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A follow-on Safety Study of CDP870 in Subjects With Crohn's Disease (CD) Who Have Completed a 26-week Double Blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] (PRECiSE 3)

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: NCT00160524
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : October 10, 2013
Last Update Posted : August 1, 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 596
Recruitment Details

This multicenter study started to enroll subjects in July 2004 in order to end up with 206 centers in 29 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 All subjects who completed the Week 26 assessment in feeder studies C87031 and C87032 were eligible to enter this open-label follow-on study C87033.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description

400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.

Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study.

Period Title: Overall Study
Started 595 [1]
Completed 117
Not Completed 478
Reason Not Completed
Adverse Event             119
Adverse Event and Other             94
Protocol Violation             16
Protocol Violation and Other             2
Withdrawal by Subject             141
Withdrawal by Subject and Other             17
Physician Decision             27
Physician Decision and Other             6
Lost to Follow-up             13
Lost to Follow-up and Other             1
Lack of Efficacy             21
Lack of Efficacy and Other             1
Other             20
[1]
One subject was enrolled erroneously and has no data in the database.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description

400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.

Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study.

Overall Number of Baseline Participants 595
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 595 participants
<=18 years
7
   1.2%
Between 18 and 65 years
574
  96.5%
>=65 years
14
   2.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 595 participants
38.1  (11.87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 595 participants
Female
307
  51.6%
Male
288
  48.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 595 participants
Belarus 12
United States 98
Serbia 29
Estonia 4
Hong Kong 2
Spain 1
Ukraine 18
Israel 13
Russian Federation 22
Italy 14
Denmark 21
Australia 30
South Africa 45
Latvia 4
Slovenia 15
Lithuania 1
Austria 4
Czech Republic 54
Hungary 48
Canada 17
Belgium 6
Poland 72
Singapore 2
Georgia 1
Bulgaria 20
Germany 21
Norway 7
New Zealand 10
Sweden 4
1.Primary Outcome
Title Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of the Study CDP870-033 (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 364) and the Safety Follow-up (Week 374)
Hide Outcome Measure Data
Hide Analysis Population Description
All 595 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:

400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.

Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study.

Overall Number of Participants Analyzed 595
Measure Type: Number
Unit of Measure: percentage of subjects
88.2
2.Primary Outcome
Title Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of This Study CDP870-033 (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 364) and the Safety Follow-up (Week 374)
Hide Outcome Measure Data
Hide Analysis Population Description
All 595 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:

400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.

Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study.

Overall Number of Participants Analyzed 595
Measure Type: Number
Unit of Measure: percentage of subjects
40.3
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 364) / (Early) Withdrawal Visit
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 594 subjects in the Intention-To-Treat (ITT) Population, 592 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:

400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.

Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study.

Overall Number of Participants Analyzed 592
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
54.7
(50.7 to 58.7)
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 Week 0 of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to Study Completion Visit (Week 364) of this study (up to 90 months) or (Early) Withdrawal Visit
Hide Outcome Measure Data
Hide Analysis Population Description
All 594 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:

400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.

Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study.

Overall Number of Participants Analyzed 594
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
21.7
(18.4 to 25.0)
5.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 364) / (Early) Withdrawal Visit
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 595 subjects in the Safety Population, 590 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:

400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.

Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study.

Overall Number of Participants Analyzed 590
Geometric Mean (95% Confidence Interval)
Unit of Measure: μg/mL
5.578
(4.898 to 6.352)
6.Secondary Outcome
Title Percentage of Subjects With Positive Anti-CZP Anti-body Status at Any Time From Week 0 of the Feeder Study CDP870-031 or CDP870-032 to the Study Completion Visit in CDP870-033
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] to Study Completion Visit (Week 364) of CDP870-033 (up to 90 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 595 subjects in the Safety Population, 593 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:

400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.

Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study.

Overall Number of Participants Analyzed 593
Measure Type: Number
Unit of Measure: percentage of subjects
22.6
7.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 364) / (Early) Withdrawal Visit
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 594 subjects in the Intention-To-Treat (ITT) Population, 593 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:

400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.

Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study.

