Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2006-003870-88 | EudraCT Number |
Not provided
Not provided
Recruitment was stopped early due to slow enrolment of this population. With no safety concerns, the study continued normally for subjects already recruited
Not provided
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The current study is designed to measure the corticosteroid-sparing effect of certolizumab pegol using a defined schedule of corticosteroid tapering in subjects with moderate to severe Crohn's disease. Subjects had to be in remission (CDAI<=150) and receiving corticosteroids at a dose no higher than 30 mg/day prednisone or equivalent during the week prior to randomization.
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Certolizumab pegol 400 mg | Experimental | Certolizumab pegol 400 mg |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| certolizumab pegol 400 mg | Biological | Certolizumab pegol 400 mg provided in solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36. Two vials will be required for each dosing. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Who Have Been Withdrawn From Prednisone or Prednisolone Therapy According to the Corticosteroid Tapering Schedule and Have Remained Off Corticosteroids and in Disease Remission at Week 38 | The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. | Week 38 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Continuous Remission Off Steroids at Week 38 | The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A subject with continuous remission off steroids at Week 38 is a subject in remission (CDAI =< 150) from the visit when he stops taking steroids to Week 38 and is off corticosteroids until Week 38. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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Not provided
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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 |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
Not provided
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
Not provided
Not provided
A Randomized Trial to Examine the Corticosteroid-sparing Effect of Certolizumab Pegol in Subjects With Moderate to Severe Crohn's Disease from November 2006 to July 2009
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Certolizumab Pegol 400 mg | Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36 |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Other | Placebo (commercially available sodium chloride 0.9% (preservative free)) provided for subcutaneous injection in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36. Two vials will be required for each dosing. |
|
| Week 38 |
| Cumulative Percentage of Subjects With Relapse/Treatment Failure at Week 38 | A subject with relapse/ treatment failure has a Crohn's Disease Activity Index (CDAI) > 150 and an increase in CDAI of >= 70 points versus Week 0. [The CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease.] | Week 38 |
| Time to Relapse/Treatment Failure During the 38-week Double-blind Treatment Period | A subject with relapse/ treatment failure has a Crohn's Disease Activity Index (CDAI) > 150 and an increase in CDAI of >= 70 points versus Week 0. [The CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease.] | During the 38-week double-blind treatment period |
| Per-subject Median Weekly Dose of Corticosteroids Over the 38-week Double-blind Treatment Period | The median weekly dose of corticosteroids is calculated for each subject, and these per-subject median values are further summarized by treatment group. The mean of the per-subject median doses in each treatment group is presented here. | Over the 38-week double-blind treatment period |
| Per-subject Cumulative Dose of Corticosteroids Over the 48-week Study Period | The cumulative dose of corticosteroids over the 48-week study period is calculated for each subject individually. The mean of these values for each treatment group is presented here. | Over the 48-week study period |
| Change From the 6-week run-in Period in Per-subject Median Weekly Dose of Corticosteroids Over the 38-week Double-blind Treatment Period | The run in period lasted a minimum of 1 week and a maximum of 6 weeks. During this period subjects were treated with any dose or type of systemic corticosteroids the Investigator felt was appropriate. To be eligible for study randomization, subjects must have been in remission (CDAI ≤150 points) and receiving corticosteroids at a dose no higher than 30 mg/day prednisone or equivalent during the week prior to randomization. Subjects who did not meet these criteria were not randomized and were withdrawn from the study. | 6-week run-in period, 38-week double-blind treatment period |
| Crohn's Disease Activity Index (CDAI) Score at Week 38 | The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | Week 38 |
| Change From Baseline in CDAI Score at Week 38 | The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | Week 0, Week 38 |
| Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 38 | The total IBDQ score will be derived as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher score indicates a better quality of life. IBDQ remission is defined as a subject having an IBDQ total score >= 170 points. | Week 38 |
| Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 38 | The total IBDQ score will be derived as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher scores indicates a better quality of life. IBDQ response is defined as an increase from baseline in the IBDQ total score >= 16 points. | Week 0, Week 38 |
| Montgomery |
| Alabama |
| United States |
| Tucson | Arizona | United States |
| La Jolla | California | United States |
| Oceanside | California | United States |
| Orange | California | United States |
| Palo Alto | California | United States |
| Roseville | California | United States |
| Golden | Colorado | United States |
| Clearwater | Florida | United States |
| Gainesville | Florida | United States |
| Hialeah | Florida | United States |
| Jacksonville | Florida | United States |
| North Miami Beach | Florida | United States |
| Sarasota | Florida | United States |
| Winter Park | Florida | United States |
| Marietta | Georgia | United States |
| Savannah | Georgia | United States |
| Chicago | Illinois | United States |
| Bloomington | Indiana | United States |
| Topeka | Kansas | United States |
| Bowling Green | Kentucky | United States |
| Louisville | Kentucky | United States |
| Metairie | Louisiana | United States |
| Annapolis | Maryland | United States |
| Newton | Massachusetts | United States |
| Chesterfield | Michigan | United States |
| Dearborn | Michigan | United States |
| Troy | Michigan | United States |
| Rochester | Minnesota | United States |
| Ocean Springs | Mississippi | United States |
| Kansas City | Missouri | United States |
| Mexico | Missouri | United States |
| New York | New York | United States |
| Syracuse | New York | United States |
| Chapel Hill | North Carolina | United States |
| Charlotte | North Carolina | United States |
| Raleigh | North Carolina | United States |
| Cincinnati | Ohio | United States |
| Cleveland | Ohio | United States |
| Dayton | Ohio | United States |
| Tulsa | Oklahoma | United States |
| Columbia | South Carolina | United States |
| Germantown | Tennessee | United States |
| Austin | Texas | United States |
| Irving | Texas | United States |
| Salt Lake City | Utah | United States |
| Burlington | Vermont | United States |
| Chesapeake | Virginia | United States |
| Richmond | Virginia | United States |
| Seattle | Washington | United States |
| Madison | Wisconsin | United States |
| Milwaukee | Wisconsin | United States |
| Monroe | Wisconsin | United States |
| Calgary | Alberta | Canada |
| Edmonton | Alberta | Canada |
| Abbotsford British Columbia | British Columbia | Canada |
| Vancouver | British Columbia | Canada |
| Winnipeg | Manitoba | Canada |
| Halifax | Nova Scotia | Canada |
| London | Ontario | Canada |
| Toronto | Ontario | Canada |
| Saskatoon | Saskatchewan | Canada |
| Frankfurt | Germany |
| Heidleberg | Germany |
| Jena | Germany |
| Magdeburg | Germany |
| Ulm | Germany |
Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Certolizumab Pegol 400 mg | Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36 |
| BG001 | Placebo | Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36 |
| BG002 | Total | Total of all reporting groups |
| 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 Who Have Been Withdrawn From Prednisone or Prednisolone Therapy According to the Corticosteroid Tapering Schedule and Have Remained Off Corticosteroids and in Disease Remission at Week 38 | The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. | Intention-to-treat (ITT) population which consists of all randomized subjects who received at least one injection of study medication. In the analyses of remission rates, subjects for whom it is impossible to assess the remission status will be conservatively considered as non-remitters in the calculations. | Posted | Number | percentage of subjects | Week 38 |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With Continuous Remission Off Steroids at Week 38 | The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A subject with continuous remission off steroids at Week 38 is a subject in remission (CDAI =< 150) from the visit when he stops taking steroids to Week 38 and is off corticosteroids until Week 38. | Intention-to-treat (ITT) population which consists of all randomized subjects who received at least one injection of study medication. In the analyses of remission rates, subjects for whom it is impossible to assess the remission status will be conservatively considered as non-remitters in the calculations. | Posted | Number | percentage of subjects | Week 38 |
| |||||||||||||||||||||||||||||||
| Secondary | Cumulative Percentage of Subjects With Relapse/Treatment Failure at Week 38 | A subject with relapse/ treatment failure has a Crohn's Disease Activity Index (CDAI) > 150 and an increase in CDAI of >= 70 points versus Week 0. [The CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease.] | Of 87 (Placebo) and 87 (Certolizumab pegol 400 mg) subjects randomized, 85 and 87 subjects respectively are included in summary of Week 38, based on conditional intention-to-treat population, consisting of all randomized subjects who received at least one injection of study medication, excluding those who were not in remission (CDAI>150) at Week 0 | Posted | Number | percentage of subjects | Week 38 |
| |||||||||||||||||||||||||||||||
| Secondary | Time to Relapse/Treatment Failure During the 38-week Double-blind Treatment Period | A subject with relapse/ treatment failure has a Crohn's Disease Activity Index (CDAI) > 150 and an increase in CDAI of >= 70 points versus Week 0. [The CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease.] | Of 87 (Placebo) and 87 (Certolizumab pegol 400 mg) subjects randomized, 85 and 87 subjects respectively are included in summary of Week 38, based on conditional intention-to-treat population, consisting of all randomized subjects who received at least one injection of study medication, excluding those who were not in remission (CDAI>150) at Week 0 | Posted | Mean | Standard Deviation | days | During the 38-week double-blind treatment period |
| ||||||||||||||||||||||||||||||
| Secondary | Per-subject Median Weekly Dose of Corticosteroids Over the 38-week Double-blind Treatment Period | The median weekly dose of corticosteroids is calculated for each subject, and these per-subject median values are further summarized by treatment group. The mean of the per-subject median doses in each treatment group is presented here. | 87 (Placebo) and 87 (Certolizumab pegol 400 mg) subjects randomized are included in the summary based on the intention-to-treat (ITT) population. Of the 87 subjects in the placebo group, 1 subject taking a daily dose of 3g with a rectal route has been excluded from the analysis. | Posted | Mean | Standard Deviation | mg per week | Over the 38-week double-blind treatment period |
