Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels (GO-LEVEL)
The purpose of this study is to gain insight into the exposure-response relationship of golimumab in moderate-to-severe Ulcerative Colitis (UC).
Patients commencing induction therapy with golimumab will be enrolled into a prospective study and evaluated at three time-points (weeks 6, 10 and 14) for clinical and biochemical UC disease activity as well as serum golimumab concentrations and the presence of anti-golimumab antibodies. Patients already established on stable golimumab maintenance therapy will be enrolled into a cross-sectional study with the same evaluations taken at a single time point.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
The study will involve two study groups designed to offer insights into the pharmacokinetics of golimumab during induction and maintenance therapy:
Cohort 1: Patients commencing golimumab induction therapy will be included in a prospective, observational study.
Cohort 2: Patients receiving golimumab maintenance therapy will be included in a cross-sectional, observational study.
Primary objective: To define a week 6 serum golimumab concentration that predicts response at week 14.
Secondary objective: To define serum golimumab concentrations at weeks 6, 10 and 14 that predict response at each time point, respectively and at week 14.
Exploratory objectives:
Correlations between serum golimumab concentrations and novel disease activity indices (PRO2), biochemical markers of disease activity (CRP, faecal calprotectin) and quality of life indices (IBD-Q and IBD-Control).
Correlations between the presence of anti-golimumab antibodies, serum golimumab concentrations and UC disease activity.
This study will also generate data that can be used to validate a commercially available golimumab assay as well as a novel patient reported outcome (PRO) assessment of clinical UC disease activity.
研究の種類
研究の種類
入学 (実際)
入学
段階
段階
- フェーズ 4
連絡先と場所
研究場所
-
-
-
London、イギリス
- Guy's & St Thomas' NHS Foundation Trust
-
-
参加基準
適格基準
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
Inclusion Criteria for cohort 1:
- Aged 18 years or over
- Moderate-to-severe UC, defined as:
SCCAI > 5 and, i. A raised fecal calprotectin (> 59 μg/g) or, ii. A raised CRP (> 5 mg/L) or, iii. Endoscopic disease activity Mayo 2 or above, Evaluated within 4 weeks of study enrollment
- Commencing golimumab treatment
- Written informed consent to participate
- Sufficient English language skills to understand the patient information sheet and consent form
Inclusion Criteria for cohort 2:
- Aged 18 years or over
- Receiving golimumab treatment for UC for over 18 weeks (6 injections)
- Written informed consent to participate
- Sufficient English language skills to understand the patient information sheet and consent form
Exclusion Criteria (cohort 1 only):
- Contra-indication to golimumab: tuberculosis or severe infections
- Imminent need for colectomy (i.e. colectomy is being planned)
- Previous primary non-response to anti-TNF therapy in the opinion of the investigator
- Previous treatment with more than one anti-TNF therapy (excluding golimumab)
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
- 主な目的：処理
- 割り当て：非ランダム化
- 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 / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
他の：Induction cohort
Golimumab induction therapy
|
A biologic agent which acts by antagonising the effects of tumour necrosis factor (TNF) alpha
他の名前：
|
|
他の：Maintenance cohort
Golimumab maintenance therapy
|
A biologic agent which acts by antagonising the effects of tumour necrosis factor (TNF) alpha
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Serum Golimumab Concentration (μg/ml)
時間枠：Week 6 during induction therapy and at the point of study entry during maintenance
|
Evaluated using an enzyme-linked immunosorbent assay (ELISA)
|
Week 6 during induction therapy and at the point of study entry during maintenance
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Patients in Clinical Remission
時間枠：Week 14 during induction therapy and at the point of study entry during maintenance therapy
|
Evaluated using the Simple Clinical Colitis Activity Index (SCCAI).
Remission defined as SCCAI < 3.
|
Week 14 during induction therapy and at the point of study entry during maintenance therapy
|
|
Faecal Calprotectin (μg/g)
時間枠：Week 14 during induction therapy and at the point of study entry during maintenance
|
Faecal inflammatory marker with higher values suggestive of increasing biochemical disease activity
|
Week 14 during induction therapy and at the point of study entry during maintenance
|
|
Serum C-Reactive Protein (mg/L)
時間枠：Week 14 during induction therapy and at the point of study entry during maintenance
|
Serum inflammatory marker with higher values suggestive of increasing biochemical disease activity
|
Week 14 during induction therapy and at the point of study entry during maintenance
|
|
Serum Albumin (g/L)
時間枠：Week 14 during induction therapy and at the point of study entry during maintenance
|
Serum protein marker with higher values associated with increasing inflammatory activity and lower serum levels of anti-TNF agents (such as golimumab)
|
Week 14 during induction therapy and at the point of study entry during maintenance
|
|
Clinical UC Disease Activity
時間枠：Week 14 during maintenance therapy and at the point of study entry during maintenance
|
Evaluated using Patient Reported Outcome 2 (PRO2).
PRO2 ranges from 0-5 with higher scores denoting increasing clinical disease activity.
|
Week 14 during maintenance therapy and at the point of study entry during maintenance
|
|
Quality of Life (IBD-Control)
時間枠：Week 14 during induction therapy and at the point of study entry during maintenance therapy
|
Evaluated using IBD-Control questionnaires.
IBD-Control scores range from 0-16 with higher scores denoting better quality of life.
|
Week 14 during induction therapy and at the point of study entry during maintenance therapy
|
|
Number of Patients With Detectable Anti-golimumab Antibodies
時間枠：At any study time point during induction therapy (weeks 6, 10 or 14) and at the point if study entry during maintenance
|
Evaluated using a drug-sensitive enzyme-linked immunosorbent assay (ELISA)
|
At any study time point during induction therapy (weeks 6, 10 or 14) and at the point if study entry during maintenance
|
協力者と研究者
協力者
協力者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (実際)
一次修了
研究の完了 (実際)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
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
その他の研究ID番号
- 2017-001374-42
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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