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Trial record 1 of 1 for:    NCT00717236
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Certolizumab Pegol for the Treatment of Patients With Active Rheumatoid Arthritis (REALISTIC)

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ClinicalTrials.gov Identifier: NCT00717236
Recruitment Status : Completed
First Posted : July 17, 2008
Results First Posted : May 6, 2011
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Drug: Certolizumab pegol (CZP)
Other: Placebo
Enrollment 1648
Recruitment Details The study started in July 2008 with subjects from the United States, Canada, France, Germany, Italy, the Netherlands, and Spain. The primary completion date occurred in March 2010, with study completion in March 2011.
Pre-assignment Details Of the 1648 subjects that were screened, 585 subjects had screen failures. Therefore, 1063 subjects were randomized in this study.
Arm/Group Title Certolizumab Pegol (CZP) Placebo
Hide Arm/Group Description 400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Period Title: Double-Blind Period
Started 851 212
Completed 771 184
Not Completed 80 28
Reason Not Completed
Adverse Event             33             6
Lack of Efficacy             6             6
Lost to Follow-up             3             5
Withdrawal by Subject             10             2
Loss of efficacy             3             0
Other: Death             1             0
Other: Pregnancy             1             0
Other: Protocol Violation             2             0
Other: Inclusion/Exclusion criteria             6             2
Other: Site withdrew             2             0
Other: Screening failure             1             0
Other: subject withdrew consent             1             1
Other: Abnormal chest X-ray             2             1
Other: History of adenoid grown             1             0
Other: History of cancer             1             0
Other: Sponsor request             1             0
Other: Inappropriate randomization             1             0
Other: Detection of Hepatitis C Virus             1             0
Other: Subject moved             1             1
Other: Stopped taking DMARD             1             0
Other: Prohibited medication taken             2             2
Other: Transportation problems             0             1
Other: Investigator Decision             0             1
Period Title: Open-Label Period
Started 771 184
Completed 646 163
Not Completed 125 21
Reason Not Completed
Adverse Event             29             4
Lack of Efficacy             30             8
Lost to Follow-up             28             4
Withdrawal by Subject             20             2
Loss of Efficacy             6             1
Other: Peripheral Neuropathy             0             1
Other: Lack of Compliance             1             1
Other: History of Basal Cell Carcinoma             1             0
Other: Moved             1             0
Other: Investigator Decision             1             0
Other: Loss of Staff (unblinded)             1             0
Other: Sponsor Request             3             0
Other: Cataract Surgery             1             0
Other: Administration of Golimumab             1             0
Other: Completion Accidently Performed             1             0
Other: Medical Monitor Recommendation             1             0
Arm/Group Title Certolizumab Pegol (CZP) Placebo Total
Hide Arm/Group Description 400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. Total of all reporting groups
Overall Number of Baseline Participants 851 212 1063
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 851 participants 212 participants 1063 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
644
  75.7%
164
  77.4%
808
  76.0%
>=65 years
207
  24.3%
48
  22.6%
255
  24.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 851 participants 212 participants 1063 participants
55.4  (12.43) 53.9  (12.66) 55.1  (12.49)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 851 participants 212 participants 1063 participants
Female
660
  77.6%
169
  79.7%
829
  78.0%
Male
191
  22.4%
43
  20.3%
234
  22.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 851 participants 212 participants 1063 participants
France 14 0 14
United States 575 141 716
Canada 65 17 82
Spain 26 8 34
Netherlands 4 0 4
Germany 154 44 198
Italy 13 2 15
1.Primary Outcome
Title American College of Rheumatology 20% (ACR20) Response at Week 12
Hide Description ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All 1063 subjects (851 CZP, 212 Placebo) included in the Full Analysis Set (FAS) are included in this analysis
Arm/Group Title Certolizumab Pegol (CZP) Placebo
Hide Arm/Group Description:
400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed 851 212
Measure Type: Number
Unit of Measure: percentage of subjects
51.1 25.9
2.Secondary Outcome
Title American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Concomitant Methotrexate (MTX) Use.
Hide Description ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 1063 subjects in the Full Analysis Set (FAS), 732 were in the concomitant methotrexate use stratum (589 CZP, 143 Placebo) and are included in this analysis.
Arm/Group Title Certolizumab Pegol (CZP) Placebo
Hide Arm/Group Description:
400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed 589 143
Measure Type: Number
Unit of Measure: percentage of subjects
52.5 28.0
3.Secondary Outcome
Title American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects Without Concomitant Methotrexate (MTX) Use.
