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Dosing Flexibility Study in Patients With Rheumatoid Arthritis (DoseFlex)

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: NCT00580840
Recruitment Status : Completed
First Posted : December 27, 2007
Results First Posted : March 19, 2012
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Drug: Certolizumab pegol
Other: Placebo
Enrollment 333
Recruitment Details The study started in December 2007 with subjects from Canada, France, and United States. The primary completion date occurred in December 2010, with study completion in March 2011.
Pre-assignment Details  
Arm/Group Title Overall CZP 400 mg and PLO + MTX CZP 200 mg and PLO + MTX PLO + MTX
Hide Arm/Group Description Overall for the Run-in period includes all 333 subjects that entered the study. Overall for the Double-blind period includes all 209 subjects that completed the Run-in period. Certolizumab Pegol (CZP) 400 mg and Placebo (PLO) + Methotrexate (MTX) Certolizumab Pegol (CZP) 200 mg and Placebo (PLO) + Methotrexate (MTX) Placebo (PTO) + Methotrexate (MTX)
Period Title: Run-in
Started 333 [1] 0 0 0
Completed 209 [2] 0 0 0
Not Completed 124 0 0 0
Reason Not Completed
Adverse Event             17             0             0             0
Lack of Efficacy             93             0             0             0
Loss of Efficacy             1             0             0             0
Lost to Follow-up             4             0             0             0
Withdrawal by Subject             5             0             0             0
Other: Per Sponsor Request             2             0             0             0
Other: Did Not Meet Joint Count Criteria             1             0             0             0
Other: Exclusionary Lab Value             1             0             0             0
[1]
620 subjects were screened for the study with 333 being enrolled.
[2]
Of the 209 randomized participants, 208 are in the Full Analysis Set (FAS).
Period Title: Double-Blind
Started 0 70 70 69
Completed 0 63 61 54
Not Completed 0 7 9 15
Reason Not Completed
Adverse Event             0             3             4             1
Loss of Efficacy             0             1             2             10
Lost to Follow-up             0             1             0             2
Withdrawal by Subject             0             1             2             2
Other: Discontinued Methotrexate             0             1             0             0
Other: Forbidden Medication             0             0             1             0
Arm/Group Title Run-in Overall
Hide Arm/Group Description Overall includes all 333 subjects that entered the Run-in period of the study
Overall Number of Baseline Participants 333
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 333 participants
<=18 years
0
   0.0%
Between 18 and 65 years
264
  79.3%
>=65 years
69
  20.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 333 participants
54.2  (12.75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 333 participants
Female
253
  76.0%
Male
80
  24.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 333 participants
France 7
United States 306
Canada 20
1.Primary Outcome
Title Percentage of ACR20 (American College of Rheumatology 20% Improvement) Responders at Week 34 in Patients Randomized at Week 18
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 34
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis which uses Non-Response Imputation (NRI).
Arm/Group Title Certolizumab Pegol 400 mg and Placebo + Methotrexate Certolizumab Pegol 200 mg and Placebo + Methotrexate Placebo + Methotrexate
Hide Arm/Group Description:
400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed 69 70 69
Measure Type: Number
Unit of Measure: percentage of subjects
65.2 67.1 44.9
2.Secondary Outcome
Title Percentage of ACR20 (American College of Rheumatology 20% Improvement) Responders at Week 16 in All Patients
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 16
Hide Outcome Measure Data
Hide Analysis Population Description
Since Non-Response Imputation (NRI) was used, all 333 subjects in the run-in period are included in this analysis
Arm/Group Title Run-in Overall
Hide Arm/Group Description:
Overall includes all 333 subjects that entered the Run-in period of the study
Overall Number of Participants Analyzed 333
Measure Type: Number
Unit of Measure: percentage of subjects
61.3
3.Secondary Outcome
Title Percentage of ACR50 (American College of Rheumatology 50% Improvement) Responders at Week 16 in All Patients
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 16
Hide Outcome Measure Data
Hide Analysis Population Description
Since Non-Response Imputation (NRI) was used, all 333 subjects in the run-in period are included in this analysis
Arm/Group Title Run-in Overall
Hide Arm/Group Description:
Overall includes all 333 subjects that entered the Run-in period of the study
Overall Number of Participants Analyzed 333
Measure Type: Number
Unit of Measure: percentage of subjects
37.8
4.Secondary Outcome
Title Percentage of ACR70 (American College of Rheumatology 70% Improvement) Responders at Week 16 in All Patients
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 16
Hide Outcome Measure Data
Hide Analysis Population Description
Since Non-Response Imputation (NRI) was used, all 333 subjects in the run-in period are included in this analysis
Arm/Group Title Run-in Overall
Hide Arm/Group Description:
Overall includes all 333 subjects that entered the Run-in period of the study
Overall Number of Participants Analyzed 333
Measure Type: Number
Unit of Measure: percentage of subjects
16.2
5.Secondary Outcome
Title Change From Baseline in DAS28 (Disease Activity Score-28 Items) at Week 16 in All Patients
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 (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.

