Crohn's Disease
Conditions
Keywords
Crohn's Disease, Certolizumab pegol, CDP870, Cimzia
Brief summary
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.
Interventions
BIOLOGICALCertolizumab pegol (CDP870)
400 mg subcutaneous (sc) injection of Certolizumab pegol (CDP870) every 2 (Q2W) or 4 (Q4W) weeks
Sponsors
UCB Pharma
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients having completed study C87042 \[NCT00308581\] (previously treated with infliximab)
Exclusion criteria
* Subject withdraw from C87042 \[NCT00308581\] study * Subject who received treatment other than certolizumab pegol and other than medications permitted in C87042 \[NCT00308581\] study * Subjects from countries where certolizumab pegol is authorized in Crohn's disease treatment * Female patients of childbearing age who are NOT practicing (in the Investigator's opinion) effective birth control. All female patients must test negative on a serum pregnancy test before study entry and negative on urine testing immediately before every certolizumab pegol administration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of at Least One Study-emergent Adverse Event During the Study (Maximum 164 Weeks) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Response at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals] | 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] | 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. |
| Remission at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals] | 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. |
| 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] | 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] | 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. |
| Time to Loss of Response After Baseline of Study C87042 (NCT00308581) on Subjects Who Were in Clinical Response at Baseline of This Study | Maximum 154 weeks | 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). |
| Occurrence of at Least 1 Hospital Stay During the Treatment Period | Maximum 152 weeks | 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. |
| Occurrence of at Least 1 Hospital Stay During the Follow-Up Period | Maximum 12 weeks | 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. |
| Occurrence of at Least 1 Hospital Stay During the During the Overall Period | Maximum 164 weeks | 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. |
| Length of Hospital Stays During the Treatment Period | Maximum 152 weeks | The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit. |
| Length of Hospital Stays During the Follow-Up Period | Maximum 12 weeks | Follow-up period starts the day after the last injection up to 84 days after last injection. |
| Length of Hospital Stays During the Overall Period | Maximum 164 weeks | Overall period corresponds to both treatment and follow-up periods in C87046. |
| Occurrence of at Least 1 Emergency Room Visit During the Treatment Period | Maximum 152 weeks | 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. |
| 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). | 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 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. |
| Occurrence of at Least 1 Emergency Room Visit During the Overall Period | Maximum 164 weeks | 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. |
| Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Treatment Period | Maximum 152 weeks | 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. |
| Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Follow-Up Period | Maximum 12 weeks | 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. |
| Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Overall Period | Maximum 164 weeks | 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. |
| Occurrence of at Least 1 General Concomitant Medication During the Treatment Period | Maximum 152 weeks | 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. |
| Occurrence of at Least 1 General Concomitant Medication During the Follow-Up Period | Maximum 12 weeks | 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. |
| Occurrence of at Least 1 General Concomitant Medication During the Overall Period | Maximum 164 weeks | 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. |
| Occurrence of at Least 1 Concurrent Medical Procedure During the Treatment Period. | Maximum 152 weeks | 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. |
| Occurrence of at Least 1 Concurrent Medical Procedure During the Follow-Up Period | Maximum 12 weeks | 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. |
| Occurrence of at Least 1 Concurrent Medical Procedure During the Overall Period | Maximum 164 weeks | 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. |
| Occurrence of at Least 1 Emergency Room Visit During the Follow-Up Period | Maximum 12 weeks | 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. |
Countries
Austria, Belgium, Canada, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, United Kingdom, United States
Participant flow
Recruitment details
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.
Pre-assignment details
The summary of Participant Flow is based on the All Subjects Population.
Participants by arm
| Arm | Count |
|---|---|
| Certolizumab Pegol 400 mg 400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks | 229 |
| Total | 229 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 44 |
| Overall Study | Lack of Efficacy | 80 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Other: Investigator decision | 1 |
| Overall Study | Other: Medical monitor decision | 1 |
| Overall Study | Other: Moved | 2 |
| Overall Study | Other: Non-compliance | 2 |
| Overall Study | Other: Physician decision | 1 |
| Overall Study | Other: Quality of life concern | 1 |
| Overall Study | Other: Recurrent squamaous cell cancer | 1 |
| Overall Study | Other: Signed consent for another study | 1 |
| Overall Study | Other: Sponsor decision | 1 |
| Overall Study | Other: Subject in need of an Entocort | 1 |
| Overall Study | Withdrawal by Subject | 24 |
Baseline characteristics
| Characteristic | Certolizumab Pegol 400 mg |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 224 Participants |
| Age, Continuous | 31.8 years STANDARD_DEVIATION 11.6 |
| Region of Enrollment Austria | 8 participants |
| Region of Enrollment Belgium | 30 participants |
| Region of Enrollment Canada | 20 participants |
| Region of Enrollment France | 20 participants |
| Region of Enrollment Germany | 34 participants |
| Region of Enrollment Italy | 24 participants |
| Region of Enrollment Netherlands | 2 participants |
| Region of Enrollment Spain | 6 participants |
| Region of Enrollment Sweden | 2 participants |
| Region of Enrollment Switzerland | 4 participants |
| Region of Enrollment United Kingdom | 9 participants |
| Region of Enrollment United States | 70 participants |
| Sex: Female, Male Female | 146 Participants |
| Sex: Female, Male Male | 83 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 190 / 229 |
| serious Total, serious adverse events | 73 / 229 |
Outcome results
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.
Time frame: Maximum 164 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol 400 mg | Occurrence of at Least One Study-emergent Adverse Event During the Study (Maximum 164 Weeks) | 92.6 percentage of participants |
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.
Time frame: 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]
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol 400 mg | 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] | -121.52 score on a scale | Standard Deviation 99.61 |
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.
Time frame: 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]
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol 400 mg | Clinical Response at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals] | 53.3 percentage of participants |
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.
Time frame: Maximum 12 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol 400 mg | Length of Hospital Stays During the Follow-Up Period | 2.782 days | Standard Deviation 7.743 |
Secondary
Length of Hospital Stays During the Overall Period
Overall period corresponds to both treatment and follow-up periods in C87046.
Time frame: Maximum 164 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol 400 mg | Length of Hospital Stays During the Overall Period | 4.620 days | Standard Deviation 9.704 |
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.
Time frame: Maximum 152 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol 400 mg | Length of Hospital Stays During the Treatment Period | 1.838 days | Standard Deviation 5.785 |
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.
Time frame: 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]
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol 400 mg | 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). | 61.8 percentage of participants |
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.
Time frame: Maximum 12 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol 400 mg | Occurrence of at Least 1 Concurrent Medical Procedure During the Follow-Up Period | 84 participants |
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.
Time frame: Maximum 164 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol 400 mg | Occurrence of at Least 1 Concurrent Medical Procedure During the Overall Period | 173 participants |
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.
Time frame: Maximum 152 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol 400 mg | Occurrence of at Least 1 Concurrent Medical Procedure During the Treatment Period. | 148 participants | 4.656 |
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.
Time frame: Maximum 12 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol 400 mg | Occurrence of at Least 1 Emergency Room Visit During the Follow-Up Period | 6.1 percentage of participants | 0.265 |
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.
Time frame: Maximum 164 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol 400 mg | Occurrence of at Least 1 Emergency Room Visit During the Overall Period | 19.2 percentage of participants | 0.471 |
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.
Time frame: Maximum 152 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol 400 mg | Occurrence of at Least 1 Emergency Room Visit During the Treatment Period | 13.1 percentage of participants | 0.413 |
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.
Time frame: Maximum 12 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol 400 mg | Occurrence of at Least 1 General Concomitant Medication During the Follow-Up Period | 71 participants | 3.395 |
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.
Time frame: Maximum 164 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol 400 mg | Occurrence of at Least 1 General Concomitant Medication During the Overall Period | 195 participants | 10.948 |
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.
Time frame: Maximum 152 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol 400 mg | Occurrence of at Least 1 General Concomitant Medication During the Treatment Period | 185 participants | 10.172 |
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.
Time frame: Maximum 164 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol 400 mg | Occurrence of at Least 1 Hospital Stay During the During the Overall Period | 37.6 percentage of participants | 0.953 |
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.
Time frame: Maximum 12 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol 400 mg | Occurrence of at Least 1 Hospital Stay During the Follow-Up Period | 21.8 percentage of participants | 0.578 |
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.
Time frame: Maximum 152 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol 400 mg | Occurrence of at Least 1 Hospital Stay During the Treatment Period | 21.4 percentage of participants | 0.73 |
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.
Time frame: Maximum 12 weeks
Population: 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.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Certolizumab Pegol 400 mg | Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Follow-Up Period | Anti tumor necrosis factor (Anti-TNF) | 16.2 percentage of participants | 0.702 |
| Certolizumab Pegol 400 mg | Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Follow-Up Period | Immunosuppresants | 5.2 percentage of participants | 0.25 |
| Certolizumab Pegol 400 mg | Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Follow-Up Period | Corticosteroids | 15.3 percentage of participants | 0.622 |
| Certolizumab Pegol 400 mg | Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Follow-Up Period | 5- Aminosalicylic Acid (5-ASA) | 2.2 percentage of participants | 0.185 |
| Certolizumab Pegol 400 mg | Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Follow-Up Period | Antibiotics | 14.0 percentage of participants | 0.829 |
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.
Time frame: Maximum 164 weeks
Population: 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.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Certolizumab Pegol 400 mg | Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Overall Period | Anti tumor necrosis factor (Anti-TNF) | 16.2 percentage of participants | 0.716 |
| Certolizumab Pegol 400 mg | Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Overall Period | Immunosuppressants | 8.3 percentage of participants | 0.337 |
| Certolizumab Pegol 400 mg | Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Overall Period | Corticosteroids | 35.4 percentage of participants | 0.986 |
| Certolizumab Pegol 400 mg | Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Overall Period | 5- Aminosalicylic Acid (5-ASA) | 7.0 percentage of participants | 0.408 |
| Certolizumab Pegol 400 mg | Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Overall Period | Antibiotics | 62.4 percentage of participants | 2.974 |
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.
Time frame: Maximum 152 weeks
Population: 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.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Certolizumab Pegol 400 mg | Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Treatment Period | Antibiotics | 55.5 percentage of participants | 2.889 |
| Certolizumab Pegol 400 mg | Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Treatment Period | Anti tumor necrosis factor (Anti-TNF) | 0.4 percentage of participants | 0.066 |
| Certolizumab Pegol 400 mg | Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Treatment Period | Immunosuppressants | 3.9 percentage of participants | 0.195 |
| Certolizumab Pegol 400 mg | Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Treatment Period | Corticosteroids | 24.0 percentage of participants | 0.733 |
| Certolizumab Pegol 400 mg | Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Treatment Period | 5- Aminosalicylic Acid (5-ASA) | 5.2 percentage of participants | 0.356 |
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.
Time frame: Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol 400 mg | Remission at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals] | 40.6 percentage of participants |
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).
Time frame: Maximum 154 weeks
Population: 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).
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol 400 mg | Time to Loss of Response After Baseline of Study C87042 (NCT00308581) on Subjects Who Were in Clinical Response at Baseline of This Study | 169.5 days | Full Range 274.1 |