Hide Description ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 1063 subjects in the Full Analysis Set (FAS), 331 were in the no concomitant methotrexate use stratum (262 CZP, 69 Placebo) and are included in this analysis.
Arm/Group Title Certolizumab Pegol (CZP) Placebo
Hide Arm/Group Description:
400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed 262 69
Measure Type: Number
Unit of Measure: percentage of subjects
48.1 21.7
4.Secondary Outcome
Title American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Prior Anti-tumor Necrosis (Anti-TNF) Use
Hide Description ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 1063 subjects in the Full Analysis Set (FAS), 400 were in the prior anti-tumor necrosis (anti-TNF) use stratum (320 CZP, 80 Placebo) and are included in this analysis.
Arm/Group Title Certolizumab Pegol (CZP) Placebo
Hide Arm/Group Description:
400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed 320 80
Measure Type: Number
Unit of Measure: percentage of subjects
47.2 27.5
5.Secondary Outcome
Title American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects Without Prior Anti-tumor Necrosis (Anti-TNF) Use
Hide Description ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 1063 subjects in the Full Analysis Set (FAS), 663 were in the no prior anti-tumor necrosis (anti-TNF) use stratum (531 CZP, 132 Placebo) and are included in this analysis.
Arm/Group Title Certolizumab Pegol (CZP) Placebo
Hide Arm/Group Description:
400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed 531 132
Measure Type: Number
Unit of Measure: percentage of subjects
53.5 25.0
6.Secondary Outcome
Title American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Disease Duration < 2 Years
Hide Description ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 1063 subjects in the Full Analysis Set (FAS), 256 were in the disease duration less than 2 years stratum (206 CZP, 50 Placebo) and are included in this analysis.
Arm/Group Title Certolizumab Pegol (CZP) Placebo
Hide Arm/Group Description:
400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed 206 50
Measure Type: Number
Unit of Measure: percentage of subjects
50.0 30.0
7.Secondary Outcome
Title American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Disease Duration ≥ 2 Years.
Hide Description ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 1063 subjects in the Full Analysis Set (FAS), 807 were in the disease duration greater than or equal to 2 years stratum (645 CZP, 162 Placebo) and are included in this analysis.
Arm/Group Title Certolizumab Pegol (CZP) Placebo
Hide Arm/Group Description:
400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed 645 162
Measure Type: Number
Unit of Measure: percentage of subjects
51.5 24.7
8.Secondary Outcome
Title American College of Rheumatology 50% (ACR50) Response at Week 12
Hide Description ACR50 responders are subjects with at least 50% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.
Arm/Group Title Certolizumab Pegol (CZP) Placebo
Hide Arm/Group Description:
400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed 851 212
Measure Type: Number
Unit of Measure: percentage of subjects
26.6 9.9
9.Secondary Outcome
Title American College of Rheumatology 70% (ACR70) Response at Week 12.
Hide Description ACR70 responders are subjects with at least 70% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.
Arm/Group Title Certolizumab Pegol (CZP) Placebo
Hide Arm/Group Description:
400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed 851 212
Measure Type: Number
Unit of Measure: percentage of subjects
12.9 2.8
10.Secondary Outcome
Title Change From Baseline in DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] at Week 12
Hide Description DAS28(CRP) is calculated using tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/L), and Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in mm). A lower score indicates less disease activity. Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 1063 subjects in the Full Analysis Set (FAS) 1037(834 CZP, 203 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.
Arm/Group Title Certolizumab Pegol (CZP) Placebo
Hide Arm/Group Description:
400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed 834 203
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.70  (1.269) -0.84  (1.209)
11.Secondary Outcome
Title Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 12
Hide Description SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 1063 subjects in the Full Analysis Set (FAS) 1024 (824 CZP, 200 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.
Arm/Group Title Certolizumab Pegol (CZP) Placebo
Hide Arm/Group Description:
400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed 824 200
Mean (Standard Deviation)
Unit of Measure: units on a scale
-19.66  (14.493) -10.78  (15.172)
12.Secondary Outcome
Title Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 12
Hide Description CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 1063 subjects in the Full Analysis Set (FAS) 1024 (824 CZP, 200 Placebo) are included in this analysis.
Arm/Group Title Certolizumab Pegol (CZP) Placebo
Hide Arm/Group Description:
400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed 824 200
Mean (Standard Deviation)
Unit of Measure: units on a scale
-18.96  (14.019) -10.93  (14.494)
13.Secondary Outcome
Title DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] Remission (<2.6) at Week 12
Hide Description DAS28(CRP) is calculated using tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/L), and Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in mm). A lower score indicates less disease activity.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.
