A follow-on Safety Study in Subjects With Crohn's Disease Who Have Previously Been Withdrawn From the Double-blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] Due to an Exacerbation of Crohn's Disease (PRECiSE 4)

• ClinicalTrials.gov Identifier: NCT00160706
• Recruitment Status: Completed
• First Posted: September 12, 2005
• Results First Posted: July 4, 2013
• Last Update Posted: August 7, 2018
• Sponsor: UCB Pharma SA
• Information provided by (Responsible Party): UCB Pharma ( UCB Pharma SA )

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Crohn's Disease
• Intervention: Biological: Certolizumab Pegol (CDP870)
• Enrollment: 310

Participant Flow

Recruitment Details	This multicenter study started to enroll subjects in February 2004 in order to end up with 141 centers in 24 countries with enrolled subjects. Participant Flow refers to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].
Pre-assignment Details	Subjects who withdrew from feeder studies for worsening of Crohn's Disease entered study C87034. Subjects in study C87031 were eligible for entry into C87034 at any time after completing the Week 2 assessment, subjects in study C87032 at any time after completing the Week 6 randomisation.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description	3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360. Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360. Up to 84 months of therapy in this study.
Period Title: Overall Study
Started	310
Completed	24
Not Completed	286
Reason Not Completed
Adverse Event	53
Adverse Event and Other Reason	105
Protocol Violation	3
Withdrawal by Subject	41
Withdrawal by Subject and Other	12
Physician Decision	10
Physician Decision and Other	3
Lost to Follow-up	4
Lost to Follow-up and Other	1
Lack of Efficacy	42
Lack of Efficacy and Other	1
Other Reason	11

Baseline Characteristics

Arm/Group Title		Certolizumab Pegol
Arm/Group Description		3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360. Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360. Up to 84 months of therapy in this study.
Overall Number of Baseline Participants		310
Baseline Analysis Population Description		Baseline Characteristics refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	310 participants
	<=18 years	2 0.6%
	Between 18 and 65 years	299 96.5%
	>=65 years	9 2.9%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	310 participants
		36.5 (11.67)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	310 participants
	Female	179 57.7%
	Male	131 42.3%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants	Number Analyzed	310 participants
Serbia		4
United States		74
Belarus		2
Estonia		5
Slovenia		3
Spain		1
Ukraine		3
Austria		7
Russian Federation		17
Israel		5
Italy		5
Czech Republic		10
Hungary		13
Canada		9
Poland		10
Belgium		8
Singapore		2
Australia		43
Denmark		11
South Africa		31
Bulgaria		1
Norway		7
Germany		29
New Zealand		10

Outcome Measures

1. Primary Outcome

Title	Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of This Study CDP870-034 (up to 84 Months)
Description	An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Time Frame	Up to 84 months from Study Entry (Week 0) to the Study End (Week 362 ) and the Safety Follow-up (Week 372)

Outcome Measure Data

Analysis Population Description

All 310 subjects in the Safety Population are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360. Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360. Up to 84 months of therapy in this study.
Overall Number of Participants Analyzed	310
Measure Type: Number; Unit of Measure: percentage of subjects
	94.2

2. Primary Outcome

Title	Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of This Study CDP870-034 (up to 84 Months)
Description	An SAE is defined as any untoward medical occurrence that occurs at any dose which results in death, is life threatening requires hospitalization, results in persistent/significant disability/incapacity, is an infection that requires parenteral antibiotics, is a congenital anomaly/birth defect, or is an important medical event.
Time Frame	Up to 84 months from Study Entry (Week 0) to the Study End (Week 362 ) and the Safety Follow-up (Week 372)

Outcome Measure Data

Analysis Population Description

All 310 subjects in the Safety Population are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360. Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360. Up to 84 months of therapy in this study.
Overall Number of Participants Analyzed	310
Measure Type: Number; Unit of Measure: percentage of subjects
	44.5

3. Secondary Outcome

Title	Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit or (Early) Withdrawal Visit
Description	HBI remission is defined as total HBI score of 4 points or less. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day.
Time Frame	Study Completion Visit (Week 362) / (Early) Withdrawal Visit

