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Open Label Long-Term Safety Study of Certolizumab Pegol (CZP) for Patients With Rheumatoid Arthritis

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: NCT00160693
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : July 9, 2012
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Intervention Biological: Certolizumab Pegol
Enrollment 402
Recruitment Details

Subjects must have participated in CZP trial C87011 [NCT00548834] or C87014 [NCT00544154] for at least 12 weeks to be eligible to enter the study.

All enrolled subjects who received at least one dose of study medication are included in the Safety Set (SS).
Pre-assignment Details Participant Flow and Baseline Characteristics refer to the Safety Set (SS). Baseline Characteristics were measured at Baseline of the respective feeder study.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description 400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
Period Title: Overall Study
Started 402
Completed 167
Not Completed 235
Reason Not Completed
Adverse Event             97
Lack of Efficacy             30
Protocol Violation             24
Lost to Follow-up             15
Withdrawal by Subject             54
Study terminated by sponsor             15
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description 400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
Overall Number of Baseline Participants 402
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 402 participants
<=18 years
0
   0.0%
Between 18 and 65 years
327
  81.3%
>=65 years
75
  18.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 402 participants
53.4  (12.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 402 participants
Female
303
  75.4%
Male
99
  24.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 402 participants
American Indian or Alaska Native
0
   0.0%
Asian
3
   0.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
19
   4.7%
White
363
  90.3%
More than one race
0
   0.0%
Unknown or Not Reported
17
   4.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 402 participants
United States 160
Czech Republic 81
Belgium 11
Ireland 8
Austria 19
Germany 87
United Kingdom 36
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram (kg)
Number Analyzed 402 participants
78.00  (17.88)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeter (cm)
Number Analyzed 402 participants
166.4  (8.6)
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilogram/ meter^2 (kg / m^2)
Number Analyzed 402 participants
28.20  (6.34)
[1]
Measure Description: The BMI was calculated as: Weight (kg)/(Height(cm)/100)^2
Disease Duration  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 402 participants
9.46  (8.13)
1.Primary Outcome
Title Percentage of Subjects With at Least One Adverse Event (AE) During the Study Period of 8 Years
Hide Description

An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.

First dose of CZP was at Baseline of one of the feeder studies C87011 [NCT00548834] or C87014 [NCT00544154] for subjects randomized to CZP, or at First Visit (Week 0) of this study for subjects randomized to Placebo.
Time Frame From first dose of CZP up to 8 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set (SS).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
Overall Number of Participants Analyzed 402
Measure Type: Number
Unit of Measure: percentage of subjects
93.5
2.Primary Outcome
Title Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study Period of 8 Years
Hide Description

An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.

The results of this Primary Outcome Measure are summarized from the Adverse Event pages of the Case Report Forms.
Time Frame From First Visit (Week 0 in this study) up to 8 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set (SS).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
Overall Number of Participants Analyzed 402
Measure Type: Number
Unit of Measure: percentage of subjects
24.9
3.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 52
Hide Description

The assessments are based on a 20% or greater improvement from Baseline to Week 52 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).

Baseline is Baseline of the respective feeder study.
Time Frame From Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 402 subjects in the Safety Set (SS), 370 subjects are included in this analysis, because they had available data at Baseline and Week 52.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
Overall Number of Participants Analyzed 370
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
58.1
(53.1 to 63.1)
4.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 100
Hide Description

The assessments are based on a 20% or greater improvement from Baseline to Week 100 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).

Baseline is Baseline of the respective feeder study.
Time Frame From Baseline to Week 100
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 402 subjects in the Safety Set (SS), 275 subjects are included in this analysis, because they had available data at Baseline and Week 100.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
Overall Number of Participants Analyzed 275
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
60.0
(54.2 to 65.8)
5.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 160
Hide Description

The assessments are based on a 20% or greater improvement from Baseline to Week 160 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).

Baseline is Baseline of the respective feeder study.
Time Frame From Baseline to Week 160
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 402 subjects in the Safety Set (SS), 247 subjects are included in this analysis, because they had available data at Baseline and Week 160.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
Overall Number of Participants Analyzed 247
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
68.4
(62.6 to 74.2)
6.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 208
Hide Description

The assessments are based on a 20% or greater improvement from Baseline to Week 208 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).