Arm/Group Title Certolizumab Pegol (CZP) Placebo
Hide Arm/Group Description:
400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed 851 212
Measure Type: Number
Unit of Measure: percentage of subjects
16.0 5.7
14.Secondary Outcome
Title SDAI (Simplified Disease Activity Index) Remission (≤3.3) at Week 12
Hide Description SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.
Arm/Group Title Certolizumab Pegol (CZP) Placebo
Hide Arm/Group Description:
400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed 851 212
Measure Type: Number
Unit of Measure: percentage of subjects
7.8 1.9
15.Secondary Outcome
Title CDAI (Clinical Disease Activity Index) Remission (≤2.8) at Week 12
Hide Description CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.
Arm/Group Title Certolizumab Pegol (CZP) Placebo
Hide Arm/Group Description:
400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed 851 212
Measure Type: Number
Unit of Measure: percentage of subjects
8.3 1.9
16.Secondary Outcome
Title Change From Baseline in Tender Joint Count (TJC) at Week 12
Hide Description TJC is calculated based on tenderness response of 28 joints. TJC possible values range from 0 to 28. A lower TJC indicates less joint tenderness. Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 1063 subjects in the Full Analysis Set (FAS) 1043 (838 CZP, 205 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.
Arm/Group Title Certolizumab Pegol (CZP) Placebo
Hide Arm/Group Description:
400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed 838 205
Mean (Standard Deviation)
Unit of Measure: units on a scale
-7.4  (7.13) -4.5  (7.38)
17.Secondary Outcome
Title Change From Baseline in Swollen Joint Count (SJC) at Week 12
Hide Description SJC is calculated based on swelling response of 28 joints. SJC possible values range from 0 to 28. A lower SJC indicates less joint swelling. Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 1063 subjects in the Full Analysis Set (FAS) 1043 (838 CZP, 205 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.
Arm/Group Title Certolizumab Pegol (CZP) Placebo
Hide Arm/Group Description:
400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed 838 205
Mean (Standard Deviation)
Unit of Measure: units on a scale
-6.4  (5.57) -3.6  (5.64)
18.Secondary Outcome
Title Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12
Hide Description HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 1063 subjects in the Full Analysis Set (FAS) 1029 (826 CZP, 203 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.
Arm/Group Title Certolizumab Pegol (CZP) Placebo
Hide Arm/Group Description:
400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed 826 203
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.38  (0.524) -0.19  (0.507)
19.Secondary Outcome
Title Change From Baseline in C-reactive Protein (CRP) at Week 12
Hide Description Change from baseline in CRP (mg/L) is computed as the ratio of Week 12 value divided by baseline value. A ratio less then 1 indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 1063 subjects in the Full Analysis Set (FAS) 1046 (841 CZP, 205 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.
Arm/Group Title Certolizumab Pegol (CZP) Placebo
Hide Arm/Group Description:
400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed 841 205
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mg/L
0.55
(0.0% to 16.6%)
1.05
(0.1% to 17.6%)
20.Secondary Outcome
Title Change From Baseline in Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS) at Week 12
Hide Description Change from Baseline in PAAP-VAS (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 1063 subjects in the Full Analysis Set (FAS) 1038 (835 CZP, 203 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.
Arm/Group Title Certolizumab Pegol (CZP) Placebo
Hide Arm/Group Description:
400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed 835 203
Mean (Standard Deviation)
Unit of Measure: mm
-22.1  (28.31) -10.7  (27.32)
21.Secondary Outcome
Title Change From Baseline in Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS) at Week 12
Hide Description Change from Baseline in PtGADA-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 1063 subjects in the Full Analysis Set (FAS) 1038 (835 CZP, 203 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.
Arm/Group Title Certolizumab Pegol (CZP) Placebo
Hide Arm/Group Description:
400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed 835 203
Mean (Standard Deviation)
Unit of Measure: mm
-21.5  (27.78) -10.1  (26.24)
22.Secondary Outcome
Title Change From Baseline in Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS) at Week 12
Hide Description Change from Baseline in PhGADA-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 1063 subjects in the Full Analysis Set (FAS) 1029 (827 CZP, 202 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.
Arm/Group Title Certolizumab Pegol (CZP) Placebo
Hide Arm/Group Description:
400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed 827 202
Mean (Standard Deviation)
Unit of Measure: mm
-31.2  (23.58) -19.0  (25.15)
23.Secondary Outcome
Title Time to Sustained American College of Rheumatology 20% (ACR20) Response
Hide Description The time from randomization to sustained ACR20 response at 2 consecutive visits (at the latest on Week 12).
