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Trial record 1 of 2 for:    NCT00674362
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Rheumatoid Arthritis (RA) Moderate to Low Disease Activity Study (CERTAIN)

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: NCT00674362
Recruitment Status : Completed
First Posted : May 7, 2008
Results First Posted : January 18, 2012
Last Update Posted : January 18, 2012
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 Biological: Certolizumab pegol
Biological: Placebo
Enrollment 194
Recruitment Details The study started in June 2008 with subjects from Germany, France, Austria, Italy, and Poland. The primary completion date occurred in May 2010, with an anticipated study completion in December 2010.
Pre-assignment Details  
Arm/Group Title Certolizumab Pegol 200 mg (CDP870) Placebo
Hide Arm/Group Description Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22) Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Period Title: Double Blind
Started 96 98
Completed 84 80
Not Completed 12 18
Reason Not Completed
Adverse Event             6             6
Lack of Efficacy             2             6
Loss of efficacy             0             1
Withdrawal by Subject             4             3
Other: Loss of Patient Compliance             0             1
Other: Surgery             0             1
Period Title: Open Label
Started 20 7
Completed 18 7
Not Completed 2 0
Reason Not Completed
Adverse Event             1             0
Other: Subject moved to extension study             1             0
Arm/Group Title Certolizumab Pegol 200 mg (CDP870) Placebo Total
Hide Arm/Group Description Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22) Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22) Total of all reporting groups
Overall Number of Baseline Participants 96 98 194
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 96 participants 98 participants 194 participants
<=18 years
0
   0.0%
1
   1.0%
1
   0.5%
Between 18 and 65 years
78
  81.3%
80
  81.6%
158
  81.4%
>=65 years
18
  18.8%
17
  17.3%
35
  18.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 96 participants 98 participants 194 participants
53.6  (11.9) 54.0  (12.4) 53.8  (12.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 96 participants 98 participants 194 participants
Female
81
  84.4%
75
  76.5%
156
  80.4%
Male
15
  15.6%
23
  23.5%
38
  19.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 96 participants 98 participants 194 participants
France 2 2 4
Poland 40 46 86
Austria 17 15 32
Germany 31 31 62
Italy 6 4 10
1.Primary Outcome
Title Clinical Disease Activity Index (CDAI) Remission (≤2.8) at Both Week 20 and Week 24
Hide Description CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI)
Time Frame Week 20 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All 194 subjects in the Full Analysis Set (FAS) are included in this analysis.
Arm/Group Title Certolizumab Pegol 200 mg (CDP870) Placebo
Hide Arm/Group Description:
Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Overall Number of Participants Analyzed 96 98
Measure Type: Number
Unit of Measure: percentage of subjects
18.8 6.1
2.Secondary Outcome
Title 28-joint Count Disease Activity Score (DAS28-ESR) Remission (<2.6) at Both Week 20 and Week 24
Hide Description DAS28-ESR is calculated using the tender joint count (TJC), swollen joint count (SJC) erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Patient Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI)
Time Frame Week 20 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Since imputation was used, all 194 subjects are included in the analysis
Arm/Group Title Certolizumab Pegol 200 mg (CDP870) Placebo
Hide Arm/Group Description:
Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Overall Number of Participants Analyzed 96 98
Measure Type: Number
Unit of Measure: percentage of subjects
19.8 3.1
3.Secondary Outcome
Title Simplified Disease Activity Index (SDAI) Remission (≤3.3) at Both Week 20 and Week 24
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 Disease Activity - Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI)
Time Frame Week 20 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Since imputation was used, all 194 subjects are included in the analysis
Arm/Group Title Certolizumab Pegol 200 mg (CDP870) Placebo
Hide Arm/Group Description:
Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Overall Number of Participants Analyzed 96 98
Measure Type: Number
Unit of Measure: percentage of subjects
14.6 4.1
4.Secondary Outcome
Title Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using Clinical Disease Activity Index (CDAI) Scores at 2 Consecutive Visits
Hide Description CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Patients losing remission (CDAI >2.8) for two consecutive visits will be considered as having the event on the day of the visit where remission was first lost. Subjects discontinued/non-remitted by Week 24 are considered as having the event on day 1.
Time Frame Week 24 up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
All 194 subjects in the Full Analysis Set (FAS) are included in this analysis.
