Trial Outcomes & Findings for Mucosal Healing Study in Crohn's Disease (CD) (NCT NCT00297648)

Last Updated: 2011-08-31

Results Overview

The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation, thus a negative change from Baseline (i.e., Week 10 score minus Baseline score) indicates improvement.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

89 participants

Primary outcome timeframe

Baseline, Week 10

Results posted on

2011-08-31

Participant Flow

Patients were recruited in sites from Germany, France and Belgium between February 2006 and October 2007. The last patient attended their Week 54 visit in December 2009.

Participant milestones

Participant milestones
Measure	CDP870 400 mg Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Overall Study STARTED	89
Overall Study COMPLETED	53
Overall Study NOT COMPLETED	36

Reasons for withdrawal

Reasons for withdrawal
Measure	CDP870 400 mg Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Overall Study Adverse Event	13
Overall Study Lack of Efficacy	18
Overall Study Lost to Follow-up	1
Overall Study Withdrawal by Subject	3
Overall Study Other: Incompliance	1

Baseline Characteristics

Mucosal Healing Study in Crohn's Disease (CD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CDP870 400 mg n=89 Participants Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Age, Categorical <=18 years	4 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	85 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	30.19 years STANDARD_DEVIATION 9.88 • n=5 Participants
Sex: Female, Male Female	59 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants
Region of Enrollment France	68 participants n=5 Participants
Region of Enrollment Belgium	16 participants n=5 Participants
Region of Enrollment Germany	5 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 10

Population: Of the 89 patients in the Intent to Treat Population, 78 patients had data at both Baseline and Week 10, and are included in this summary. Change from Baseline has been calculated as the Week 10 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	CDP870 400 mg n=78 Participants Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Local Non-blinded Assessments	-6.47 score on a scale 95% Confidence Interval 5.01 • Interval -7.6 to -5.34

PRIMARY outcome

Timeframe: Baseline, Week 10

Population: Of the 89 patients in the Intent to Treat Population, 44 patients were in the subpopulation with a blinded assessment at Week 10 and Baseline, and are included in this summary. Change from Baseline has been calculated as the Week 10 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	CDP870 400 mg n=44 Participants Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Central Blinded Assessments	-3.79 Score on a scale Interval -5.08 to -2.5

SECONDARY outcome

Timeframe: Week 10

Population: Of the 89 patients in the Intent to Treat Population, 78 patients had data at Week 10, and are included in this summary. Percentage of patients is calculated by dividing the number of patients who achieved mucosal healing at Week 10 by the total number of patients with data collected, multiplied by 100.

Mucosal healing is defined as complete absence of ulceration contribution in the CDEIS (Crohn's Disease Endoscopic Index of Severity) score

Outcome measures

Outcome measures
Measure	CDP870 400 mg n=78 Participants Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Percentage of Patients Achieving Mucosal Healing at Week 10 Using Local Non-blinded Assessments	5.1 percentage of patients Interval 1.4 to 12.6

SECONDARY outcome

Timeframe: Week 10

Population: Of the 89 patients in the Intent to Treat Population, 51 patients were in the subpopulation who had a blinded assessment at Week 10 and are included here. Percentage of patients is calculated by dividing the number of patients who achieved mucosal healing at Week 10 by the total number of patients with data collected, multiplied by 100.

Mucosal healing is defined as complete absence of ulceration contribution in the CDEIS (Crohn's Disease Endoscopic Index of Severity) score

Outcome measures

Outcome measures
Measure	CDP870 400 mg n=51 Participants Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Percentage of Patients Achieving Mucosal Healing at Week 10 Using Central Blinded Assessments	3.9 percentage of patients Interval 0.5 to 13.5

SECONDARY outcome

Timeframe: Week 54

Population: Of the 89 patients in the Intent to Treat Population, 53 patients had data at Week 54, and are included in this summary. Percentage of patients is calculated by dividing the number of patients who achieved mucosal healing at Week 54 by the total number of patients with data collected, multiplied by 100.