Baseline is Baseline of the respective feeder study.
Time Frame From Baseline to Week 208
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 402 subjects in the Safety Set (SS), 223 subjects are included in this analysis, because they had available data at Baseline and Week 208.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
Overall Number of Participants Analyzed 223
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
72.6
(66.8 to 78.5)
7.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 256
Hide Description

The assessments are based on a 20% or greater improvement from Baseline to Week 256 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).

Baseline is Baseline of the respective feeder study.
Time Frame From Baseline to Week 256
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 402 subjects in the Safety Set (SS), 211 subjects are included in this analysis, because they had available data at Baseline and Week 256.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
Overall Number of Participants Analyzed 211
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
75.4
(69.5 to 81.2)
8.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 316
Hide Description

The assessments are based on a 20% or greater improvement from Baseline to Week 316 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).

Baseline is Baseline of the respective feeder study.
Time Frame From Baseline to Week 316
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 402 subjects in the Safety Set (SS), 140 subjects are included in this analysis, because they had available data at Baseline and Week 316.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
Overall Number of Participants Analyzed 140
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
76.4
(69.4 to 83.5)
9.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Completion Visit or Early Withdrawal Visit
Hide Description The assessments are based on a 20% or greater improvement from Baseline to the Completion Visit or early Withdrawal Visit in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).
Time Frame From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set (SS).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
Overall Number of Participants Analyzed 402
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
57.2
(52.4 to 62.1)
10.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 50% Response Criteria (ACR50) at Completion Visit or Early Withdrawal Visit
Hide Description The assessments are based on a 50% or greater improvement from Baseline to the Completion Visit or early Withdrawal Visit in the number of tender joints, a 50% or more improvement in the number of swollen joints, and a 50% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).
Time Frame From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set (SS).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
Overall Number of Participants Analyzed 402
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
27.6
(23.2 to 32.0)
11.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 70% Response Criteria (ACR70) at Completion Visit or Early Withdrawal Visit
Hide Description The assessments are based on a 70% or greater improvement from Baseline to the Completion Visit or early Withdrawal Visit in the number of tender joints, a 70% or more improvement in the number of swollen joints, and a 70% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).
Time Frame From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set (SS).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
Overall Number of Participants Analyzed 402
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
7.7
(5.1 to 10.3)
12.Secondary Outcome
Title Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ- DI) at Completion Visit or Early Withdrawal Visit
Hide Description The HAQ-DI assesses the degree of difficulty experienced in eight domains (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Gripping, Other Activities) of daily living activities using 20 questions. The HAQ-DI is calculated by summing the domain scores and dividing them by the number of domains. It ranges from 0 (no difficulty) to 3 (unable to do). Negative values indicate an improvement from Baseline to the Post-Baseline Visit with larger negative values showing a better improvement.
Time Frame From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 402 subjects in the Safety Set (SS), 400 subjects are included in this analysis, because they had available data at Baseline and Completion or early Withdrawal Visit.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
Overall Number of Participants Analyzed 400
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.305  (0.620)
13.Secondary Outcome
Title Percentage of Subjects Who Withdrew Due to Lack of Efficacy During the Study Period of 8 Years
Hide Description [Not Specified]
Time Frame From First Visit (Week 0 in this study) up to 8 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set (SS).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
Overall Number of Participants Analyzed 402
Measure Type: Number
Unit of Measure: percentage of subjects
7.5
14.Secondary Outcome
Title Percentage of Subjects Utilizing Common Additional Arthritis Medications During the Study Period of 8 Years
Hide Description This Secondary Outcome Measure shows additional arthritis medications received by at least 20% of subjects during the 8-year study.
Time Frame From First Visit (Week 0 in this study) up to 8 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set (SS).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
Overall Number of Participants Analyzed 402
Measure Type: Number
Unit of Measure: percentage of subjects
Acetylsalicylic acid 21.9
Celecoxib 22.9
Diclofenac 23.4
Folic acid 65.2
Ibuprofen 26.4
Methotrexate 60.9
Methylprednisolone 33.8
Other Immunosuppressive agents 25.9
Paracetamol 29.6
Prednisolone 20.4
Prednisone 39.3
Time Frame Adverse Events (AEs) were collected over the whole Study Period of 8 Years from first dose of study medication (Baseline of feeder study or First Visit of this study for subjects randomized to Placebo) to 24 Weeks post last dose (Last Follow-up Visit).
Adverse Event Reporting Description AEs refer to the Safety Set (SS). SS includes all of the 402 enrolled subjects.
 
