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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-001729-24 | EudraCT Number |
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The study will continue to assess the safety of certolizumab pegol (CDP870) as well as examine the evolution of long term efficacy in Crohn's disease patients who completed study C87042 [NCT00308581]. It will also assess the effect of subcutaneous CDP870 400 mg on direct cost parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Certolizumab pegol 400 mg | Experimental | 400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Certolizumab pegol (CDP870) | Biological | 400 mg subcutaneous (sc) injection of Certolizumab pegol (CDP870) every 2 (Q2W) or 4 (Q4W) weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of at Least One Study-emergent Adverse Event During the Study (Maximum 164 Weeks) | Study-emergent adverse events are defined as treatment-emergent adverse events with an onset date on or after the first study drug administration date of this study but not later than 12 weeks (84 days) after last injection. Results are presented as the percentage of subjects with at least one treatment-emergent adverse event during this study. | Maximum 164 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Maintenance of Response at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals] Among the Subjects in Clinical Response at Baseline of This Study (Week 26 of Study C87042). | Clinical response is defined as at least a 100 point decrease from Baseline of study C87042 (NCT00308581) in Crohn's Disease Activity Index (CDAI). Subjects maintained their clinical response at Last Visit if they did not meet criteria for loss of response [CDAI score >150 points and a minimum increase in CDAI of 70 points versus Baseline of study C87042 (NCT00308581)] at 2 consecutive visits. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. Results are presented as the percentage of subjects maintaining response at Last visit. |
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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 |
|---|---|---|---|---|---|---|
| Gainesville | Florida | United States | ||||
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| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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The summary of Participant Flow is based on the All Subjects Population.
This study started in October 2006, with recruitment in the United States, Austria, Belgium, Canada, France, Germany, Italy, Spain, Sweden, Switzerland, the United Kingdom and the Netherlands. This study completed in April 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Certolizumab Pegol 400 mg | 400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Baseline (corresponding to Week 26 of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals] |
| Clinical Response at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals] | Clinical response is defined as at least a 100 point decrease from Baseline of study C87042 (NCT00308581) in Crohn's Disease Activity Index (CDAI). 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. Results are presented as the percentage of subjects achieving clinical response at Last visit. | Baseline of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals] |
| Remission at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals] | Remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points 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. Results are presented as the percentage of subjects in remission at Last visit. | Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals] |
| Change From Baseline of Study C87042 (NCT00308581) in Crohn's Disease Activity Index (CDAI) at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals] | 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 of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals] |
| Time to Loss of Response After Baseline of Study C87042 (NCT00308581) on Subjects Who Were in Clinical Response at Baseline of This Study | Clinical response at Baseline of this study of at least a 100 point decrease from Baseline of study C87042 in Crohn's Disease Activity Index (CDAI) Loss of response = both a CDAI score >150 points and a minimum increase in CDAI of 70 points versus Baseline (Week 26 of study C87042) as confirmed at 2 consecutive visits. Subjects losing response will be considered as having the event on the date of the first visit where response was lost. Subjects who discontinued the study without having lost response will be censored on the date of discontinuation (i.e. date of last visit performed). | Maximum 154 weeks |
| Occurrence of at Least 1 Hospital Stay During the Treatment Period | The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit. Results are presented as the percentage of subjects with at least 1 hospital stay during the treatment period. | Maximum 152 weeks |
| Occurrence of at Least 1 Hospital Stay During the Follow-Up Period | Follow-up period starts the day after the last injection up to 84 days after last injection. Results are presented as the percentage of subjects with at least 1 hospital stay during the follow-up period. | Maximum 12 weeks |
| Occurrence of at Least 1 Hospital Stay During the During the Overall Period | Overall period corresponds to both treatment and follow-up periods in C87046. Results are presented as the percentage of subjects with at least 1 hospital stay during the overall period. | Maximum 164 weeks |
| Length of Hospital Stays During the Treatment Period | The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit. | Maximum 152 weeks |
| Length of Hospital Stays During the Follow-Up Period | Follow-up period starts the day after the last injection up to 84 days after last injection. | Maximum 12 weeks |
| Length of Hospital Stays During the Overall Period | Overall period corresponds to both treatment and follow-up periods in C87046. | Maximum 164 weeks |
| Occurrence of at Least 1 Emergency Room Visit During the Treatment Period | The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit. Results are presented as the percentage of subjects with at least 1 emergency room visit during the treatment period. | Maximum 152 weeks |
| Occurrence of at Least 1 Emergency Room Visit During the Follow-Up Period | Follow-up period starts the day after the last injection up to 84 days after last injection. Results are presented as the percentage of subjects with at least 1 emergency room visit during the follow-up period. | Maximum 12 weeks |
| Occurrence of at Least 1 Emergency Room Visit During the Overall Period | Overall period corresponds to both treatment and follow-up periods in C87046. Results are presented as the percentage of subjects with at least 1 emergency room visit during the overall period. | Maximum 164 weeks |
| Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Treatment Period | The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit. Medication categories are anti tumor necrosis factor (anti-TNFs), immunosuppressants, corticosteroids, 5 aminosalicylic acid (5-ASA) and antibiotics. Results are presented as the percentage of subjects with at least 1 concomitant medication potentially influencing Crohn's disease during the treatment period. | Maximum 152 weeks |
| Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Follow-Up Period | Follow-up period start the day after the last injection up to 84 days after last injection. Medication categories are anti tumor necrosis factor (anti-TNFs), immunosuppressants, corticosteroids, 5 aminosalicylic acid (5-ASA) and antibiotics. Results are presented as the percentage of subjects with at least 1 concomitant medication potentially influencing Crohn's disease during the follow-up period. | Maximum 12 weeks |
| Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Overall Period | Overall period corresponds to both treatment and follow-up periods in C87046. Medication categories are anti tumor necrosis factor (anti-TNFs), immunosuppressants, corticosteroids, 5 aminosalicylic acid (5-ASA) and antibiotics. Results are presented as the percentage of subjects with at least 1 concomitant medication potentially influencing Crohn's disease during the overall period. | Maximum 164 weeks |
| Occurrence of at Least 1 General Concomitant Medication During the Treatment Period | The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit. Results are presented as the number of subjects who used at least 1 concomitant medication during the treatment period. | Maximum 152 weeks |
| Occurrence of at Least 1 General Concomitant Medication During the Follow-Up Period | Follow-up period start the day after the last injection up to 84 days after last injection. Results are presented as the number of subjects who used at least 1 concomitant medication during the follow-up period. | Maximum 12 weeks |
| Occurrence of at Least 1 General Concomitant Medication During the Overall Period | Overall period corresponds to both treatment and follow-up periods in C87046. Results are presented as the number of subjects who used at least 1 concomitant medication during the overall period. | Maximum 164 weeks |
| Occurrence of at Least 1 Concurrent Medical Procedure During the Treatment Period. | The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit. Results are presented as the number of subjects who had at least 1 concurrent medical procedure during the treatment period. | Maximum 152 weeks |
| Occurrence of at Least 1 Concurrent Medical Procedure During the Follow-Up Period | Follow-up period start the day after the last injection up to 84 days after last injection. Results are presented as the number of subjects who had at least 1 concurrent medical procedure during the follow-up period. | Maximum 12 weeks |
| Occurrence of at Least 1 Concurrent Medical Procedure During the Overall Period | Overall period corresponds to both treatment and follow-up periods in C87046. Results are presented as the number of subjects who had at least 1 concurrent medical procedure during the overall period. | Maximum 164 weeks |
| Atlanta |
| Georgia |
| United States |
| Chicago | Illinois | United States |
| Indianapolis | Indiana | United States |
| Louisville | Kentucky | United States |
| Baton Rouge | Louisiana | United States |
| Lincoln | Nebraska | United States |
| New York | New York | United States |
| Chapel Hill | North Carolina | United States |
| Charleston | North Carolina | United States |
| Cincinnati | Ohio | United States |
| Cleveland | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Portland | Oregon | United States |
| Charleston | South Carolina | United States |
| Germantown | Tennessee | United States |
| Nashville | Tennessee | United States |
| Houston | Texas | United States |
| Seattle | Washington | United States |
| Innsbruck | Austria |
| Vienna | Austria |
| Bonheiden | Belgium |
| Brussels | Belgium |
| Genk | Belgium |
| Ghent | Belgium |
| Leuven | Belgium |
| Liège | Belgium |
| Roeselare | Belgium |
| Edmonton | Alberta | Canada |
| Vancouver | British Columbia | Canada |
| London | Ontario | Canada |
| Toronto | Ontario | Canada |
| Calgary | Canada |
| Clichy | France |
| Lille | France |
| Nice | France |
| Paris | France |
| Pessac | France |
| Berlin | Germany |
| Hamburg | Germany |
| Herne | Germany |
| Kiel | Germany |
| Leipzig | Germany |
| Minden | Germany |
| Munich | Germany |
| München | Germany |
| Bologna | Italy |
| Milan | Italy |
| Padova | Italy |
| Palermo | Italy |
| Roma | Italy |
| Torino | Italy |
| Eindhoven | Netherlands |
| Heerlen | Netherlands |
| Barcelona | Spain |
| Madrid | Spain |
| Santiago de Compostela | Spain |
| Seville | Spain |
| Valencia | Spain |
| Stockholm | Sweden |
| Bern | Switzerland |
| Lausanne | Switzerland |
| Bristol | United Kingdom |
| London | United Kingdom |
| Oxford | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Certolizumab Pegol 400 mg | 400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Baseline characteristics are based on the ITT population; Participant flow is based on the All Subjects population. | Count of Participants | Participants |
| ||||||||||||||||||||||
| Age, Continuous | Baseline characteristics are based on the ITT population; Participant flow is based on the All Subjects population. | Mean | Standard Deviation | years |
| |||||||||||||||||||||
| Sex: Female, Male | Baseline characteristics are based on the ITT population; Participant flow is based on the All Subjects population. | Count of Participants | Participants |
| ||||||||||||||||||||||
| Region of Enrollment | Baseline characteristics are based on the ITT population; Participant flow is based on the All Subjects population. | 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 | Occurrence of at Least One Study-emergent Adverse Event During the Study (Maximum 164 Weeks) | Study-emergent adverse events are defined as treatment-emergent adverse events with an onset date on or after the first study drug administration date of this study but not later than 12 weeks (84 days) after last injection. Results are presented as the percentage of subjects with at least one treatment-emergent adverse event during this study. | Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population. | Posted | Number | percentage of participants | Maximum 164 weeks |
|
|
| ||||||||||||||||||||||||||
| Secondary | Maintenance of Response at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals] Among the Subjects in Clinical Response at Baseline of This Study (Week 26 of Study C87042). | Clinical response is defined as at least a 100 point decrease from Baseline of study C87042 (NCT00308581) in Crohn's Disease Activity Index (CDAI). Subjects maintained their clinical response at Last Visit if they did not meet criteria for loss of response [CDAI score >150 points and a minimum increase in CDAI of 70 points versus Baseline of study C87042 (NCT00308581)] at 2 consecutive visits. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. Results are presented as the percentage of subjects maintaining response at Last visit. | Of the 233 subjects in the study, 166 are in the Intent to Treat (ITT) population and were in clinical response at Baseline of this study, and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population. | Posted | Number | percentage of participants | Baseline (corresponding to Week 26 of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals] |
| ||||||||||||||||||||||||||||
| Secondary | Clinical Response at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals] | Clinical response is defined as at least a 100 point decrease from Baseline of study C87042 (NCT00308581) in Crohn's Disease Activity Index (CDAI). 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. Results are presented as the percentage of subjects achieving clinical response at Last visit. | Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population. | Posted | Number | percentage of participants | Baseline of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals] |
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| Secondary | Remission at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals] | Remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points 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. Results are presented as the percentage of subjects in remission at Last visit. | Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population. | Posted | Number | percentage of participants | Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals] |
|
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline of Study C87042 (NCT00308581) in Crohn's Disease Activity Index (CDAI) at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals] | 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 233 subjects in the study, 215 are in the Intent to Treat (ITT) population with Crohn's Disease Activity Index (CDAI) scores at Baseline and Last/Withdrawal visits and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population. | Posted | Mean | Standard Deviation | score on a scale | Baseline of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals] |
|
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| Secondary | Time to Loss of Response After Baseline of Study C87042 (NCT00308581) on Subjects Who Were in Clinical Response at Baseline of This Study | Clinical response at Baseline of this study of at least a 100 point decrease from Baseline of study C87042 in Crohn's Disease Activity Index (CDAI) Loss of response = both a CDAI score >150 points and a minimum increase in CDAI of 70 points versus Baseline (Week 26 of study C87042) as confirmed at 2 consecutive visits. Subjects losing response will be considered as having the event on the date of the first visit where response was lost. Subjects who discontinued the study without having lost response will be censored on the date of discontinuation (i.e. date of last visit performed). | Of the 233 subjects in the study 153 are in the Modified Intent to Treat (MITT) population and are responders at Baseline of this study and are in this analysis. The MITT population includes subjects that are in the ITT population that were correctly randomized at Week 6 of study C87042 (NCT00308581). | Posted | Median | Full Range | days | Maximum 154 weeks |
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| Secondary | Occurrence of at Least 1 Hospital Stay During the Treatment Period | The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit. Results are presented as the percentage of subjects with at least 1 hospital stay during the treatment period. | Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population. | Posted | Number | percentage of participants | Maximum 152 weeks |
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| Secondary | Occurrence of at Least 1 Hospital Stay During the Follow-Up Period | Follow-up period starts the day after the last injection up to 84 days after last injection. Results are presented as the percentage of subjects with at least 1 hospital stay during the follow-up period. | Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population. | Posted | Number | percentage of participants | Maximum 12 weeks |
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| Secondary | Occurrence of at Least 1 Hospital Stay During the During the Overall Period | Overall period corresponds to both treatment and follow-up periods in C87046. Results are presented as the percentage of subjects with at least 1 hospital stay during the overall period. | Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population. | Posted | Number | percentage of participants | Maximum 164 weeks |
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| Secondary | Length of Hospital Stays During the Treatment Period | The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit. | Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population. | Posted | Mean | Standard Deviation | days | Maximum 152 weeks |
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| Secondary | Length of Hospital Stays During the Follow-Up Period | Follow-up period starts the day after the last injection up to 84 days after last injection. | Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population. | Posted | Mean | Standard Deviation | days | Maximum 12 weeks |
|
| ||||||||||||||||||||||||||
| Secondary | Length of Hospital Stays During the Overall Period | Overall period corresponds to both treatment and follow-up periods in C87046. | Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population. | Posted | Mean | Standard Deviation | days | Maximum 164 weeks |
|
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| Secondary | Occurrence of at Least 1 Emergency Room Visit During the Treatment Period | The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit. Results are presented as the percentage of subjects with at least 1 emergency room visit during the treatment period. | Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population. | Posted | Number | percentage of participants | Maximum 152 weeks |
|
| |||||||||||||||||||||||||||
| Secondary | Occurrence of at Least 1 Emergency Room Visit During the Follow-Up Period | Follow-up period starts the day after the last injection up to 84 days after last injection. Results are presented as the percentage of subjects with at least 1 emergency room visit during the follow-up period. | Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population. | Posted | Number | percentage of participants | Maximum 12 weeks |
|
| |||||||||||||||||||||||||||
| Secondary | Occurrence of at Least 1 Emergency Room Visit During the Overall Period | Overall period corresponds to both treatment and follow-up periods in C87046. Results are presented as the percentage of subjects with at least 1 emergency room visit during the overall period. | Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population. | Posted | Number | percentage of participants | Maximum 164 weeks |
|
| |||||||||||||||||||||||||||
| Secondary | Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Treatment Period | The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit. Medication categories are anti tumor necrosis factor (anti-TNFs), immunosuppressants, corticosteroids, 5 aminosalicylic acid (5-ASA) and antibiotics. Results are presented as the percentage of subjects with at least 1 concomitant medication potentially influencing Crohn's disease during the treatment period. | Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population. | Posted | Number | percentage of participants | Maximum 152 weeks |
|
| |||||||||||||||||||||||||||
| Secondary | Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Follow-Up Period | Follow-up period start the day after the last injection up to 84 days after last injection. Medication categories are anti tumor necrosis factor (anti-TNFs), immunosuppressants, corticosteroids, 5 aminosalicylic acid (5-ASA) and antibiotics. Results are presented as the percentage of subjects with at least 1 concomitant medication potentially influencing Crohn's disease during the follow-up period. | Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population. | Posted | Number | percentage of participants | Maximum 12 weeks |
|
| |||||||||||||||||||||||||||
| Secondary | Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Overall Period | Overall period corresponds to both treatment and follow-up periods in C87046. Medication categories are anti tumor necrosis factor (anti-TNFs), immunosuppressants, corticosteroids, 5 aminosalicylic acid (5-ASA) and antibiotics. Results are presented as the percentage of subjects with at least 1 concomitant medication potentially influencing Crohn's disease during the overall period. | Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population. | Posted | Number | percentage of participants | Maximum 164 weeks |