Mucosal healing is defined as complete absence of ulceration contribution in the CDEIS (Crohn's Disease Endoscopic Index of Severity) score

Outcome measures

Outcome measures
Measure	CDP870 400 mg n=53 Participants Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Percentage of Patients Achieving Mucosal Healing at Week 54 Using Local Non-blinded Assessments	13.2 percentage of patients Interval 5.5 to 25.3

SECONDARY outcome

Timeframe: Week 54

Population: Of the 89 patients in the Intent to Treat Population, 33 patients were in the subpopulation who had a blinded assessment at Week 54 and are included here. Percentage of patients is calculated by dividing the number of patients who achieved mucosal healing at Week 54 by the total number of patients with data collected, multiplied by 100.

Mucosal healing is defined as complete absence of ulceration contribution in the CDEIS (Crohn's Disease Endoscopic Index of Severity) score

Outcome measures

Outcome measures
Measure	CDP870 400 mg n=33 Participants Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Percentage of Patients Achieving Mucosal Healing at Week 54 Using Central Blinded Assessments	3.0 percentage of patients Interval 0.1 to 15.8

SECONDARY outcome

Timeframe: Baseline, Week 10

Population: Of the 89 patients in the Intent to Treat Population, 78 patients had data at Week 10 and at Baseline, and are included here. Percentage of patients is calculated by dividing the number of patients with a CDEIS decrease of at least 5 points at Week 10 by the number of patients with CDEIS data at both Baseline and Week 10, multiplied by 100.

Outcome measures

Outcome measures
Measure	CDP870 400 mg n=78 Participants Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Percentage of Patients With Endoscopic Response (Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 10 Using Local Non-blinded Assessments	61.5 percentage of patients Interval 49.8 to 72.3

SECONDARY outcome

Timeframe: Baseline, Week 10

Population: Of the 89 patients in the Intent to Treat Population, 44 patients had a blinded assessment at Week 10 and at Baseline, and are included here. Percentage patients is calculated by dividing the number of patients with a CDEIS decrease of at least 5 points at Week 10 by the number of patients with CDEIS data at Baseline and Week 10, multiplied by 100.

Outcome measures

Outcome measures
Measure	CDP870 400 mg n=44 Participants Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Percentage of Patients With Endoscopic Response (Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 10 Using Central Blinded Assessments	38.6 percentage of patients Interval 24.4 to 54.5

SECONDARY outcome

Timeframe: Baseline, Week 54

Population: Of the 89 patients in the Intent to Treat Population, 53 patients had data at Week 54 and at Baseline, and are included here. Percentage of patients is calculated by dividing the number of patients with a CDEIS decrease of at least 5 points at Week 54 by the number of patients with CDEIS data at both Baseline and Week 54, multiplied by 100.

Outcome measures

Outcome measures
Measure	CDP870 400 mg n=53 Participants Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Percentage of Patients With Endoscopic Response (Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 54 Using Local Non-blinded Assessments	62.3 percentage of patients Interval 47.9 to 75.2

SECONDARY outcome

Timeframe: Baseline, Week 54

Population: Of 89 patients in the Intent to Treat Population 28 had matching nonblinded/blinded assessments and are in the subpopulation with blinded assessment at Week 54 and Baseline. Percentage is calculated by dividing the number patients with CDEIS decrease of at least 5 points at Week 54 by the number with CDEIS at Baseline and Week 54, multiplied by 100

Outcome measures

Outcome measures
Measure	CDP870 400 mg n=28 Participants Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Percentage of Patients With Endoscopic Response (Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 54 Using Central Blinded Assessments	39.3 percentage of patients Interval 21.5 to 59.4

SECONDARY outcome

Timeframe: Week 10

Population: Of the 89 patients in the Intent to Treat Population, 78 patients had data at Week 10, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score \<6 at Week 10 by the total number of patients with CDEIS data at Week 10, multiplied by 100.

Outcome measures

Outcome measures
Measure	CDP870 400 mg n=78 Participants Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Percentage of Patients With Endoscopic Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 10 Using Local Non-blinded Assessments	42.3 percentage of patients Interval 31.2 to 54.0

SECONDARY outcome

Timeframe: Week 10

Population: Of the 89 patients in the Intent to Treat Population, 44 patients had a blinded assessment at Week 10 and Baseline, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score \<6 at Week 10 by the total number of patients with CDEIS data at Week 10, multiplied by 100.

