Follow-up to Welcome Study C87042 [NCT00308581] Examining Certolizumab Pegol (CDP870) in Subjects With Crohn's Disease (Welcome2)

• ClinicalTrials.gov Identifier: NCT00333788
• Recruitment Status: Completed
• First Posted: June 6, 2006
• Results First Posted: July 12, 2011
• Last Update Posted: August 7, 2018
• Sponsor: UCB Pharma
• Information provided by (Responsible Party): UCB Pharma

• Study Type: Interventional
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Crohn's Disease
• Intervention: Biological: Certolizumab pegol (CDP870)
• Enrollment: 233

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.

Arm/Group Title	Certolizumab Pegol 400 mg
Arm/Group Description	400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Period Title: Overall Study
Started	233 [1]
Completed	71
Not Completed	162
Reason Not Completed
Adverse Event	44
Lack of Efficacy	80
Lost to Follow-up	2
Withdrawal by Subject	24
Other: Non-compliance	2
Other: Moved	2
Other: Recurrent squamaous cell cancer	1
Other: Investigator decision	1
Other: Quality of life concern	1
Other: Sponsor decision	1
Other: Subject in need of an Entocort	1
Other: Medical monitor decision	1
Other: Physician decision	1
Other: Signed consent for another study	1
[1] Participant flow based on All Subjects population; Baseline characteristics based on ITT population.

Baseline Characteristics

Arm/Group Title		Certolizumab Pegol 400 mg
Arm/Group Description		400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Baseline Participants		229
Baseline Analysis Population Description		[Not Specified]
Age, Categorical [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	229 participants
	<=18 years	1 0.4%
	Between 18 and 65 years	224 97.8%
	>=65 years	4 1.7%
		[1] Measure Description: Baseline characteristics are based on the ITT population; Participant flow is based on the All Subjects population.
Age, Continuous [1]; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	229 participants
		31.8 (11.6)
		[1] Measure Description: Baseline characteristics are based on the ITT population; Participant flow is based on the All Subjects population.
Sex: Female, Male [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	229 participants
	Female	146 63.8%
	Male	83 36.2%
		[1] Measure Description: Baseline characteristics are based on the ITT population; Participant flow is based on the All Subjects population.
Region of Enrollment [1]; Measure Type: Number; Unit of measure: Participants	Number Analyzed	229 participants
France		20
United States		70
Canada		20
Spain		6
Belgium		30
Austria		8
Netherlands		2
Germany		34
United Kingdom		9
Switzerland		4
Italy		24
Sweden		2
		[1] Measure Description: Baseline characteristics are based on the ITT population; Participant flow is based on the All Subjects population.

Outcome Measures

1. Primary Outcome

Title	Occurrence of at Least One Study-emergent Adverse Event During the Study (Maximum 164 Weeks)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Certolizumab Pegol 400 mg
Arm/Group Description:	400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Participants Analyzed	229
Measure Type: Number; Unit of Measure: percentage of participants
	92.6

2. Secondary Outcome

Title	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).
Description	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]

Outcome Measure Data

Analysis Population Description

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/Group Title	Certolizumab Pegol 400 mg
Arm/Group Description:	400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Participants Analyzed	166
Measure Type: Number; Unit of Measure: percentage of participants
	61.8

3. Secondary Outcome

Title	Clinical Response at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
Description	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]

Outcome Measure Data

Analysis Population Description

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/Group Title	Certolizumab Pegol 400 mg
Arm/Group Description:	400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Participants Analyzed	229
Measure Type: Number; Unit of Measure: percentage of participants
	53.3

4. Secondary Outcome

Title	Remission at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
Description	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]

Outcome Measure Data

Analysis Population Description

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/Group Title	Certolizumab Pegol 400 mg
Arm/Group Description:	400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Participants Analyzed	229
Measure Type: Number; Unit of Measure: percentage of participants
	40.6

5. Secondary Outcome

Title	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]
Description	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]

Outcome Measure Data

Analysis Population Description

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/Group Title	Certolizumab Pegol 400 mg
Arm/Group Description:	400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Participants Analyzed	215
Mean (Standard Deviation); Unit of Measure: score on a scale
	-121.52 (99.61)

6. Secondary Outcome

Title	Time to Loss of Response After Baseline of Study C87042 (NCT00308581) on Subjects Who Were in Clinical Response at Baseline of This Study
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Certolizumab Pegol 400 mg
Arm/Group Description:	400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Participants Analyzed	153
Median (Full Range); Unit of Measure: days
	169.5; (85 to 814)