|
| |||||||||||||||||||||||||||
| Secondary | Occurrence of at Least 1 General Concomitant Medication During the Treatment Period | The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit. Results are presented as the number of subjects who used at least 1 concomitant medication during the treatment period. | Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population. | Posted | Number | participants | Maximum 152 weeks |
|
| |||||||||||||||||||||||||||
| Secondary | Occurrence of at Least 1 General Concomitant Medication During the Follow-Up Period | Follow-up period start the day after the last injection up to 84 days after last injection. Results are presented as the number of subjects who used at least 1 concomitant medication during the follow-up period. | Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population. | Posted | Number | participants | Maximum 12 weeks |
|
| |||||||||||||||||||||||||||
| Secondary | Occurrence of at Least 1 General Concomitant Medication During the Overall Period | Overall period corresponds to both treatment and follow-up periods in C87046. Results are presented as the number of subjects who used at least 1 concomitant medication during the overall period. | Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population. | Posted | Number | participants | Maximum 164 weeks |
|
| |||||||||||||||||||||||||||
| Secondary | Occurrence of at Least 1 Concurrent Medical Procedure During the Treatment Period. | The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit. Results are presented as the number of subjects who had at least 1 concurrent medical procedure during the treatment period. | Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population. | Posted | Number | participants | Maximum 152 weeks |
|
| |||||||||||||||||||||||||||
| Secondary | Occurrence of at Least 1 Concurrent Medical Procedure During the Follow-Up Period | Follow-up period start the day after the last injection up to 84 days after last injection. Results are presented as the number of subjects who had at least 1 concurrent medical procedure during the follow-up period. | Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population. | Posted | Number | participants | Maximum 12 weeks |
|
| |||||||||||||||||||||||||||
| Secondary | Occurrence of at Least 1 Concurrent Medical Procedure During the Overall Period | Overall period corresponds to both treatment and follow-up periods in C87046. Results are presented as the number of subjects who had at least 1 concurrent medical procedure during the overall period. | Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population. | Posted | Number | participants | Maximum 164 weeks |
|
|
Maximum of 166 weeks
Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
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 | 400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks | 73 | 229 | 190 | 229 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Diabetes insipidus | Endocrine disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Colonic stenosis | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Faecal incontinence | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Frequent bowel movements | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Gastrointestinal obstruction | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Hernial eventration | 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 stenosis | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Rectal perforation | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Small intestinal stenosis | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Abdominal wall abscess | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Breast abscess | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Clostridial infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Fusobacterium infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Infective tenosynovitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Parotitis | Infections and infestations | 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 |
| |
| Perirectal abscess | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Rectal abscess | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Anastomotic stenosis | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Gastrointestinal stoma complication | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Hyporeflexia | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Wallenberg syndrome | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Mental disorder | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Bladder prolapse | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Acute febrile neutrophilic dermatosis | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pustular psoriasis | Skin and subcutaneous tissue disorders | 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 |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal 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 |
| |
| Haematochezia | 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 |
| |
| Asthenia | General 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 |
| |
| Bronchitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | 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 |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB Clinical Trial Call Center | UCB, Inc | +1 877 822 9493 |
| 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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