|
| |||||||||||||||||||||||||||||
| Secondary | Per-subject Cumulative Dose of Corticosteroids Over the 48-week Study Period | The cumulative dose of corticosteroids over the 48-week study period is calculated for each subject individually. The mean of these values for each treatment group is presented here. | 87 (Placebo) and 87 (Certolizumab pegol 400 mg) subjects randomized are included in the summary based on the intention-to-treat (ITT) population. Of the 87 subjects in the placebo group, 1 subject taking a daily dose of 3g with a rectal route has been excluded from the analysis. | Posted | Mean | Standard Deviation | mg | Over the 48-week study period |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From the 6-week run-in Period in Per-subject Median Weekly Dose of Corticosteroids Over the 38-week Double-blind Treatment Period | The run in period lasted a minimum of 1 week and a maximum of 6 weeks. During this period subjects were treated with any dose or type of systemic corticosteroids the Investigator felt was appropriate. To be eligible for study randomization, subjects must have been in remission (CDAI ≤150 points) and receiving corticosteroids at a dose no higher than 30 mg/day prednisone or equivalent during the week prior to randomization. Subjects who did not meet these criteria were not randomized and were withdrawn from the study. | Of the 87 (Placebo) and 87 (Certolizumab pegol 400 mg) subjects randomized, 86 in each group had available values at the 6-week run-in period and over the 38-week double-blind treatment period. | Posted | Mean | Standard Deviation | mg per week | 6-week run-in period, 38-week double-blind treatment period |
| ||||||||||||||||||||||||||||||
| Secondary | Crohn's Disease Activity Index (CDAI) Score at Week 38 | The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | Of the 87 (Placebo) and 87 (Certolizumab pegol 400 mg) subjects randomized, 22 and 27 subjects respectively are included in the summary of the Week 38, based on the intention-to-treat (ITT) population. | Posted | Mean | Standard Deviation | score on a scale | Week 38 |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in CDAI Score at Week 38 | The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | Of the 87 (Placebo) and 87 (Certolizumab pegol 400 mg) subjects randomized, 22 and 27 subjects respectively had available values at Baseline and at Week 38 and are included in the summary based on the intention-to-treat (ITT) population. | Posted | Mean | Standard Deviation | score on a scale | Week 0, Week 38 |
|
| |||||||||||||||||||||||||||||
| Secondary | Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 38 | The total IBDQ score will be derived as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher score indicates a better quality of life. IBDQ remission is defined as a subject having an IBDQ total score >= 170 points. | Of the 87 (Placebo) and 87 (Certolizumab pegol 400 mg) subjects randomized, 23 and 27 subjects respectively had available values at Week 38 and are included in the summary based on the intention-to-treat (ITT) population. | Posted | Mean | Standard Deviation | score on a scale | Week 38 |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 38 | The total IBDQ score will be derived as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher scores indicates a better quality of life. IBDQ response is defined as an increase from baseline in the IBDQ total score >= 16 points. | Of the 87 (Placebo) and 87 (Certolizumab Pegol 400 mg) subjects randomized, 23 and 26 subjects respectively had available values at Baseline and Week 38 and are included in the summary based on the intention-to-treat (ITT) population. | Posted | Mean | Standard Deviation | score on a scale | Week 0, Week 38 |
|
|
48-week study period
Not provided
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 400 mg | Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36 | 9 | 87 | 70 | 87 | ||
| EG001 | Placebo | Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36 | 8 | 87 | 73 | 87 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bundle Branch Block Left | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Crohn's Disease | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Abdominal Hernia | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Upper Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Colonic Stenosis | Gastrointestinal 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 |
| |
| Intestinal Perforation | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Volvulus | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Granuloma | General disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Clostridium Difficile Colitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Abscess Intestinal | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Gastroenteritis Viral | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Ankle Fracture | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Postoperative Ileus | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Grand Mal Convulsion | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Suicidal Ideation | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Renal Failure Acute | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Crohn's Disease | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Abdominal Pain Lower | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Injection Site Reaction | General disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
Recruitment was stopped early due to slow enrolment of this population. With no safety concerns, the study continued normally for the 174 subjects already recruited. Results should be treated with caution due to the early termination of this study.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | UCB Clinical Trial Call Center | +1 877 822 9493 |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| 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
| >=65 years |
|
| Male |
|
| Canada |
|
| Germany |
|
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