Outcome measures

Outcome measures
Measure	CDP870 400 mg n=44 Participants Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Percentage of Patients With Endoscopic Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 10 Using Central Blinded Assessments	45.5 percentage of patients Interval 30.4 to 61.2

SECONDARY outcome

Timeframe: Week 54

Population: Of the 89 patients in the Intent to Treat Population, 53 patients had data at Week 54, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score \<6 at Week 54 by the total number of patients with CDEIS data at Week 54, multiplied by 100.

Outcome measures

Outcome measures
Measure	CDP870 400 mg n=53 Participants Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Percentage of Patients With Endoscopic Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 54 Using Local Non-blinded Assessments	28.3 percentage of patients Interval 16.8 to 42.3

SECONDARY outcome

Timeframe: Week 54

Population: Of 89 patients in the Intent to Treat Population, 28 had matching nonblinded/blinded assessments and were in the subpopulation with a blinded assessment at Week 54 and Baseline. Percentage is calculated by dividing the number of patients with a CDEIS score \<6 at Week 54 by the total number of patients with CDEIS data at Week 54, multiplied by 100.

Outcome measures

Outcome measures
Measure	CDP870 400 mg n=28 Participants Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Percentage of Patients With Endoscopic Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 54 Using Central Blinded Assessments	32.1 percentage of patients Interval 15.9 to 52.4

SECONDARY outcome

Timeframe: Week 10

Population: Of the 89 patients in the Intent to Treat Population, 78 patients had data at Week 10, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score \<3 at Week 10 by the total number of patients with CDEIS data at Week 10, multiplied by 100.

Outcome measures

Outcome measures
Measure	CDP870 400 mg n=78 Participants Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Percentage of Patients With Endoscopic Complete Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 3) at Week 10 Using Local Non-blinded Assessments	11.5 percentage of patients Interval 5.4 to 20.8

SECONDARY outcome

Timeframe: Week 10

Population: Of the 89 patients in the Intent to Treat Population, 44 patients had a blinded assessment at Week 10 and Baseline, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score \<3 at Week 10 by the total number of patients with CDEIS data at Week 10, multiplied by 100.

Outcome measures

Outcome measures
Measure	CDP870 400 mg n=44 Participants Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Percentage of Patients With Endoscopic Complete Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 3) at Week 10 Using Central Blinded Assessments	20.5 percentage of patients Interval 9.8 to 35.3

SECONDARY outcome

Timeframe: Week 54

Population: Of the 89 patients in the Intent to Treat Population, 53 patients had data at Week 54, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score \<3 at Week 54 by the total number of patients with CDEIS data at Week 54, multiplied by 100.

Outcome measures

Outcome measures
Measure	CDP870 400 mg n=53 Participants Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Percentage of Patients With Endoscopic Complete Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 3) at Week 54 Using Local Non-blinded Assessments	18.9 percentage of patients Interval 9.4 to 32.0

SECONDARY outcome

Timeframe: Week 54

Population: Of 89 patients in the Intent to Treat Population, 28 had matching nonblinded/blinded assessments and were in the subpopulation with a blinded assessment at Week 54 and Baseline. Percentage is calculated by dividing the number of patients with a CDEIS score \<3 at Week 54 by the total number of patients with CDEIS data at Week 54, multiplied by 100.

Outcome measures

Outcome measures
Measure	CDP870 400 mg n=28 Participants Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Percentage of Patients With Endoscopic Complete Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 3) at Week 54 Using Central Blinded Assessments	17.9 percentage of patients Interval 6.1 to 36.9

SECONDARY outcome

Timeframe: Baseline, Week 10

Population: Of the 89 patients in the Intent to Treat Population, 75 patients had data at Week 10 and at Baseline for the blinded assessment, and are included in this summary. Change from Baseline has been calculated as the Week 10 score minus the Baseline score, thus a negative change from Baseline indicates improvement.

The histological Crohn's disease score combines active inflammatory changes: infiltration of mononuclear cells, polymorphonuclear cells, presence of erosions and/or ulcers, and chronic architectural changes. Scores range from 0 to 44, with higher scores indicating greater disease.