Time Frame Baseline up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.
Arm/Group Title Certolizumab Pegol (CZP) Placebo
Hide Arm/Group Description:
400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed 851 212
Measure Type: Number
Unit of Measure: percentage of subjects
40.4 13.2
24.Secondary Outcome
Title European League Against Rheumatism (EULAR) Response at Week 12
Hide Description EULAR response (good response, moderate response, or no response) is defined based on the present value and improvement from baseline in DAS28(CRP) [Disease Activity Score-28 (C-reactive protein)].
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.
Arm/Group Title Certolizumab Pegol (CZP) Placebo
Hide Arm/Group Description:
400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed 851 212
Measure Type: Number
Unit of Measure: percentage of subjects
Good response 28.9 10.4
Moderate response 44.5 37.3
No response 26.6 52.4
25.Secondary Outcome
Title American College of Rheumatology 20% (ACR20) Response at Week 28
Hide Description ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS). This analysis was carried out using imputation.
Time Frame Baseline, Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Since imputation was used, all 954 subjects from the Open Label (OL) Set are included in this analysis
Arm/Group Title Open Label Certolizumab Pegol (CZP)
Hide Arm/Group Description:
Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed 954
Measure Type: Number
Unit of Measure: percentage of subjects
58.5
26.Secondary Outcome
Title American College of Rheumatology 50% (ACR50) Response at Week 28
Hide Description ACR50 responders are subjects with at least 50% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS). This analysis was carried out using imputation.
Time Frame Baseline, Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Since imputation was used, all 954 subjects from the Open Label (OL) Set are included in this analysis
Arm/Group Title Open Label Certolizumab Pegol (CZP)
Hide Arm/Group Description:
Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed 954
Measure Type: Number
Unit of Measure: percentage of subjects
35.0
27.Secondary Outcome
Title American College of Rheumatology 70% (ACR70) Response at Week 28
Hide Description ACR70 responders are subjects with at least 70% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS). This analysis was carried out using imputation.
Time Frame Baseline, Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Since imputation was used, all 954 subjects from the Open Label (OL) Set are included in this analysis
Arm/Group Title Open Label Certolizumab Pegol (CZP)
Hide Arm/Group Description:
Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed 954
Measure Type: Number
Unit of Measure: percentage of subjects
17.4
28.Secondary Outcome
Title Change From Baseline in DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] at Week 28
Hide Description DAS28(CRP) is calculated using tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/L), and Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in mm). A lower score indicates less disease activity. Change from Baseline is computed as the value at Week 28 minus Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).
Time Frame Baseline, Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 954 subjects in the Open Label Set (OLS) 840 had observed values at Week 28 and Baseline and are included in this analysis.
Arm/Group Title Open Label Certolizumab Pegol (CZP)
Hide Arm/Group Description:
Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed 840
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.94  (0.055)
29.Secondary Outcome
Title Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 28
Hide Description SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. Change from Baseline is computed as the value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).
Time Frame Baseline, Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 954 subjects in the Open Label Set (OLS) 828 had observed values at Week 28 and Baseline and are included in this analysis.
Arm/Group Title Open Label Certolizumab Pegol (CZP)
Hide Arm/Group Description:
Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed 828
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-22.35  (0.546)
30.Secondary Outcome
Title Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 28
Hide Description CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. Change from Baseline is computed as value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).
Time Frame Baseline, Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 954 subjects in the Open Label Set (OLS) 840 had observed values at Week 28 and Baseline and are included in this analysis.
Arm/Group Title Open Label Certolizumab Pegol (CZP)
Hide Arm/Group Description:
Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed 840
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-21.66  (0.533)
31.Secondary Outcome
Title DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] Remission (<2.6) at Week 28
Hide Description DAS28(CRP) is calculated using tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/L), and Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in mm). A lower score indicates less disease activity. This analysis was carried out using imputation.
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Since imputation was used, all 954 subjects from the Open Label (OL) Set are included in this analysis
Arm/Group Title Open Label Certolizumab Pegol (CZP)
Hide Arm/Group Description:
Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed 954
Measure Type: Number
Unit of Measure: percentage of subjects
22.6
32.Secondary Outcome
Title SDAI (Simplified Disease Activity Index) Remission (≤3.3) at Week 28
Hide Description SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. This analysis was carried out using imputation.