Outcome Measure Data

Analysis Population Description

All 309 subjects in the Intention-To-Treat (ITT) Population are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360. Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360. Up to 84 months of therapy in this study.
Overall Number of Participants Analyzed	309
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of subjects
	34.6; (29.3 to 39.9)

4. Secondary Outcome

Title	Percentage of Subjects in Harvey Bradshaw Index (HBI) Response (HBI Change ≥ 3) at Study Completion Visit or (Early) Withdrawal Visit From Week 0 of Feeder Study CDP870-031 or CDP870-032
Description	Response is defined as decrease in total Harvey Bradshaw Index (HBI) score of 3 or more points. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day.
Time Frame	From Baseline of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to Study Completion Visit (Week 362) or (Early) Withdrawal Visit of this study (up to 90 months)

Outcome Measure Data

Analysis Population Description

Of the 309 subjects in the Intention-To-Treat (ITT) Population, 307 subjects are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360. Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360. Up to 84 months of therapy in this study.
Overall Number of Participants Analyzed	307
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of subjects
	52.8; (47.2 to 58.4)

5. Secondary Outcome

Title	Percentage of Subjects in Harvey Bradshaw Index (HBI) Response (HBI Change ≥ 3) at Study Completion Visit or (Early) Withdrawal Visit From Week 0 of CDP870-034
Description	Response is defined as decrease in total Harvey Bradshaw Index (HBI) score of 3 or more points. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day.
Time Frame	From Week 0 of study CDP870-034 to Study Completion Visit (Week 362) or (Early) Withdrawal Visit (up to 84 months)

Outcome Measure Data

Analysis Population Description

Of the 309 subjects in the Intention-To-Treat (ITT) Population, 299 subjects are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360. Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360. Up to 84 months of therapy in this study.
Overall Number of Participants Analyzed	299
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of subjects
	65.6; (60.2 to 70.9)

6. Secondary Outcome

Title	Plasma Concentration of Certolizumab Pegol at Study Completion Visit or (Early) Withdrawal Visit
Description	Plasma Samples for determination of Certolizumab Pegol were taken prior to Certolizumab Pegol administration.
Time Frame	Study Completion Visit (Week 362) / (Early) Withdrawal Visit

Outcome Measure Data

Analysis Population Description

Of the 310 subjects in the Safety Population, 307 subjects are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360. Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360. Up to 84 months of therapy in this study.
Overall Number of Participants Analyzed	307
Geometric Mean (95% Confidence Interval); Unit of Measure: µg/mL
	5.870; (4.915 to 7.009)

7. Secondary Outcome

Title	Percentage of Subjects With Positive Anti-CZP Anti-body Status at Any Time From Week 0 of the Feeder Studies CDP870-031 or CDP870-032 to the Study Completion Visit in CDP870-034
Description	Subjects are counted as antibody positive to Certolizumab Pegol if they have at least one positive result from Week 0 in one of the previous studies CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to the last Visit in this study. A positive result is defined as Anti-CZP antibody levels > 2.4 units/mL.
Time Frame	From Week 0 of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] up to Study Completion Visit (Week 362) of CDP870-034 (up to 90 months)

Outcome Measure Data

Analysis Population Description

Of the 310 subjects in the Safety Population, 309 subjects are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360. Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360. Up to 84 months of therapy in this study.
Overall Number of Participants Analyzed	309
Measure Type: Number; Unit of Measure: percentage of subjects
	23.6

8. Secondary Outcome

Title	C-Reactive Protein (CRP) Level at Study Completion Visit or (Early) Withdrawal Visit
Description	[Not Specified]
Time Frame	Study Completion Visit (Week 362) / (Early) Withdrawal Visit

Outcome Measure Data

Analysis Population Description

All 309 subjects in the Intention-To-Treat (ITT) Population are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360. Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360. Up to 84 months of therapy in this study.
Overall Number of Participants Analyzed	309
Geometric Mean (95% Confidence Interval); Unit of Measure: mg/L
	10.78; (9.28 to 12.53)