7. Secondary Outcome

Title	Occurrence of at Least 1 Hospital Stay During the Treatment Period
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Certolizumab Pegol 400 mg
Arm/Group Description:	400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Participants Analyzed	229
Measure Type: Number; Unit of Measure: percentage of participants
	21.4

8. Secondary Outcome

Title	Occurrence of at Least 1 Hospital Stay During the Follow-Up Period
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Certolizumab Pegol 400 mg
Arm/Group Description:	400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Participants Analyzed	229
Measure Type: Number; Unit of Measure: percentage of participants
	21.8

9. Secondary Outcome

Title	Occurrence of at Least 1 Hospital Stay During the During the Overall Period
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Certolizumab Pegol 400 mg
Arm/Group Description:	400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Participants Analyzed	229
Measure Type: Number; Unit of Measure: percentage of participants
	37.6

10. Secondary Outcome

Title	Length of Hospital Stays During the Treatment Period
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Certolizumab Pegol 400 mg
Arm/Group Description:	400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Participants Analyzed	229
Mean (Standard Deviation); Unit of Measure: days
	1.838 (5.785)

11. Secondary Outcome

Title	Length of Hospital Stays During the Follow-Up Period
Description	Follow-up period starts the day after the last injection up to 84 days after last injection.
Time Frame	Maximum 12 weeks

Outcome Measure Data

Analysis Population Description

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/Group Title	Certolizumab Pegol 400 mg
Arm/Group Description:	400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Participants Analyzed	229
Mean (Standard Deviation); Unit of Measure: days
	2.782 (7.743)

12. Secondary Outcome

Title	Length of Hospital Stays During the Overall Period
Description	Overall period corresponds to both treatment and follow-up periods in C87046.
Time Frame	Maximum 164 weeks

Outcome Measure Data

Analysis Population Description

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/Group Title	Certolizumab Pegol 400 mg
Arm/Group Description:	400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Participants Analyzed	229
Mean (Standard Deviation); Unit of Measure: days
	4.620 (9.704)

13. Secondary Outcome

Title	Occurrence of at Least 1 Emergency Room Visit During the Treatment Period
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Certolizumab Pegol 400 mg
Arm/Group Description:	400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Participants Analyzed	229
Measure Type: Number; Unit of Measure: percentage of participants
	13.1

14. Secondary Outcome

Title	Occurrence of at Least 1 Emergency Room Visit During the Follow-Up Period
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Certolizumab Pegol 400 mg
Arm/Group Description:	400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Participants Analyzed	229
Measure Type: Number; Unit of Measure: percentage of participants
	6.1

15. Secondary Outcome

Title	Occurrence of at Least 1 Emergency Room Visit During the Overall Period
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Certolizumab Pegol 400 mg
Arm/Group Description:	400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Participants Analyzed	229
Measure Type: Number; Unit of Measure: percentage of participants
	19.2

16. Secondary Outcome

Title	Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Treatment Period
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Certolizumab Pegol 400 mg
Arm/Group Description:	400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Participants Analyzed	229
Measure Type: Number; Unit of Measure: percentage of participants
Anti tumor necrosis factor (Anti-TNF)	0.4
Immunosuppressants	3.9
Corticosteroids	24.0
5- Aminosalicylic Acid (5-ASA)	5.2
Antibiotics	55.5

17. Secondary Outcome

Title	Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Follow-Up Period
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Certolizumab Pegol 400 mg
Arm/Group Description:	400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Participants Analyzed	229
Measure Type: Number; Unit of Measure: percentage of participants
Anti tumor necrosis factor (Anti-TNF)	16.2
Immunosuppresants	5.2
Corticosteroids	15.3
5- Aminosalicylic Acid (5-ASA)	2.2
Antibiotics	14.0

18. Secondary Outcome

Title	Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Overall Period
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Certolizumab Pegol 400 mg
Arm/Group Description:	400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Participants Analyzed	229
Measure Type: Number; Unit of Measure: percentage of participants
Anti tumor necrosis factor (Anti-TNF)	16.2
Immunosuppressants	8.3
Corticosteroids	35.4
5- Aminosalicylic Acid (5-ASA)	7.0
Antibiotics	62.4

19. Secondary Outcome

Title	Occurrence of at Least 1 General Concomitant Medication During the Treatment Period
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Certolizumab Pegol 400 mg
Arm/Group Description:	400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Participants Analyzed	229
Measure Type: Number; Unit of Measure: participants
	185

20. Secondary Outcome

Title	Occurrence of at Least 1 General Concomitant Medication During the Follow-Up Period
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Certolizumab Pegol 400 mg
Arm/Group Description:	400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Participants Analyzed	229
Measure Type: Number; Unit of Measure: participants
	71

21. Secondary Outcome

Title	Occurrence of at Least 1 General Concomitant Medication During the Overall Period
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Certolizumab Pegol 400 mg
Arm/Group Description:	400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Participants Analyzed	229
Measure Type: Number; Unit of Measure: participants
	195

22. Secondary Outcome

Title	Occurrence of at Least 1 Concurrent Medical Procedure During the Treatment Period.
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Certolizumab Pegol 400 mg
Arm/Group Description:	400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Participants Analyzed	229
Measure Type: Number; Unit of Measure: participants
	148

23. Secondary Outcome

Title	Occurrence of at Least 1 Concurrent Medical Procedure During the Follow-Up Period
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Certolizumab Pegol 400 mg
Arm/Group Description:	400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Participants Analyzed	229
Measure Type: Number; Unit of Measure: participants
	84

24. Secondary Outcome

Title	Occurrence of at Least 1 Concurrent Medical Procedure During the Overall Period
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Certolizumab Pegol 400 mg
Arm/Group Description:	400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Participants Analyzed	229
Measure Type: Number; Unit of Measure: participants
	173

Adverse Events

Time Frame	Maximum of 166 weeks
Adverse Event Reporting Description	Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Arm/Group Title	Certolizumab Pegol 400 mg
Arm/Group Description	400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
All-Cause Mortality
	Certolizumab Pegol 400 mg
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	Certolizumab Pegol 400 mg
	Affected / at Risk (%)	# Events
Total	73/229 (31.88%)
Blood and lymphatic system disorders
Anaemia * 1	1/229 (0.44%)	1
Cardiac disorders
Supraventricular tachycardia * 1	1/229 (0.44%)	1
Ear and labyrinth disorders
Vertigo * 1	1/229 (0.44%)	1
Vertigo positional * 1	1/229 (0.44%)	1
Endocrine disorders
Diabetes insipidus * 1	1/229 (0.44%)	1
Gastrointestinal disorders
Abdominal hernia * 1	1/229 (0.44%)	1
Abdominal pain * 1	4/229 (1.75%)	5
Anal fistula * 1	2/229 (0.87%)	2
Ascites * 1	1/229 (0.44%)	1
Colonic stenosis * 1	5/229 (2.18%)	5
Constipation * 1	1/229 (0.44%)	1
Crohn's disease * 1	22/229 (9.61%)	23
Faecal incontinence * 1	1/229 (0.44%)	1
Frequent bowel movements * 1	1/229 (0.44%)	2
Gastrointestinal haemorrhage * 1	1/229 (0.44%)	1
Gastrointestinal obstruction * 1	1/229 (0.44%)	1
Gastrooesophageal reflux disease * 1	1/229 (0.44%)	1
Hernial eventration * 1	1/229 (0.44%)	1
Ileal stenosis * 1	1/229 (0.44%)	1
Intestinal obstruction * 1	2/229 (0.87%)	2
Intestinal stenosis * 1	2/229 (0.87%)	2
Pancreatitis * 1	1/229 (0.44%)	1
Rectal perforation * 1	1/229 (0.44%)	1
Small intestinal obstruction * 1	2/229 (0.87%)	2
Small intestinal stenosis * 1	1/229 (0.44%)	1
Vomiting * 1	1/229 (0.44%)	1
General disorders
Chest pain * 1	3/229 (1.31%)	3
Pyrexia * 1	1/229 (0.44%)	1
Hepatobiliary disorders
Cholecystitis * 1	1/229 (0.44%)	1
Hepatitis * 1	1/229 (0.44%)	1
Infections and infestations
Abdominal abscess * 1	5/229 (2.18%)	5
Abdominal wall abscess * 1	1/229 (0.44%)	1
Anal abscess * 1	2/229 (0.87%)	2
Breast abscess * 1	1/229 (0.44%)	1
Clostridial infection * 1	1/229 (0.44%)	1
Empyema * 1	1/229 (0.44%)	1
Fusobacterium infection * 1	1/229 (0.44%)	1
Gastroenteritis viral * 1	2/229 (0.87%)	2
Infective tenosynovitis * 1	1/229 (0.44%)	1
Parotitis * 1	1/229 (0.44%)	1
Perianal abscess * 1	5/229 (2.18%)	7
Perineal abscess * 1	1/229 (0.44%)	1
Perirectal abscess * 1	1/229 (0.44%)	1
Pneumonia * 1	2/229 (0.87%)	2
Rectal abscess * 1	1/229 (0.44%)	1
Sepsis * 1	1/229 (0.44%)	1
Septic shock * 1	1/229 (0.44%)	1
Tuberculosis * 1	1/229 (0.44%)	1
Urinary tract infection * 1	1/229 (0.44%)	1
Wound infection * 1	1/229 (0.44%)	1
Injury, poisoning and procedural complications
Anastomotic stenosis * 1	2/229 (0.87%)	3
Gastrointestinal stoma complication * 1	1/229 (0.44%)	1
Incisional hernia * 1	2/229 (0.87%)	2
Tendon rupture * 1	1/229 (0.44%)	1
Wound complication * 1	1/229 (0.44%)	1
Investigations
Alanine aminotransferase increased * 1	1/229 (0.44%)	1
Weight decreased * 1	2/229 (0.87%)	2
Metabolism and nutrition disorders
Dehydration * 1	1/229 (0.44%)	1
Hypoalbuminaemia * 1	1/229 (0.44%)	1
Hypokalaemia * 1	2/229 (0.87%)	2
Malnutrition * 1	2/229 (0.87%)	2
Musculoskeletal and connective tissue disorders
Arthralgia * 1	1/229 (0.44%)	1
Fistula * 1	2/229 (0.87%)	4
Nervous system disorders
Cerebral infarction * 1	1/229 (0.44%)	1
Dizziness * 1	1/229 (0.44%)	1
Hemiparesis * 1	1/229 (0.44%)	1
Hyporeflexia * 1	1/229 (0.44%)	1
Syncope * 1	1/229 (0.44%)	1
Wallenberg syndrome * 1	1/229 (0.44%)	1
Psychiatric disorders
Anxiety * 1	1/229 (0.44%)	1
Depression * 1	1/229 (0.44%)	1
Mental disorder * 1	1/229 (0.44%)	1
Renal and urinary disorders
Bladder prolapse * 1	1/229 (0.44%)	1
Nephrolithiasis * 1	1/229 (0.44%)	1
Renal colic * 1	1/229 (0.44%)	1
Renal failure acute * 1	1/229 (0.44%)	1
Reproductive system and breast disorders
Ovarian cyst * 1	1/229 (0.44%)	1
Skin and subcutaneous tissue disorders
Acute febrile neutrophilic dermatosis * 1	1/229 (0.44%)	1
Pustular psoriasis * 1	1/229 (0.44%)	1
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA (9.0)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Certolizumab Pegol 400 mg
	Affected / at Risk (%)	# Events
Total	190/229 (82.97%)
Gastrointestinal disorders
Abdominal pain * 1	45/229 (19.65%)	63
Abdominal pain upper * 1	18/229 (7.86%)	23
Anal fissure * 1	14/229 (6.11%)	16
Constipation * 1	14/229 (6.11%)	20
Crohn's disease * 1	41/229 (17.90%)	48
Diarrhoea * 1	33/229 (14.41%)	44
Haematochezia * 1	14/229 (6.11%)	16
Nausea * 1	23/229 (10.04%)	43
Vomiting * 1	24/229 (10.48%)	34
General disorders
Asthenia * 1	12/229 (5.24%)	15
Fatigue * 1	21/229 (9.17%)	29
Pyrexia * 1	47/229 (20.52%)	93
Infections and infestations
Bronchitis * 1	23/229 (10.04%)	33
Gastroenteritis * 1	16/229 (6.99%)	20
Herpes simplex * 1	24/229 (10.48%)	39
Influenza * 1	30/229 (13.10%)	35
Nasopharyngitis * 1	63/229 (27.51%)	117
Sinusitis * 1	23/229 (10.04%)	30
Upper respiratory tract infection * 1	12/229 (5.24%)	15
Urinary tract infection * 1	19/229 (8.30%)	31
Musculoskeletal and connective tissue disorders
Arthralgia * 1	44/229 (19.21%)	68
Back pain * 1	27/229 (11.79%)	31
Muscle spasms * 1	12/229 (5.24%)	16
Pain in extremity * 1	12/229 (5.24%)	19
Nervous system disorders
Headache * 1	47/229 (20.52%)	80
Respiratory, thoracic and mediastinal disorders
Cough * 1	28/229 (12.23%)	31
Pharyngolaryngeal pain * 1	21/229 (9.17%)	27
Skin and subcutaneous tissue disorders
Rash * 1	20/229 (8.73%)	37
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA (9.0)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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.

Results Point of Contact

• Name/Title: UCB Clinical Trial Call Center
• Organization: UCB, Inc
• Phone: +1 877 822 9493

• Responsible Party: UCB Pharma
• ClinicalTrials.gov Identifier: NCT00333788
• Other Study ID Numbers: C87046; 2006-001729-24 ( EudraCT Number )
• First Submitted: June 2, 2006
• First Posted: June 6, 2006
• Results First Submitted: April 13, 2011
• Results First Posted: July 12, 2011
• Last Update Posted: August 7, 2018