Arm/Group Title Certolizumab Pegol 200 mg (CDP870) Placebo
Hide Arm/Group Description:
Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Overall Number of Participants Analyzed 96 98
Mean (Standard Deviation)
Unit of Measure: days
12.1  (2.83) 3.4  (1.02)
5.Secondary Outcome
Title Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using Simplified Disease Activity Index (SDAI) Scores at 2 Consecutive Visits
Hide Description SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (mg/dL), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in cm) and Physician's Global Assessment of Disease Activity (PhGADA-VAS in cm). 28 joints are examined. A lower score indicates less disease activity. Patients losing remission (SDAI >3.3) for two consecutive visits will be considered as having the event on the day of the visit where remission was first lost. Subjects discontinued/non-remitted by Week 24 are considered as having the event on day 1.
Time Frame Week 24 up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
All 194 subjects in the Full Analysis Set (FAS) are included in this analysis.
Arm/Group Title Certolizumab Pegol 200 mg (CDP870) Placebo
Hide Arm/Group Description:
Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Overall Number of Participants Analyzed 96 98
Mean (Standard Deviation)
Unit of Measure: days
9.8  (2.57) 2.1  (0.53)
6.Secondary Outcome
Title Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using DAS28-ESR Scores at 2 Consecutive Visits
Hide Description DAS28-ESR is calculated using tender joint count (TJC), swollen joint count (SJC), erythrocyte sedimentation rate (ESR mm/hour) and Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS mm). 0.56x√(TJC) + 0.28x√(SJC) + 0.70xlognat(ESR) + 0.014xPtGADA-VAS. 28 joints are examined. Lower score indicates less disease activity. Patients losing remission (DAS28-ESR≥2.6) for two consecutive visits will be considered as having the event on the first of the two visits. Subjects discontinued/non-remitted by Week 24 are considered as having the event on day 1.
Time Frame Week 24 up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
All 194 subjects in the Full Analysis Set (FAS) are included in this analysis.
Arm/Group Title Certolizumab Pegol 200 mg (CDP870) Placebo
Hide Arm/Group Description:
Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Overall Number of Participants Analyzed 96 98
Mean (Standard Deviation)
Unit of Measure: Days
12.1  (2.96) 1.0  (0.00)
7.Secondary Outcome
Title American College of Rheumatology 20% (ACR20) Response at Week 24
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, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Since imputation was used, all 194 subjects are included in the analysis
Arm/Group Title Certolizumab Pegol 200 mg (CDP870) Placebo
Hide Arm/Group Description:
Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Overall Number of Participants Analyzed 96 98
Measure Type: Number
Unit of Measure: percentage of subjects
36.5 15.3
8.Secondary Outcome
Title American College of Rheumatology 50% (ACR50) Response at Week 24
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, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Since imputation was used, all 194 subjects are included in the analysis
Arm/Group Title Certolizumab Pegol 200 mg (CDP870) Placebo
Hide Arm/Group Description:
Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Overall Number of Participants Analyzed 96 98
Measure Type: Number
Unit of Measure: percentage of subjects
20.8 7.1
9.Secondary Outcome
Title American College of Rheumatology 70% (ACR70) Response at Week 24
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, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Since imputation was used, all 194 subjects are included in the analysis
Arm/Group Title Certolizumab Pegol 200 mg (CDP870) Placebo
Hide Arm/Group Description:
Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Overall Number of Participants Analyzed 96 98
Measure Type: Number
Unit of Measure: percentage of subjects
9.4 3.1
10.Secondary Outcome
Title Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24
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 24 minus the 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 24
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 194 subjects, 182 (91 CZP, 91 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.
Arm/Group Title Certolizumab Pegol 200 mg (CDP870) Placebo
Hide Arm/Group Description:
Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Overall Number of Participants Analyzed 91 91
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.25  (0.460) -0.03  (0.490)
11.Secondary Outcome
Title Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Component Summary (PCS) Scores at Week 24
Hide Description PCS norm-based scores are calculated based upon the following 8 domain scores, Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, and range from 1 to 81, where 50 represents the normative value. A larger positive value in change from Baseline indicates an improvement.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 194 subjects in the Full Analysis Set (FAS), 164 (82 CZP, 82 Placebo) had values at Baseline and Week 24 and are included in this analysis.
