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Mucosal Healing Study in Crohn's Disease (CD) (MUSIC)

2011年8月30日更新者：UCB Pharma

A Phase IIIB Multicentre Open Label 54 Weeks Clinical Trial Evaluating Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNFα) on Endoscopic and Mucosal Healing in Patients Suffering From Active Crohn's Disease.

The aim of the study will be to investigate the effect of certolizumab pegol on the intestinal mucosa in active Crohn's disease.

調査の概要

状態

完了

条件

クローン病

介入・治療

生物学的：Certolizumab pegol

研究の種類

介入

入学 (実際)

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
- - Berlin、ドイツ
  - Bonn、ドイツ
フランス
- - Amiens、フランス
  - Besancon、フランス
  - Chambray-Les-Tours、フランス
  - Clichy、フランス
  - Grenoble、フランス
  - Lille、フランス
  - Marseille、フランス
  - Nice、フランス
  - Paris、フランス
  - Reims、フランス
  - Rouen、フランス
  - Strasbourg、フランス
  - Vandoeuvre Les Nancy、フランス
ベルギー
- - Bonheiden、ベルギー
  - Brussels、ベルギー
  - Edegem、ベルギー
  - Leuven、ベルギー

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:

Patients suffering from active Crohn's disease [Crohn's Disease Activity Index(CDAI) ≥ 220 and ≤ 450] and at least 2 segments with endoscopic ulcerative lesions with Baseline Crohn's Disease Endoscopic Index of Severity (CDEIS) ≥ 8
Patients who need to be treated by anti-tumor necrosis factor (anti-TNF) therapy

Exclusion Criteria:

Obstructive intestinal strictures, bowel resection, proctocolectomy or total colectomy, current total parenteral nutrition, short bowel syndrome
History of tuberculosis or positive tests for tuberculosis at screening
All the concomitant diseases or pathological conditions that could interfere with Crohn's disease assessment or to be harmful for the well being of the patient
Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial

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）

アーム数

武器と介入

参加者グループ / アーム	介入・治療
実験的：CDP870 400 mg Certolizumab pegol (CDP870) 400 mg	生物学的：Certolizumab pegol Certolizumab pegol (CDP870) 400 mg administered subcutaneously (sc) at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug end, either Q4W or Q2W, according to their administration frequency at Week 52. 他の名前：シムジア CZP CDP870

参加者グループ / アーム

介入・治療

実験的：CDP870 400 mg

Certolizumab pegol (CDP870) 400 mg

生物学的：Certolizumab pegol

Certolizumab pegol (CDP870) 400 mg administered subcutaneously (sc) at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug end, either Q4W or Q2W, according to their administration frequency at Week 52.

他の名前：

シムジア
CZP
CDP870

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 CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Local Non-blinded Assessments 時間枠：Baseline, Week 10	The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation, thus a negative change from Baseline (i.e., Week 10 score minus Baseline score) indicates improvement.	Baseline, Week 10
Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Central Blinded Assessments 時間枠：Baseline, Week 10	The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation, thus a negative change from Baseline (i.e., Week 10 score minus Baseline score) indicates improvement.	Baseline, Week 10