9. Secondary Outcome

Title	Fecal Calprotectin Level at Week 256 or (Early) Withdrawal Visit, if it is Earlier Than Week 256
Description	[Not Specified]
Time Frame	Week 256 / (Early) Withdrawal Visit, if it is earlier than Week 256

Outcome Measure Data

Analysis Population Description

Of the 309 subjects in the Intention-To-Treat (ITT) Population, 280 subjects are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360. Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360. Up to 84 months of therapy in this study.
Overall Number of Participants Analyzed	280
Geometric Mean (95% Confidence Interval); Unit of Measure: µg/g stool
	460.784; (382.149 to 555.599)

Adverse Events

Time Frame	Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 372).
Adverse Event Reporting Description	Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].
Arm/Group Title	Certolizumab Pegol
Arm/Group Description	3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360. Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360. Up to 84 months of therapy in this study.
All-Cause Mortality
	Certolizumab Pegol
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	Certolizumab Pegol
	Affected / at Risk (%)	# Events
Total	138/310 (44.52%)
Blood and lymphatic system disorders
Anaemia * 1	5/310 (1.61%)	5
Secondary anaemia * 1	2/310 (0.65%)	2
Iron deficiency anaemia * 1	1/310 (0.32%)	1
Cardiac disorders
Acute coronary syndrome * 1	1/310 (0.32%)	1
Myocardial infarction * 1	1/310 (0.32%)	1
Myocardial ischaemia * 1	1/310 (0.32%)	1
Congenital, familial and genetic disorders
Pigmented naevus * 1	1/310 (0.32%)	1
Eye disorders
Glaucoma * 1	1/310 (0.32%)	1
Optic neuritis * 1	1/310 (0.32%)	1
Gastrointestinal disorders
Crohn's disease * 1	49/310 (15.81%)	50
Abdominal pain * 1	8/310 (2.58%)	8
Small intestinal obstruction * 1	7/310 (2.26%)	9
Colonic stenosis * 1	2/310 (0.65%)	2
Gastrointestinal haemorrhage * 1	2/310 (0.65%)	2
Haemorrhoids * 1	2/310 (0.65%)	2
Ileal stenosis * 1	2/310 (0.65%)	2
Intestinal obstruction * 1	2/310 (0.65%)	3
Irritable bowel syndrome * 1	2/310 (0.65%)	3
Perirectal abscess * 1	2/310 (0.65%)	2
Vomiting * 1	2/310 (0.65%)	2
Abdominal hernia obstructive * 1	1/310 (0.32%)	1
Abdominal pain upper * 1	1/310 (0.32%)	1
Anal discomfort * 1	1/310 (0.32%)	1
Anal fissure * 1	1/310 (0.32%)	1
Aphthous stomatitis * 1	1/310 (0.32%)	1
Constipation * 1	1/310 (0.32%)	1
Diarrhoea * 1	1/310 (0.32%)	1
Duodenal ulcer haemorrhage * 1	1/310 (0.32%)	1
Duodenitis * 1	1/310 (0.32%)	1
Enterovesical fistula * 1	1/310 (0.32%)	1
Faecaloma * 1	1/310 (0.32%)	1
Gastritis erosive * 1	1/310 (0.32%)	1
Gastroduodenitis * 1	1/310 (0.32%)	1
Gastrointestinal disorder * 1	1/310 (0.32%)	1
Gastrointestinal irritation * 1	1/310 (0.32%)	1
Gastrooesophageal reflux disease * 1	1/310 (0.32%)	1
Intestinal fistula * 1	1/310 (0.32%)	1
Intestinal perforation * 1	1/310 (0.32%)	1
Jejunal perforation * 1	1/310 (0.32%)	1
Large intestine perforation * 1	1/310 (0.32%)	1
Mechanical ileus * 1	1/310 (0.32%)	1
Nausea * 1	1/310 (0.32%)	1
Oesophageal ulcer * 1	1/310 (0.32%)	1