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description 400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
All-Cause Mortality
Certolizumab Pegol
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Certolizumab Pegol
Affected / at Risk (%) # Events
Total   184/402 (45.77%)    
Blood and lymphatic system disorders   
Anaemia * 1  2/402 (0.50%)  3
Hilar lymphadenopathy * 1  1/402 (0.25%)  1
Iron deficiency anaemia * 1  1/402 (0.25%)  1
Lymphadenitis * 1  2/402 (0.50%)  2
Thrombocytopenia * 1  1/402 (0.25%)  1
Cardiac disorders   
Acute coronary syndrome * 1  1/402 (0.25%)  1
Acute myocardial infarction * 1  2/402 (0.50%)  2
Angina pectoris * 1  3/402 (0.75%)  3
Angina unstable * 1  2/402 (0.50%)  2
Arrhythmia * 1  1/402 (0.25%)  2
Atrial fibrillation * 1  4/402 (1.00%)  5
Atrioventricular block * 1  1/402 (0.25%)  1
Bradycardia * 1  1/402 (0.25%)  1
Cardiac arrest * 1  1/402 (0.25%)  1
Cardiac failure * 1  4/402 (1.00%)  4
Coronary artery disease * 1  6/402 (1.49%)  6
Coronary artery stenosis * 1  2/402 (0.50%)  2
Myocardial infarction * 1  5/402 (1.24%)  5
Myocardial ischaemia * 1  2/402 (0.50%)  2
Sinus bradycardia * 1  1/402 (0.25%)  1
Sinus tachycardia * 1  1/402 (0.25%)  1
Endocrine disorders   
Goitre * 1  1/402 (0.25%)  1
Hyperthyroidism * 1  2/402 (0.50%)  2
Eye disorders   
Conjunctivitis * 1  1/402 (0.25%)  1
Maculopathy * 1  1/402 (0.25%)  1
Optic nerve disorder * 1  1/402 (0.25%)  1
Gastrointestinal disorders   
Abdominal adhesions * 1  1/402 (0.25%)  1
Abdominal hernia * 1  2/402 (0.50%)  2
Diarrhoea * 1  1/402 (0.25%)  1
Diverticular perforation * 1  1/402 (0.25%)  1
Diverticulum * 1  1/402 (0.25%)  1
Diverticulum duodenal * 1  1/402 (0.25%)  1
Gastric ulcer * 1  1/402 (0.25%)  1
Gastritis * 1  2/402 (0.50%)  2
Gastritis erosive * 1  1/402 (0.25%)  1
Gastrointestinal haemorrhage * 1  1/402 (0.25%)  1
Hiatus hernia * 1  2/402 (0.50%)  2
Ileus paralytic * 1  1/402 (0.25%)  1
Inflammatory bowel disease * 1  1/402 (0.25%)  1
Inguinal hernia * 1  2/402 (0.50%)  2
Leukoplakia oral * 1  1/402 (0.25%)  1
Melaena * 1  1/402 (0.25%)  1
Oedematous pancreatitis * 1  1/402 (0.25%)  1
Oesophageal rupture * 1  1/402 (0.25%)  1
Pancreatitis acute * 1  1/402 (0.25%)  1
Peritonitis * 1  1/402 (0.25%)  1
Rectal haemorrhage * 1  1/402 (0.25%)  1
Stomatitis * 1  1/402 (0.25%)  1
Subileus * 1  1/402 (0.25%)  1
Umbilical hernia * 1  1/402 (0.25%)  1
General disorders   
Asthenia * 1  1/402 (0.25%)  1
Chest pain * 1  3/402 (0.75%)  4
Chills * 1  1/402 (0.25%)  1
Impaired healing * 1  2/402 (0.50%)  4
Malaise * 1  1/402 (0.25%)  2
Multi-organ failure * 1  1/402 (0.25%)  1
Non-cardiac chest pain * 1  1/402 (0.25%)  1
Oedema * 1  1/402 (0.25%)  1
Oedema peripheral * 1  1/402 (0.25%)  1
Pyrexia * 1  3/402 (0.75%)  3
Hepatobiliary disorders   
Bile duct stone * 1  2/402 (0.50%)  2
Cholangitis * 1  2/402 (0.50%)  2
Cholecystitis * 1  3/402 (0.75%)  3
Cholecystitis acute * 1  1/402 (0.25%)  1