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Since imputation was used, all 954 subjects from the Open Label (OL) Set are included in this analysis
Arm/Group Title Open Label Certolizumab Pegol (CZP)
Hide Arm/Group Description:
Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed 954
Measure Type: Number
Unit of Measure: percentage of subjects
11.4
33.Secondary Outcome
Title CDAI (Clinical Disease Activity Index) Remission (≤2.8) at Week 28
Hide Description CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. This analysis was carried out using imputation.
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Since imputation was used, all 954 subjects from the Open Label (OL) Set are included in this analysis
Arm/Group Title Open Label Certolizumab Pegol (CZP)
Hide Arm/Group Description:
Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed 954
Measure Type: Number
Unit of Measure: percentage of subjects
12.1
34.Secondary Outcome
Title Change From Baseline in Tender Joint Count (TJC) at Week 28
Hide Description TJC is calculated based on tenderness response of 28 joints. TJC possible values range from 0 to 28. A lower TJC indicates less joint tenderness. Change from Baseline is computed as the value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).
Time Frame Baseline, Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 954 subjects in the Open Label Set (OLS) 861 had observed values at Week 28 and Baseline and are included in this analysis.
Arm/Group Title Open Label Certolizumab Pegol (CZP)
Hide Arm/Group Description:
Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed 861
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-8.6  (0.26)
35.Secondary Outcome
Title Change From Baseline in Swollen Joint Count (SJC) at Week 28
Hide Description SJC is calculated based on swelling response of 28 joints. SJC possible values range from 0 to 28. A lower SJC indicates less joint swelling. Change from baseline is computed as the value at Week 28 minus the baseline value. A negative value in change from baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).
Time Frame Baseline, Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 954 subjects in the Open Label Set (OLS) 861 had observed values at Week 28 and Baseline and are included in this analysis.
Arm/Group Title Open Label Certolizumab Pegol (CZP)
Hide Arm/Group Description:
Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed 861
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-7.2  (0.19)
36.Secondary Outcome
Title Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 28
Hide Description HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Change from baseline is computed as the value at Week 28 minus the baseline value. A negative value in change from baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).
Time Frame Baseline, Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 954 subjects in the Open Label Set (OLS) 854 had observed values at Week 28 and Baseline and are included in this analysis
Arm/Group Title Open Label Certolizumab Pegol (CZP)
Hide Arm/Group Description:
Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed 854
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.46  (0.023)
37.Secondary Outcome
Title Change From Baseline in C-reactive Protein (CRP) at Week 28
Hide Description Change from Baseline in CRP (mg/L) is computed as the ratio of the value at Week 28 divided by Baseline value. A ratio less then 1 indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).
Time Frame Baseline, Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 954 subjects in the Open Label Set (OLS) 851 had observed values at Week 28 and Baseline and are included in this analysis
Arm/Group Title Open Label Certolizumab Pegol (CZP)
Hide Arm/Group Description:
Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed 851
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg/L
0.59
(0.55 to 0.63)
38.Secondary Outcome
Title Change From Baseline in Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS) at Week 28
Hide Description Change from Baseline in PAAP-VAS (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) is computed as the value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).
Time Frame Baseline, Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 954 subjects in the Open Label Set (OLS) 856 had observed values at Week 28 and Baseline and are included in this analysis
Arm/Group Title Open Label Certolizumab Pegol (CZP)
Hide Arm/Group Description:
Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed 856
Least Squares Mean (Standard Error)
Unit of Measure: mm
-23.1  (1.06)
39.Secondary Outcome
Title Change From Baseline in Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS) at Week 28
Hide Description Change from Baseline in PtGADA-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).
Time Frame Baseline, Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 954 subjects in the Open Label Set (OLS) 857 had observed values at Week 28 and Baseline and are included in this analysis
Arm/Group Title Open Label Certolizumab Pegol (CZP)
Hide Arm/Group Description:
Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed 857
Least Squares Mean (Standard Error)
Unit of Measure: mm
-23.0  (1.04)
40.Secondary Outcome
Title Change From Baseline in Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS) at Week 28
Hide Description Change from Baseline in PhGADA-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).
Time Frame Baseline, Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 954 subjects in the Open Label Set (OLS) 848 had observed values at Week 28 and Baseline and are included in this analysis
Arm/Group Title Open Label Certolizumab Pegol (CZP)
Hide Arm/Group Description:
Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed 848
Least Squares Mean (Standard Error)
Unit of Measure: mm
-35.6  (0.85)
Time Frame The first two columns refer to the 12-week double blind phase, and an additional 12-week follow up for those who withdrew during the double blind period. The third column displays AEs for the 56-week open label phase and the 12-week safety follow-up.
