An Efficacy and Safety Study of Infliximab in Participants With Rheumatoid Arthritis
2013年9月11日 更新者：Xian-Janssen Pharmaceutical Ltd.
A Multi-Center, Pre-Marketing Clinical Trial to Evaluate the Efficacy and Safety of Infliximab Treatment on Rheumatoid Arthritis
The purpose of this study is to compare the effectiveness of iInfliximab plus methotrexate (MTX) in treatment of Rheumatoid rheumatoid Arthritis arthritis (RA) (it is an autoimmune disease that causes pain, swelling, stiffness and loss of function in joints) in participants with moderate disease versus participants with severe disease and to compare the efficacy and safety of the MTX subgroups.
調査の概要
詳細な説明
This is an open-label (all people know the identity of the intervention), multi-center (study conducted in more than 1 center), prospective (study following participants forward in time) study comparing the American College of Rheumatology (ACR) scores of participants with moderate RA (defined as having a score greater than 3.2, but less than 5.1 on the Disease Activity Score 28 [DAS 28]) to those participants with severe RA (defined as having a score greater than 5.1 on the DAS 28 score) disease while being treated with infliximab and MTX.
DAS evaluates RA activity by several parameters including the number of swollen and tender joints and the participant's own assessment of their pain.
Participants will receive infliximab 3 milligram (mg) per kilogram (kg) intravenous infusion (drug given into a vein) (over no less than 2 hours) at Weeks 0, 2, 6, 14 and 22 along oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 Weeks.
Participants will have a follow-up visit on Week 26.
Efficacy will primarily be assessed by the percentage of participants obtaining ACR20, ACR50 and ACR70 response at Week 26.
Participants' safety will be assessed throughout the study.
研究の種類
介入
入学 (実際)
234
段階
- フェーズ 4
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～65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:
- Participants who have a definitive diagnosis of rheumatoid arthritis (RA) based on the American College of Rheumatology Criteria 1987
- Participants must have been on Methotrexate (MTX) for 12 weeks at the stable dose for at least 4 weeks
- Participants using oral corticosteroids, must have been on a stable dose of prednisone less than 10 milligram per day (mg/day) or its equivalent for at least 4 weeks before screening or if currently not using corticosteroids, the participant must not have received corticosteroids for at least 4 weeks before screening
- Participants with moderate to severe RA (Disease Activity Score [DAS28] greater than 3.2)
- Male participants shall adopt contraceptive measures during the trial and within 6 months after the completion of trial (such as spermicidal barrier), or their female sexual partners shall agree to adopt effective contraceptive measures during the trial or within 6 months after the completion of trial (such as oral contraceptives, contraceptives for injection, intrauterine device [IUD], or sterilization by surgery); female participants of childbearing potential with negative urine pregnancy test upon enrollment in addition to adopting the said contraceptive measures
Exclusion Criteria:
- Participant who has a known allergy to human immunoglobulin proteins or other components of infliximab
- Participant who has a history of receiving infliximab or any other biological preparations
- Participant who is in stage IV RA evaluated by X-ray
- Participants suffering from tuberculosis
- Female participant or male participant's wife who plans to become pregnant during this study and within 6 months after completion of this 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：非ランダム化
- 介入モデル：並列代入
- 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：Infliximab + Methotrexate (Moderate RA)
Participants with moderate RA (score greater than 3.2, but less than 5.1 on the disease activity score [DAS] 28) received infliximab 3 milligram per kilogram (mg/kg) intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX IN a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
|
Infliximab 3 mg per kg intravenous infusion at Week 0, 2, 6, 14 and 22.
MTX stable dose (7.5 to 20 mg/week equal to the dose used before participation in the study) for 22 weeks.
|
|
実験的：Infliximab + Methotrexate (Severe RA)
Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (mg/week) equal to the dose used before participation in the study) for 22 weeks.
|
Infliximab 3 mg per kg intravenous infusion at Week 0, 2, 6, 14 and 22.
