ClinicalTrials.gov
ClinicalTrials.gov Menu

A follow-on Safety Study in Subjects With Crohn's Disease Who Have Previously Been Withdrawn From the Double-blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] Due to an Exacerbation of Crohn's Disease (PRECiSE 4)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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:
Information provided by (Responsible Party):
UCB Pharma ( UCB Pharma SA )

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

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
Hide 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
Arm/Group Title Certolizumab Pegol
Hide 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
Hide 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
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)
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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)
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Hide Description [Not Specified]
Time Frame Study Completion Visit (Week 362) / (Early) Withdrawal Visit
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Hide Description [Not Specified]
Time Frame Week 256 / (Early) Withdrawal Visit, if it is earlier than Week 256
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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)
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
Hide 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   --/--    
Show Serious Adverse Events Hide 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
Show Other (Not Including Serious) Adverse Events Hide 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
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)
Responsible Party: UCB Pharma ( UCB Pharma SA )
ClinicalTrials.gov Identifier: NCT00160706     History of Changes
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