二次結果の測定

結果測定	メジャーの説明	時間枠
Percentage of Patients Achieving Mucosal Healing at Week 10 Using Local Non-blinded Assessments 時間枠：Week 10	Mucosal healing is defined as complete absence of ulceration contribution in the CDEIS (Crohn's Disease Endoscopic Index of Severity) score	Week 10
Percentage of Patients Achieving Mucosal Healing at Week 10 Using Central Blinded Assessments 時間枠：Week 10	Mucosal healing is defined as complete absence of ulceration contribution in the CDEIS (Crohn's Disease Endoscopic Index of Severity) score	Week 10
Percentage of Patients Achieving Mucosal Healing at Week 54 Using Local Non-blinded Assessments 時間枠：Week 54	Mucosal healing is defined as complete absence of ulceration contribution in the CDEIS (Crohn's Disease Endoscopic Index of Severity) score	Week 54
Percentage of Patients Achieving Mucosal Healing at Week 54 Using Central Blinded Assessments 時間枠：Week 54	Mucosal healing is defined as complete absence of ulceration contribution in the CDEIS (Crohn's Disease Endoscopic Index of Severity) score	Week 54
Percentage of Patients With Endoscopic Response (Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 10 Using Local Non-blinded Assessments 時間枠：Baseline, Week 10	The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.	Baseline, Week 10
Percentage of Patients With Endoscopic Response (Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 10 Using Central Blinded Assessments 時間枠：Baseline, Week 10	The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.	Baseline, Week 10
Percentage of Patients With Endoscopic Response (Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 54 Using Local Non-blinded Assessments 時間枠：Baseline, Week 54	The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.	Baseline, Week 54
Percentage of Patients With Endoscopic Response (Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 54 Using Central Blinded Assessments 時間枠：Baseline, Week 54	The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.	Baseline, Week 54
Percentage of Patients With Endoscopic Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 10 Using Local Non-blinded Assessments 時間枠：Week 10	The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.	Week 10
Percentage of Patients With Endoscopic Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 10 Using Central Blinded Assessments 時間枠：Week 10	The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.	Week 10
Percentage of Patients With Endoscopic Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 54 Using Local Non-blinded Assessments 時間枠：Week 54	The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.	Week 54
Percentage of Patients With Endoscopic Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 54 Using Central Blinded Assessments 時間枠：Week 54	The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.	Week 54
Percentage of Patients With Endoscopic Complete Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 3) at Week 10 Using Local Non-blinded Assessments 時間枠：Week 10	The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.	Week 10
Percentage of Patients With Endoscopic Complete Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 3) at Week 10 Using Central Blinded Assessments 時間枠：Week 10	The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.	Week 10
Percentage of Patients With Endoscopic Complete Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 3) at Week 54 Using Local Non-blinded Assessments 時間枠：Week 54	The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.	Week 54
Percentage of Patients With Endoscopic Complete Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 3) at Week 54 Using Central Blinded Assessments 時間枠：Week 54	The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.	Week 54
Change From Baseline in Histological Crohn's Disease Score at Week 10 Using Central Blinded Assessment 時間枠：Baseline, Week 10	The histological Crohn's disease score combines active inflammatory changes: infiltration of mononuclear cells, polymorphonuclear cells, presence of erosions and/or ulcers, and chronic architectural changes. Scores range from 0 to 44, with higher scores indicating greater disease.	Baseline, Week 10
Change From Baseline in Histological Crohn's Disease Score at Week 54 Using Central Blinded Assessment 時間枠：Baseline, Week 54	The histological Crohn's disease score combines active inflammatory changes: infiltration of mononuclear cells, polymorphonuclear cells, presence of erosions and/or ulcers, and chronic architectural changes. Scores range from 0 to 44, with higher scores indicating greater disease.	Baseline, Week 54
Percentage of Patients Achieving Crohn's Disease Activity Index (CDAI) Response (Defined as a Decrease of at Least 100 Points in CDAI Score From Baseline) at Week 10 時間枠：Baseline, Week 10	Crohn's disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.	Baseline, Week 10
Percentage of Patients Achieving Crohn's Disease Activity Index (CDAI) Response (Defined as a Decrease of at Least 100 Points in CDAI Score From Baseline) at Week 54 時間枠：Baseline, Week 54	Crohn's disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.	Baseline, Week 54
Percentage of Patients Achieving Crohn's Disease Activity Index (CDAI) Remission (Defined as a CDAI Score Less Than or Equal to 150) at Week 10 時間枠：Week 10	Crohn's disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.	Week 10
Percentage of Patients Achieving Crohn's Disease Activity Index (CDAI) Remission (Defined as a CDAI Score Less Than or Equal to 150) at Week 54 時間枠：Week 54	Crohn's disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.	Week 54
Geometric Mean C-Reactive Protein (CRP) Level (mg/L) at Week 10 時間枠：Week 10		Week 10
Ratio to Baseline of C-Reactive Protein (CRP) Level (mg/L) at Week 10 時間枠：Baseline, Week 10	Ratio is calculated as the Week 10 value divided by the Baseline value for patients with data at both timepoints.	Baseline, Week 10
Geometric Mean C-Reactive Protein (CRP) Level (mg/L) at Week 52 時間枠：Week 52		Week 52
Ratio to Baseline of C-Reactive Protein (CRP) Level (mg/L) at Week 52 時間枠：Baseline, Week 52	The ratio is calculated as the Week 52 value divided by Baseline value for patients with data at both timepoints.	Baseline, Week 52
Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Crohn's Disease Activity Index (CDAI) Score at Week 10 時間枠：Week 10	Crohn's disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.	Week 10
Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Crohn's Disease Endoscopic Index of Severity (CDEIS) Score at Week 10 Using Local Non-blinded Assessment 時間枠：Week 10	The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.	Week 10
Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Crohn's Disease Endoscopic Index of Severity (CDEIS) Score at Week 10 Using Central Blinded Assessment 時間枠：Week 10	The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.	Week 10
Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Histological Crohn's Disease Score at Week 10 Using Central Blinded Assessment 時間枠：Week 10	The histological Crohn's disease score combines active inflammatory changes: infiltration of mononuclear cells, polymorphonuclear cells, presence of erosions and/or ulcers, and chronic architectural changes. Scores range from 0 to 44, with higher scores indicating greater disease	Week 10
Change From Baseline in Crohn's Disease Endoscopic Index of Severity (CDEIS) Score at Week 54 Using Local Non-blinded Assessment 時間枠：Baseline, Week 54	The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.	Baseline, Week 54
Change From Baseline in Crohn's Disease Endoscopic Index of Severity (CDEIS) Score at Week 54 Using Central Blinded Assessment 時間枠：Baseline, Week 54	The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.	Baseline, Week 54
Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 10 時間枠：Baseline, Week 10	Crohn's disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.	Baseline, Week 10
Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 54 時間枠：Baseline, Week 54	Crohn's disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.	Baseline, Week 54