MTX stable dose (7.5 to 20 mg/week equal to the dose used before participation in the study) for 22 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 Achieving American College of Rheumatology Score 20 Percent (ACR20) Response
時間枠：Week 26
|
ACR20 is achieved if the participant has 20% improvement from Baseline in swollen joint count; tender joint count and in at least 3 of the following 5 assessments: participants' assessment of pain; participants' global assessment of disease activity; physician's global assessment of disease activity; participants' assessment of physical function (Health Assessment Questionnaire [HAQ]) and C-reactive protein (CRP).
|
Week 26
|
|
Percentage of Participants Achieving American College of Rheumatology Score 50 Percent (ACR50) Response
時間枠：Week 26
|
ACR50 is achieved if the participant has 50% improvement from Baseline in swollen joint count; tender joint count and in at least 3 of the following 5 assessments: participants' assessment of pain; participants' global assessment of disease activity; physician's global assessment of disease activity; participants' assessment of physical function (Health Assessment Questionnaire [HAQ]) and C-reactive protein (CRP).
|
Week 26
|
|
Percentage of Participants Achieving American College of Rheumatology Score 70 Percent (ACR70) Response
時間枠：Week 26
|
ACR70 is achieved if the participant has 70% improvement from Baseline in swollen joint count; tender joint count and in at least 3 of the following 5 assessments: participants' assessment of pain; participants' global assessment of disease activity; physician's global assessment of disease activity; participants' assessment of physical function (Health Assessment Questionnaire [HAQ]) and C-reactive protein (CRP).
|
Week 26
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change From Baseline in Swollen Joints Count at Week 26
時間枠：Baseline and Week 26
|
Number of swollen joints were determined by examination of 28 joints and identifying when swelling is present.
The number of swollen joints was recorded on the joint assessment form at each visit; the swelling was graded on a scale ranging from 0-2 (0=no swelling, 1=swelling, but bony landmarks seen, 2=swelling but bone marks not seen).
Participants categorized as Hepatitis B Virus antigen (HBsAb) positive/negative (at least 1 of HbsAg, HBeAg, Anti-HbeAg and Anti-HbcAg were positive or all were negative).
|
Baseline and Week 26
|
|
Change From Baseline in Tender Joints Count at Week 26
時間枠：Baseline and Week 26
|
Number of tender joints was determined by examination of 28 joints and identifying when tenderness is present.
The number of tender joints was recorded on the joint assessment form at each visit; the tenderness of symptomatic joints was graded on a scale ranging from 0-3 (0=no pain, 1=mild, 2= moderate and 3=severe).
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Baseline and Week 26
|
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Change From Baseline in Participant's Pain Visual Analogue Scale (VAS) Score at Week 26
時間枠：Baseline and Week 26
|
Participant's pain was assessed on VAS of 0 to 100 mm (0=not at all to 100=extreme pain).
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Baseline and Week 26
|
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Change From Baseline in Participants' Global Disease Assessment at Week 26
時間枠：Baseline and Week 26
|
Participants scored the overall disease state using VAS of 0-100 mm.
Participants might have assessed the Control of their current disease using "0 mm=very good" to "100 mm=very poor" scale.
|
Baseline and Week 26
|
|
Change From Baseline in Physicians' Global Disease Assessment at Week 26
時間枠：Baseline and Week 26
|
Physicians scored the overall disease state using VAS of 0-100 mm.
Physicians might have assessed the activity of RA using "0=no active RA" to "100=most serious active RA" scale.
|
Baseline and Week 26
|
|
Change From Baseline in Duration of Morning Stiffness at Week 26
時間枠：Baseline and Week 26
|
Duration of morning stiffness: Time elapsed in minutes when participant woke up in morning and was able to resume normal activities without stiffness.
Increase in stiffness duration from Baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
|
Baseline and Week 26
|
|
Change From Baseline in Health Assessment Questionnaire (HAQ) at Week 26
時間枠：Baseline and Week 26
|
The HAQ, a 20-question instrument, assesses the degree of difficulty a person has in accomplishing tasks in eight functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores).
Responses in each area are scored from 0=no difficulty to 3=inability to perform a task in that area.
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Baseline and Week 26
|
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Change From Baseline in C-Reactive Protein (CRP) at Week 26
時間枠：Baseline and Week 26
|
CRP is a protein found in the blood, the levels of which rise in response to inflammation.
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Baseline and Week 26
|
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Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 26
時間枠：Baseline and Week 26
|
ESR is also called a sedimentation rate or Westergren ESR, is the rate at which red blood cells sediment in a period of 1 hour.
It is a common hematology test, and is a non-specific measure of inflammation.
|
Baseline and Week 26
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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。
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
2007年6月1日
一次修了 (実際)
2008年4月1日
研究の完了 (実際)
2008年4月1日
試験登録日
最初に提出
2009年5月7日
QC基準を満たした最初の提出物
2009年5月7日
最初の投稿 (見積もり)
2009年5月11日
学習記録の更新
投稿された最後の更新 (見積もり)
2013年9月13日
QC基準を満たした最後の更新が送信されました
2013年9月11日
最終確認日
2013年9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。
Infliximabの臨床試験
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Onze Lieve Vrouwe GasthuisSanteonわからない