Pancreatitis acute * 1	1/310 (0.32%)	1
Peritonitis * 1	1/310 (0.32%)	1
Rectal stenosis * 1	1/310 (0.32%)	1
Rectovaginal fistula * 1	1/310 (0.32%)	1
Small intestinal stricture * 1	1/310 (0.32%)	1
General disorders
Pyrexia * 1	3/310 (0.97%)	3
Chest pain * 1	2/310 (0.65%)	2
General physical health deterioration * 1	1/310 (0.32%)	1
Impaired healing * 1	1/310 (0.32%)	1
Non-cardiac chest pain * 1	1/310 (0.32%)	1
Hepatobiliary disorders
Bile duct stone * 1	1/310 (0.32%)	1
Hepatitis toxic * 1	1/310 (0.32%)	1
Infections and infestations
Perianal abscess * 1	9/310 (2.90%)	10
Abdominal abscess * 1	4/310 (1.29%)	4
Sepsis * 1	4/310 (1.29%)	4
Abscess intestinal * 1	2/310 (0.65%)	2
Pneumonia * 1	2/310 (0.65%)	2
Subcutaneous abscess * 1	2/310 (0.65%)	3
Urinary tract infection * 1	2/310 (0.65%)	2
Anal fistula infection * 1	1/310 (0.32%)	1
Appendiceal abscess * 1	1/310 (0.32%)	1
Breast abscess * 1	1/310 (0.32%)	1
Bronchitis acute * 1	1/310 (0.32%)	1
Cystitis acute * 1	1/310 (0.32%)	1
Gastrointestinal infection * 1	1/310 (0.32%)	1
Genital abscess * 1	1/310 (0.32%)	1
Influenza * 1	1/310 (0.32%)	1
Kidney infection * 1	1/310 (0.32%)	1
Mastitis * 1	1/310 (0.32%)	1
Pelvic abscess * 1	1/310 (0.32%)	1
Staphylococcal infection * 1	1/310 (0.32%)	1
Tonsillitis streptococcal * 1	1/310 (0.32%)	1
Viral infection * 1	1/310 (0.32%)	1
Injury, poisoning and procedural complications
Anastomotic leak * 1	1/310 (0.32%)	1
Cartilage injury * 1	1/310 (0.32%)	1
Foot fracture * 1	1/310 (0.32%)	1
Joint injury * 1	1/310 (0.32%)	1
Medical device complication * 1	1/310 (0.32%)	1
Meniscus lesion * 1	1/310 (0.32%)	1
Postoperative haematoma * 1	1/310 (0.32%)	1
Venom poisoning * 1	1/310 (0.32%)	1
Investigations
Haemoglobin decreased * 1	1/310 (0.32%)	1
Sperm analysis abnormal * 1	1/310 (0.32%)	1
Metabolism and nutrition disorders
Dehydration * 1	2/310 (0.65%)	2
Hypoalbuminaemia * 1	2/310 (0.65%)	2
Acidosis * 1	1/310 (0.32%)	1
Hypocalcaemia * 1	1/310 (0.32%)	1
Hypomagnesaemia * 1	1/310 (0.32%)	1
Musculoskeletal and connective tissue disorders
Fistula * 1	3/310 (0.97%)	3
Arthralgia * 1	2/310 (0.65%)	2
Back pain * 1	2/310 (0.65%)	3
Groin pain * 1	1/310 (0.32%)	1
Osteoporotic fracture * 1	1/310 (0.32%)	1
Tendon disorder * 1	1/310 (0.32%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma * 1	3/310 (0.97%)	3
Breast cancer metastatic * 1	1/310 (0.32%)	1
Metastatic malignant melanoma * 1	1/310 (0.32%)	1
Non-Hodgkin's lymphoma * 1	1/310 (0.32%)	1
Squamous cell carcinoma of skin * 1	1/310 (0.32%)	1
Uterine leiomyoma * 1	1/310 (0.32%)	1
Nervous system disorders
Convulsion * 1	1/310 (0.32%)	1
Syncope * 1	1/310 (0.32%)	1
Pregnancy, puerperium and perinatal conditions
Pregnancy * 1	2/310 (0.65%)	2
Abortion spontaneous * 1	1/310 (0.32%)	1
Pregnancy on oral contraceptive * 1	1/310 (0.32%)	1
Unintended pregnancy * 1	1/310 (0.32%)	1
Psychiatric disorders
Alcoholism * 1	1/310 (0.32%)	1
Bipolar I Disorder * 1	1/310 (0.32%)	1
Depression * 1	1/310 (0.32%)	1
Post-traumatic stress disorder * 1	1/310 (0.32%)	1
Psychological factor affecting medical condition * 1	1/310 (0.32%)	1