Overall Number of Participants Analyzed 593
Geometric Mean (95% Confidence Interval)
Unit of Measure: mg/L
7.93
(7.14 to 8.81)
8.Secondary Outcome
Title Faecal Calprotectin Level at Week 258 Visit or (Early) Withdrawal Visit, if it is Earlier Than Week 258
Hide Description [Not Specified]
Time Frame Week 258 / (Early) Withdrawal Visit, if it is earlier than Week 258
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 594 subjects in the Intention-To-Treat (ITT) Population, 567 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:

400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.

Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study.

Overall Number of Participants Analyzed 567
Geometric Mean (95% Confidence Interval)
Unit of Measure: μg/g stool
302.540
(267.759 to 341.839)
Time Frame Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374).
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

400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.

Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. 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   240/595 (40.34%)    
Blood and lymphatic system disorders   
Anaemia * 1  6/595 (1.01%)  6
Neutropenia * 1  3/595 (0.50%)  3
Iron deficiency anaemia * 1  2/595 (0.34%)  3
Lymphadenitis * 1  2/595 (0.34%)  2
Pancytopenia * 1  2/595 (0.34%)  2
Leukopenia * 1  1/595 (0.17%)  1
Thrombocytopenia * 1  1/595 (0.17%)  1
Cardiac disorders   
Cardiac failure * 1  1/595 (0.17%)  1
Myocardial ischaemia * 1  1/595 (0.17%)  2
Gastrointestinal disorders   
Crohn's disease * 1  67/595 (11.26%)  75
Small intestinal obstruction * 1  13/595 (2.18%)  16
Intestinal obstruction * 1  10/595 (1.68%)  10
Abdominal pain * 1  9/595 (1.51%)  9
Ileal stenosis * 1  7/595 (1.18%)  7
Perirectal abscess * 1  5/595 (0.84%)  5
Anal fistula * 1  4/595 (0.67%)  5
Pancreatitis acute * 1  3/595 (0.50%)  3
Subileus * 1  3/595 (0.50%)  4
Vomiting * 1  3/595 (0.50%)  3
Gastritis * 1  2/595 (0.34%)  2
Inguinal hernia * 1  2/595 (0.34%)  2
Intestinal mass * 1  2/595 (0.34%)  2
Large intestine perforation * 1  2/595 (0.34%)  2
Nausea * 1  2/595 (0.34%)  2
Rectovaginal fistula * 1  2/595 (0.34%)  2
Abdominal hernia * 1  1/595 (0.17%)  1
Anal haemorrhage * 1  1/595 (0.17%)  1
Anal inflammation * 1  1/595 (0.17%)  1
Anal stenosis * 1  1/595 (0.17%)  1
Colonic stenosis * 1  1/595 (0.17%)  1
Constipation * 1  1/595 (0.17%)  1
Dyspepsia * 1  1/595 (0.17%)  1
Dysphagia * 1  1/595 (0.17%)  2
Enterovesical fistula * 1  1/595 (0.17%)  1
Gastric ulcer * 1  1/595 (0.17%)  1
Gastrointestinal mucosal disorder * 1  1/595 (0.17%)  1
Gastrooesophageal reflux disease * 1  1/595 (0.17%)  1
Haemorrhoids * 1  1/595 (0.17%)  1
Intestinal fistula * 1  1/595 (0.17%)  1
Intestinal stenosis * 1  1/595 (0.17%)  1
Jejunal stenosis * 1  1/595 (0.17%)  1
Mouth ulceration * 1  1/595 (0.17%)  1
Oesophageal perforation * 1  1/595 (0.17%)  1
Oesophageal stenosis acquired * 1  1/595 (0.17%)  2
