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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Induction cohort | Other | Golimumab induction therapy |
|
| Maintenance cohort | Other | Golimumab maintenance therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Golimumab | Drug | A biologic agent which acts by antagonising the effects of tumour necrosis factor (TNF) alpha |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum Golimumab Concentration (μg/ml) | Evaluated using an enzyme-linked immunosorbent assay (ELISA) | Week 6 during induction therapy and at the point of study entry during maintenance |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients in Clinical Remission | 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) |
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Inclusion Criteria for cohort 1:
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
Inclusion Criteria for cohort 2:
Exclusion Criteria (cohort 1 only):
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guy's & St Thomas' NHS Foundation Trust | London | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32506695 | Derived | Samaan MA, Cunningham G, Tamilarasan AG, Beltran L, Pavlidis P, Ray S, Mawdsley J, Anderson SH, Sanderson JD, Arkir Z, Irving PM. Therapeutic thresholds for golimumab serum concentrations during induction and maintenance therapy in ulcerative colitis: results from the GO-LEVEL study. Aliment Pharmacol Ther. 2020 Jul;52(2):292-302. doi: 10.1111/apt.15808. Epub 2020 Jun 7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Golimumab Induction Therapy | Patients commencing golimumab |
| FG001 | Golimumab Maintenance Therapy | Patients receiving golimumab maintenance therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Golimumab Induction Therapy | Patients commencing golimumab |
| BG001 | Golimumab Maintenance Therapy | Patients receiving golimumab maintenance therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Serum Golimumab Concentration (μg/ml) | Evaluated using an enzyme-linked immunosorbent assay (ELISA) | Posted | Median | Full Range | ug/ml | Week 6 during induction therapy and at the point of study entry during maintenance |
|
|
During the 14 week induction study for patients commencing treatment and at a single time point (the point of recruitment) for patients on maintenance therapy.
Only serious adverse events (including all-cause mortality) were recorded. Non-serious adverse events were not recorded.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Golimumab Induction Therapy | Patients commencing golimumab induction | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Facet join injection | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Mark Samaan | Guy's & St Thomas' Hospital | 07740637713 | mark.samaan@gstt.nhs.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 13, 2019 | Jun 9, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 1, 2017 | May 13, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C529000 | golimumab |
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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) | 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) | 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 | 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) | 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 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Number of Patients in Clinical Remission | Evaluated using the Simple Clinical Colitis Activity Index (SCCAI). Remission defined as SCCAI < 3. | Posted | Count of Participants | Participants | Week 14 during induction therapy and at the point of study entry during maintenance therapy |
|
|
|
| Secondary | Faecal Calprotectin (μg/g) | Faecal inflammatory marker with higher values suggestive of increasing biochemical disease activity | Posted | Median | Full Range | ug/g | Week 14 during induction therapy and at the point of study entry during maintenance |
|
|
|
| Secondary | Serum C-Reactive Protein (mg/L) | Serum inflammatory marker with higher values suggestive of increasing biochemical disease activity | Posted | Median | Full Range | mg/L | Week 14 during induction therapy and at the point of study entry during maintenance |
|
|
|
| Secondary | Serum Albumin (g/L) | Serum protein marker with higher values associated with increasing inflammatory activity and lower serum levels of anti-TNF agents (such as golimumab) | Posted | Median | Full Range | g/L | Week 14 during induction therapy and at the point of study entry during maintenance |
|
|
|
| Secondary | Clinical UC Disease Activity | Evaluated using Patient Reported Outcome 2 (PRO2). PRO2 ranges from 0-5 with higher scores denoting increasing clinical disease activity. | Posted | Median | Full Range | score on a scale | Week 14 during maintenance therapy and at the point of study entry during maintenance |
|
|
|
| Secondary | Quality of Life (IBD-Control) | Evaluated using IBD-Control questionnaires. IBD-Control scores range from 0-16 with higher scores denoting better quality of life. | Posted | Median | Full Range | score on a scale | Week 14 during induction therapy and at the point of study entry during maintenance therapy |
|
|
|
| Secondary | Number of Patients With Detectable Anti-golimumab Antibodies | Evaluated using a drug-sensitive enzyme-linked immunosorbent assay (ELISA) | Posted | Count of Participants | Participants | At any study time point during induction therapy (weeks 6, 10 or 14) and at the point if study entry during maintenance |
|
|
|
| 42 |
| 4 |
| 42 |
| 0 |
| 0 |
| EG001 | Golimumab Maintenance Therapy | Patients receiving golimumab maintenance therapy | 0 | 70 | 0 | 70 | 0 | 0 |
| Pancreatitis | Hepatobiliary disorders | Systematic Assessment | Azathioprine induced pancreatitis |
|
| Ulcerative colitis flare requiring admission | Gastrointestinal disorders | Systematic Assessment |
|
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| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |