Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2005-002623-13 | EudraCT Number |
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A follow-on safety study in subjects with Crohn's Disease who have previously been withdrawn from the double-blind study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] due to an exacerbation of Crohn's Disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Certolizumab Pegol | Experimental | 3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Certolizumab Pegol (CDP870) | Biological | Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360. Up to 84 months of therapy in this study. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of This Study CDP870-034 (up to 84 Months) | An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. | Up to 84 months from Study Entry (Week 0) to the Study End (Week 362 ) and the Safety Follow-up (Week 372) |
| Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of This Study CDP870-034 (up to 84 Months) | An SAE is defined as any untoward medical occurrence that occurs at any dose which results in death, is life threatening requires hospitalization, results in persistent/significant disability/incapacity, is an infection that requires parenteral antibiotics, is a congenital anomaly/birth defect, or is an important medical event. | Up to 84 months from Study Entry (Week 0) to the Study End (Week 362 ) and the Safety Follow-up (Week 372) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit or (Early) Withdrawal Visit | HBI remission is defined as total HBI score of 4 points or less. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day. |
Not provided
Inclusion Criteria:
Participation in either of the CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] clinical studies in which the subject completed the Week 2 assessment in CDP870-031 [NCT00152490] or the Week 6 randomization in CDP870-032 [NCT00152425] but whose Crohn's Disease was significantly worse as determined by the investigator and whose Clinical Disease Activity Index (CDAI) score at entry to this study is either (subjects may have received active or placebo treatment):
Subjects must be able to understand the information provided to them and give written informed consent
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 |
|---|---|---|---|---|---|---|
| 45102 | Birmingham | Alabama | United States | |||
| 45028 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20363366 | Result | Sandborn WJ, Schreiber S, Hanauer SB, Colombel JF, Bloomfield R, Lichtenstein GR; PRECiSE 4 Study Investigators. Reinduction with certolizumab pegol in patients with relapsed Crohn's disease: results from the PRECiSE 4 Study. Clin Gastroenterol Hepatol. 2010 Aug;8(8):696-702.e1. doi: 10.1016/j.cgh.2010.03.024. Epub 2010 Apr 2. |
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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Subjects who withdrew from feeder studies for worsening of Crohn's Disease entered study C87034. Subjects in study C87031 were eligible for entry into C87034 at any time after completing the Week 2 assessment, subjects in study C87032 at any time after completing the Week 6 randomisation.
This multicenter study started to enroll subjects in February 2004 in order to end up with 141 centers in 24 countries with enrolled subjects.
Participant Flow refers to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Certolizumab Pegol | 3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360. Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360. Up to 84 months of therapy in this study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
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|
| Study Completion Visit (Week 362) / (Early) Withdrawal Visit |
| Percentage of Subjects in Harvey Bradshaw Index (HBI) Response (HBI Change ≥ 3) at Study Completion Visit or (Early) Withdrawal Visit From Week 0 of Feeder Study CDP870-031 or CDP870-032 | Response is defined as decrease in total Harvey Bradshaw Index (HBI) score of 3 or more points. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day. | From Baseline of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to Study Completion Visit (Week 362) or (Early) Withdrawal Visit of this study (up to 90 months) |
| Percentage of Subjects in Harvey Bradshaw Index (HBI) Response (HBI Change ≥ 3) at Study Completion Visit or (Early) Withdrawal Visit From Week 0 of CDP870-034 | Response is defined as decrease in total Harvey Bradshaw Index (HBI) score of 3 or more points. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day. | From Week 0 of study CDP870-034 to Study Completion Visit (Week 362) or (Early) Withdrawal Visit (up to 84 months) |
| Plasma Concentration of Certolizumab Pegol at Study Completion Visit or (Early) Withdrawal Visit | Plasma Samples for determination of Certolizumab Pegol were taken prior to Certolizumab Pegol administration. | Study Completion Visit (Week 362) / (Early) Withdrawal Visit |
| Percentage of Subjects With Positive Anti-CZP Anti-body Status at Any Time From Week 0 of the Feeder Studies CDP870-031 or CDP870-032 to the Study Completion Visit in CDP870-034 | Subjects are counted as antibody positive to Certolizumab Pegol if they have at least one positive result from Week 0 in one of the previous studies CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to the last Visit in this study. A positive result is defined as Anti-CZP antibody levels > 2.4 units/mL. | From Week 0 of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] up to Study Completion Visit (Week 362) of CDP870-034 (up to 90 months) |
| C-Reactive Protein (CRP) Level at Study Completion Visit or (Early) Withdrawal Visit | Study Completion Visit (Week 362) / (Early) Withdrawal Visit |
| Fecal Calprotectin Level at Week 256 or (Early) Withdrawal Visit, if it is Earlier Than Week 256 | Week 256 / (Early) Withdrawal Visit, if it is earlier than Week 256 |
| Huntsville |
| Alabama |
| United States |
| 45044 | Little Rock | Arkansas | United States |
| 45095 | Orange | California | United States |
| 45101 | San Francisco | California | United States |
| 45130 | Colorado Springs | Colorado | United States |
| 45094 | Gainesville | Florida | United States |
| 45005 | Hialeah | Florida | United States |
| 45087 | Miami | Florida | United States |
| 45004 | North Miami Beach | Florida | United States |
| 45016 | Chicago | Illinois | United States |
| 45037 | Indianapolis | Indiana | United States |
| 45019 | Lexington | Kentucky | United States |
| 45033 | Chevy Chase | Maryland | United States |
| 45013 | Laurel | Maryland | United States |
| 45083 | Rochester | Minnesota | United States |
| 45108 | Jefferson City | Missouri | United States |
| 45035 | Berlin | New Jersey | United States |
| 45009 | Great Neck | New York | United States |
| 45070 | New York | New York | United States |
| 45145 | Greenville | North Carolina | United States |
| 45067 | High Point | North Carolina | United States |
| 45003 | Raleigh | North Carolina | United States |
| 45040 | Winston-Salem | North Carolina | United States |
| 45081 | Cincinnati | Ohio | United States |
| 45091 | Cincinnati | Ohio | United States |
| 45054 | Dayton | Ohio | United States |
| 45025 | Mayfield Heights | Ohio | United States |
| 45039 | Oklahoma City | Oklahoma | United States |
| 45041 | Tulsa | Oklahoma | United States |
| 45093 | Hershey | Pennsylvania | United States |
| 45113 | Germantown | Tennessee | United States |
| 45119 | Nashville | Tennessee | United States |
| 45022 | Houston | Texas | United States |
| 45073 | San Antonio | Texas | United States |
| 45139 | Salt Lake City | Utah | United States |
| 45052 | South Ogden | Utah | United States |
| 45134 | Charlottesville | Virginia | United States |
| 45078 | Christiansburg | Virginia | United States |
| 45109 | Norfolk | Virginia | United States |
| 45141 | Seattle | Washington | United States |
| 11011 | Bankstown | New South Wales | Australia |
| 11005 | New Lambton | New South Wales | Australia |
| 11017 | Herston | Queensland | Australia |
| 11006 | South Brisbane | Queensland | Australia |
| 11014 | Lauceston | Tasmania | Australia |
| 11016 | Ballarat | Victoria | Australia |
| 11007 | Box Hill | Victoria | Australia |
| 11002 | Fitzroy | Victoria | Australia |
| 11013 | Frankston | Victoria | Australia |
| 11012 | Parkville | Victoria | Australia |
| 11009 | Adelaide | Australia |
| 11010 | Fremantle | Australia |
| 11015 | Garran | Australia |
| 11018 | Newtown | Australia |
| 46006 | Linz | Austria |
| 46003 | Salzburg | Austria |
| 46002 | Vienna | Austria |
| 12001 | Minsk | Belarus |
| 13004 | Brussels | Belgium |
| 13001 | Ghent | Belgium |
| 13003 | Leuven | Belgium |
| 15001 | Sofia | Bulgaria |
| 16005 | Winnipeg | Manitoba | Canada |
| 16014 | Halifax | Nova Scotia | Canada |
| 16013 | Toronto | Ontario | Canada |
| 16008 | Montreal | Quebec | Canada |
| 18006 | Hradek Kralove | Czechia |
| 18001 | Ostrava | Czechia |
| 18002 | Prague | Czechia |
| 18004 | Prague | Czechia |
| 19004 | Aalborg | Denmark |
| 19009 | Copenhagen | Denmark |
| 19010 | Herlev | Denmark |
| 19007 | Hvidovre | Denmark |
| 19003 | Vejle | Denmark |
| 20001 | Tallinn | Estonia |
| 20002 | Tartu | Estonia |
| 22002 | Berlin | Germany |
| 22009 | Berlin | Germany |
| 22004 | Celle | Germany |
| 22019 | Frankfurt | Germany |
| 22013 | Göttingen | Germany |
| 22017 | Hanover | Germany |
| 22015 | Kiel | Germany |
| 22016 | Leipzig | Germany |
| 22001 | Minden | Germany |
| 22012 | Munich | Germany |
| 22008 | Münster | Germany |
| 24002 | Budapest | Hungary |
| 24009 | Pécs | Hungary |
| 24011 | Szekszárd | Hungary |
| 26004 | Beersheba | Israel |
| 26007 | Haifa | Israel |
| 26005 | Petha Tikva | Israel |
| 27001 | Milan | Italy |
| 27004 | Palermo | Italy |
| 27007 | Roma | Italy |
| 31002 | Auckland | New Zealand |
| 31001 | Christchurch | New Zealand |
| 31005 | Hamilton | New Zealand |
| 31004 | Milford | New Zealand |
| 31003 | Tauranga | New Zealand |
| 32005 | Oslo | Norway |
| 32008 | Oslo | Norway |
| 32004 | Tromsø | Norway |
| 33008 | Bydgoszcz | Poland |
| 33003 | Gdansk | Poland |
| 33018 | Lublin | Poland |
| 33013 | Szczecin | Poland |
| 33007 | Warsaw | Poland |
| 33009 | Warsaw | Poland |
| 34017 | Lipetsk | Russia |
| 34006 | Moscow | Russia |
| 34016 | Nizhny Novgorod | Russia |
| 34001 | Saint Petersburg | Russia |
| 34005 | Saint Petersburg | Russia |
| 34007 | Saint Petersburg | Russia |
| 34013 | Saint Petersburg | Russia |
| 35001 | Belgrade | Serbia |
| 35002 | Belgrade | Serbia |
| 35004 | Belgrade | Serbia |
| 36002 | Singapore | Singapore |
| 38001 | Celje | Slovenia |
| 38003 | Ljubljana | Slovenia |
| 39013 | Johannesburg | Gauteng | South Africa |
| 39003 | Cape Town | Somerset West | South Africa |
| 39016 | Cape Town | South Africa |
| 39018 | Cape Town | South Africa |
| 39012 | Goodwood | South Africa |
| 39010 | Johannesburg | South Africa |
| 39008 | Midrand | South Africa |
| 39004 | Port Elizabeth | South Africa |
| 39006 | Pretoria | South Africa |
| 39009 | Pretoria | South Africa |
| 39014 | Pretoria | South Africa |
| 39019 | Pretoria | South Africa |
| 40009 | Barcelona | Spain |
| 43008 | Dniepropetrovsk | Ukraine |
| 43003 | Lviv | Ukraine |
| 43006 | Odesa | Ukraine |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline Characteristics refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Certolizumab Pegol | 3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360. Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360. Up to 84 months of therapy in this study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of This Study CDP870-034 (up to 84 Months) | An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. | All 310 subjects in the Safety Population are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425]. | Posted | Number | percentage of subjects | Up to 84 months from Study Entry (Week 0) to the Study End (Week 362 ) and the Safety Follow-up (Week 372) |
|
|
| ||||||||||||||||||||||||||
| Primary | Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of This Study CDP870-034 (up to 84 Months) | An SAE is defined as any untoward medical occurrence that occurs at any dose which results in death, is life threatening requires hospitalization, results in persistent/significant disability/incapacity, is an infection that requires parenteral antibiotics, is a congenital anomaly/birth defect, or is an important medical event. | All 310 subjects in the Safety Population are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425]. | Posted | Number | percentage of subjects | Up to 84 months from Study Entry (Week 0) to the Study End (Week 362 ) and the Safety Follow-up (Week 372) |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit or (Early) Withdrawal Visit | HBI remission is defined as total HBI score of 4 points or less. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day. | All 309 subjects in the Intention-To-Treat (ITT) Population are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study. | Posted | Number | 95% Confidence Interval | percentage of subjects | Study Completion Visit (Week 362) / (Early) Withdrawal Visit |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Subjects in Harvey Bradshaw Index (HBI) Response (HBI Change ≥ 3) at Study Completion Visit or (Early) Withdrawal Visit From Week 0 of Feeder Study CDP870-031 or CDP870-032 | Response is defined as decrease in total Harvey Bradshaw Index (HBI) score of 3 or more points. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day. | Of the 309 subjects in the Intention-To-Treat (ITT) Population, 307 subjects are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study. | Posted | Number | 95% Confidence Interval | percentage of subjects | From Baseline of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to Study Completion Visit (Week 362) or (Early) Withdrawal Visit of this study (up to 90 months) |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Subjects in Harvey Bradshaw Index (HBI) Response (HBI Change ≥ 3) at Study Completion Visit or (Early) Withdrawal Visit From Week 0 of CDP870-034 | Response is defined as decrease in total Harvey Bradshaw Index (HBI) score of 3 or more points. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day. | Of the 309 subjects in the Intention-To-Treat (ITT) Population, 299 subjects are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study. | Posted | Number | 95% Confidence Interval | percentage of subjects | From Week 0 of study CDP870-034 to Study Completion Visit (Week 362) or (Early) Withdrawal Visit (up to 84 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Plasma Concentration of Certolizumab Pegol at Study Completion Visit or (Early) Withdrawal Visit | Plasma Samples for determination of Certolizumab Pegol were taken prior to Certolizumab Pegol administration. | Of the 310 subjects in the Safety Population, 307 subjects are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425]. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | Study Completion Visit (Week 362) / (Early) Withdrawal Visit |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With Positive Anti-CZP Anti-body Status at Any Time From Week 0 of the Feeder Studies CDP870-031 or CDP870-032 to the Study Completion Visit in CDP870-034 | Subjects are counted as antibody positive to Certolizumab Pegol if they have at least one positive result from Week 0 in one of the previous studies CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to the last Visit in this study. A positive result is defined as Anti-CZP antibody levels > 2.4 units/mL. | Of the 310 subjects in the Safety Population, 309 subjects are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425]. | Posted | Number | percentage of subjects | From Week 0 of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] up to Study Completion Visit (Week 362) of CDP870-034 (up to 90 months) |
|
| |||||||||||||||||||||||||||
| Secondary | C-Reactive Protein (CRP) Level at Study Completion Visit or (Early) Withdrawal Visit | All 309 subjects in the Intention-To-Treat (ITT) Population are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study. | Posted | Geometric Mean | 95% Confidence Interval | mg/L | Study Completion Visit (Week 362) / (Early) Withdrawal Visit |
|
| |||||||||||||||||||||||||||
| Secondary | Fecal Calprotectin Level at Week 256 or (Early) Withdrawal Visit, if it is Earlier Than Week 256 | Of the 309 subjects in the Intention-To-Treat (ITT) Population, 280 subjects are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study. | Posted | Geometric Mean | 95% Confidence Interval | µg/g stool | Week 256 / (Early) Withdrawal Visit, if it is earlier than Week 256 |
|
|
Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 372).
Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Certolizumab Pegol | 3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360. Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360. Up to 84 months of therapy in this study. | 138 | 310 | 248 | 310 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Secondary anaemia | Blood and lymphatic system disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Pigmented naevus | Congenital, familial and genetic disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Optic neuritis | Eye disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Colonic stenosis | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Ileal stenosis | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Perirectal abscess | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Abdominal hernia obstructive | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Anal discomfort | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Duodenitis | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Enterovesical fistula | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Gastroduodenitis | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Gastrointestinal irritation | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Intestinal fistula | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Jejunal perforation | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Mechanical ileus | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Oesophageal ulcer | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Peritonitis | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Rectal stenosis | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Rectovaginal fistula | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Small intestinal stricture | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Hepatitis toxic | Hepatobiliary disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Perianal abscess | Infections and infestations | MedDRA 6.1 | Non-systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA 6.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 6.1 | Non-systematic Assessment |
| |
| Abscess intestinal | Infections and infestations | MedDRA 6.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 6.1 | Non-systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 6.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 6.1 | Non-systematic Assessment |
| |
| Anal fistula infection | Infections and infestations | MedDRA 6.1 | Non-systematic Assessment |
| |
| Appendiceal abscess | Infections and infestations | MedDRA 6.1 | Non-systematic Assessment |
| |
| Breast abscess | Infections and infestations | MedDRA 6.1 | Non-systematic Assessment |
| |
| Bronchitis acute | Infections and infestations | MedDRA 6.1 | Non-systematic Assessment |
| |
| Cystitis acute | Infections and infestations | MedDRA 6.1 | Non-systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA 6.1 | Non-systematic Assessment |
| |
| Genital abscess | Infections and infestations | MedDRA 6.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 6.1 | Non-systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA 6.1 | Non-systematic Assessment |
| |
| Mastitis | Infections and infestations | MedDRA 6.1 | Non-systematic Assessment |
| |
| Pelvic abscess | Infections and infestations | MedDRA 6.1 | Non-systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 6.1 | Non-systematic Assessment |
| |
| Tonsillitis streptococcal | Infections and infestations | MedDRA 6.1 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 6.1 | Non-systematic Assessment |
| |
| Anastomotic leak | Injury, poisoning and procedural complications | MedDRA 6.1 | Non-systematic Assessment |
| |
| Cartilage injury | Injury, poisoning and procedural complications | MedDRA 6.1 | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 6.1 | Non-systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA 6.1 | Non-systematic Assessment |
| |
| Medical device complication | Injury, poisoning and procedural complications | MedDRA 6.1 | Non-systematic Assessment |
| |
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA 6.1 | Non-systematic Assessment |
| |
| Postoperative haematoma | Injury, poisoning and procedural complications | MedDRA 6.1 | Non-systematic Assessment |
| |
| Venom poisoning | Injury, poisoning and procedural complications | MedDRA 6.1 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 6.1 | Non-systematic Assessment |
| |
| Sperm analysis abnormal | Investigations | MedDRA 6.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Osteoporotic fracture | Musculoskeletal and connective tissue disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Tendon disorder | Musculoskeletal and connective tissue disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 6.1 | Non-systematic Assessment |
| |
| Breast cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 6.1 | Non-systematic Assessment |
| |
| Metastatic malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 6.1 | Non-systematic Assessment |
| |
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 6.1 | Non-systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 6.1 | Non-systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 6.1 | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 6.1 | Non-systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 6.1 | Non-systematic Assessment |
| |
| Pregnancy on oral contraceptive | Pregnancy, puerperium and perinatal conditions | MedDRA 6.1 | Non-systematic Assessment |
| |
| Unintended pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 6.1 | Non-systematic Assessment |
| |
| Alcoholism | Psychiatric disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Bipolar I Disorder | Psychiatric disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Post-traumatic stress disorder | Psychiatric disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Psychological factor affecting medical condition | Psychiatric disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Vesical fistula | Renal and urinary disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Endometrioma | Reproductive system and breast disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Endometriosis | Reproductive system and breast disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Alveolitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Chronic obstructive airways disease exacerbated | Respiratory, thoracic and mediastinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Acute febrile neutrophilic dermatosis | Skin and subcutaneous tissue disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Urticaria generalised | Skin and subcutaneous tissue disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Refusal of treatment by patient | Social circumstances | MedDRA 6.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 6.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 6.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 6.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 6.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 6.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 6.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 6.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 6.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 6.1 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB Clinical Trial Call Center | UCB | +1 877 822 9493 (UCB) |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068582 | Certolizumab Pegol |
| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D007140 | Immunoglobulin Fab Fragments |
| 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 |
Not provided
Not provided
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| Estonia |
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| Slovenia |
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| Spain |
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| Ukraine |
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| Austria |
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| Russian Federation |
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| Israel |
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| Italy |
|
| Czech Republic |
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| Hungary |
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| Canada |
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| Poland |
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| Belgium |
|
| Singapore |
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| Australia |
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| Denmark |
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| South Africa |
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| Bulgaria |
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| Norway |
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| Germany |
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| New Zealand |
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