< 2.6 Remission,

> = 2.6 - < =3.2 Low, > 3.2 - < = 5.1 Moderate, > 5.1 High

Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 333 subjects in the Run-in period, 325 are included in this analysis using the Last Observation Carried Forward (LOCF) method.
Arm/Group Title Run-in Overall
Hide Arm/Group Description:
Overall includes all 333 subjects that entered the Run-in period of the study
Overall Number of Participants Analyzed 325
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.3  (1.3)
6.Secondary Outcome
Title Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 16 in All Patients
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 (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.

<= 3.3 Remission, > 3.3 - <= 11 Low, > 11 - <= 26 Moderate, > 26 High

Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 333 subjects in the Run-in period, 326 are included in this analysis using the Last Observation Carried Forward (LOCF) method.
Arm/Group Title Run-in Overall
Hide Arm/Group Description:
Overall includes all 333 subjects that entered the Run-in period of the study
Overall Number of Participants Analyzed 326
Mean (Standard Deviation)
Unit of Measure: units on a scale
-24.1  (13.5)
7.Secondary Outcome
Title Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 16 in All Patients
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 (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.

The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity.

Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 333 subjects in the Run-in period, 328 are included in this analysis using the Last Observation Carried Forward (LOCF) method.
Arm/Group Title Run-in Overall
Hide Arm/Group Description:
Overall includes all 333 subjects that entered the Run-in period of the study
Overall Number of Participants Analyzed 328
Mean (Standard Deviation)
Unit of Measure: units on a scale
-23.3  (13.2)
8.Secondary Outcome
Title DAS28 (Disease Activity Score-28 Items) Remission (DAS28 <2.6) at Week 16 in All Patients
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 (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x 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).

< 2.6 (Remission),

> = 2.6 - < =3.2 Low, > 3.2 - < = 5.1 Moderate, > 5.1 High

Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Since Non-Response Imputation (NRI) was used, all 333 subjects in the run-in period are included in this analysis
Arm/Group Title Run-in Overall
Hide Arm/Group Description:
Overall includes all 333 subjects that entered the Run-in period of the study
Overall Number of Participants Analyzed 333
Measure Type: Number
Unit of Measure: percentage of subjects
17.7
9.Secondary Outcome
Title SDAI (Simplified Disease Activity Index) Remission (SDAI ≤3.3) at Week 16 in All Patients
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 (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI).

<= 3.3 (Remission), > 3.3 - <= 11 Low, > 11 - <= 26 Moderate, > 26 High

Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Since Non-Response Imputation (NRI) was used, all 333 subjects in the run-in period are included in this analysis
Arm/Group Title Run-in Overall
Hide Arm/Group Description:
Overall includes all 333 subjects that entered the Run-in period of the study
Overall Number of Participants Analyzed 333
Measure Type: Number
Unit of Measure: percentage of subjects
15.9
10.Secondary Outcome
Title CDAI (Clinical Disease Activity Index) Remission (CDAI ≤2.8) at Week 16 in All Patients
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 (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI).

The range for the CDAI is 0 - 76 with a lower CDAI score indicating approvement in activity and a higher score indicating a decline activity.

Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Since Non-Response Imputation (NRI) was used, all 333 subjects in the run-in period are included in this analysis
Arm/Group Title Run-in Overall
Hide Arm/Group Description:
Overall includes all 333 subjects that entered the Run-in period of the study
Overall Number of Participants Analyzed 333
Measure Type: Number
Unit of Measure: percentage of subjects
17.1
11.Secondary Outcome
Title Ratio From Baseline in CRP (C-reactive Protein) Level at Week 16 in All Patients
Hide Description Ratio is defined as the CRP value at Week 16 divided by the CRP value at Baseline. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 333 subjects in the Run-in period, 330 are included in this analysis using the Last Observation Carried Forward (LOCF) method.
Arm/Group Title Run-in Overall
Hide Arm/Group Description:
Overall includes all 333 subjects that entered the Run-in period of the study
Overall Number of Participants Analyzed 330
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio
0.5
(122.6%)
12.Secondary Outcome
Title Change From Baseline in HAQ-DI (Health Assessment Questionnaire-Disability Index) Score at Week 16 in All Patients
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). Thus, the mean also has a range from 0-3. Change from baseline is computed as the value at Week 16 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 16
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 333 subjects in the Run-in period, 330 are included in this analysis using the Last Observation Carried Forward (LOCF) method.
Arm/Group Title Run-in Overall
Hide Arm/Group Description:
Overall includes all 333 subjects that entered the Run-in period of the study
Overall Number of Participants Analyzed 330
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.5  (0.6)
13.Secondary Outcome
Title Percentage of ACR50 (American College of Rheumatology 50% Improvement) Responders at Week 34 in Patients Randomized at Week 18
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 34
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis which uses Non-Response Imputation (NRI).
Arm/Group Title Certolizumab Pegol 400 mg and Placebo + Methotrexate Certolizumab Pegol 200 mg and Placebo + Methotrexate Placebo + Methotrexate
Hide Arm/Group Description:
400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed 69 70 69
Measure Type: Number
Unit of Measure: percentage of subjects
52.2 50.0 30.4
14.Secondary Outcome
Title Percentage of ACR70 (American College of Rheumatology 70% Improvement) Responders at Week 34 in Patients Randomized at Week 18
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 34
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis which uses Non-Response Imputation (NRI).
Arm/Group Title Certolizumab Pegol 400 mg and Placebo + Methotrexate Certolizumab Pegol 200 mg and Placebo + Methotrexate Placebo + Methotrexate
Hide Arm/Group Description:
400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed 69 70 69
Measure Type: Number
Unit of Measure: percentage of subjects
37.7 30.0 15.9
15.Secondary Outcome
Title Change From Baseline in DAS28 (Disease Activity Score-28 Items) at Week 34 in Patients Randomized at Week 18
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 (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward.

< 2.6 Remission,

> = 2.6 - < =3.2 Low, > 3.2 - < = 5.1 Moderate, > 5.1 High

Time Frame Baseline, Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 208 subjects in the Full Analysis Set (FAS) 204 subjects (69 400 mg CZP, 68 200 mg CZP, 67 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.
Arm/Group Title Certolizumab Pegol 400 mg and Placebo + Methotrexate Certolizumab Pegol 200 mg and Placebo + Methotrexate Placebo + Methotrexate
Hide Arm/Group Description:
400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed 69 68 67
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-3.04  (0.163) -2.83  (0.164) -1.65  (0.166)
16.Secondary Outcome
Title Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 34 in Patients Randomized at Week 18
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 (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.

<= 3.3 Remission, > 3.3 - <= 11 Low, > 11 - <= 26 Moderate, > 26 High

Time Frame Baseline, Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 208 subjects in the Full Analysis Set (FAS) 205 subjects (68 400 mg CZP, 70 200 mg CZP, 67 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.
Arm/Group Title Certolizumab Pegol 400 mg and Placebo + Methotrexate Certolizumab Pegol 200 mg and Placebo + Methotrexate Placebo + Methotrexate
Hide Arm/Group Description:
400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed 68 70 67
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-30.46  (1.554) -28.15  (1.532) -17.35  (1.571)
17.Secondary Outcome
Title Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 34 in Patients Randomized at Week 18
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 (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score. Range for CDAI is 0-76 with a lower CDAI score reflects approvement in activity and a higher score reflects a decline.
Time Frame Baseline, Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 208 subjects in the Full Analysis Set (FAS) 206 subjects (69 400 mg CZP, 70 200 mg CZP, 67 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.
Arm/Group Title Certolizumab Pegol 400 mg and Placebo + Methotrexate Certolizumab Pegol 200 mg and Placebo + Methotrexate Placebo + Methotrexate
Hide Arm/Group Description:
400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed 69 70 67
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-29.06  (1.509) -27.14  (1.498) -17.03  (1.536)
18.Secondary Outcome
Title DAS28 (Disease Activity Score-28 Items) Remission (DAS28 <2.6) at Week 34 in Patients Randomized at Week 18
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 (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x 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).

< 2.6 (Remission),

> = 2.6 - < =3.2 Low, > 3.2 - < = 5.1 Moderate, > 5.1 High

Time Frame Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis which uses Non-Response Imputation (NRI).
Arm/Group Title Certolizumab Pegol 400 mg and Placebo + Methotrexate Certolizumab Pegol 200 mg and Placebo + Methotrexate Placebo + Methotrexate
Hide Arm/Group Description:
400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed 69 70 69
Measure Type: Number
Unit of Measure: percentage of subjects
29.0 18.6 5.8
19.Secondary Outcome
Title SDAI (Simplified Disease Activity Index) Remission (SDAI ≤3.3) at Week 34 in Patients Randomized at Week 18
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 (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI).