Adverse Event Reporting Description Of the 1063 subjects in the Full Analysis Set (FAS), 1055 are included in the adverse event reporting based upon the Safety Set (SS) population. The Safety Set includes all subjects randomized who received at least 1 dosing.
 
Arm/Group Title Certolizumab Pegol (CZP) Placebo Open Label Certolizumab Pegol (CZP)
Hide Arm/Group Description 400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. From Week 12, 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available. Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. From Week 12, 200 mg certolizumab pegol (CZP) given as 1 subcutaneous injection every other week for a minimum 16 additional weeks until CZP is commercially available. Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
All-Cause Mortality
Certolizumab Pegol (CZP) Placebo Open Label Certolizumab Pegol (CZP)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Certolizumab Pegol (CZP) Placebo Open Label Certolizumab Pegol (CZP)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   52/846 (6.15%)      12/209 (5.74%)      77/954 (8.07%)    
Blood and lymphatic system disorders       
Anaemia * 1  0/846 (0.00%)  0 1/209 (0.48%)  1 0/954 (0.00%)  0
Lymphadenopathy * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Cardiac disorders       
Coronary artery disease * 1  1/846 (0.12%)  1 0/209 (0.00%)  0 0/954 (0.00%)  0
Cardiac failure * 1  1/846 (0.12%)  1 0/209 (0.00%)  0 1/954 (0.10%)  1
Acute myocardial infarction * 1  2/846 (0.24%)  2 0/209 (0.00%)  0 2/954 (0.21%)  2
Arteriospasm coronary * 1  1/846 (0.12%)  1 0/209 (0.00%)  0 0/954 (0.00%)  0
Myocardial infarction * 1  1/846 (0.12%)  1 0/209 (0.00%)  0 3/954 (0.31%)  3
Artial fibrillation * 1  1/846 (0.12%)  1 0/209 (0.00%)  0 2/954 (0.21%)  3
Cardiac failure congestive * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 3/954 (0.31%)  3
Perocardial effusion * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Supraventricular tachycardia * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Angina Pectoris * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Ear and labyrinth disorders       
Vertigo * 1  1/846 (0.12%)  1 0/209 (0.00%)  0 0/954 (0.00%)  0
Ear pain * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Gastrointestinal disorders       
Pancreatitis * 1  1/846 (0.12%)  1 0/209 (0.00%)  0 0/954 (0.00%)  0
Abdominal pain * 1  2/846 (0.24%)  2 0/209 (0.00%)  0 0/954 (0.00%)  0
Nausea * 1  1/846 (0.12%)  1 1/209 (0.48%)  1 0/954 (0.00%)  0
Vomiting * 1  2/846 (0.24%)  2 0/209 (0.00%)  0 0/954 (0.00%)  0
Umbilical hernia * 1  1/846 (0.12%)  1 0/209 (0.00%)  0 0/954 (0.00%)  0
Gastrooesophageal reflux disease * 1  1/846 (0.12%)  1 0/209 (0.00%)  0 0/954 (0.00%)  0
Colitis ischaemic * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Diarrhoea * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 2/954 (0.21%)  2
Impaired gastric emptying * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Large intestine perforation * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Volvulus * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Stomatitis * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
General disorders       
Chest pain * 1  3/846 (0.35%)  3 2/209 (0.96%)  2 1/954 (0.10%)  1
Non-cardiac chest pain * 1  1/846 (0.12%)  1 0/209 (0.00%)  0 0/954 (0.00%)  0
Impaired healing * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Necrosis * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Hepatobiliary disorders       
Cholecystitis * 1  1/846 (0.12%)  1 0/209 (0.00%)  0 0/954 (0.00%)  0
Immune system disorders       
Drug hypersensitivity * 1  1/846 (0.12%)  1 0/209 (0.00%)  0 0/954 (0.00%)  0
Infections and infestations       
Diverticulitis * 1  1/846 (0.12%)  1 0/209 (0.00%)  0 2/954 (0.21%)  2
Bronchopulmonary aspergillosis * 1  2/846 (0.24%)  3 0/209 (0.00%)  0 0/954 (0.00%)  0
Cellulitis * 1  1/846 (0.12%)  1 0/209 (0.00%)  0 5/954 (0.52%)  5
Bursitis infective * 1  1/846 (0.12%)  1 0/209 (0.00%)  0 0/954 (0.00%)  0
Osteomyelitis * 1  1/846 (0.12%)  1 0/209 (0.00%)  0 0/954 (0.00%)  0
Abscess limb * 1  2/846 (0.24%)  2 0/209 (0.00%)  0 0/954 (0.00%)  0
Bronchitis * 1  2/846 (0.24%)  2 0/209 (0.00%)  0 3/954 (0.31%)  4
Pneumonia * 1  4/846 (0.47%)  4 1/209 (0.48%)  1 8/954 (0.84%)  8
Pneumonia necrotising * 1  1/846 (0.12%)  1 0/209 (0.00%)  0 0/954 (0.00%)  0
Urosepsis * 1  1/846 (0.12%)  1 0/209 (0.00%)  0 0/954 (0.00%)  0
Staphylococcal infection * 1  1/846 (0.12%)  1 0/209 (0.00%)  0 0/954 (0.00%)  0
Pharyngitis streptococcal * 1  0/846 (0.00%)  0 1/209 (0.48%)  1 1/954 (0.10%)  1
Upper respiratory tract infection * 1  1/846 (0.12%)  1 0/209 (0.00%)  0 0/954 (0.00%)  0
Cystitis * 1  0/846 (0.00%)  0 1/209 (0.48%)  1 0/954 (0.00%)  0
Pyelonephritis acute * 1  1/846 (0.12%)  1 0/209 (0.00%)  0 0/954 (0.00%)  0
Urinary tract infection * 1  3/846 (0.35%)  3 0/209 (0.00%)  0 3/954 (0.31%)  3
Gastroenteritis viral * 1  1/846 (0.12%)  1 0/209 (0.00%)  0 0/954 (0.00%)  0
Pyelonephritis * 1  1/846 (0.12%)  1 1/209 (0.48%)  1 0/954 (0.00%)  0
Clostridial infection * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Gastroenteritis * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Ear lobe infection * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Postoperative wound infection * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Pneumonia streptococcal * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Disseminated tuberculosis * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Sinusitis * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 2/954 (0.21%)  2
Gastritis viral * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Injury, poisoning and procedural complications       
Femoral neck fracture * 1  0/846 (0.00%)  0 1/209 (0.48%)  1 0/954 (0.00%)  0
Hip fracture * 1  1/846 (0.12%)  1 0/209 (0.00%)  0 0/954 (0.00%)  0
Lower limb fracture * 1  0/846 (0.00%)  0 1/209 (0.48%)  1 0/954 (0.00%)  0
Tibia fracture * 1  1/846 (0.12%)  1 0/209 (0.00%)  0 0/954 (0.00%)  0
Foreign body trauma * 1  1/846 (0.12%)  1 0/209 (0.00%)  0 0/954 (0.00%)  0
Spinal compression fracture * 1  1/846 (0.12%)  1 0/209 (0.00%)  0 0/954 (0.00%)  0
Concussion * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Subdural haematoma * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Device breakage * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Gastrointestinal disorder postoperative * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Ankle fracture * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Polytraumatism * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Skin laceration * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Upper limb fracture * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Investigations       
Blood glucose increased * 1  1/846 (0.12%)  1 0/209 (0.00%)  0 1/954 (0.10%)  1
Metabolism and nutrition disorders       
Dehydration * 1  1/846 (0.12%)  1 0/209 (0.00%)  0 3/954 (0.31%)  3
Diabetes mellitus * 1  0/846 (0.00%)  0 1/209 (0.48%)  1 0/954 (0.00%)  0
Hyponatraemia * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Musculoskeletal and connective tissue disorders       
Rheumatoid arthritis * 1  1/846 (0.12%)  1 0/209 (0.00%)  0 3/954 (0.31%)  3
Spinal column stenosis * 1  1/846 (0.12%)  1 0/209 (0.00%)  0 0/954 (0.00%)  0
Bursitis * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Intervertebral disc protrusion * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 2/954 (0.21%)  2
Rotator cuff syndrome * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Arthralgia * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Osteoarthritis * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 2/954 (0.21%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Breast cancer * 1  0/846 (0.00%)  0 1/209 (0.48%)  1 1/954 (0.10%)  1
Carcinoid tumour * 1  1/846 (0.12%)  1 0/209 (0.00%)  0 0/954 (0.00%)  0
Hepatic neoplasm * 1  0/846 (0.00%)  0 1/209 (0.48%)  1 0/954 (0.00%)  0
Adenocarcinoma pancreas * 1  1/846 (0.12%)  1 0/209 (0.00%)  0 0/954 (0.00%)  0
Malignant melanoma * 1  1/846 (0.12%)  1 1/209 (0.48%)  1 1/954 (0.10%)  1
Sarcoma uterus * 1  1/846 (0.12%)  1 0/209 (0.00%)  0 0/954 (0.00%)  0
Colon adenoma * 1  1/846 (0.12%)  1 0/209 (0.00%)  0 0/954 (0.00%)  0
Breast cancer metastatic * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Ovarian granulosa-theca cell tumor * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Mycosis fungoides * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Small cell lung cancer metastatic * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 2/954 (0.21%)  2