Cholecystitis chronic * 1  1/402 (0.25%)  1
Cholelithiasis * 1  3/402 (0.75%)  3
Hepatitis cholestatic * 1  1/402 (0.25%)  1
Hepatotoxicity * 1  1/402 (0.25%)  1
Liver disorder * 1  1/402 (0.25%)  1
Perforation bile duct * 1  1/402 (0.25%)  1
Immune system disorders   
Drug hypersensitivity * 1  1/402 (0.25%)  1
Infections and infestations   
Abscess intestinal * 1  1/402 (0.25%)  1
Abscess neck * 1  1/402 (0.25%)  1
Arthritis infective * 1  1/402 (0.25%)  1
Bronchitis * 1  3/402 (0.75%)  3
Bronchitis acute * 1  1/402 (0.25%)  1
Bronchopneumonia * 1  2/402 (0.50%)  2
Cellulitis * 1  4/402 (1.00%)  9
Cholangitis suppurative * 1  1/402 (0.25%)  1
Cholecystitis infective * 1  1/402 (0.25%)  1
Chronic sinusitis * 1  1/402 (0.25%)  1
Chronic tonsillitis * 1  1/402 (0.25%)  1
Clostridial infection * 1  1/402 (0.25%)  1
Device related infection * 1  1/402 (0.25%)  1
Diverticulitis * 1  1/402 (0.25%)  1
Empyema * 1  1/402 (0.25%)  1
Erysipelas * 1  1/402 (0.25%)  1
Escherichia sepsis * 1  1/402 (0.25%)  1
Gastroenteritis * 1  3/402 (0.75%)  3
Gastroenteritis clostridial * 1  1/402 (0.25%)  1
Gastroenteritis viral * 1  1/402 (0.25%)  1
Herpes simplex * 1  1/402 (0.25%)  1
Herpes zoster * 1  2/402 (0.50%)  2
Histoplasmosis disseminated * 1  1/402 (0.25%)  1
Infected skin ulcer * 1  1/402 (0.25%)  1
Infection * 1  1/402 (0.25%)  1
Liver abscess * 1  1/402 (0.25%)  1
Lobar pneumonia * 1  1/402 (0.25%)  1
Lower respiratory tract infection * 1  1/402 (0.25%)  1
Lymph node tuberculosis * 1  1/402 (0.25%)  1
Mastitis * 1  1/402 (0.25%)  1
Necrotising fasciitis * 1  1/402 (0.25%)  1
Neutropenic sepsis * 1  1/402 (0.25%)  1
Pelvic abscess * 1  1/402 (0.25%)  1
Pneumocystis jiroveci pneumonia * 1  1/402 (0.25%)  1
Pneumonia * 1  9/402 (2.24%)  10
Pneumonia legionella * 1  1/402 (0.25%)  1
Pneumonia staphylococcal * 1  1/402 (0.25%)  1
Pneumonia streptococcal * 1  1/402 (0.25%)  1
Pulmonary tuberculosis * 1  1/402 (0.25%)  1
Purulent synovitis * 1  1/402 (0.25%)  1
Pyelonephritis * 1  2/402 (0.50%)  2
Pyelonephritis acute * 1  1/402 (0.25%)  1
Respiratory tract infection viral * 1  1/402 (0.25%)  1
Sepsis * 1  1/402 (0.25%)  1
Staphylococcal infection * 1  1/402 (0.25%)  1
Subcutaneous abscess * 1  2/402 (0.50%)  3
Tonsillitis * 1  2/402 (0.50%)  2
Tracheobronchitis * 1  1/402 (0.25%)  1
Tuberculosis * 1  1/402 (0.25%)  1
Urinary tract infection * 1  3/402 (0.75%)  3
Injury, poisoning and procedural complications   
Brain contusion * 1  1/402 (0.25%)  1
Contrast media reaction * 1  1/402 (0.25%)  1
Contusion * 1  1/402 (0.25%)  1
Device failure * 1  1/402 (0.25%)  2
Fall * 1  3/402 (0.75%)  4
Femoral neck fracture * 1  1/402 (0.25%)  1
Femur fracture * 1  1/402 (0.25%)  1
Forearm fracture * 1  1/402 (0.25%)  1
Foreign body trauma * 1  1/402 (0.25%)  1
Hip fracture * 1  1/402 (0.25%)  1
Humerus fracture * 1  2/402 (0.50%)  2
Incisional hernia * 1  1/402 (0.25%)  1
Injury * 1  2/402 (0.50%)  2