Arm/Group Title Certolizumab Pegol 200 mg (CDP870) Placebo
Hide Arm/Group Description:
Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Overall Number of Participants Analyzed 82 82
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.0  (7.50) 1.7  (7.56)
12.Secondary Outcome
Title Change From Baseline in Short Form 36-items Health Survey (SF-36) Mental Component Summary (MCS) Scores at Week 24
Hide Description MCS norm-based scores are calculated based upon the following 8 domain scores, Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, and range from -9 to 82, where 50 represents the normative value. A larger positive value in change from Baseline indicates an improvement
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 194 subjects in the Full Analysis Set (FAS), 164 (82 CZP, 82 Placebo) had values at Baseline and Week 24 and are included in this analysis.
Arm/Group Title Certolizumab Pegol 200 mg (CDP870) Placebo
Hide Arm/Group Description:
Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Overall Number of Participants Analyzed 82 82
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.0  (9.77) 0.5  (9.26)
13.Secondary Outcome
Title Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Functioning Domain at Week 24
Hide Description There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 194 subjects in the Full Analysis Set (FAS), 168 (83 CZP, 85 Placebo) had values at Baseline and Week 24 and are included in this analysis.
Arm/Group Title Certolizumab Pegol 200 mg (CDP870) Placebo
Hide Arm/Group Description:
Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Overall Number of Participants Analyzed 83 85
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.1  (7.36) 0.4  (8.90)
14.Secondary Outcome
Title Change From Baseline in Short Form 36-items Health Survey (SF-36) Role Physical Domain at Week 24
Hide Description There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 194 subjects in the Full Analysis Set (FAS), 167 (83 CZP, 84 Placebo) had values at Baseline and Week 24 and are included in this analysis.
Arm/Group Title Certolizumab Pegol 200 mg (CDP870) Placebo
Hide Arm/Group Description:
Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Overall Number of Participants Analyzed 83 84
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.7  (9.77) 1.7  (7.81)
15.Secondary Outcome
Title Change From Baseline in Short Form 36-items Health Survey (SF-36) Bodily Pain Domain at Week 24
Hide Description There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 194 subjects in the Full Analysis Set (FAS), 167 (83 CZP, 84 Placebo) had values at Baseline and Week 24 and are included in this analysis.
Arm/Group Title Certolizumab Pegol 200 mg (CDP870) Placebo
Hide Arm/Group Description:
Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Overall Number of Participants Analyzed 83 84
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.0  (8.70) 2.8  (8.50)
16.Secondary Outcome
Title Change From Baseline in Short Form 36-items Health Survey (SF-36) General Health Domain at Week 24
Hide Description There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 194 subjects in the Full Analysis Set (FAS), 166 (82 CZP, 84 Placebo) had values at Baseline and Week 24 and are included in this analysis.
Arm/Group Title Certolizumab Pegol 200 mg (CDP870) Placebo
Hide Arm/Group Description:
Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Overall Number of Participants Analyzed 82 84
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.0  (7.59) 0.9  (8.06)
17.Secondary Outcome
Title Change From Baseline in Short Form 36-items Health Survey (SF-36) Vitality Domain at Week 24
Hide Description There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 194 subjects in the Full Analysis Set (FAS), 168 (83 CZP, 85 Placebo) had values at Baseline and Week 24 and are included in this analysis.
Arm/Group Title Certolizumab Pegol 200 mg (CDP870) Placebo
Hide Arm/Group Description:
Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Overall Number of Participants Analyzed 83 85
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.4  (8.74) 0.6  (8.41)
18.Secondary Outcome
Title Change From Baseline in Short Form 36-items Health Survey (SF-36) Social Functioning Domain at Week 24
Hide Description There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 194 subjects in the Full Analysis Set (FAS), 168 (83 CZP, 85 Placebo) had values at Baseline and Week 24 and are included in this analysis.
Arm/Group Title Certolizumab Pegol 200 mg (CDP870) Placebo
Hide Arm/Group Description:
Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Overall Number of Participants Analyzed 83 85
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.3  (10.21) 0.8  (8.89)
19.Secondary Outcome
Title Change From Baseline in Short Form 36-items Health Survey (SF-36) Role Emotional Domain at Week 24
Hide Description There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 194 subjects in the Full Analysis Set (FAS), 166 (83 CZP, 83 Placebo) had values at Baseline and Week 24 and are included in this analysis.
Arm/Group Title Certolizumab Pegol 200 mg (CDP870) Placebo
Hide Arm/Group Description:
Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Overall Number of Participants Analyzed 83 83
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.2  (13.74) -0.2  (12.33)
20.Secondary Outcome
Title Change From Baseline in Short Form 36-items Health Survey (SF-36) Mental Health Domain at Week 24
Hide Description There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 194 subjects in the Full Analysis Set (FAS), 168 (83 CZP, 85 Placebo) had values at Baseline and Week 24 and are included in this analysis.
