated from the 8 categories by dividing the sum of the individual categories by the number of categories answered, yielding a score from 0 (without any difficulty) to 3 (unable to do).
Screening and Weeks 8, 16, and 24
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score
時間枠：Screening and Weeks 8, 16, and 24
The FACIT fatigue scale is base on a 13-item questionnaire to assess the therapy-induced fatigue. Participants were requested to score each question on a scale ranging from 0 (best) to 4 (worst). The scoring system of the FACIT fatigue scale adds up to a total scale ranging from 0 (best) to 52 (worst). The assessment was originally developed for chronic illnesses and is now validated for patients with rheumatoid arthritis (RA). The questionnaire was provided in a German translation.
Screening and Weeks 8, 16, and 24
Short-Form 36 (SF-36) Physical Composite Scores (PCS) and Mental Composite Scores (MCS)
時間枠：Screening and Weeks 8, 16, and 24
The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the physical and mental composite t-scores (PCS and MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.
Screening and Weeks 8, 16, and 24
SF-36 Domain Scores
時間枠：Screening and Weeks 8, 16, and 24
The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to two distinct higher-ordered clusters: the physical and mental composite t-scores (PCS and MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.
Screening and Weeks 8, 16, and 24
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50% or 70% Response (ACR20/ACR50/ACR70)
時間枠：Weeks 8, 16, and 24
ACR20/50/70 response: ≥20%, ≥50%, or ≥70% improvement, respectively, in tender or swollen joint counts and ≥20%, ≥50%, or ≥70% improvement, respectively, in 3 of the following 5 criteria: 1) Physician's Global Assessment of Disease Activity, 2) Patient's Global Assessment of Disease Activity, 3) Patient's Assessment of Pain, 4) participant assessment of functional disability via a HAQ-DI, and 5) C-reactive protein or ESR at each visit.
Weeks 8, 16, and 24
Swollen Joint Count (SJC)
時間枠：Screening and Weeks 8, 16, and 24
The 28 joints to be assessed for tenderness and swelling were shoulder, elbow, wrist, metacarpophalangeal (MCP) joints 1-5, proximal interphalangeal (PIP) joints 1-5, and knee on both sides of the body. The sum of swollen joints, each, ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.
Screening and Weeks 8, 16, and 24
Tender Joint Count (TJC)
時間枠：Screening and Weeks 8, 16, and 24
The 28 joints to be assessed for tenderness and swelling were shoulder, elbow, wrist, metacarpophalangeal (MCP) joints 1-5, proximal interphalangeal (PIP) joints 1-5, and knee on both sides of the body. The sum of tender joints ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.
Screening and Weeks 8, 16, and 24
Physician's Global Assessment of Disease Activity
時間枠：Screening and Weeks 8, 16, and 24
Physicians assessed the disease (RA) activity on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as "no disease activity" (symptom-free and no arthritis symptoms) and the right hand extreme (100 mm) as "maximum disease activity" (maximum arthritis disease activity).
Screening and Weeks 8, 16, and 24
Patient's Assessment of Disease Activity
時間枠：Screening and Weeks 8, 16, and 24
Participants were to assess the disease (RA) activity on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as "no disease activity" (symptom-free and no arthritis symptoms) and the right hand extreme (100 mm) as "maximum disease activity" (maximum arthritis disease activity).
Screening and Weeks 8, 16, and 24
Patient's Assessment of Pain
時間枠：Screening and Weeks 8, 16, and 24
Participants were to assess their current level of pain on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as "no pain" and the right-hand (100 mm) as "unbearable pain".
Screening and Weeks 8, 16, and 24
C-Reactive Protein (CRP)
時間枠：Screening, Days 1 and 15, and Weeks 8, 16, and 24
Mean CRP as measured as an acute phase reactant by mg per deciliter (mg/dL) at screening, Days 1 and 15, and Weeks 8, 16, and 24.
Screening, Days 1 and 15, and Weeks 8, 16, and 24
Erythrocyte Sedimentation Rate (ESR)
時間枠：Screening, Days 1 and 15, and Weeks 8, 16, and 24
Mean ESR, as an acute phase reactant, measured in mm/hr at screening, Days 1 and 15, and Weeks 8, 16, and 24.
Screening, Days 1 and 15, and Weeks 8, 16, and 24
Rheumatoid Factor (RF)
時間枠：Screening and Weeks 8, 16, and 24
Mean RF as measured by international unit per milliliter (IU/mL) at screening and Weeks 8, 16, and 24.
Screening and Weeks 8, 16, and 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

Hoffmann-La Roche

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

2006年11月1日

一次修了 (実際)

2010年11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

2014年3月4日

QC基準を満たした最初の提出物

2014年3月4日

最初の投稿 (見積もり)

2014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7月29日

QC基準を満たした最後の更新が送信されました

2016年6月30日

最終確認日

2016年6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

  • ML19070

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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