Joint dislocation * 1  1/402 (0.25%)  1
Lumbar vertebral fracture * 1  1/402 (0.25%)  1
Medical device complication * 1  1/402 (0.25%)  1
Medication error * 1  1/402 (0.25%)  1
Patella fracture * 1  1/402 (0.25%)  1
Pelvic fracture * 1  1/402 (0.25%)  1
Pubic rami fracture * 1  1/402 (0.25%)  1
Radius fracture * 1  2/402 (0.50%)  2
Spinal compression fracture * 1  1/402 (0.25%)  1
Sternal fracture * 1  1/402 (0.25%)  1
Subdural haematoma * 1  1/402 (0.25%)  1
Synovial rupture * 1  1/402 (0.25%)  1
Tendon injury * 1  1/402 (0.25%)  1
Tendon rupture * 1  1/402 (0.25%)  1
Tibia fracture * 1  1/402 (0.25%)  1
Ulna fracture * 1  1/402 (0.25%)  1
Upper limb fracture * 1  1/402 (0.25%)  1
Wrist fracture * 1  1/402 (0.25%)  1
XIth nerve injury * 1  1/402 (0.25%)  1
Metabolism and nutrition disorders   
Dehydration * 1  1/402 (0.25%)  1
Diabetes mellitus * 1  1/402 (0.25%)  2
Diabetic ketoacidosis * 1  1/402 (0.25%)  1
Hypokalaemia * 1  1/402 (0.25%)  1
Hyponatraemia * 1  2/402 (0.50%)  2
Hypovolaemia * 1  1/402 (0.25%)  1
Obesity * 1  1/402 (0.25%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  2/402 (0.50%)  3
Arthritis * 1  2/402 (0.50%)  2
Arthrofibrosis * 1  1/402 (0.25%)  1
Back pain * 1  2/402 (0.50%)  2
Bursitis * 1  2/402 (0.50%)  2
Exostosis * 1  1/402 (0.25%)  1
Finger deformity * 1  1/402 (0.25%)  1
Fistula * 1  2/402 (0.50%)  2
Groin pain * 1  1/402 (0.25%)  1
Intervertebral disc degeneration * 1  1/402 (0.25%)  1
Intervertebral disc disorder * 1  1/402 (0.25%)  1
Intervertebral disc protrusion * 1  4/402 (1.00%)  4
Joint destruction * 1  1/402 (0.25%)  1
Joint swelling * 1  1/402 (0.25%)  1
Lumbar spinal stenosis * 1  1/402 (0.25%)  1
Myalgia * 1  1/402 (0.25%)  1
Osteoarthritis * 1  16/402 (3.98%)  21
Pain in extremity * 1  1/402 (0.25%)  1
Rheumatoid arthritis * 1  16/402 (3.98%)  20
Rheumatoid nodule * 1  2/402 (0.50%)  2
Rotator cuff syndrome * 1  1/402 (0.25%)  1
Spinal column stenosis * 1  2/402 (0.50%)  2
Spinal osteoarthritis * 1  1/402 (0.25%)  1
Synovial cyst * 1  1/402 (0.25%)  1
Synovitis * 1  2/402 (0.50%)  3
Tendon disorder * 1  1/402 (0.25%)  1
Tenosynovitis * 1  1/402 (0.25%)  1
Toe deformity * 1  5/402 (1.24%)  5
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Basal cell carcinoma * 1  4/402 (1.00%)  4
Breast cancer * 1  3/402 (0.75%)  3
Cholesteatoma * 1  1/402 (0.25%)  1
Colon adenoma * 1  1/402 (0.25%)  1
Diffuse large B-cell lymphoma * 1  1/402 (0.25%)  1
Lung adenocarcinoma * 1  1/402 (0.25%)  1
Lung adenocarcinoma stage I * 1  1/402 (0.25%)  1
Lung cancer metastatic * 1  1/402 (0.25%)  1
Lung neoplasm malignant * 1  1/402 (0.25%)  1
Lymphocytic leukaemia * 1  1/402 (0.25%)  1
Malignant melanoma in situ * 1  1/402 (0.25%)  1
Oncocytoma * 1  1/402 (0.25%)  1
Ovarian cancer * 1  1/402 (0.25%)  1
Parathyroid tumour benign * 1  1/402 (0.25%)  1
Prostate cancer * 1  1/402 (0.25%)  1
Prostatic adenoma * 1  1/402 (0.25%)  1
Renal cell carcinoma stage I * 1  1/402 (0.25%)  1