Arm/Group Title Certolizumab Pegol 200 mg (CDP870) Placebo
Hide Arm/Group Description:
Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Overall Number of Participants Analyzed 83 85
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.2  (8.43) 1.2  (7.72)
21.Secondary Outcome
Title Change From Baseline in Patient's Assessment of Arthritis Pain-Visual Analog Scale (VAS) at Week 24
Hide Description Change from Baseline in Patient's Assessment of Arthritis Pain-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 24 minus the 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 24
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 194 subjects, 162 (81 CZP, 81 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method
Arm/Group Title Certolizumab Pegol 200 mg (CDP870) Placebo
Hide Arm/Group Description:
Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Overall Number of Participants Analyzed 81 81
Mean (Standard Deviation)
Unit of Measure: mm
-12.4  (25.49) 1.0  (24.27)
22.Secondary Outcome
Title Change From Baseline in Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS) at Week 24
Hide Description Change from Baseline in Patient's Global Assessment of Disease Activity-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Week 24 minus the 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 24
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Hide Analysis Population Description
Of the 194 subjects, 183 (92 CZP, 91 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method
Arm/Group Title Certolizumab Pegol 200 mg (CDP870) Placebo
Hide Arm/Group Description:
Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Overall Number of Participants Analyzed 92 91
Mean (Standard Deviation)
Unit of Measure: mm
-7.6  (28.69) 2.9  (25.43)
23.Secondary Outcome
Title Change From Baseline in Fatigue Assessment Scale at Week 24
Hide Description Change from Baseline in Fatigue Assessment scale (0 to 10, 0 is "No Fatigue" and 10 is "Fatigue as bad as you can imagine") is computed as the value at Week 24 minus the 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 24
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 194 subjects, 180 (90 CZP, 90 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method
Arm/Group Title Certolizumab Pegol 200 mg (CDP870) Placebo
Hide Arm/Group Description:
Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Overall Number of Participants Analyzed 90 90
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.2  (2.24) 0.1  (2.12)
24.Other Pre-specified Outcome
Title Time From Stopping Treatment (Week 24) to First Flare (up to Week 52) Using Clinical Disease Activity Index (CDAI) at 2 Consecutive Visits
Hide Description Subjects having a flare (CDAI ≥11) between Week 24 and Week 52 for two consecutive visits will be considered as having the event on the day of the visit where flare first appeared.
Time Frame From Week 24 up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description

All 194 subjects in the Full Analysis Set (FAS) are included in this analysis.

An ad-hoc analysis has been performed on the Week 24 Responder Set (W24RS) which showed similar results.
Arm/Group Title Certolizumab Pegol 200 mg (CDP870) Placebo
Hide Arm/Group Description:
Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Overall Number of Participants Analyzed 96 98
Mean (Standard Error)
Unit of Measure: days
82.3  (10.28) 34.5  (4.93)
25.Other Pre-specified Outcome
Title Association Between Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) Activity States at Week 24
Hide Description The number representing the association is the Kappa Correlation Coefficient for CDAI/SDAI for each category of activity (Low Disease Activity (LDA) vs. non-LDA, Medium Disease Activity (MDA) vs. non-MDA, and High Disease Activity (HDA) vs. non-HDA).
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 194 subjects in the Full Analysis Set (FAS) 143 (76 CZP, 67 Placebo) had measures for both CDAI and SDAI at Week 24 and are included in this analysis.
Arm/Group Title Certolizumab Pegol 200 mg (CDP870) Placebo
Hide Arm/Group Description:
Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Overall Number of Participants Analyzed 76 67
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Kappa Correlation Coefficient
LDA vs. Non-LDA
0.82
(0.69 to 0.95)
0.96
(0.89 to 1.00)
MDA vs. Non-MDA
0.68
(0.49 to 0.87)
0.71
(0.54 to 0.88)
HDA vs. Non-HDA
0.59
(0.27 to 0.90)
0.71
(0.53 to 0.89)
26.Other Pre-specified Outcome
Title Association Between Clinical Disease Activity Index (CDAI) and Disease Activity Score (DAS28-ESR) Activity States at Week 24
Hide Description The number representing the association is the Kappa Correlation Coefficient for CDAI/DAS28-ESR for each category of activity (Low Disease Activity (LDA) vs. non-LDA, Medium Disease Activity (MDA) vs. non-MDA, and High Disease Activity (HDA) vs. non-HDA).