Outcome measures

Outcome measures
Measure	CDP870 400 mg n=75 Participants Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Change From Baseline in Histological Crohn's Disease Score at Week 10 Using Central Blinded Assessment	-1.4 score on a scale Standard Deviation 3.7

SECONDARY outcome

Timeframe: Baseline, Week 54

Population: Of the 89 patients in the Intent to Treat Population, 52 patients had data at Week 54 and at Baseline for blinded assessment, and are included in this summary. Change from Baseline has been calculated as the Week 54 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	CDP870 400 mg n=52 Participants Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Change From Baseline in Histological Crohn's Disease Score at Week 54 Using Central Blinded Assessment	-2.5 score on a scale Standard Deviation 4.3

SECONDARY outcome

Timeframe: Baseline, Week 10

Population: The 89 patients from Intent to Treat Population are included in this summary. In case of missing CDAI score, patients are counted as non-responders. Percentage is calculated by dividing the number of patients with a CDAI decrease of at least 100 points at Week 10 by the total number of patients in the Intent to Treat Population, multiplied by 100.

Crohn's disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). 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.

Outcome measures

Outcome measures
Measure	CDP870 400 mg n=89 Participants Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Percentage of Patients Achieving Crohn's Disease Activity Index (CDAI) Response (Defined as a Decrease of at Least 100 Points in CDAI Score From Baseline) at Week 10	50.6 percentage of patients Interval 39.8 to 61.3

SECONDARY outcome

Timeframe: Baseline, Week 54

Population: The 89 patients from Intent to Treat Population are included in this summary. In case of missing CDAI score, patients are counted as non-responders. Percentage is calculated by dividing the number of patients with a CDAI decrease of at least 100 points at Week 54 by the total number of patients in the Intent to Treat Population, multiplied by 100.

Outcome measures

Outcome measures
Measure	CDP870 400 mg n=89 Participants Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Percentage of Patients Achieving Crohn's Disease Activity Index (CDAI) Response (Defined as a Decrease of at Least 100 Points in CDAI Score From Baseline) at Week 54	32.6 percentage of patients Interval 23.0 to 43.3

SECONDARY outcome

Timeframe: Week 10

Population: The 89 patients from Intent to Treat Population are included in this summary. In case of missing CDAI score, patients are counted as remitters. Percentage is calculated by dividing the number of patients with a CDAI less than or equal to 150 points at Week 10 by the total number of patients in the Intent to Treat Population, multiplied by 100.

Outcome measures

Outcome measures
Measure	CDP870 400 mg n=89 Participants Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Percentage of Patients Achieving Crohn's Disease Activity Index (CDAI) Remission (Defined as a CDAI Score Less Than or Equal to 150) at Week 10	46.1 percentage of patients Interval 35.4 to 57.0

SECONDARY outcome

Timeframe: Week 54

Population: The 89 patients from Intent to Treat Population are included in this summary. In case of missing CDAI score, patients are counted as remitters. Percentage is calculated by dividing the number of patients with a CDAI less than or equal to 150 points at Week 54 by the total number of patients in the Intent to Treat Population, multiplied by 100.

Outcome measures

Outcome measures
Measure	CDP870 400 mg n=89 Participants Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Percentage of Patients Achieving Crohn's Disease Activity Index (CDAI) Remission (Defined as a CDAI Score Less Than or Equal to 150) at Week 54	27.0 percentage of patients Interval 18.1 to 37.4

SECONDARY outcome

Timeframe: Week 10

Population: Of the 89 patients in the Intent to Treat Population, 76 patients had plasma level data at Week 10 and are included in this summary.

Outcome measures

Outcome measures
Measure	CDP870 400 mg n=76 Participants Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Geometric Mean C-Reactive Protein (CRP) Level (mg/L) at Week 10	6.84 mg/L Interval 0.2 to 219.3

SECONDARY outcome

Timeframe: Baseline, Week 10

Population: Of the 89 patients in the Intent to Treat Population, 76 patients had plasma levels taken at Week 10 and Baseline and are included in this summary. Ratio is calculated as the Week 10 value divided by the Baseline value for patients with data at both timepoints.

Ratio is calculated as the Week 10 value divided by the Baseline value for patients with data at both timepoints.

Outcome measures

Outcome measures
Measure	CDP870 400 mg n=76 Participants Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Ratio to Baseline of C-Reactive Protein (CRP) Level (mg/L) at Week 10	0.40 ratio Interval 0.0 to 23.1

SECONDARY outcome

Timeframe: Week 52

Population: Of the 89 patients in the Intent to Treat Population, 51 patients had plasma level data at Week 54 and are included in this summary.

Outcome measures

Outcome measures
Measure	CDP870 400 mg n=51 Participants Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Geometric Mean C-Reactive Protein (CRP) Level (mg/L) at Week 52	10.24 mg/L Interval 0.3 to 99.5

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: Of the 89 patients in the Intent to Treat Population, 51 patients had plasma level data at Week 54 and Baseline and are included in this summary. Ratio was calculated by dividing the Week 54 value by the Baseline value for the patients with data at both timepoints.

The ratio is calculated as the Week 52 value divided by Baseline value for patients with data at both timepoints.

Outcome measures

Outcome measures
Measure	CDP870 400 mg n=51 Participants Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Ratio to Baseline of C-Reactive Protein (CRP) Level (mg/L) at Week 52	0.52 ratio Interval 0.0 to 16.6

SECONDARY outcome

Timeframe: Week 10

Population: Of the 89 patients in the Intent to Treat Population, 73 patients had plasma level data and a CDAI score at Week 10 and are included in this summary.

Outcome measures

Outcome measures
Measure	CDP870 400 mg n=73 Participants Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Crohn's Disease Activity Index (CDAI) Score at Week 10	0.043 Pearson Correlation Coefficient Interval 0.0 to 0.27

SECONDARY outcome

Timeframe: Week 10

Population: Of the 89 patients in the Intent to Treat Population, 76 patients had plasma level data and a CDEIS score at Week 10 and are included in this summary.

Outcome measures

Outcome measures
Measure	CDP870 400 mg n=76 Participants Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Crohn's Disease Endoscopic Index of Severity (CDEIS) Score at Week 10 Using Local Non-blinded Assessment	0.131 Pearson Correlation Coefficient Interval 0.0 to 0.346

SECONDARY outcome

Timeframe: Week 10

Population: Of the 89 patients in the Intent to Treat Population, 51 patients were in the subpopulation with a blinded assessment at Week 10. 48 patients had both CDEIS and CRP data at Week 10.

Outcome measures

Outcome measures
Measure	CDP870 400 mg n=48 Participants Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Crohn's Disease Endoscopic Index of Severity (CDEIS) Score at Week 10 Using Central Blinded Assessment	0.646 Pearson Correlation Coefficient Interval 0.443 to 0.786

SECONDARY outcome

Timeframe: Week 10

Population: Of the 89 patients in the Intent to Treat Population, 72 patients had plasma data and histological Crohn's disease score assessment at Week 10, and are included in this summary.

Outcome measures

Outcome measures
Measure	CDP870 400 mg n=72 Participants Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Histological Crohn's Disease Score at Week 10 Using Central Blinded Assessment	0.086 Pearson Correlation Coefficient Interval 0.0 to 0.312

SECONDARY outcome

Timeframe: Baseline, Week 54

Population: Of the 89 patients in the Intent to Treat Population, 52 had a CDEIS score at Week 54 and at Baseline and are included here. Change from Baseline has been calculated as the Week 54 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	CDP870 400 mg n=52 Participants Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Change From Baseline in Crohn's Disease Endoscopic Index of Severity (CDEIS) Score at Week 54 Using Local Non-blinded Assessment	-5.49 score on a scale Standard Deviation 7.02

SECONDARY outcome

Timeframe: Baseline, Week 54

Population: Of 89 patients in the Intent to Treat Population, 28 had matching nonblinded/blinded assessments and were in the subpopulation with a blinded assessment at Week 54 and Baseline. Change from Baseline has been calculated as the Week 54 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	CDP870 400 mg n=28 Participants Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Change From Baseline in Crohn's Disease Endoscopic Index of Severity (CDEIS) Score at Week 54 Using Central Blinded Assessment	-2.95 score on a scale Standard Deviation 7.13