Squamous cell carcinoma of skin * 1  1/402 (0.25%)  1
Thyroid gland cancer * 1  1/402 (0.25%)  1
Thyroid neoplasm * 1  1/402 (0.25%)  1
Tonsil cancer * 1  1/402 (0.25%)  1
Uterine cancer * 1  1/402 (0.25%)  1
Uterine leiomyoma * 1  1/402 (0.25%)  1
Nervous system disorders   
Cerebral ischaemia * 1  1/402 (0.25%)  1
Cerebrovascular accident * 1  3/402 (0.75%)  6
Disturbance in attention * 1  1/402 (0.25%)  1
Dizziness postural * 1  1/402 (0.25%)  1
Epilepsy * 1  1/402 (0.25%)  1
Global amnesia * 1  1/402 (0.25%)  1
Grand mal convulsion * 1  1/402 (0.25%)  1
Headache * 1  1/402 (0.25%)  1
Ischaemic stroke * 1  1/402 (0.25%)  1
Loss of consciousness * 1  1/402 (0.25%)  1
Neuropathy peripheral * 1  1/402 (0.25%)  1
Paraesthesia * 1  1/402 (0.25%)  1
Subarachnoid haemorrhage * 1  1/402 (0.25%)  1
Syncope * 1  2/402 (0.50%)  3
Transient ischaemic attack * 1  1/402 (0.25%)  1
Psychiatric disorders   
Depression * 1  1/402 (0.25%)  1
Panic disorder * 1  1/402 (0.25%)  1
Post-traumatic stress disorder * 1  1/402 (0.25%)  1
Renal and urinary disorders   
Acute prerenal failure * 1  1/402 (0.25%)  1
Incontinence * 1  1/402 (0.25%)  1
Mixed incontinence * 1  1/402 (0.25%)  1
Nephrolithiasis * 1  4/402 (1.00%)  5
Renal colic * 1  1/402 (0.25%)  1
Renal failure acute * 1  1/402 (0.25%)  1
Stress incontinence * 1  1/402 (0.25%)  1
Urinary incontinence * 1  1/402 (0.25%)  1
Reproductive system and breast disorders   
Benign prostatic hyperplasia * 1  2/402 (0.50%)  2
Cystocele * 1  1/402 (0.25%)  1
Endometriosis * 1  1/402 (0.25%)  1
Menorrhagia * 1  1/402 (0.25%)  1
Metrorrhagia * 1  1/402 (0.25%)  1
Rectocele * 1  1/402 (0.25%)  1
Vaginal prolapse * 1  1/402 (0.25%)  1
Respiratory, thoracic and mediastinal disorders   
Acute respiratory failure * 1  1/402 (0.25%)  1
Chronic obstructive pulmonary disease * 1  4/402 (1.00%)  4
Cough * 1  1/402 (0.25%)  1
Pleurisy * 1  1/402 (0.25%)  1
Pulmonary embolism * 1  4/402 (1.00%)  4
Respiratory failure * 1  3/402 (0.75%)  3
Skin and subcutaneous tissue disorders   
Erythema * 1  1/402 (0.25%)  2
Skin ulcer * 1  1/402 (0.25%)  1
Surgical and medical procedures   
Synovectomy * 1  1/402 (0.25%)  2
Vascular disorders   
Aortic aneurysm * 1  1/402 (0.25%)  1
Arterial occlusive disease * 1  1/402 (0.25%)  1
Arterial stenosis * 1  1/402 (0.25%)  1
Circulatory collapse * 1  1/402 (0.25%)  1
Deep vein thrombosis * 1  4/402 (1.00%)  4
Embolism * 1  1/402 (0.25%)  1
Hypertension * 1  2/402 (0.50%)  2
Hypertensive crisis * 1  1/402 (0.25%)  1
Hypotension * 1  1/402 (0.25%)  1
Peripheral ischaemia * 1  1/402 (0.25%)  1
Thrombophlebitis * 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 (9.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Certolizumab Pegol
Affected / at Risk (%) # Events
Total   348/402 (86.57%)    
Blood and lymphatic system disorders   
Anaemia * 1  25/402 (6.22%)  31
Eye disorders   
Conjunctivitis * 1  29/402 (7.21%)  34