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 194 subjects in the Full Analysis Set (FAS) 148 (79 CZP, 69 Placebo) had measures for both CDAI and DAS28-ESR at Week 24 and are included in this analysis.
Arm/Group Title Certolizumab Pegol 200 mg (CDP870) Placebo
Hide Arm/Group Description:
Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Overall Number of Participants Analyzed 79 69
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Kappa Correlation Coefficient
LDA vs. Non-LDA
0.08
(-0.10 to 0.26)
0.08
(-0.15 to 0.31)
MDA vs. Non-MDA
0.36
(0.19 to 0.54)
0.44
(0.27 to 0.60)
HDA vs. Non-HDA
0.54
(0.22 to 0.85)
0.65
(0.46 to 0.84)
27.Other Pre-specified Outcome
Title Association Between Disease Activity Score (DAS28-ESR) and Simplified Disease Activity Index (SDAI) Activity States at Week 24
Hide Description The number representing the association is the Kappa Correlation Coefficient for DAS28-ESR/SDAI for each category of activity (Low Disease Activity (LDA) vs. non-LDA, Medium Disease Activity (MDA) vs. non-MDA, and High Disease Activity (HDA) vs. non-HDA).
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 194 subjects in the Full Analysis Set (FAS) 142 (76 CZP, 66 Placebo) had measures for both DAS28-ESR and SDAI at Week 24 and are included in this analysis.
Arm/Group Title Certolizumab Pegol 200 mg (CDP870) Placebo
Hide Arm/Group Description:
Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Overall Number of Participants Analyzed 76 66
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Kappa Correlation Coefficient
LDA vs. Non-LDA
0.20
(0.03 to 0.37)
0.10
(-0.13 to 0.33)
MDA vs. Non-MDA
0.44
(0.26 to 0.62)
0.59
(0.42 to 0.77)
HDA vs. Non-HDA
0.74
(0.39 to 1.00)
0.91
(0.79 to 1.00)
28.Other Pre-specified Outcome
Title Association Between Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) Remission at Week 24
Hide Description The number representing the association is the Kappa Correlation Coefficient for CDAI/SDAI remission.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 194 subjects in the Full Analysis Set (FAS) 143 (76 CZP, 67 Placebo) had measures for both CDAI and SDAI at Week 24 and are included in this analysis.
Arm/Group Title Certolizumab Pegol 200 mg (CDP870) Placebo
Hide Arm/Group Description:
Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Overall Number of Participants Analyzed 76 67
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Kappa Correlation Coefficient
0.88
(0.74 to 1.00)
1.00
(1.00 to 1.00)
29.Other Pre-specified Outcome
Title Association Between Clinical Disease Activity Index (CDAI) and Disease Activity Score (DAS28-ESR) Remission at Week 24
Hide Description The number representing the association is the Kappa Correlation Coefficient for CDAI/DAS28-ESR remission
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 194 subjects in the Full Analysis Set (FAS) 148 (79 CZP, 69 Placebo) had measures for both CDAI and DAS28-ESR at Week 24 and are included in this analysis.
Arm/Group Title Certolizumab Pegol 200 mg (CDP870) Placebo
Hide Arm/Group Description:
Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Overall Number of Participants Analyzed 79 69
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Kappa Correlation Coefficient
0.53
(0.32 to 0.75)
0.31
(-0.07 to 0.69)
30.Other Pre-specified Outcome
Title Association Between Disease Activity Score (DAS28-ESR) and Simplified Disease Activity Index (SDAI) Remission at Week 24
Hide Description The number representing the association is the Kappa Correlation Coefficient for DAS28-ESR/SDAI remission.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 194 subjects in the Full Analysis Set (FAS) 142 (76 CZP, 66 Placebo) had measures for both DAS28-ESR and SDAI at Week 24 and are included in this analysis.
Arm/Group Title Certolizumab Pegol 200 mg (CDP870) Placebo
Hide Arm/Group Description:
Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Overall Number of Participants Analyzed 76 66
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Kappa Correlation Coefficient
0.61
(0.41 to 0.81)
0.31
(-0.08 to 0.69)
Time Frame The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up.
Adverse Event Reporting Description A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.
