Atacicept in Combination With Rituximab in Subjects With Rheumatoid Arthritis (August III) (August III)
2016年11月4日 更新者：Merck KGaA, Darmstadt, Germany
A Randomized, Double-blind, Placebo Controlled, Multi-centre, Exploratory, Pilot, Phase II Trial of 150mg Atacicept Given Subcutaneously in Combination With Rituximab in Subjects With Rheumatoid Arthritis.
The primary objective of this study is to assess the safety and tolerability of combined treatment with atacicept and rituximab in subjects with active rheumatoid arthritis (RA) receiving re-treatment with rituximab.
調査の概要
研究の種類
介入
入学 (実際)
27
段階
- フェーズ2
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。
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:
- Male and female subjects
- Greater than and equal to (>=) 18 years of age at the time of Informed Consent
- Who have rheumatoid arthritis satisfying American College of Rheumatology (ACR) criteria with a disease history of at least 12 months
- Subjects must have active disease defined by DAS28 >3.2
- Subjects must have received previous treatment with rituximab and must be candidates for re-treatment with rituximab
- Female subjects of childbearing potential must be willing to avoid pregnancy by using an adequate method of contraception for 4 weeks before study day 1 (SD1), during the treatment period and for 12 months after the last dose of rituximab, and must have a negative urine pregnancy test at the screening visit and SD1
- Other protocol defined inclusion criteria could apply
Exclusion Criteria:
- Current neurological disease excluding migraine
- Inflammatory joint disease other than rheumatoid arthritis
- Any contraindication to rituximab as per national label
- Use of disease-modifying anti-rheumatic drugs (DMARDs; including methotrexate) for less than 3 months or change in dosing regimen within 28 days before SD1, or methotrexate dose regimen >25 mg/week
- Participation in any interventional clinical trial within 1 month before SD1 (or within 5 half-lives of the investigated compound before SD1, whichever is longer)
- Prednisone dose regimen >10 mg/day (or equivalent), or change in steroid dosing regimen within 28 days before SD1
- Active or latent tuberculosis within the year before screening or major infection requiring hospitalization or intravenous anti-infectives within 28 days before SD1
- Serum Immunoglobulin G (IgG) below 6 gram per liter (g/L)
- Known hypersensitivity to atacicept or to any of the components of the formulated atacicpet
- Known hypersensitivity to rituximab, to any of the components of the formulated rituximab or to murine proteins
- Breastfeeding or pregnancy
- Other protocol defined exclusion criteria could apply
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：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Rituximab Plus Atacicept
Rituximab will be administered as an intravenous infusion at a dose of 1000 mg at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
|
Rituximab will be administered as an intravenous infusion at a dose of 1000 mg at Weeks 1 and 3.
Atacicept will be administered at a dose of 150 mg subcutaneously once a week from Week 7 to 32.
|
|
プラセボコンパレーター：Rituximab Plus Placebo
Rituximab will be administered as an intravenous infusion at a dose of 1000 mg at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
|
Rituximab will be administered as an intravenous infusion at a dose of 1000 mg at Weeks 1 and 3.
Placebo matched to atacicept will be administered subcutaneously once a week from Week 7 to 32.
|
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 |
|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
時間枠：Baseline up to Week 64
|
An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship.
An SAE was defined as an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
Baseline up to Week 64
|
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Percentage of Participants With Immunoglobulin G (IgG) Level Less Than 3 Gram Per Liter (g/L)
時間枠：Week 64
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Week 64
|
|
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Percent Change From Baseline in Vital Signs and Routine Safety Lab Parameters at Week 32
時間枠：Baseline, Week 32
|
Vital signs assessed included blood pressure (systolic and diastolic), pulse and body temperature.
Routine safety lab parameters evaluated included red blood cell (RBC), hemoglobin, hematocrit, platelets, mean cellular hemoglobin (MCH), MCH concentration, MCH volume, white blood cell (WBC), lymphocytes, monocytes, eosinophils, basophils, neutrophils, gamma glutamyl transferase (GGT), alanine aminotransferase (ALT), albumin, alkaline phosphatase (AP), aspartate aminotransferase (AST), bilirubin, calcium, creatinine, glucose, potassium, total protein, sodium, uric acid, and blood urea nitrogen.
Percent change from baseline was calculated as ([Week 32 value minus baseline value] multiplied by 100) divided by baseline value.
|
Baseline, Week 32
|
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Percent Change From Baseline in Anti-tetanus and Anti-diphteria Immunization Titer at Week 32
時間枠：Baseline, Week 32
|
Percent change from baseline was calculated as ([Week 32 value minus baseline value] multiplied by 100) divided by baseline value.
|
Baseline, Week 32
|
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Percent Change From Baseline in Anti-pneumococcus Titer at Week 32
時間枠：Baseline, Week 32
|
Percent change from baseline was calculated as ([Week 32 value minus baseline value] multiplied by 100) divided by baseline value.
|
Baseline, Week 32
|
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 American College of Rheumatology 20 Response Based on C-reactive Protein (ACR20-CRP), ACR50-CRP and ACR70-CRP at Week 32
時間枠：Week 32
|
ACR20-CRP response: greater than or equal to (>=) 20 percent (%) improvement in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with >=20% improvement in at least 3 of the following: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) acute-phase marker (CRP).
ACR50-CRP and ACR70-CRP response are defined as >=50% and >=70% improvement in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) respectively together with >=50% and >=70% improvement in at least 3 of the following respectively: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) CRP.
|
Week 32
|
|
Change From Baseline in Disease Activity Score in 28 Joints (DAS28) Based on CRP (DAS28-CRP) at Week 32
時間枠：Baseline, Week 32
|
DAS28-CRP incorporates non-graded joint counts for tenderness and swelling based on a total of 28 joints, CRP as a marker of inflammation, and a general health assessment using a 100 mm visual analog scale (the participant's global assessment of disease activity).
DAS28 score ranges between 0 and 10 representing current disease activity.
A value above 5.1 represents high disease activity, a value below 3.2 represents low disease activity, and a value below 2.6 represents remission.
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Baseline, Week 32
|
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Median Percentage Change From Baseline in Levels of Total, Mature and Memory B Cells
時間枠：Baseline, Week 3, 7, 12, 16, 26 and 32
|
Flow cytometric analysis of lymphocyte populations using four-color fluorescence-activated cell sorting was performed for the analysis of total, mature and memory B cell levels.
|
Baseline, Week 3, 7, 12, 16, 26 and 32
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出版物と役立つリンク
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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
2008年3月1日
一次修了 (実際)
2010年10月1日
研究の完了 (実際)
2010年10月1日
試験登録日
最初に提出
2008年4月21日
QC基準を満たした最初の提出物
2008年4月22日
最初の投稿 (見積もり)
2008年4月23日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年12月30日
QC基準を満たした最後の更新が送信されました
2016年11月4日
最終確認日
2016年11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。
Rituximabの臨床試験
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