SECONDARY outcome

Timeframe: Baseline, Week 10

Population: Of the 89 patients in the Intent to Treat Population, 73 patients had data at both Baseline and Week 10, and are included in this summary. Change from Baseline has been calculated as the Week 10 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	CDP870 400 mg n=73 Participants Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 10	-148.82 score on a scale Standard Deviation 109.61

SECONDARY outcome

Timeframe: Baseline, Week 54

Population: Of the 89 patients in the Intent to Treat Population, 39 had CDAI scores at Week 54 and Baseline and are included in this summary. Change from Baseline has been calculated as the Week 54 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	CDP870 400 mg n=39 Participants Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 54	-169.59 score on a scale Standard Deviation 109.98

Adverse Events

CDP870 400 mg

Serious events: 34 serious events

Other events: 83 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CDP870 400 mg n=89 participants at risk Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Infections and infestations Abdominal abscess	1.1% 1/89 • Number of events 1 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Gastrointestinal disorders Abdominal pain	3.4% 3/89 • Number of events 3 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Infections and infestations Abdominal wall abscess	1.1% 1/89 • Number of events 1 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Gastrointestinal disorders Abdominal wall mass	1.1% 1/89 • Number of events 1 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Blood and lymphatic system disorders Anaemia	1.1% 1/89 • Number of events 1 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Infections and infestations Anal abscess	5.6% 5/89 • Number of events 6 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Gastrointestinal disorders Anal fistula	2.2% 2/89 • Number of events 2 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Musculoskeletal and connective tissue disorders Arthritis	1.1% 1/89 • Number of events 2 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
General disorders Asthenia	1.1% 1/89 • Number of events 1 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Infections and infestations Bacteraemia	1.1% 1/89 • Number of events 1 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Hepatobiliary disorders Cholelithiasis	1.1% 1/89 • Number of events 1 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Infections and infestations Clostridial infection	1.1% 1/89 • Number of events 1 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Infections and infestations Colitis pseudomembranous	1.1% 1/89 • Number of events 1 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	1.1% 1/89 • Number of events 1 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Gastrointestinal disorders Crohn's disease	5.6% 5/89 • Number of events 6 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Metabolism and nutrition disorders Dehydration	1.1% 1/89 • Number of events 1 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Gastrointestinal disorders Diarrhoea	4.5% 4/89 • Number of events 4 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Gastrointestinal disorders Enterocutaneous fistula	1.1% 1/89 • Number of events 1 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Gastrointestinal disorders Gastrointestinal haemorrhage	1.1% 1/89 • Number of events 1 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Infections and infestations Genital abscess	1.1% 1/89 • Number of events 1 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Gastrointestinal disorders Haematochezia	1.1% 1/89 • Number of events 1 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Infections and infestations Herpes zoster	1.1% 1/89 • Number of events 1 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
General disorders Hyperthermia	1.1% 1/89 • Number of events 1 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Gastrointestinal disorders Ileal stenosis	1.1% 1/89 • Number of events 1 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Gastrointestinal disorders Intestinal obstruction	1.1% 1/89 • Number of events 1 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Injury, poisoning and procedural complications Joint dislocation	1.1% 1/89 • Number of events 1 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Injury, poisoning and procedural complications Keratorhexis	1.1% 1/89 • Number of events 1 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Gastrointestinal disorders Large intestine perforation	1.1% 1/89 • Number of events 1 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Infections and infestations Localised infection	1.1% 1/89 • Number of events 1 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Metabolism and nutrition disorders Malnutrition	2.2% 2/89 • Number of events 2 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Musculoskeletal and connective tissue disorders Pain in extremity	1.1% 1/89 • Number of events 1 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Infections and infestations Perianal abscess	3.4% 3/89 • Number of events 3 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Infections and infestations Perineal abscess	1.1% 1/89 • Number of events 1 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Reproductive system and breast disorders Perineal fistula	2.2% 2/89 • Number of events 2 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pregnancy on oral contraceptive	1.1% 1/89 • Number of events 1 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Skin and subcutaneous tissue disorders Purpura	1.1% 1/89 • Number of events 1 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Infections and infestations Pyelonephritis	1.1% 1/89 • Number of events 1 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
General disorders Pyrexia	2.2% 2/89 • Number of events 2 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Immune system disorders Serum sickness	1.1% 1/89 • Number of events 1 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Reproductive system and breast disorders Uterine haemorrhage	1.1% 1/89 • Number of events 1 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Gastrointestinal disorders Vomiting	1.1% 1/89 • Number of events 1 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.