Pancreatitis * 1  1/595 (0.17%)  1
Peritoneal adhesions * 1  1/595 (0.17%)  1
Proctalgia * 1  1/595 (0.17%)  5
Rectal haemorrhage * 1  1/595 (0.17%)  1
Small intestinal perforation * 1  1/595 (0.17%)  1
Small intestinal stricture * 1  1/595 (0.17%)  1
Stomatitis * 1  1/595 (0.17%)  1
Upper gastrointestinal haemorrhage * 1  1/595 (0.17%)  1
General disorders   
General physical health deterioration * 1  1/595 (0.17%)  1
Impaired healing * 1  1/595 (0.17%)  1
Pain * 1  1/595 (0.17%)  1
Hepatobiliary disorders   
Cholelithiasis * 1  2/595 (0.34%)  2
Autoimmune hepatitis * 1  1/595 (0.17%)  1
Biliary cirrhosis * 1  1/595 (0.17%)  1
Biliary colic * 1  1/595 (0.17%)  1
Gallbladder non-functioning * 1  1/595 (0.17%)  1
Hepatic cirrhosis * 1  1/595 (0.17%)  1
Liver disorder * 1  1/595 (0.17%)  1
Immune system disorders   
Sarcoidosis * 1  1/595 (0.17%)  1
Infections and infestations   
Perianal abscess * 1  9/595 (1.51%)  10
Abdominal abscess * 1  8/595 (1.34%)  9
Pneumonia * 1  7/595 (1.18%)  7
Gastroenteritis * 1  6/595 (1.01%)  7
Cellulitis * 1  3/595 (0.50%)  3
Disseminated tuberculosis * 1  3/595 (0.50%)  3
Pulmonary tuberculosis * 1  3/595 (0.50%)  3
Urinary tract infection * 1  3/595 (0.50%)  3
Bronchitis * 1  2/595 (0.34%)  2
Bronchopneumonia * 1  2/595 (0.34%)  2
Gastroenteritis viral * 1  2/595 (0.34%)  2
Postoperative abscess * 1  2/595 (0.34%)  4
Pyelonephritis * 1  2/595 (0.34%)  2
Sepsis * 1  2/595 (0.34%)  2
Staphylococcal infection * 1  2/595 (0.34%)  2
Subcutaneous abscess * 1  2/595 (0.34%)  2
Abscess * 1  1/595 (0.17%)  1
Abscess intestinal * 1  1/595 (0.17%)  1
Acute tonsillitis * 1  1/595 (0.17%)  1
Anal abscess * 1  1/595 (0.17%)  1
Bronchitis acute * 1  1/595 (0.17%)  1
Campylobacter gastroenteritis * 1  1/595 (0.17%)  1
Candidiasis * 1  1/595 (0.17%)  1
Cellulitis orbital * 1  1/595 (0.17%)  1
Chronic tonsillitis * 1  1/595 (0.17%)  1
Clostridial infection * 1  1/595 (0.17%)  1
Enterocolitis infectious * 1  1/595 (0.17%)  1
Epiglottitis * 1  1/595 (0.17%)  1
Erysipelas * 1  1/595 (0.17%)  1
Fungal infection * 1  1/595 (0.17%)  1
Gastroenteritis clostridial * 1  1/595 (0.17%)  1
Groin abscess * 1  1/595 (0.17%)  1
Herpes Zoster * 1  1/595 (0.17%)  1
Lobar pneumonia * 1  1/595 (0.17%)  1
Localised infection * 1  1/595 (0.17%)  1
Lung abscess * 1  1/595 (0.17%)  1
Oesophageal candidiasis * 1  1/595 (0.17%)  1
Osteomyelitis acute * 1  1/595 (0.17%)  1
Pelvic abscess * 1  1/595 (0.17%)  1
Pelvic inflammatory disease * 1  1/595 (0.17%)  1
Perineal abscess * 1  1/595 (0.17%)  1
Pneumonia bacterial * 1  1/595 (0.17%)  1
Pneumonia haemophilus * 1  1/595 (0.17%)  1
Pneumonia streptococcal * 1  1/595 (0.17%)  1
Rectal abscess * 1  1/595 (0.17%)  2
Salpingitis * 1  1/595 (0.17%)  1
Staphylococcal sepsis * 1  1/595 (0.17%)  1
Streptococcal sepsis * 1  1/595 (0.17%)  1
Tracheobronchitis * 1  1/595 (0.17%)  1
Viral infection * 1  1/595 (0.17%)  1
Wound infection * 1  1/595 (0.17%)  1
