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Trial record 1 of 1 for:    NCT00552344
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A Study to Evaluate Safety of Long Term Therapy of Certolizumab Pegol Patients With Crohn's Disease

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: NCT00552344
Recruitment Status : Completed
First Posted : November 1, 2007
Results First Posted : January 21, 2016
Last Update Posted : August 9, 2018
Sponsor:
Collaborator:
PPD
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES GmbH )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Crohn Disease
Intervention Biological: Cimzia
Enrollment 403
Recruitment Details The study started to enroll patients in May 2008 and concluded in Dec 2014. Participant Flow refers to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
Pre-assignment Details 406 subjects were screened: 3 subjects were considered as screen failures and were not enrolled. 403 subjects entered the study from C87085. 1 subject was enrolled in this study, but did not receive any open-label study medication and was withdrawn from the study; this subject was, therefore, not included in any of the analyses.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
Period Title: Overall Study
Started 402
Completed 87
Not Completed 315
Reason Not Completed
Lack of Efficacy             55
Loss of efficacy             75
Lost to Follow-up             8
Withdrawal by Subject             48
SAE, non-fatal             6
AE, non-serious non-fatal             38
SAE,non-fatal+AE,non-serious non-fatal             62
SAE, fatal + AE, non-serious non-fatal             1
Other Reason             22
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
Overall Number of Baseline Participants 402
Hide Baseline Analysis Population Description
Baseline Characteristics refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication. Demographics presented below were collected at Screening of the feeder study C87085.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 402 participants
18 - < 65 years 393
65 - < 85 years 9
>= 85 years 0
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 402 participants
37.3  (12.68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 402 participants
Female
221
  55.0%
Male
181
  45.0%
1.Primary Outcome
Title Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of the Study C87088 (up to 272 Weeks)
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 From study start to the end of the Safety Follow-up Period (up to 272 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
Overall Number of Participants Analyzed 402
Measure Type: Number
Unit of Measure: percentage of subjects
89.6
2.Primary Outcome
Title Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of the Study C87088 (up to 272 Weeks)
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 From study start to the end of the Safety Follow-up Period (up to 272 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
Overall Number of Participants Analyzed 402
Measure Type: Number
Unit of Measure: percentage of subjects
37.1
3.Secondary Outcome
Title Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit (Week 262)
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 Week 262
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat (ITT) population including all enrolled subjects irrespective of any protocol deviations who received at least 1 open-label injection of study treatment and who had at least 1 efficacy measurement after the first open-label injection.
Arm/Group Title Certolizumab Pegol (Intention-to-Treat)
Hide Arm/Group Description:

Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.

The ITT Population includes all enrolled subjects irrespective of any protocol deviations who received at least 1 open-label injection of study treatment and who had at least 1 efficacy measurement after the first open-label injection.
Overall Number of Participants Analyzed 397
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
11.6
(8.4 to 14.7)
4.Secondary Outcome
Title Percentage of Subjects Achieving Inflamatory Bowel Disease Questionnaire (IBDQ) Remission (IBDQ ≥ 170) at Study Completion Visit (Week 262)
Hide Description IBDQ remission is defined as having a total IBDQ score of 170 points or greater. IBDQ score consists of 32 questions eaching having a score of 1 to 7. Overall scores range from 32 to 224.
Time Frame Week 262
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat (ITT) population including all enrolled subjects irrespective of any protocol deviations who received at least 1 open-label injection of study treatment and who had at least 1 efficacy measurement after the first open-label injection.
Arm/Group Title Certolizumab Pegol (Intention-to-Treat)
Hide Arm/Group Description:

Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.

The ITT Population includes all enrolled subjects irrespective of any protocol deviations who received at least 1 open-label injection of study treatment and who had at least 1 efficacy measurement after the first open-label injection.