 
Arm/Group Title Certolizumab Pegol 200 mg (CDP870) Placebo Open Label Phase
Hide Arm/Group Description Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22) Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22) At Week 24 subjects are evaluated. Non-remitters are discontinued from the study with the opportunity to enter another open label (OL) study. Remitters stop randomized treatment and are followed up until Week 52. Remitters who flare up between Week 24 and Week 52 will be re-treated with (3 administrations of 400 mg CZP, given every other week, followed by 200 mg CZP given every other week) up to and including Week 50. Of the 27 subjects in the OL phase 15 were retreated and 12 were not retreated.
All-Cause Mortality
Certolizumab Pegol 200 mg (CDP870) Placebo Open Label Phase
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Certolizumab Pegol 200 mg (CDP870) Placebo Open Label Phase
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/96 (5.21%)      7/98 (7.14%)      1/27 (3.70%)    
Gastrointestinal disorders       
Irritable Bowel Syndrome * 1  1/96 (1.04%)  1 0/98 (0.00%)  0 0/27 (0.00%)  0
Infections and infestations       
Otitis Media * 1  1/96 (1.04%)  1 0/98 (0.00%)  0 0/27 (0.00%)  0
Haemophilus Sepsis * 1  1/96 (1.04%)  1 0/98 (0.00%)  0 0/27 (0.00%)  0
Pneumonia * 1  0/96 (0.00%)  0 1/98 (1.02%)  1 0/27 (0.00%)  0
Injury, poisoning and procedural complications       
Tendon Rupture * 1  0/96 (0.00%)  0 1/98 (1.02%)  1 0/27 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Polyarthritis * 1  1/96 (1.04%)  1 0/98 (0.00%)  0 0/27 (0.00%)  0
Intervertebral Disc Protrusion * 1  1/96 (1.04%)  1 0/98 (0.00%)  0 0/27 (0.00%)  0
Joint Effusion * 1  0/96 (0.00%)  0 1/98 (1.02%)  1 0/27 (0.00%)  0
Rheumatoid Arthritis * 1  1/96 (1.04%)  1 0/98 (0.00%)  0 0/27 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Breast Cancer * 1  0/96 (0.00%)  0 1/98 (1.02%)  1 0/27 (0.00%)  0
Basal Cell Carcinoma * 1  0/96 (0.00%)  0 1/98 (1.02%)  1 0/27 (0.00%)  0
Nervous system disorders       
Cerebrovascular Accident * 1 [1]  0/96 (0.00%)  0 1/98 (1.02%)  1 1/27 (3.70%)  1
Respiratory, thoracic and mediastinal disorders       
Wegener's Granulomatosis * 1  0/96 (0.00%)  0 1/98 (1.02%)  1 0/27 (0.00%)  0
Pleurisy * 1  0/96 (0.00%)  0 1/98 (1.02%)  1 0/27 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.0)
[1]
The Cerebrovascular Accident occurring during the open label (OL) phase occurred in a subject who did not receive treatment throughout the duration of the OL phase.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Certolizumab Pegol 200 mg (CDP870) Placebo Open Label Phase
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   32/96 (33.33%)      34/98 (34.69%)      4/27 (14.81%)    
Gastrointestinal disorders       
Diarrhoea * 1  5/96 (5.21%)  7 6/98 (6.12%)  6 0/27 (0.00%)  0
Nausea * 1  5/96 (5.21%)  5 5/98 (5.10%)  6 2/27 (7.41%)  2
Infections and infestations       
Nasopharyngitis * 1  10/96 (10.42%)  12 11/98 (11.22%)  13 0/27 (0.00%)  0
Upper Respiratory Tract Infection * 1  6/96 (6.25%)  6 4/98 (4.08%)  5 0/27 (0.00%)  0
Urinary Tract Infection * 1  6/96 (6.25%)  6 5/98 (5.10%)  5 0/27 (0.00%)  0
Bronchitis * 1  3/96 (3.13%)  4 5/98 (5.10%)  5 2/27 (7.41%)  2
Musculoskeletal and connective tissue disorders       
Rheumatoid Arthritis * 1  2/96 (2.08%)  2 5/98 (5.10%)  6 0/27 (0.00%)  0
Nervous system disorders       
Headache * 1  1/96 (1.04%)  1 5/98 (5.10%)  6 0/27 (0.00%)  0
*
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.
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00674362    
Other Study ID Numbers: C87076
2007-000828-40 ( EudraCT Number )
First Submitted: May 5, 2008
First Posted: May 7, 2008
Results First Submitted: December 9, 2011
Results First Posted: January 18, 2012
Last Update Posted: January 18, 2012