Basal cell carcinoma * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Uterine leiomyoma * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Nervous system disorders       
Syncope * 1  1/846 (0.12%)  1 0/209 (0.00%)  0 2/954 (0.21%)  2
Brain stem infarction * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Grand mal convulsion * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Dizziness * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Pregnancy, puerperium and perinatal conditions       
Pregnancy * 1  1/846 (0.12%)  1 0/209 (0.00%)  0 1/954 (0.10%)  1
Psychiatric disorders       
Suicide attempt * 1  1/846 (0.12%)  1 0/209 (0.00%)  0 0/954 (0.00%)  0
Depression * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Renal and urinary disorders       
Bladder prolapse * 1  1/846 (0.12%)  1 0/209 (0.00%)  0 0/954 (0.00%)  0
Azotaemia * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Renal failure * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 2/954 (0.21%)  2
Renal failure acute * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Renal impairment * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Nephrolithiasis * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Reproductive system and breast disorders       
Cervical dysplasia * 1  1/846 (0.12%)  1 0/209 (0.00%)  0 0/954 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Dyspnoea exertional * 1  0/846 (0.00%)  0 1/209 (0.48%)  1 1/954 (0.10%)  1
Asthma * 1  1/846 (0.12%)  1 0/209 (0.00%)  0 1/954 (0.10%)  1
Chronic obstructive pulmonary disease * 1  2/846 (0.24%)  2 0/209 (0.00%)  0 0/954 (0.00%)  0
Pulmonary oedema * 1  1/846 (0.12%)  1 0/209 (0.00%)  0 0/954 (0.00%)  0
Dyspnoea * 1  1/846 (0.12%)  1 0/209 (0.00%)  0 1/954 (0.10%)  1
Pneumonitis * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Plural effusion * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Pulmonary embolism * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 2/954 (0.21%)  2
Skin and subcutaneous tissue disorders       
Angioneurotic oedema * 1  1/846 (0.12%)  1 0/209 (0.00%)  0 0/954 (0.00%)  0
Urticaria * 1  1/846 (0.12%)  1 0/209 (0.00%)  0 0/954 (0.00%)  0
Drug eurption * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Skin ulcer * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Surgical and medical procedures       
Gastric bypass * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Synoviorthesis * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Vascular disorders       
Hypertensive crisis * 1  1/846 (0.12%)  1 0/209 (0.00%)  0 0/954 (0.00%)  0
Peripheral artery aneurysm * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Deep vein thrombosis * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 2/954 (0.21%)  2
Femoral arterial stenosis * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 1/954 (0.10%)  1
Hypertension * 1  0/846 (0.00%)  0 0/209 (0.00%)  0 2/954 (0.21%)  3
*
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 (CZP) Placebo Open Label Certolizumab Pegol (CZP)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   174/846 (20.57%)      42/209 (20.10%)      246/954 (25.79%)    
Infections and infestations       
Upper respiratory tract infection * 1  62/846 (7.33%)  68 11/209 (5.26%)  12 76/954 (7.97%)  83
Nasopharyngitis * 1  27/846 (3.19%)  31 4/209 (1.91%)  4 53/954 (5.56%)  58
Urinary Tract Infection * 1  24/846 (2.84%)  28 9/209 (4.31%)  10 64/954 (6.71%)  76
Musculoskeletal and connective tissue disorders       
Rheumatoid Arthritis * 1  37/846 (4.37%)  46 16/209 (7.66%)  18 68/954 (7.13%)  83
Nervous system disorders       
Headache * 1  46/846 (5.44%)  57 11/209 (5.26%)  13 35/954 (3.67%)  40
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.0)
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.
UCB has > 60 but <= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that the results shall be published regardless of outcome.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB (Study Director)
Organization: UCB Clinical Trial Call Center
Phone: +1 887 822 9493
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00717236    
Other Study ID Numbers: C87094
2008-005427-28 ( EudraCT Number )
First Submitted: July 15, 2008
First Posted: July 17, 2008
Results First Submitted: March 10, 2011
Results First Posted: May 6, 2011
Last Update Posted: August 1, 2018