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

UCB Pharma

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

便利なリンク

FDA Safety Alerts and Recalls

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2月1日

一次修了 (実際)

2008年1月1日

研究の完了 (実際)

2009年12月1日

試験登録日

最初に提出

2006年2月27日

QC基準を満たした最初の提出物

2006年2月27日

最初の投稿 (見積もり)

2006年2月28日

学習記録の更新

投稿された最後の更新 (見積もり)

2011年8月31日

QC基準を満たした最後の更新が送信されました

2011年8月30日

最終確認日

2011年2月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

C87043
EudraCT Number 2005-003977-25 (その他の識別子：EudraCT)

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。

クローン病の臨床試験

Adelphi Values LLC
Blueprint Medicines Corporation

完了

全身性肥満細胞症の患者報告アウトカムアンケート

肥満細胞性白血病 (MCL) | 攻撃的な全身性肥満細胞症 (ASM) | SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD) | くすぶり全身性肥満細胞症 (SSM) | 無痛性全身性肥満細胞症 (ISM) ISM サブグループが完全に募集されました

アメリカ

Certolizumab pegolの臨床試験

University of Maryland, Baltimore

積極的、募集していない

2157GCCC:新規 Dx AML における Calaspargase Pegol-mknl w/シタラビンおよびイダルビシンの第 1 相

急性骨髄性白血病

アメリカ
Baxalta now part of Shire

積極的、募集していない

血友病Aの参加者におけるADYNOVI / ADYNOVATEの長期研究

血友病A

スペイン, タイ, ハンガリー, 台湾, 大韓民国, チェコ, ドイツ, スウェーデン, イタリア, クロアチア, アメリカ, ブルガリア, オランダ
Bayer

完了

重度の血友病 A (血液凝固第 VIII 因子の欠乏に起因する出血性疾患) の患者における薬物ジビ (BAY 94-9027) とアディノビの体の分布と排泄方法を比較する研究

血友病A

ブルガリア
TME Pharma AG
Merck Sharp & Dohme LLC

完了

結腸直腸癌および膵臓癌における Olaptesed (NOX-A12) 単独およびペムブロリズマブとの併用 (Keynote-559)

転移性結腸直腸がん | 転移性膵臓がん

ドイツ
Bayer

募集

血友病 A 患者の予防レジメン (PREDICT)

血友病A | 出血の予防

アメリカ
OHSU Knight Cancer Institute
Genentech, Inc.; Oregon Health and Science University; Servier Pharmaceuticals, LLC

