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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT Number 2005-003977-25 | Other Identifier | EudraCT |
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The aim of the study will be to investigate the effect of certolizumab pegol on the intestinal mucosa in active Crohn's disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CDP870 400 mg | Experimental | Certolizumab pegol (CDP870) 400 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Certolizumab pegol | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Local Non-blinded Assessments | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Achieving Mucosal Healing at Week 10 Using Local Non-blinded Assessments | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bonheiden | Belgium | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24184736 | Derived | Colombel JF, Sandborn WJ, Allez M, Dupas JL, Dewit O, D'Haens G, Bouhnik Y, Parker G, Pierre-Louis B, Hebuterne X. Association between plasma concentrations of certolizumab pegol and endoscopic outcomes of patients with Crohn's disease. Clin Gastroenterol Hepatol. 2014 Mar;12(3):423-31.e1. doi: 10.1016/j.cgh.2013.10.025. Epub 2013 Nov 1. | |
| 22525883 |
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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Patients were recruited in sites from Germany, France and Belgium between February 2006 and October 2007. The last patient attended their Week 54 visit in December 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | CDP870 400 mg | Certolizumab pegol (CDP870) 400 mg administered 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 is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CDP870 400 mg | Certolizumab pegol (CDP870) 400 mg administered 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 is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Note: The 4 patients in the '<=18 years' category were all 18 years of age at Baseline. |
| 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 | Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Local Non-blinded Assessments | 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. | Of the 89 patients in the Intent to Treat Population, 78 patients had data at both Baseline and Week 10, and are included in this summary. Change from Baseline has been calculated as the Week 10 score minus the Baseline score, thus a negative Change from Baseline indicates improvement. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, Week 10 |
|
The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
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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 | CDP870 400 mg | Certolizumab pegol (CDP870) 400 mg administered 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 is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal abscess | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB Clinical Trial Call Center | UCB Pharma | +1 877 822 9493 |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000068582 | Certolizumab Pegol |
| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D007140 | Immunoglobulin Fab Fragments |
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|
|
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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Week 10 |
| Ratio to Baseline of C-Reactive Protein (CRP) Level (mg/L) at 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 | Week 52 |
| Ratio to Baseline of C-Reactive Protein (CRP) Level (mg/L) at 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| Brussels |
| Belgium |
| Edegem | Belgium |
| Leuven | Belgium |
| Amiens | France |
| Besançon | France |
| Chambray-lès-Tours | France |
| Clichy | France |
| Grenoble | France |
| Lille | France |
| Marseille | France |
| Nice | France |
| Paris | France |
| Reims | France |
| Rouen | France |
| Strasbourg | France |
| Vandœuvre-lès-Nancy | France |
| Berlin | Germany |
| Bonn | Germany |
| Hebuterne X, Lemann M, Bouhnik Y, Dewit O, Dupas JL, Mross M, D'Haens G, Mitchev K, Ernault E, Vermeire S, Brixi-Benmansour H, Moreels TG, Mary JY, Marteau P, Colombel JF. Endoscopic improvement of mucosal lesions in patients with moderate to severe ileocolonic Crohn's disease following treatment with certolizumab pegol. Gut. 2013 Feb;62(2):201-8. doi: 10.1136/gutjnl-2012-302262. Epub 2012 Apr 23. |
| Withdrawal by Subject |
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| Other: Incompliance |
|
| Count of Participants |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Secondary | Percentage of Patients Achieving Mucosal Healing at Week 10 Using Local Non-blinded Assessments | Mucosal healing is defined as complete absence of ulceration contribution in the CDEIS (Crohn's Disease Endoscopic Index of Severity) score | Of the 89 patients in the Intent to Treat Population, 78 patients had data at Week 10, and are included in this summary. Percentage of patients is calculated by dividing the number of patients who achieved mucosal healing at Week 10 by the total number of patients with data collected, multiplied by 100. | Posted | Dec 2010 | Number | 95% Confidence Interval | percentage of patients | Week 10 |
|
|