Overall Number of Participants Analyzed 397
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
7.8
(5.2 to 10.4)
5.Secondary Outcome
Title Plasma Concentration of Certolizumab Pegol After 1 Year (Week 52)
Hide Description Plasma samples for determination of Certolizumab Pegol were taken prior to Certolizumab Pegol administration.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
Overall Number of Participants Analyzed 402
Geometric Mean (95% Confidence Interval)
Unit of Measure: μg/mL
6.317
(5.407 to 7.381)
6.Secondary Outcome
Title Percentage of Subjects With Positive Anti-CZP Anti-body Status at Any Time From Week 0 of the Feeder Study C87085 to the Study Completion Visit in C87088
Hide Description Subjects are counted as antibody positive to Certolizumab Pegol if they have at least one positive result from Week 0 in the previous study C87085 [NCT00552058] 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 C87085 [NCT00552058] to Study Completion Visit (Week 262) of C87088 (up to 268 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
Overall Number of Participants Analyzed 402
Measure Type: Number
Unit of Measure: percentage of subjects
10.2
Time Frame Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Event Reporting Description Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
 
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
All-Cause Mortality
Certolizumab Pegol
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Certolizumab Pegol
Affected / at Risk (%) # Events
Total   149/402 (37.06%)    
Blood and lymphatic system disorders   
Anaemia * 1  3/402 (0.75%)  3
Coagulopathy * 1  1/402 (0.25%)  1
Iron deficiency anaemia * 1  1/402 (0.25%)  1
Cardiac disorders   
Atrial flutter * 1  1/402 (0.25%)  1
Endocrine disorders   
Goitre * 1  1/402 (0.25%)  1
Eye disorders   
Cataract * 1  1/402 (0.25%)  1
Retinal artery occlusion * 1  1/402 (0.25%)  1
Gastrointestinal disorders   
Abdominal distension * 1  1/402 (0.25%)  1
Abdominal pain * 1  6/402 (1.49%)  6
Anal fistula * 1  2/402 (0.50%)  3
Anorectal disorder * 1  1/402 (0.25%)  1
Colon dysplasia * 1  1/402 (0.25%)  1
Crohn's disease * 1  51/402 (12.69%)  59
Enteritis * 1  1/402 (0.25%)  1
Enterocolonic fistula * 1  2/402 (0.50%)  2
Enterocutaneous fistula * 1  1/402 (0.25%)  2
Enterovesical fistula * 1  1/402 (0.25%)  1
Gastrointestinal haemorrhage * 1  2/402 (0.50%)  2
Gastrointestinal inflammation * 1  1/402 (0.25%)  1
Gastrointestinal mucosal disorder * 1  1/402 (0.25%)  1
Gastrooesophageal reflux disease * 1  1/402 (0.25%)  1
Ileal fistula * 1  1/402 (0.25%)  1
Ileal stenosis * 1  2/402 (0.50%)  2
Ileus * 1  2/402 (0.50%)  2
Intestinal fistula * 1  1/402 (0.25%)  1
Intestinal obstruction * 1  11/402 (2.74%)  11
Intestinal perforation * 1  2/402 (0.50%)  2
Intestinal stenosis * 1  2/402 (0.50%)  2
Irritable bowel syndrome * 1  1/402 (0.25%)  1
Large intestinal ulcer * 1  1/402 (0.25%)  1
Large intestine perforation * 1  1/402 (0.25%)  1
Mechanical ileus * 1  1/402 (0.25%)  1
Oesophageal perforation * 1  1/402 (0.25%)  1
Pancreatitis * 1  2/402 (0.50%)  2
Proctitis * 1  1/402 (0.25%)  1
Rectal prolapse * 1  1/402 (0.25%)  1
Small intestinal obstruction * 1  6/402 (1.49%)  6
Subileus * 1  2/402 (0.50%)  2
Umbilical hernia * 1  1/402 (0.25%)  1
Vomiting * 1  2/402 (0.50%)  2
General disorders   
Chest pain * 1  1/402 (0.25%)  1
Incarcerated hernia * 1  1/402 (0.25%)  1
Mass * 1  1/402 (0.25%)  2
Pyrexia * 1  2/402 (0.50%)  2
Unevaluable event * 1  1/402 (0.25%)  1
Hepatobiliary disorders   
Cholelithiasis * 1  1/402 (0.25%)  1
Hepatic necrosis * 1  1/402 (0.25%)  1
Infections and infestations   
Abdominal abscess * 1  4/402 (1.00%)  4
Abdominal sepsis * 1  1/402 (0.25%)  1
Abdominal wall abscess * 1  1/402 (0.25%)  1
Anal abscess * 1  2/402 (0.50%)  2
Appendicitis * 1  1/402 (0.25%)  1
Clostridium difficile infection * 1  1/402 (0.25%)  1
Dengue fever * 1  1/402 (0.25%)  1
Diverticulitis * 1  1/402 (0.25%)  1
Ear infection * 1  1/402 (0.25%)  2
Gastroenteritis * 1  2/402 (0.50%)  2
Gastrointestinal viral infection * 1  2/402 (0.50%)  2
Infectious mononucleosis * 1  1/402 (0.25%)  1
Mastoiditis * 1  1/402 (0.25%)  1
Otitis externa * 1  1/402 (0.25%)  1
Perirectal abscess * 1  1/402 (0.25%)  1
Peritonsillar abscess * 1  1/402 (0.25%)  1
Pharyngitis * 1  1/402 (0.25%)  1
Pneumonia * 1  2/402 (0.50%)  2
Psoas abscess * 1  2/402 (0.50%)  2
Pulmonary tuberculosis * 1  1/402 (0.25%)  1
Pyelonephritis * 1  1/402 (0.25%)  1
Respiratory tract infection viral * 1  1/402 (0.25%)  1
Sepsis * 1  2/402 (0.50%)  2
Septic shock * 1  1/402 (0.25%)  1
Subdiaphragmatic abscess * 1  1/402 (0.25%)  1
Upper respiratory tract infection * 1  1/402 (0.25%)  1
Urinary tract infection * 1  5/402 (1.24%)  5
Vulval abscess * 1  1/402 (0.25%)  1
Injury, poisoning and procedural complications   
Abdominal wound dehiscence * 1  1/402 (0.25%)  1
Alcohol poisoning * 1  1/402 (0.25%)  1
Anastomotic haemorrhage * 1  1/402 (0.25%)  1
Cervical vertebral fracture * 1  1/402 (0.25%)  1
Facial bones fracture * 1  1/402 (0.25%)  1
Intestinal anastomosis complication * 1  1/402 (0.25%)  1
Joint injury * 1  1/402 (0.25%)  1
Post procedural inflammation * 1  1/402 (0.25%)  1
Radius fracture * 1  1/402 (0.25%)  1
Road traffic accident * 1  1/402 (0.25%)  1
Transfusion-related acute lung injury * 1  1/402 (0.25%)  1
Wound dehiscence * 1  1/402 (0.25%)  1
Investigations   
Colonoscopy * 1  1/402 (0.25%)  1
Investigation * 1  1/402 (0.25%)  1
Metabolism and nutrition disorders   
Dehydration * 1  2/402 (0.50%)  2
Electrolyte imbalance * 1  1/402 (0.25%)  1
Musculoskeletal and connective tissue disorders   
Back pain * 1  2/402 (0.50%)  2
Fistula * 1  1/402 (0.25%)  1
Flank pain * 1  1/402 (0.25%)  1
Spinal osteoarthritis * 1  1/402 (0.25%)  1
Tenosynovitis * 1  1/402 (0.25%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Basal cell carcinoma * 1  4/402 (1.00%)  4
Benign neoplasm of thyroid gland * 1  1/402 (0.25%)  1
Breast cancer * 1  1/402 (0.25%)  1
Malignant melanoma * 1  1/402 (0.25%)  1
Renal cancer * 1  1/402 (0.25%)  1
Squamous cell carcinoma of skin * 1  1/402 (0.25%)  1
Uterine leiomyoma * 1  1/402 (0.25%)  1
Nervous system disorders   
Brain oedema * 1  1/402 (0.25%)  1
Carpal tunnel syndrome * 1  1/402 (0.25%)  1
Convulsion * 1  1/402 (0.25%)  1
Demyelination * 1  1/402 (0.25%)  1
Migraine * 1  1/402 (0.25%)  1
Sciatica * 1  1/402 (0.25%)  5
Syncope * 1  1/402 (0.25%)  1
Pregnancy, puerperium and perinatal conditions   
Abortion spontaneous * 1  1/402 (0.25%)  1
Pregnancy * 1  1/402 (0.25%)  1
Pregnancy on contraceptive * 1  5/402 (1.24%)  5
Psychiatric disorders   
Acute psychosis * 1  1/402 (0.25%)  1
Depression * 1  3/402 (0.75%)  3
Depression suicidal * 1  1/402 (0.25%)  1
Renal and urinary disorders   
Calculus ureteric * 1  1/402 (0.25%)  1
Calculus urinary * 1  1/402 (0.25%)  1
Haemorrhage urinary tract * 1  1/402 (0.25%)  1
Nephrolithiasis * 1  5/402 (1.24%)  5
Renal colic * 1  2/402 (0.50%)  2
Ureteric obstruction * 1  2/402 (0.50%)  2
Reproductive system and breast disorders   
Menstrual disorder * 1  1/402 (0.25%)  1
Ovarian cyst * 1  1/402 (0.25%)  1
Pelvic prolapse * 1  1/402 (0.25%)  1
Vaginal inflammation * 1  1/402 (0.25%)  1
Respiratory, thoracic and mediastinal disorders   
Pleural effusion * 1  1/402 (0.25%)  1
Pulmonary artery thrombosis * 1  1/402 (0.25%)  1
Pulmonary mass * 1  1/402 (0.25%)  1
Pulmonary oedema * 1  1/402 (0.25%)  1
Pulmonary vasculitis * 1  1/402 (0.25%)  1
Social circumstances   
Physical assault * 1  1/402 (0.25%)  1
Social stay hospitalisation * 1  1/402 (0.25%)  1
Victim of abuse * 1  1/402 (0.25%)  1
Vascular disorders   
Arteritis * 1  1/402 (0.25%)  1
Hypotension * 1  1/402 (0.25%)  1
Varicose vein * 1  1/402 (0.25%)  1
Venous thrombosis * 1  1/402 (0.25%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 17.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Certolizumab Pegol
Affected / at Risk (%) # Events
Total   351/402 (87.31%)    
Blood and lymphatic system disorders   
Anaemia * 1  34/402 (8.46%)  45
Gastrointestinal disorders   
Crohn's disease * 1  127/402 (31.59%)  191
Abdominal pain * 1  75/402 (18.66%)  122
Diarrhoea * 1  61/402 (15.17%)  93
Nausea * 1  46/402 (11.44%)  63
Vomiting * 1  43/402 (10.70%)  60
Dyspepsia * 1  32/402 (7.96%)  37
Abdominal pain upper * 1  24/402 (5.97%)  28
General disorders   
Pyrexia * 1  54/402 (13.43%)  106
Influenza like illness * 1  23/402 (5.72%)  40
Infections and infestations   
Upper respiratory tract infection * 1  63/402 (15.67%)  99
Nasopharyngitis * 1  46/402 (11.44%)  88
Influenza * 1  30/402 (7.46%)  35
Sinusitis * 1  29/402 (7.21%)  48
Urinary tract infection * 1  25/402 (6.22%)  31
Bronchitis * 1  21/402 (5.22%)  32
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  57/402 (14.18%)  79
Back pain * 1  36/402 (8.96%)  40
Nervous system disorders   
Headache * 1  45/402 (11.19%)  58
Respiratory, thoracic and mediastinal disorders   
Cough * 1  39/402 (9.70%)  49
Oropharyngeal pain * 1  23/402 (5.72%)  27
Skin and subcutaneous tissue disorders   
Rash * 1  27/402 (6.72%)  39
Vascular disorders   
Hypertension * 1  28/402 (6.97%)  30
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 17.1
[Not Specified]
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
Layout table for Results Point of Contact information
Name/Title: UCB (Study Director)
Organization: UCB Cares
Phone: +1 887 822 9493
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB BIOSCIENCES GmbH )
ClinicalTrials.gov Identifier: NCT00552344    
Other Study ID Numbers: C87088
2007-002716-26 ( EudraCT Number )
First Submitted: October 31, 2007
First Posted: November 1, 2007
Results First Submitted: December 14, 2015
Results First Posted: January 21, 2016
Last Update Posted: August 9, 2018