募集

局所進行性または転移性膵臓癌の治療のためのカラスパルガーゼ Pegol-Mnkl およびコビメチニブ

ステージ II 膵臓がん AJCC v8 | ステージ III 膵臓がん AJCC v8 | ステージ IV 膵臓がん AJCC v8 | 転移性膵臓腺癌 | 局所進行膵腺癌 | ステージ IIA 膵臓がん AJCC v8 | ステージ IIB 膵臓がん AJCC v8

アメリカ
Children's Oncology Group

募集

白血病またはリンパ腫の化学療法から肝臓を保護するためのレボカルニチン

リンパ芽球性リンパ腫 | B 急性リンパ芽球性白血病 | B t(9;22)(q34.1;q11.2)を伴う急性リンパ芽球性白血病; BCR-ABL1 | T 急性リンパ芽球性白血病 | 混合型急性白血病 | B 急性リンパ芽球性白血病、BCR-ABL1 様

アメリカ, カナダ
Children's Oncology Group
National Cancer Institute (NCI)

募集

Bリンパ芽球性リンパ腫または再発または難治性CD22陽性のB型急性リンパ芽球性白血病の若年患者の治療におけるイノツズマブオゾガマイシン

再発B型急性リンパ芽球性白血病 | 難治性 B 急性リンパ芽球性白血病 | 再発 B リンパ芽球性リンパ腫 | 難治性 B リンパ芽球性リンパ腫

アメリカ, プエルトリコ
Children's Oncology Group

募集

再発または難治性白血病と診断された患者に対する化学療法と組み合わせたレブメニブの研究

再発性急性リンパ芽球性白血病 | 難治性急性リンパ芽球性白血病 | 再発混合表現型急性白血病 | 難治性混合表現型急性白血病 | 血統不明の難治性急性白血病 | 血統不明再発急性白血病 | 系統不明の急性白血病からの系統転換による再発性急性骨髄性白血病 | B型急性リンパ芽球性白血病、KMT2A再構成からの系統転換による再発性急性骨髄性白血病 | 混合表現型急性白血病からの系統転換による再発性急性骨髄性白血病 | 系統不明の急性白血病からの系統転換による難治性急性骨髄性白血病 | B型急性リンパ芽球性白血病、KMT2A再構成からの系統転換による難治性急性骨髄性白血病 | 混合表現型急性白血病からの系統転換による難治性急性骨髄性白血病

アメリカ
Children's Oncology Group
National Cancer Institute (NCI)

完了

新たに高リスク急性リンパ芽球性白血病と診断された若年患者の治療におけるカラスパルガーゼペゴールまたはペガスパルガーゼと併用化学療法

急性リンパ芽球性白血病 | 成人B型急性リンパ芽球性白血病 | 小児B 急性リンパ芽球性白血病

アメリカ

Mucosal Healing Study in Crohn's Disease (CD) (MUSIC)

A Phase IIIB Multicentre Open Label 54 Weeks Clinical Trial Evaluating Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNFα) on Endoscopic and Mucosal Healing in Patients Suffering From Active Crohn's Disease.

調査の概要

状態

条件

介入・治療

研究の種類

入学 (実際)

段階

連絡先と場所

研究場所

参加基準

適格基準

就学可能な年齢

健康ボランティアの受け入れ

受講資格のある性別

説明

研究計画

研究はどのように設計されていますか？

デザインの詳細

アーム数

武器と介入

参加者グループ / アーム

介入・治療

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

二次結果の測定

結果測定

メジャーの説明

時間枠

協力者と研究者

スポンサー

出版物と役立つリンク

一般刊行物

便利なリンク

研究記録日

主要日程の研究

研究開始

一次修了 (実際)

研究の完了 (実際)

試験登録日

最初に提出

QC基準を満たした最初の提出物

最初の投稿 (見積もり)

学習記録の更新

投稿された最後の更新 (見積もり)

QC基準を満たした最後の更新が送信されました

最終確認日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

クローン病の臨床試験

Certolizumab pegolの臨床試験

類似の治験を検索

スポンサーと協力者

医学的状態

薬物療法

CROs by country

CROs in Norway

条件

まれな病気

薬物療法

ダイエットサプリメント

スポンサー/協力者

場所