Gastrointestinal disorders   
Abdominal pain upper * 1  22/402 (5.47%)  31
Constipation * 1  24/402 (5.97%)  29
Diarrhoea * 1  64/402 (15.92%)  135
Dyspepsia * 1  41/402 (10.20%)  60
Nausea * 1  49/402 (12.19%)  65
Vomiting * 1  37/402 (9.20%)  58
General disorders   
Fatigue * 1  65/402 (16.17%)  86
Oedema peripheral * 1  38/402 (9.45%)  54
Infections and infestations   
Bronchitis * 1  58/402 (14.43%)  89
Bronchitis acute * 1  25/402 (6.22%)  45
Cystitis * 1  33/402 (8.21%)  45
Herpes simplex * 1  44/402 (10.95%)  70
Herpes zoster * 1  24/402 (5.97%)  27
Influenza * 1  40/402 (9.95%)  56
Lower respiratory tract infection * 1  27/402 (6.72%)  65
Nasopharyngitis * 1  141/402 (35.07%)  380
Pharyngitis * 1  21/402 (5.22%)  36
Sinusitis * 1  74/402 (18.41%)  123
Upper respiratory tract infection * 1  93/402 (23.13%)  198
Urinary tract infection * 1  84/402 (20.90%)  159
Viral infection * 1  27/402 (6.72%)  42
Injury, poisoning and procedural complications   
Contusion * 1  30/402 (7.46%)  44
Fall * 1  28/402 (6.97%)  42
Investigations   
Alanine aminotransferase increased * 1  27/402 (6.72%)  34
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  65/402 (16.17%)  118
Back pain * 1  90/402 (22.39%)  137
Bursitis * 1  28/402 (6.97%)  40
Joint swelling * 1  21/402 (5.22%)  39
Muscle spasms * 1  27/402 (6.72%)  34
Neck pain * 1  22/402 (5.47%)  26
Osteoarthritis * 1  26/402 (6.47%)  49
Pain in extremity * 1  46/402 (11.44%)  68
Rheumatoid arthritis * 1  63/402 (15.67%)  109
Nervous system disorders   
Dizziness * 1  42/402 (10.45%)  59
Headache * 1  86/402 (21.39%)  135
Paraesthesia * 1  23/402 (5.72%)  29
Sciatica * 1  28/402 (6.97%)  34
Psychiatric disorders   
Depression * 1  39/402 (9.70%)  49
Insomnia * 1  36/402 (8.96%)  44
Respiratory, thoracic and mediastinal disorders   
Cough * 1  82/402 (20.40%)  126
Dyspnoea * 1  22/402 (5.47%)  32
Pharyngolaryngeal pain * 1  38/402 (9.45%)  52
Skin and subcutaneous tissue disorders   
Rash * 1  66/402 (16.42%)  104
Vascular disorders   
Hypertension * 1  78/402 (19.40%)  94
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.0)
[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 Clinical Trial Call Center
Organization: UCB
Phone: +1 877 822 9493 (UCB)
Publications of Results:
Fleischmann R, van Vollenhoven RF, Vencovsky J, Alten R, Davies O, Mountian I, de Longueville M, Carter D, Choy E. Long-Term Maintenance of Certolizumab Pegol Safety and Efficacy, in Combination with Methotrexate and as Monotherapy, in Rheumatoid Arthritis Patients. Rheumatol Ther. 2017 Jun;4(1):57-69. doi: 10.1007/s40744-017-0060-8. Epub 2017 Mar 28.
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00160693    
Other Study ID Numbers: C87015
2005-002617-21 ( EudraCT Number )
First Submitted: September 6, 2005
First Posted: September 12, 2005
Results First Submitted: February 15, 2012
Results First Posted: July 9, 2012
Last Update Posted: August 1, 2018