Suicide attempt * 1	1/310 (0.32%)	1
Renal and urinary disorders
Calculus ureteric * 1	3/310 (0.97%)	4
Nephrolithiasis * 1	3/310 (0.97%)	3
Renal failure acute * 1	1/310 (0.32%)	1
Vesical fistula * 1	1/310 (0.32%)	1
Reproductive system and breast disorders
Cervical dysplasia * 1	1/310 (0.32%)	1
Endometrioma * 1	1/310 (0.32%)	1
Endometriosis * 1	1/310 (0.32%)	1
Respiratory, thoracic and mediastinal disorders
Alveolitis allergic * 1	1/310 (0.32%)	1
Chronic obstructive airways disease exacerbated * 1	1/310 (0.32%)	1
Skin and subcutaneous tissue disorders
Acute febrile neutrophilic dermatosis * 1	1/310 (0.32%)	1
Urticaria generalised * 1	1/310 (0.32%)	1
Social circumstances
Refusal of treatment by patient * 1	1/310 (0.32%)	1
Vascular disorders
Deep vein thrombosis * 1	1/310 (0.32%)	1
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA 6.1
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Certolizumab Pegol
	Affected / at Risk (%)	# Events
Total	248/310 (80.00%)
Blood and lymphatic system disorders
Anaemia * 1	18/310 (5.81%)	23
Gastrointestinal disorders
Crohn's disease * 1	107/310 (34.52%)	138
Abdominal pain * 1	62/310 (20.00%)	98
Diarrhoea * 1	41/310 (13.23%)	61
Nausea * 1	40/310 (12.90%)	55
Vomiting * 1	32/310 (10.32%)	50
Constipation * 1	18/310 (5.81%)	24
Anal fissure * 1	17/310 (5.48%)	29
Dyspepsia * 1	17/310 (5.48%)	20
Abdominal pain upper * 1	16/310 (5.16%)	18
General disorders
Pyrexia * 1	32/310 (10.32%)	45
Fatigue * 1	20/310 (6.45%)	24
Influenza like illness * 1	17/310 (5.48%)	21
Infections and infestations
Nasopharyngitis * 1	44/310 (14.19%)	71
Urinary tract infection * 1	36/310 (11.61%)	60
Influenza * 1	34/310 (10.97%)	56
Upper respiratory tract infection * 1	34/310 (10.97%)	69
Sinusitis * 1	26/310 (8.39%)	45
Gastroenteritis * 1	18/310 (5.81%)	23
Musculoskeletal and connective tissue disorders
Arthralgia * 1	49/310 (15.81%)	65
Back pain * 1	29/310 (9.35%)	38
Nervous system disorders
Headache * 1	48/310 (15.48%)	61
Psychiatric disorders
Anxiety * 1	19/310 (6.13%)	28
Insomnia * 1	19/310 (6.13%)	22
Depression * 1	18/310 (5.81%)	20
Skin and subcutaneous tissue disorders
Rash * 1	25/310 (8.06%)	30
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA 6.1

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.

Results Point of Contact

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

Publications of Results:

Sandborn WJ, Schreiber S, Hanauer SB, Colombel JF, Bloomfield R, Lichtenstein GR; PRECiSE 4 Study Investigators. Reinduction with certolizumab pegol in patients with relapsed Crohn's disease: results from the PRECiSE 4 Study. Clin Gastroenterol Hepatol. 2010 Aug;8(8):696-702.e1. doi: 10.1016/j.cgh.2010.03.024. Epub 2010 Apr 2.

• Responsible Party: UCB Pharma ( UCB Pharma SA )
• ClinicalTrials.gov Identifier: NCT00160706
• Other Study ID Numbers: C87034; 2005-002623-13 ( EudraCT Number )
• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Results First Submitted: May 16, 2013
• Results First Posted: July 4, 2013
• Last Update Posted: August 7, 2018