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| Secondary | Percentage of Patients Achieving Mucosal Healing at Week 10 Using Central Blinded Assessments | Mucosal healing is defined as complete absence of ulceration contribution in the CDEIS (Crohn's Disease Endoscopic Index of Severity) score | Of the 89 patients in the Intent to Treat Population, 51 patients were in the subpopulation who had a blinded assessment at Week 10 and are included here. Percentage of patients is calculated by dividing the number of patients who achieved mucosal healing at Week 10 by the total number of patients with data collected, multiplied by 100. | Posted | Dec 2010 | Number | 95% Confidence Interval | percentage of patients | Week 10 |
|
|
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| Secondary | Percentage of Patients Achieving Mucosal Healing at Week 54 Using Local Non-blinded Assessments | Mucosal healing is defined as complete absence of ulceration contribution in the CDEIS (Crohn's Disease Endoscopic Index of Severity) score | Of the 89 patients in the Intent to Treat Population, 53 patients had data at Week 54, and are included in this summary. Percentage of patients is calculated by dividing the number of patients who achieved mucosal healing at Week 54 by the total number of patients with data collected, multiplied by 100. | Posted | Dec 2010 | Number | 95% Confidence Interval | percentage of patients | Week 54 |
|
|
|
| Secondary | Percentage of Patients Achieving Mucosal Healing at Week 54 Using Central Blinded Assessments | Mucosal healing is defined as complete absence of ulceration contribution in the CDEIS (Crohn's Disease Endoscopic Index of Severity) score | Of the 89 patients in the Intent to Treat Population, 33 patients were in the subpopulation who had a blinded assessment at Week 54 and are included here. Percentage of patients is calculated by dividing the number of patients who achieved mucosal healing at Week 54 by the total number of patients with data collected, multiplied by 100. | Posted | Dec 2010 | Number | 95% Confidence Interval | percentage of patients | Week 54 |
|
|
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| Secondary | 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 | 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. | Of the 89 patients in the Intent to Treat Population, 78 patients had data at Week 10 and at Baseline, and are included here. Percentage of patients is calculated by dividing the number of patients with a CDEIS decrease of at least 5 points at Week 10 by the number of patients with CDEIS data at both Baseline and Week 10, multiplied by 100. | Posted | Dec 2010 | Number | 95% Confidence Interval | percentage of patients | Baseline, Week 10 |
|
|
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| Secondary | 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 | 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. | Of the 89 patients in the Intent to Treat Population, 44 patients had a blinded assessment at Week 10 and at Baseline, and are included here. Percentage patients is calculated by dividing the number of patients with a CDEIS decrease of at least 5 points at Week 10 by the number of patients with CDEIS data at Baseline and Week 10, multiplied by 100. | Posted | Dec 2010 | Number | 95% Confidence Interval | percentage of patients | Baseline, Week 10 |
|
|
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| Secondary | 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 | 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. | Of the 89 patients in the Intent to Treat Population, 53 patients had data at Week 54 and at Baseline, and are included here. Percentage of patients is calculated by dividing the number of patients with a CDEIS decrease of at least 5 points at Week 54 by the number of patients with CDEIS data at both Baseline and Week 54, multiplied by 100. | Posted | Dec 2010 | Number | 95% Confidence Interval | percentage of patients | Baseline, Week 54 |
|
|
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| Secondary | 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 | 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. | Of 89 patients in the Intent to Treat Population 28 had matching nonblinded/blinded assessments and are in the subpopulation with blinded assessment at Week 54 and Baseline. Percentage is calculated by dividing the number patients with CDEIS decrease of at least 5 points at Week 54 by the number with CDEIS at Baseline and Week 54, multiplied by 100 | Posted | Dec 2010 | Number | 95% Confidence Interval | percentage of patients | Baseline, Week 54 |
|
|
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| Secondary | 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 | 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. | Of the 89 patients in the Intent to Treat Population, 78 patients had data at Week 10, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score <6 at Week 10 by the total number of patients with CDEIS data at Week 10, multiplied by 100. | Posted | Dec 2010 | Number | 95% Confidence Interval | percentage of patients | Week 10 |
|
|
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| Primary | Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Central Blinded Assessments | 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. | Of the 89 patients in the Intent to Treat Population, 44 patients were in the subpopulation with a blinded assessment at Week 10 and Baseline, and are included in this summary. Change from Baseline has been calculated as the Week 10 score minus the Baseline score, thus a negative Change from Baseline indicates improvement. | Posted | Dec 2010 | Mean | 95% Confidence Interval | Score on a scale | Baseline, Week 10 |
|
|
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| Secondary | Percentage of Patients With Endoscopic Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 10 Using Central Blinded Assessments | 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. | Of the 89 patients in the Intent to Treat Population, 44 patients had a blinded assessment at Week 10 and Baseline, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score <6 at Week 10 by the total number of patients with CDEIS data at Week 10, multiplied by 100. | Posted | Dec 2010 | Number | 95% Confidence Interval | percentage of patients | Week 10 |
|
|
|
| Secondary | 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 | 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. | Of the 89 patients in the Intent to Treat Population, 53 patients had data at Week 54, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score <6 at Week 54 by the total number of patients with CDEIS data at Week 54, multiplied by 100. | Posted | Dec 2010 | Number | 95% Confidence Interval | percentage of patients | Week 54 |
|
|
|
| Secondary | Percentage of Patients With Endoscopic Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 54 Using Central Blinded Assessments | 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. | Of 89 patients in the Intent to Treat Population, 28 had matching nonblinded/blinded assessments and were in the subpopulation with a blinded assessment at Week 54 and Baseline. Percentage is calculated by dividing the number of patients with a CDEIS score <6 at Week 54 by the total number of patients with CDEIS data at Week 54, multiplied by 100. | Posted | Dec 2010 | Number | 95% Confidence Interval | percentage of patients | Week 54 |
|
|
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| Secondary | 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 | 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. | Of the 89 patients in the Intent to Treat Population, 78 patients had data at Week 10, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score <3 at Week 10 by the total number of patients with CDEIS data at Week 10, multiplied by 100. | Posted | Dec 2010 | Number | 95% Confidence Interval | percentage of patients | Week 10 |
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|
| Secondary | 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 | 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. | Of the 89 patients in the Intent to Treat Population, 44 patients had a blinded assessment at Week 10 and Baseline, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score <3 at Week 10 by the total number of patients with CDEIS data at Week 10, multiplied by 100. | Posted | Dec 2010 | Number | 95% Confidence Interval | percentage of patients | Week 10 |
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|
|
| Secondary | 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 | 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. | Of the 89 patients in the Intent to Treat Population, 53 patients had data at Week 54, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score <3 at Week 54 by the total number of patients with CDEIS data at Week 54, multiplied by 100. | Posted | Dec 2010 | Number | 95% Confidence Interval | percentage of patients | Week 54 |
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|
|
| Secondary | 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 | 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. | Of 89 patients in the Intent to Treat Population, 28 had matching nonblinded/blinded assessments and were in the subpopulation with a blinded assessment at Week 54 and Baseline. Percentage is calculated by dividing the number of patients with a CDEIS score <3 at Week 54 by the total number of patients with CDEIS data at Week 54, multiplied by 100. | Posted | Dec 2010 | Number | 95% Confidence Interval | percentage of patients | Week 54 |
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|
| Secondary | Change From Baseline in Histological Crohn's Disease Score at Week 10 Using Central Blinded Assessment | 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. | Of the 89 patients in the Intent to Treat Population, 75 patients had data at Week 10 and at Baseline for the blinded assessment, and are included in this summary. Change from Baseline has been calculated as the Week 10 score minus the Baseline score, thus a negative change from Baseline indicates improvement. | Posted | Dec 2010 | Mean | Standard Deviation | score on a scale | Baseline, Week 10 |
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|
| Secondary | Change From Baseline in Histological Crohn's Disease Score at Week 54 Using Central Blinded Assessment | 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. | Of the 89 patients in the Intent to Treat Population, 52 patients had data at Week 54 and at Baseline for blinded assessment, and are included in this summary. Change from Baseline has been calculated as the Week 54 score minus the Baseline score, thus a negative Change from Baseline indicates improvement. | Posted | Dec 2010 | Mean | Standard Deviation | score on a scale | Baseline, Week 54 |
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| Secondary | 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 | 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. | The 89 patients from Intent to Treat Population are included in this summary. In case of missing CDAI score, patients are counted as non-responders. Percentage is calculated by dividing the number of patients with a CDAI decrease of at least 100 points at Week 10 by the total number of patients in the Intent to Treat Population, multiplied by 100. | Posted | Dec 2010 | Number | 95% Confidence Interval | percentage of patients | Baseline, Week 10 |
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|
| Secondary | 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 | 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. | The 89 patients from Intent to Treat Population are included in this summary. In case of missing CDAI score, patients are counted as non-responders. Percentage is calculated by dividing the number of patients with a CDAI decrease of at least 100 points at Week 54 by the total number of patients in the Intent to Treat Population, multiplied by 100. | Posted | Dec 2010 | Number | 95% Confidence Interval | percentage of patients | Baseline, Week 54 |
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| Secondary | 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 | 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. | The 89 patients from Intent to Treat Population are included in this summary. In case of missing CDAI score, patients are counted as remitters. Percentage is calculated by dividing the number of patients with a CDAI less than or equal to 150 points at Week 10 by the total number of patients in the Intent to Treat Population, multiplied by 100. | Posted | Dec 2010 | Number | 95% Confidence Interval | percentage of patients | Week 10 |
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| Secondary | 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 | 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. | The 89 patients from Intent to Treat Population are included in this summary. In case of missing CDAI score, patients are counted as remitters. Percentage is calculated by dividing the number of patients with a CDAI less than or equal to 150 points at Week 54 by the total number of patients in the Intent to Treat Population, multiplied by 100. | Posted | Dec 2010 | Number | 95% Confidence Interval | percentage of patients | Week 54 |
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| Secondary | Geometric Mean C-Reactive Protein (CRP) Level (mg/L) at Week 10 | Of the 89 patients in the Intent to Treat Population, 76 patients had plasma level data at Week 10 and are included in this summary. | Posted | Dec 2010 | Geometric Mean | Full Range | mg/L | Week 10 |
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| Secondary | Ratio to Baseline of C-Reactive Protein (CRP) Level (mg/L) at Week 10 | Ratio is calculated as the Week 10 value divided by the Baseline value for patients with data at both timepoints. | Of the 89 patients in the Intent to Treat Population, 76 patients had plasma levels taken at Week 10 and Baseline and are included in this summary. Ratio is calculated as the Week 10 value divided by the Baseline value for patients with data at both timepoints. | Posted | Dec 2010 | Geometric Mean | Full Range | ratio | Baseline, Week 10 |
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| Secondary | Geometric Mean C-Reactive Protein (CRP) Level (mg/L) at Week 52 | Of the 89 patients in the Intent to Treat Population, 51 patients had plasma level data at Week 54 and are included in this summary. | Posted | Dec 2010 | Geometric Mean | Full Range | mg/L | Week 52 |
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| Secondary | Ratio to Baseline of C-Reactive Protein (CRP) Level (mg/L) at Week 52 | The ratio is calculated as the Week 52 value divided by Baseline value for patients with data at both timepoints. | Of the 89 patients in the Intent to Treat Population, 51 patients had plasma level data at Week 54 and Baseline and are included in this summary. Ratio was calculated by dividing the Week 54 value by the Baseline value for the patients with data at both timepoints. | Posted | Dec 2010 | Geometric Mean | Full Range | ratio | Baseline, Week 52 |
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| Secondary | Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Crohn's Disease Activity Index (CDAI) Score at 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. | Of the 89 patients in the Intent to Treat Population, 73 patients had plasma level data and a CDAI score at Week 10 and are included in this summary. | Posted | Dec 2010 | Number | 95% Confidence Interval | Pearson Correlation Coefficient | Week 10 |
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|
| Secondary | 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 | 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. | Of the 89 patients in the Intent to Treat Population, 76 patients had plasma level data and a CDEIS score at Week 10 and are included in this summary. | Posted | Dec 2010 | Number | 95% Confidence Interval | Pearson Correlation Coefficient | Week 10 |
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|