<= 3.3 (Remission), > 3.3 - <= 11 Low, > 11 - <= 26 Moderate, > 26 High

Time Frame Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis which uses Non-Response Imputation (NRI).
Arm/Group Title Certolizumab Pegol 400 mg and Placebo + Methotrexate Certolizumab Pegol 200 mg and Placebo + Methotrexate Placebo + Methotrexate
Hide Arm/Group Description:
400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed 69 70 69
Measure Type: Number
Unit of Measure: percentage of subjects
29.0 17.1 13.0
20.Secondary Outcome
Title CDAI (Clinical Disease Activity Index) Remission (CDAI ≤2.8) at Week 34 in Patients Randomized at Week 18
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 (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI).

The range for the CDAI is 0 - 76 with a lower CDAI score indicating approvement in activity and a higher score indicating a decline activity.

Time Frame Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis which uses Non-Response Imputation (NRI).
Arm/Group Title Certolizumab Pegol 400 mg and Placebo + Methotrexate Certolizumab Pegol 200 mg and Placebo + Methotrexate Placebo + Methotrexate
Hide Arm/Group Description:
400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed 69 70 69
Measure Type: Number
Unit of Measure: percentage of subjects
27.5 21.4 15.9
21.Secondary Outcome
Title Ratio From Baseline in CRP (C-reactive Protein) Level at Week 34 in Patients Randomized at Week 18
Hide Description Ratio is defined as the CRP value at Week 34 divided by the CRP value at Baseline. This analysis was carried out using the Last Observation Carried Forward (LOCF) method with an ANCOVA model on observed log transformed data with factors treatment and log transformed Baseline CRP level. The number presented is the geometric least squares mean with it's 95% confidence interval.
Time Frame Baseline, Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.
Arm/Group Title Certolizumab Pegol 400 mg and Placebo + Methotrexate Certolizumab Pegol 200 mg and Placebo + Methotrexate Placebo + Methotrexate
Hide Arm/Group Description:
400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed 69 70 68
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Ratio
0.44
(0.36 to 0.53)
0.48
(0.40 to 0.58)
0.82
(0.68 to 0.99)
22.Secondary Outcome
Title Change From Baseline in HAQ-DI (Health Assessment Questionnaire-Disability Index) Score at Week 34 in Patients Randomized at Week 18
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). Thus, the mean also has a range from 0-3. Change from baseline is computed as the value at Week 34 minus the baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
Time Frame Baseline, Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.
Arm/Group Title Certolizumab Pegol 400 mg and Placebo + Methotrexate Certolizumab Pegol 200 mg and Placebo + Methotrexate Placebo + Methotrexate
Hide Arm/Group Description:
400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed 69 70 68
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.64  (0.060) -0.72  (0.060) -0.38  (0.061)
23.Secondary Outcome
Title Change From Baseline in Fatigue Assessment Scale (FAS) at Week 34 in Patients Randomized at Week 18
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 34 minus the Baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
Time Frame Baseline, Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 208 subjects in the Full Analysis Set (FAS) 205 subjects (68 400 mg CZP, 70 200 mg CZP, 67 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.
Arm/Group Title Certolizumab Pegol 400 mg and Placebo + Methotrexate Certolizumab Pegol 200 mg and Placebo + Methotrexate Placebo + Methotrexate
Hide Arm/Group Description:
400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed 68 70 67
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.39  (0.261) -3.03  (0.258) -1.33  (0.264)
24.Secondary Outcome
Title Change From Baseline in Physical Functioning (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18
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. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
Time Frame Baseline, Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.
Arm/Group Title Certolizumab Pegol 400 mg and Placebo + Methotrexate Certolizumab Pegol 200 mg and Placebo + Methotrexate Placebo + Methotrexate
Hide Arm/Group Description:
400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed 69 70 68
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
8.39  (1.080) 9.07  (1.076) 4.09  (1.086)
25.Secondary Outcome
Title Change From Baseline in Role Physical (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18
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. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
Time Frame Baseline, Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 208 subjects in the Full Analysis Set (FAS) 206 subjects (69 400 mg CZP, 69 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.
Arm/Group Title Certolizumab Pegol 400 mg and Placebo + Methotrexate Certolizumab Pegol 200 mg and Placebo + Methotrexate Placebo + Methotrexate
Hide Arm/Group Description:
400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed 69 69 68
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
9.80  (1.095) 11.06  (1.097) 7.14  (1.099)
26.Secondary Outcome
Title Change From Baseline in Bodily Pain (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18
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. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
Time Frame Baseline, Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 208 subjects in the Full Analysis Set (FAS) 206 subjects (69 400 mg CZP, 69 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.
Arm/Group Title Certolizumab Pegol 400 mg and Placebo + Methotrexate Certolizumab Pegol 200 mg and Placebo + Methotrexate Placebo + Methotrexate
Hide Arm/Group Description:
400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed 69 69 68
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
12.95  (1.042) 11.28  (1.044) 6.12  (1.047)
27.Secondary Outcome
Title Change From Baseline in General Health (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18
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. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
Time Frame Baseline, Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 208 subjects in the Full Analysis Set (FAS) 205 subjects (68 400 mg CZP, 69 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.
Arm/Group Title Certolizumab Pegol 400 mg and Placebo + Methotrexate Certolizumab Pegol 200 mg and Placebo + Methotrexate Placebo + Methotrexate
Hide Arm/Group Description:
400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed 68 69 68
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
5.46  (0.959) 5.51  (0.956) 3.16  (0.961)
28.Secondary Outcome
Title Change From Baseline in Vitality (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18
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. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
Time Frame Baseline, Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 208 subjects in the Full Analysis Set (FAS) 205 subjects (68 400 mg CZP, 69 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.
Arm/Group Title Certolizumab Pegol 400 mg and Placebo + Methotrexate Certolizumab Pegol 200 mg and Placebo + Methotrexate Placebo + Methotrexate
Hide Arm/Group Description:
400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed 68 69 68
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
9.88  (1.127) 11.53  (1.123) 5.47  (1.129)
29.Secondary Outcome
Title Change From Baseline in Social Functioning (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18
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. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
Time Frame Baseline, Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.
Arm/Group Title Certolizumab Pegol 400 mg and Placebo + Methotrexate Certolizumab Pegol 200 mg and Placebo + Methotrexate Placebo + Methotrexate
Hide Arm/Group Description:
400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed 69 70 68
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
8.87  (1.179) 10.03  (1.170) 6.42  (1.187)
30.Secondary Outcome
Title Change From Baseline in Role Emotional (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18
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. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
Time Frame Baseline, Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 208 subjects in the Full Analysis Set (FAS) 204 subjects (67 400 mg CZP, 69 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.
Arm/Group Title Certolizumab Pegol 400 mg and Placebo + Methotrexate Certolizumab Pegol 200 mg and Placebo + Methotrexate Placebo + Methotrexate
Hide Arm/Group Description:
400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed 67 69 68
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
6.86  (1.322) 8.86  (1.313) 5.86  (1.306)
31.Secondary Outcome
Title Change From Baseline in Mental Health (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18
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. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
Time Frame Baseline, Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 208 subjects in the Full Analysis Set (FAS) 205 subjects (68 400 mg CZP, 69 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.
Arm/Group Title Certolizumab Pegol 400 mg and Placebo + Methotrexate Certolizumab Pegol 200 mg and Placebo + Methotrexate Placebo + Methotrexate
Hide Arm/Group Description:
400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed 68 69 68
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
5.38  (1.050) 7.44  (1.042) 4.13  (1.049)
32.Secondary Outcome
Title Change From Baseline in PCS (Short Form 36-item Health Survey Physical Component Summary) at Week 34 in Patients Randomized at Week 18
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. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
Time Frame Baseline, Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 208 subjects in the Full Analysis Set (FAS) 202 subjects (66 400 mg CZP, 68 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.
Arm/Group Title Certolizumab Pegol 400 mg and Placebo + Methotrexate Certolizumab Pegol 200 mg and Placebo + Methotrexate Placebo + Methotrexate
Hide Arm/Group Description:
400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed 66 68 68
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
10.54  (0.939) 9.65  (0.928) 5.09  (0.926)
33.Secondary Outcome
Title Change From Baseline in MCS (Short Form 36-item Health Survey Mental Component Summary) at Week 34 in Patients Randomized at Week 18
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. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
Time Frame Baseline, Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 208 subjects in the Full Analysis Set (FAS) 202 subjects (66 400 mg CZP, 68 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.
Arm/Group Title Certolizumab Pegol 400 mg and Placebo + Methotrexate Certolizumab Pegol 200 mg and Placebo + Methotrexate Placebo + Methotrexate
Hide Arm/Group Description:
400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed 66 68 68
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
5.51  (1.162) 8.59  (1.147) 4.90  (1.143)
34.Secondary Outcome
Title Change From Baseline in PAAP (Patient's Assessment of Arthritis Pain) at Week 34 in Patients Randomized at Week 18
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 34 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
Time Frame Baseline, Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.
Arm/Group Title Certolizumab Pegol 400 mg and Placebo + Methotrexate Certolizumab Pegol 200 mg and Placebo + Methotrexate Placebo + Methotrexate
Hide Arm/Group Description:
400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed 69 70 68
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-36.41  (2.894) -34.33  (2.869) -17.47  (2.911)
35.Secondary Outcome
Title Change From Baseline in PtGADA (Patient's Global Assessment of Disease Activity) at Week 34 in Patients Randomized at Week 18
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 34 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
Time Frame Baseline, Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.
Arm/Group Title Certolizumab Pegol 400 mg and Placebo + Methotrexate Certolizumab Pegol 200 mg and Placebo + Methotrexate Placebo + Methotrexate
Hide Arm/Group Description:
400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed 69 70 68
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-35.58  (2.966) -33.07  (2.946) -16.37  (2.987)
36.Secondary Outcome
Title Median Time to Loss of ACR20 (American College of Rheumatology 20% Improvement) Response After Week 18 in Patients Randomized at Week 18.
Hide Description ACR20 loss are subjects with <20% improvement from Baseline for tender joint count, swollen joint count, and at least 3/5 core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein, 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 at 2 consecutive visits. Subjects losing response for 2 consecutive visits are considered as having the event on the day of the visit where response was first lost.
Time Frame Week 18 up to Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis.
Arm/Group Title Certolizumab Pegol 400 mg and Placebo + Methotrexate Certolizumab Pegol 200 mg and Placebo + Methotrexate Placebo + Methotrexate
Hide Arm/Group Description:
400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed 69 70 69
Median (Inter-Quartile Range)
Unit of Measure: days
NA [1] 
(100.0 to NA)
NA [1] 
(NA to NA)
98.0 [1] 
(17.0 to NA)
[1]
Because the analysis was run on the Full Analysis Set (FAS) the survival curves drop dramatically initially causing values to be non-computable.
37.Other Pre-specified Outcome
Title Ratio From Baseline in ESR (Erythrocyte Sedimentation Rate) Level at Week 16 in All Patients
Hide Description Ratio is defined as the ESR value at Week 16 divided by the ESR value at Baseline. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 333 subjects in the Run-in period, 328 are included in this analysis using the Last Observation Carried Forward (LOCF) method.
Arm/Group Title Run-in Overall
Hide Arm/Group Description:
Overall includes all 333 subjects that entered the Run-in period of the study
Overall Number of Participants Analyzed 328
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio
0.6
(76.7%)
38.Other Pre-specified Outcome
Title Ratio From Baseline in ESR (Erythrocyte Sedimentation Rate) Level at Week 34 in Patients Randomized at Week 18
Hide Description Ratio is defined as the ESR value at Week 34 divided by the ESR value at Baseline. This analysis was carried out using the Last Observation Carried Forward (LOCF) method with an ANCOVA model on observed log transformed data with factors treatment and log transformed Baseline CRP level. The number presented is the geometric least squares mean with it's 95% confidence interval.
Time Frame Baseline, Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 208 subjects in the Full Analysis Set (FAS) 205 subjects (69 400 mg CZP, 68 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.
Arm/Group Title Certolizumab Pegol 400 mg and Placebo + Methotrexate Certolizumab Pegol 200 mg and Placebo + Methotrexate Placebo + Methotrexate
Hide Arm/Group Description:
400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed 69 68 68
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Ratio
0.56
(0.48 to 0.65)
0.62
(0.53 to 0.72)
0.84
(0.71 to 0.98)
39.Other Pre-specified Outcome
Title Change From Baseline in PhGADA (Physician's Global Assessment of Disease Activity) at Week 34 in Patients Randomized at Week 18
Hide Description Change from Baseline in Physician'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 34 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
Time Frame Baseline, Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 208 subjects in the Full Analysis Set (FAS) 206 subjects (69 400 mg CZP, 70 200 mg CZP, 67 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.
Arm/Group Title Certolizumab Pegol 400 mg and Placebo + Methotrexate Certolizumab Pegol 200 mg and Placebo + Methotrexate Placebo + Methotrexate
Hide Arm/Group Description:
400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed 69 70 67
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-44.62  (2.428) -40.24  (2.427) -25.97  (2.476)
40.Other Pre-specified Outcome
Title Change From Baseline in TJC (Tender Joint Count) at Week 34 in Patients Randomized at Week 18
Hide Description Change from Baseline in Tender Joint Count is computed as the value at Week 34 minus the Baseline value (28 joints were assessed at each visit). A negative value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
Time Frame Baseline, Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.
Arm/Group Title Certolizumab Pegol 400 mg and Placebo + Methotrexate Certolizumab Pegol 200 mg and Placebo + Methotrexate Placebo + Methotrexate
Hide Arm/Group Description:
400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed 69 70 68
Least Squares Mean (Standard Error)
Unit of Measure: Joints
-11.81  (0.702) -11.33  (0.692) -7.16  (0.707)
41.Other Pre-specified Outcome
Title Change From Baseline in SJC (Swollen Joint Count) at Week 34 in Patients Randomized at Week 18
Hide Description Change from Baseline in Swollen Joint Count is computed as the value at Week 34 minus the Baseline value (28 joints were assessed at each visit). A negative value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
Time Frame Baseline, Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.
Arm/Group Title Certolizumab Pegol 400 mg and Placebo + Methotrexate Certolizumab Pegol 200 mg and Placebo + Methotrexate Placebo + Methotrexate
Hide Arm/Group Description:
400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed 69 70 68
Least Squares Mean (Standard Error)
Unit of Measure: Joints
-9.29  (0.542) -8.37  (0.540) -5.41  (0.547)
Time Frame The first column represents Adverse Event (AE) reporting for the 16-Week run-in period. The last three columns represents AE reporting for the 18-Week double-blind period.
Adverse Event Reporting Description Of the 209 randomized participants, 208 are in the Full Analysis Set (FAS), as 1 subject was randomized but did not receive treatment during the Double-Blind (DB) period.
 
Arm/Group Title Run-in Overall Certolizumab Pegol 400 mg and Placebo + Methotrexate Certolizumab Pegol 200 mg and Placebo + Methotrexate Placebo + Methotrexate
Hide Arm/Group Description Overall includes all 333 subjects that entered the Run-in period of the study 400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate 200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
All-Cause Mortality
Run-in Overall Certolizumab Pegol 400 mg and Placebo + Methotrexate Certolizumab Pegol 200 mg and Placebo + Methotrexate Placebo + Methotrexate
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Run-in Overall Certolizumab Pegol 400 mg and Placebo + Methotrexate Certolizumab Pegol 200 mg and Placebo + Methotrexate Placebo + Methotrexate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/333 (5.41%)      2/69 (2.90%)      5/70 (7.14%)      0/69 (0.00%)    
Blood and lymphatic system disorders         
Pancytopenia * 1  1/333 (0.30%)  1 0/69 (0.00%)  0 0/70 (0.00%)  0 0/69 (0.00%)  0
Thrombocytopenia * 1  1/333 (0.30%)  1 0/69 (0.00%)  0 0/70 (0.00%)  0 0/69 (0.00%)  0
Cardiac disorders         
Coronary artery disease * 1  1/333 (0.30%)  1 0/69 (0.00%)  0 0/70 (0.00%)  0 0/69 (0.00%)  0
Angina pectoris * 1  1/333 (0.30%)  1 0/69 (0.00%)  0 0/70 (0.00%)  0 0/69 (0.00%)  0
Ventricular tachycardia * 1  1/333 (0.30%)  1 0/69 (0.00%)  0 0/70 (0.00%)  0 0/69 (0.00%)  0
Coronary artery occlusion * 1  0/333 (0.00%)  0 0/69 (0.00%)  0 1/70 (1.43%)  1 0/69 (0.00%)  0
Pericardial effusion * 1  0/333 (0.00%)  0 0/69 (0.00%)  0 1/70 (1.43%)  1 0/69 (0.00%)  0
Gastrointestinal disorders         
Abdominal pain * 1  1/333 (0.30%)  1 0/69 (0.00%)  0 0/70 (0.00%)  0 0/69 (0.00%)  0
Colitis * 1  1/333 (0.30%)  1 0/69 (0.00%)  0 0/70 (0.00%)  0 0/69 (0.00%)  0
Gastrointestinal haemorrhage * 1  1/333 (0.30%)  1 0/69 (0.00%)  0 0/70 (0.00%)  0 0/69 (0.00%)  0
General disorders         
Chest pain * 1  1/333 (0.30%)  1 0/69 (0.00%)  0 0/70 (0.00%)  0 0/69 (0.00%)  0
Pyrexia * 1  0/333 (0.00%)  0 0/69 (0.00%)  0 1/70 (1.43%)  1 0/69 (0.00%)  0
Infections and infestations         
Cellulitis * 1  3/333 (0.90%)  3 0/69 (0.00%)  0 0/70 (0.00%)  0 0/69 (0.00%)  0
Pneumonia * 1  2/333 (0.60%)  2 0/69 (0.00%)  0 1/70 (1.43%)  1 0/69 (0.00%)  0
Pneumonia pneumococcal * 1  1/333 (0.30%)  1 0/69 (0.00%)  0 0/70 (0.00%)  0 0/69 (0.00%)  0
Upper respiratory tract infection * 1  1/333 (0.30%)  1 0/69 (0.00%)  0 0/70 (0.00%)  0 0/69 (0.00%)  0
Pyelonephritis * 1  1/333 (0.30%)  1 0/69 (0.00%)  0 0/70 (0.00%)  0 0/69 (0.00%)  0
Oral candidiasis * 1  0/333 (0.00%)  0 0/69 (0.00%)  0 1/70 (1.43%)  1 0/69 (0.00%)  0
Herpes pharyngitis * 1  0/333 (0.00%)  0 0/69 (0.00%)  0 1/70 (1.43%)  1 0/69 (0.00%)  0
Kidney infection * 1  0/333 (0.00%)  0 0/69 (0.00%)  0 1/70 (1.43%)  1 0/69 (0.00%)  0
Injury, poisoning and procedural complications         
Drug toxicity * 1  1/333 (0.30%)  1 0/69 (0.00%)  0 0/70 (0.00%)  0 0/69 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Bursitis * 1  1/333 (0.30%)  1 0/69 (0.00%)  0 0/70 (0.00%)  0 0/69 (0.00%)  0
Osteoarthritis * 1  1/333 (0.30%)  1 0/69 (0.00%)  0 0/70 (0.00%)  0 0/69 (0.00%)  0
Lupus-like syndrome * 1  0/333 (0.00%)  0 0/69 (0.00%)  0 1/70 (1.43%)  2 0/69 (0.00%)  0
Back pain * 1  0/333 (0.00%)  0 0/69 (0.00%)  0 1/70 (1.43%)  1 0/69 (0.00%)  0
Musculoskeletal chest pain * 1  0/333 (0.00%)  0 1/69 (1.45%)  1 0/70 (0.00%)  0 0/69 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Basal cell carcinoma * 1  1/333 (0.30%)  1 0/69 (0.00%)  0 0/70 (0.00%)  0 0/69 (0.00%)  0
Psychiatric disorders         
Depression * 1  1/333 (0.30%)  1 0/69 (0.00%)  0 0/70 (0.00%)  0 0/69 (0.00%)  0
Renal and urinary disorders         
Renal failure acute * 1  1/333 (0.30%)  1 0/69 (0.00%)  0 0/70 (0.00%)  0 0/69 (0.00%)  0
Reproductive system and breast disorders         
Pelvic peritoneal adhesions * 1  0/333 (0.00%)  0 0/69 (0.00%)  0 1/70 (1.43%)  1 0/69 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Dyspnoea * 1  1/333 (0.30%)  1 0/69 (0.00%)  0 0/70 (0.00%)  0 0/69 (0.00%)  0
Epistaxis * 1  1/333 (0.30%)  1 0/69 (0.00%)  0 0/70 (0.00%)  0 0/69 (0.00%)  0
Painful respiration * 1  1/333 (0.30%)  1 0/69 (0.00%)  0 0/70 (0.00%)  0 0/69 (0.00%)  0
Skin and subcutaneous tissue disorders         
Dermal cyst * 1  0/333 (0.00%)  0 1/69 (1.45%)  1 0/70 (0.00%)  0 0/69 (0.00%)  0
Surgical and medical procedures         
Implantable defibrillator insertion * 1  1/333 (0.30%)  1 0/69 (0.00%)  0 0/70 (0.00%)  0 0/69 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Run-in Overall Certolizumab Pegol 400 mg and Placebo + Methotrexate Certolizumab Pegol 200 mg and Placebo + Methotrexate Placebo + Methotrexate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   80/333 (24.02%)      20/69 (28.99%)      12/70 (17.14%)      27/69 (39.13%)    
Infections and infestations         
Nasopharyngitis * 1  7/333 (2.10%)  7 1/69 (1.45%)  1 1/70 (1.43%)  1 4/69 (5.80%)  4
Upper respiratory tract infection * 1  42/333 (12.61%)  46 8/69 (11.59%)  8 5/70 (7.14%)  6 10/69 (14.49%)  11
Urinary tract infection * 1  27/333 (8.11%)  31 6/69 (8.70%)  6 5/70 (7.14%)  5 7/69 (10.14%)  8
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  10/333 (3.00%)  12 5/69 (7.25%)  5 1/70 (1.43%)  1 2/69 (2.90%)  2
Rheumatoid arthritis * 1  9/333 (2.70%)  10 2/69 (2.90%)  2 1/70 (1.43%)  2 6/69 (8.70%)  6
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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: NCT00580840    
Other Study ID Numbers: C87077
2007-005288-86 ( EudraCT Number )
First Submitted: December 21, 2007
First Posted: December 27, 2007
Results First Submitted: December 14, 2011
Results First Posted: March 19, 2012
Last Update Posted: August 2, 2018