Other adverse events

Other adverse events
Measure	CDP870 400 mg n=89 participants at risk Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Gastrointestinal disorders Abdominal pain	20.2% 18/89 • Number of events 21 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Gastrointestinal disorders Abdominal pain upper	11.2% 10/89 • Number of events 14 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Skin and subcutaneous tissue disorders Acne	10.1% 9/89 • Number of events 9 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Blood and lymphatic system disorders Anaemia	9.0% 8/89 • Number of events 10 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Gastrointestinal disorders Anal fissure	16.9% 15/89 • Number of events 18 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Gastrointestinal disorders Anal fistula	6.7% 6/89 • Number of events 6 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Psychiatric disorders Anxiety	5.6% 5/89 • Number of events 7 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Gastrointestinal disorders Aphthous stomatitis	11.2% 10/89 • Number of events 10 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Musculoskeletal and connective tissue disorders Arthralgia	30.3% 27/89 • Number of events 43 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
General disorders Asthenia	20.2% 18/89 • Number of events 22 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Musculoskeletal and connective tissue disorders Back pain	7.9% 7/89 • Number of events 10 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Infections and infestations Bronchitis	10.1% 9/89 • Number of events 12 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Respiratory, thoracic and mediastinal disorders Cough	5.6% 5/89 • Number of events 6 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Gastrointestinal disorders Crohn's disease	12.4% 11/89 • Number of events 11 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Gastrointestinal disorders Diarrhoea	14.6% 13/89 • Number of events 20 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Nervous system disorders Dizziness	7.9% 7/89 • Number of events 8 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Gastrointestinal disorders Dyspepsia	6.7% 6/89 • Number of events 7 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
General disorders Fatigue	7.9% 7/89 • Number of events 7 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Infections and infestations Gastroenteritis	9.0% 8/89 • Number of events 9 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Gastrointestinal disorders Haemorrhoids	9.0% 8/89 • Number of events 10 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Nervous system disorders Headache	33.7% 30/89 • Number of events 56 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Infections and infestations Herpes simplex	12.4% 11/89 • Number of events 16 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Infections and infestations Influenza	7.9% 7/89 • Number of events 7 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
General disorders Influenza like illness	7.9% 7/89 • Number of events 7 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
General disorders Injection site erythema	7.9% 7/89 • Number of events 8 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Psychiatric disorders Insomnia	11.2% 10/89 • Number of events 10 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Metabolism and nutrition disorders Iron deficiency	5.6% 5/89 • Number of events 5 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Musculoskeletal and connective tissue disorders Muscle spasms	6.7% 6/89 • Number of events 8 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Infections and infestations Nasopharyngitis	23.6% 21/89 • Number of events 37 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Gastrointestinal disorders Nausea	18.0% 16/89 • Number of events 26 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Skin and subcutaneous tissue disorders Night sweats	5.6% 5/89 • Number of events 5 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Infections and infestations Pharyngitis	12.4% 11/89 • Number of events 12 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	12.4% 11/89 • Number of events 12 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Gastrointestinal disorders Proctalgia	5.6% 5/89 • Number of events 6 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Skin and subcutaneous tissue disorders Pruritus	7.9% 7/89 • Number of events 7 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
General disorders Pyrexia	16.9% 15/89 • Number of events 20 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Gastrointestinal disorders Rectal haemorrhage	5.6% 5/89 • Number of events 5 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Infections and infestations Rhinitis	9.0% 8/89 • Number of events 9 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Infections and infestations Sinusitis	6.7% 6/89 • Number of events 7 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Infections and infestations Urinary tract infection	9.0% 8/89 • Number of events 14 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Metabolism and nutrition disorders Vitamin B12 deficiency	6.7% 6/89 • Number of events 6 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Gastrointestinal disorders Vomiting	12.4% 11/89 • Number of events 14 • The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.

Additional Information

UCB Clinical Trial Call Center

UCB Pharma

Phone: +1 877 822 9493

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

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