Injury, poisoning and procedural complications   
Postoperative fever * 1  2/595 (0.34%)  3
Tibia fracture * 1  2/595 (0.34%)  2
Animal bite * 1  1/595 (0.17%)  1
Ankle fracture * 1  1/595 (0.17%)  1
Femur fracture * 1  1/595 (0.17%)  1
Haemothorax * 1  1/595 (0.17%)  1
Hand fracture * 1  1/595 (0.17%)  1
Hip fracture * 1  1/595 (0.17%)  1
Incisional hernia * 1  1/595 (0.17%)  1
Joint dislocation * 1  1/595 (0.17%)  1
Lower limb fracture * 1  1/595 (0.17%)  2
Meniscus lesion * 1  1/595 (0.17%)  1
Pelvic fracture * 1  1/595 (0.17%)  1
Pneumothorax traumatic * 1  1/595 (0.17%)  1
Polytraumatism * 1  1/595 (0.17%)  1
Post procedural diarrhoea * 1  1/595 (0.17%)  1
Post procedural pain * 1  1/595 (0.17%)  1
Tendon injury * 1  1/595 (0.17%)  1
Wrist fracture * 1  1/595 (0.17%)  1
Investigations   
Autoantibody positive * 1  1/595 (0.17%)  1
International normalised ratio increased * 1  1/595 (0.17%)  1
Weight decreased * 1  1/595 (0.17%)  1
Metabolism and nutrition disorders   
Dehydration * 1  1/595 (0.17%)  1
Hypoalbuminaemia * 1  1/595 (0.17%)  1
Malnutrition * 1  1/595 (0.17%)  1
Musculoskeletal and connective tissue disorders   
Intervertebral disc protrusion * 1  3/595 (0.50%)  3
Arthralgia * 1  1/595 (0.17%)  1
Bone erosion * 1  1/595 (0.17%)  1
Chondropathy * 1  1/595 (0.17%)  1
Fistula * 1  1/595 (0.17%)  1
Flank pain * 1  1/595 (0.17%)  1
Sacroiliitis * 1  1/595 (0.17%)  1
Scleroderma * 1  1/595 (0.17%)  1
Spondylolisthesis acquired * 1  1/595 (0.17%)  1
Synovitis * 1  1/595 (0.17%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Uterine leiomyoma * 1  3/595 (0.50%)  3
Basal cell carcinoma * 1  2/595 (0.34%)  2
Small intestine carcinoma * 1  2/595 (0.34%)  2
Laryngeal cancer * 1  1/595 (0.17%)  1
Lentigo maligna stage unspecified * 1  1/595 (0.17%)  1
Lip neoplasm malignant stage unspecified * 1  1/595 (0.17%)  1
Medullary thyroid cancer * 1  1/595 (0.17%)  1
Metastatic malignant melanoma * 1  1/595 (0.17%)  1
Non-small cell lung cancer * 1  1/595 (0.17%)  1
Prostate cancer * 1  1/595 (0.17%)  1
Rectal cancer * 1  1/595 (0.17%)  1
Squamous cell carcinoma * 1  1/595 (0.17%)  1
Squamous cell carcinoma of skin * 1  1/595 (0.17%)  1
Nervous system disorders   
Spinal column stenosis * 1  2/595 (0.34%)  2
Arachnoid cyst * 1  1/595 (0.17%)  1
Cauda equina syndrome * 1  1/595 (0.17%)  1
Cerebral infarction * 1  1/595 (0.17%)  1
Cerebrovascular accident * 1  1/595 (0.17%)  1
Sciatica * 1  1/595 (0.17%)  1
Transient ischaemic attack * 1  1/595 (0.17%)  1
Trigeminal neuralgia * 1  1/595 (0.17%)  1
Pregnancy, puerperium and perinatal conditions   
Pregnancy * 1  2/595 (0.34%)  2
Unintended pregnancy * 1  2/595 (0.34%)  2
Pregnancy on oral contraceptive * 1  1/595 (0.17%)  1
Psychiatric disorders   
Suicide attempt * 1  1/595 (0.17%)  1
Renal and urinary disorders   
Nephrolithiasis * 1  5/595 (0.84%)  5
Calculus ureteric * 1  2/595 (0.34%)  3
Dysuria * 1  1/595 (0.17%)  1
Glomerulonephritis focal * 1  1/595 (0.17%)  1
Renal colic * 1  1/595 (0.17%)  1
Renal tubular acidosis * 1  1/595 (0.17%)  1
Reproductive system and breast disorders   
Ovarian cyst * 1  3/595 (0.50%)  3
Azoospermia * 1  1/595 (0.17%)  1
Dysfunctional uterine bleeding * 1  1/595 (0.17%)  1
Endometriosis * 1  1/595 (0.17%)  1
Epididymitis * 1  1/595 (0.17%)  1
Female genital-digestive tract fistula * 1  1/595 (0.17%)  1
Menometrorrhagia * 1  1/595 (0.17%)  1
Metrorrhagia * 1  1/595 (0.17%)  1
Ovarian disorder * 1  1/595 (0.17%)  1
Prostatitis * 1  1/595 (0.17%)  1
Respiratory, thoracic and mediastinal disorders   
Asphyxia * 1  1/595 (0.17%)  1
Dyspnoea * 1  1/595 (0.17%)  1
Interstitial lung disease * 1  1/595 (0.17%)  1
Nasal septum deviation * 1  1/595 (0.17%)  1
Pneumonia aspiration * 1  1/595 (0.17%)  1
Skin and subcutaneous tissue disorders   
Alopecia totalis * 1  1/595 (0.17%)  1
Dermatitis allergic * 1  1/595 (0.17%)  1
Psoriasis * 1  1/595 (0.17%)  1
Social circumstances   
Pregnancy of partner * 1  3/595 (0.50%)  3
Surgical and medical procedures   
Abortion induced * 1  1/595 (0.17%)  1
Vascular disorders   
Deep vein thrombosis * 1  1/595 (0.17%)  1
Haematoma * 1  1/595 (0.17%)  1
Lymphangitis * 1  1/595 (0.17%)  1
Raynaud's phenomenon * 1  1/595 (0.17%)  2
Thrombophlebitis superficial * 1  1/595 (0.17%)  1
Venous thrombosis limb * 1  1/595 (0.17%)  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   410/595 (68.91%)    
Blood and lymphatic system disorders   
Anaemia * 1  34/595 (5.71%)  43
Gastrointestinal disorders   
Crohn's disease * 1  130/595 (21.85%)  189
Abdominal pain * 1  89/595 (14.96%)  152
Diarrhoea * 1  64/595 (10.76%)  85
Nausea * 1  50/595 (8.40%)  83
Dyspepsia * 1  39/595 (6.55%)  46
Vomiting * 1  33/595 (5.55%)  48
General disorders   
Pyrexia * 1  56/595 (9.41%)  98
Infections and infestations   
Nasopharyngitis * 1  91/595 (15.29%)  201
Urinary tract infection * 1  82/595 (13.78%)  160
Influenza * 1  72/595 (12.10%)  105
Upper respiratory tract infection * 1  63/595 (10.59%)  110
Sinusitis * 1  43/595 (7.23%)  77
Gastroenteritis * 1  41/595 (6.89%)  52
Bronchitis * 1  37/595 (6.22%)  52
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  70/595 (11.76%)  99
Back pain * 1  41/595 (6.89%)  52
Nervous system disorders   
Headache * 1  60/595 (10.08%)  99
Psychiatric disorders   
Insomnia * 1  30/595 (5.04%)  39
Respiratory, thoracic and mediastinal disorders   
Cough * 1  35/595 (5.88%)  42
Skin and subcutaneous tissue disorders   
Rash * 1  40/595 (6.72%)  51
Vascular disorders   
Hypertension * 1  34/595 (5.71%)  37
*
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: NCT00160524     History of Changes
Other Study ID Numbers: C87033
2005-002622-60 ( EudraCT Number )
First Submitted: September 8, 2005
First Posted: September 12, 2005
Results First Submitted: August 2, 2013
Results First Posted: October 10, 2013
Last Update Posted: August 1, 2018