| Secondary | 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 | 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. | Of the 89 patients in the Intent to Treat Population, 51 patients were in the subpopulation with a blinded assessment at Week 10. 48 patients had both CDEIS and CRP data at Week 10. | Posted | Dec 2010 | Number | 95% Confidence Interval | Pearson Correlation Coefficient | Week 10 |
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| Secondary | Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Histological Crohn's Disease Score at Week 10 Using Central Blinded Assessment | 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 | Of the 89 patients in the Intent to Treat Population, 72 patients had plasma data and histological Crohn's disease score assessment at Week 10, and are included in this summary. | Posted | Dec 2010 | Number | 95% Confidence Interval | Pearson Correlation Coefficient | Week 10 |
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| Secondary | Change From Baseline in Crohn's Disease Endoscopic Index of Severity (CDEIS) Score at Week 54 Using Local Non-blinded Assessment | 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. | Of the 89 patients in the Intent to Treat Population, 52 had a CDEIS score at Week 54 and at Baseline and are included here. Change from Baseline has been calculated as the Week 54 score minus the Baseline score, thus a negative Change from Baseline indicates improvement. | Posted | Dec 2010 | Mean | Standard Deviation | score on a scale | Baseline, Week 54 |
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|
|
| Secondary | Change From Baseline in Crohn's Disease Endoscopic Index of Severity (CDEIS) Score at Week 54 Using Central Blinded Assessment | 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. | Of 89 patients in the Intent to Treat Population, 28 had matching nonblinded/blinded assessments and were in the subpopulation with a blinded assessment at Week 54 and Baseline. Change from Baseline has been calculated as the Week 54 score minus the Baseline score, thus a negative Change from Baseline indicates improvement. | Posted | Dec 2010 | Mean | Standard Deviation | score on a scale | Baseline, Week 54 |
|
|
|
| Secondary | Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at 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. | Of the 89 patients in the Intent to Treat Population, 73 patients had data at both Baseline and Week 10, and are included in this summary. Change from Baseline has been calculated as the Week 10 score minus the Baseline score, thus a negative Change from Baseline indicates improvement. | Posted | Dec 2010 | Mean | Standard Deviation | score on a scale | Baseline, Week 10 |
|
|
|
| Secondary | Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at 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. | Of the 89 patients in the Intent to Treat Population, 39 had CDAI scores at Week 54 and Baseline and are included in this summary. Change from Baseline has been calculated as the Week 54 score minus the Baseline score, thus a negative Change from Baseline indicates improvement. | Posted | Dec 2010 | Mean | Standard Deviation | score on a scale | Baseline, Week 54 |
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|
|
| 34 |
| 89 |
| 83 |
| 89 |
| Abdominal pain | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Abdominal wall abscess | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| Abdominal wall mass | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Anal abscess | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| Anal fistula | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Clostridial infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| Colitis pseudomembranous | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
|
| Crohn's disease | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Enterocutaneous fistula | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Genital abscess | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| Hyperthermia | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Ileal stenosis | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
|
| Keratorhexis | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
|
| Large intestine perforation | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Perianal abscess | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| Perineal abscess | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| Perineal fistula | Reproductive system and breast disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Pregnancy on oral contraceptive | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
|
| Purpura | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Serum sickness | Immune system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Uterine haemorrhage | Reproductive system and breast disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Anal fissure | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Anal fistula | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Crohn's disease | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Iron deficiency | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| Vitamin B12 deficiency | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
UCB has > 60 days but <= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
| D007410 | Intestinal Diseases |
| D007128 |
| Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |