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Trial record 1 of 1 for:    RA0064
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A Comparison of Two Assessment Tools in Predicting Treatment Success of Cimzia in Rheumatoid Arthritis Subjects (PREDICT)

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: NCT01255761
Recruitment Status : Completed
First Posted : December 7, 2010
Results First Posted : March 7, 2014
Last Update Posted : July 31, 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
Intervention Biological: Certolizumab Pegol (CZP)
Enrollment 736
Recruitment Details

Enrollment began in November 2010. Overall study completion occurred in December 2012.

The Participant Flow consists of the Randomized Set (RS). The RS consists of all subjects randomized into the study.

The Baseline Characteristics consists of the Safety Set (SS). SS consists of all subjects that received at least 1 dose of study medication.

Pre-assignment Details

The Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.

FAS-NRI: For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).

Arm/Group Title RAPID3 to Assess Response to Cimzia CDAI to Assess Response to Cimzia
Hide Arm/Group Description

RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points

CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)

Period Title: Overall Study
Started 369 367
Completed 187 192
Not Completed 182 175
Reason Not Completed
Adverse Event             29             43
Lack of Efficacy             86             74
Protocol Violation             9             5
Lost to Follow-up             10             8
Withdrawal by Subject             11             27
Other Reasons             37             18
Arm/Group Title RAPID3 to Assess Response to Cimzia CDAI to Assess Response to Cimzia Total
Hide Arm/Group Description

RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points

CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)

Total of all reporting groups
Overall Number of Baseline Participants 369 367 736
Hide Baseline Analysis Population Description
The Baseline Characteristics consists of the Safety Set (SS). SS consists of all subjects that received at least 1 dose of study medication.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 369 participants 367 participants 736 participants
<=18 years
0
   0.0%
1
   0.3%
1
   0.1%
Between 18 and 65 years
295
  79.9%
276
  75.2%
571
  77.6%
>=65 years
74
  20.1%
90
  24.5%
164
  22.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 369 participants 367 participants 736 participants
54.1  (12.5) 55.7  (12.8) 54.9  (12.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 369 participants 367 participants 736 participants
Female
280
  75.9%
293
  79.8%
573
  77.9%
Male
89
  24.1%
74
  20.2%
163
  22.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 369 participants 367 participants 736 participants
369 367 736
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram
Number Analyzed 369 participants 367 participants 736 participants
84.08  (21.35) 80.17  (19.23) 82.13  (20.40)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 369 participants 367 participants 736 participants
164.94  (9.91) 164.00  (9.25) 164.47  (9.59)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/ m^2
Number Analyzed 369 participants 367 participants 736 participants
30.87  (7.23) 29.82  (6.90) 30.34  (7.08)
1.Primary Outcome
Title Response at Week 12 as Assessed by Randomized Tool [Clinical Disease Activity Index (CDAI) or Routine Assessment of Patient Index Data 3 (RAPID3)]
Hide Description

For subjects randomized to CDAI, response is defined as CDAI ≤10 or 20% improvement from Baseline. For subjects randomized to RAPID3, response is defined as RAPID3 ≤6 or 20% improvement from Baseline.

CDAI is the sum of tender joint count, swollen joint count, Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - VAS (VAS in cm). 28 joints are examined.

RAPID3 is the sum of the MDHAQ subscores of physical function, pain, and patient's global status.

Time Frame Baseline (Week 0) to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).
Arm/Group Title RAPID3 to Assess Response to Cimzia CDAI to Assess Response to Cimzia
Hide Arm/Group Description:

RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points

CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)

Overall Number of Participants Analyzed 368 365
Measure Type: Number
Unit of Measure: percentage of participants
Yes 64.7 76.4
No 35.3 23.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RAPID3 to Assess Response to Cimzia, CDAI to Assess Response to Cimzia
Comments

The null hypothesis was: (Proportion of Rapid 3 responders)-(Proportion of CDAI responders) ≤ delta with a delta of -10 %.

A 2-sided 95 % Confidence Interval (CI) for the difference in proportion of responders was computed.

Type of Statistical Test Non-Inferiority or Equivalence
Comments If the lower bound of the 2-sided 95 % CI was greater than -10 %, the null hypothesis was rejected and RAPID3 was deemed comparable to CDAI in assessing response to Certolizumab Pegol therapy at 12 weeks.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Study was intended to show the comparability of RAPID3 with CDAI. Assessment of whether the study objective was met was based on CIs rather than p-values. Both variables need to be significant to claim comparability between the two assessment tools.
Method ANCOVA
Comments Difference in proportions from ANCOVA with tool as factor & Baseline DAS28(ESR), gender, age, prior anti-TNF use & disease duration as covariates.
Method of Estimation Estimation Parameter Difference in proportion
Estimated Value -0.119
Confidence Interval (2-Sided) 95%
-0.184 to -0.053
Estimation Comments [Not Specified]
2.Primary Outcome
Title Responders at Week 12 (as Assessed by Randomized Tool Clinical Disease Activity Index [CDAI] or Routine Assessment of Patient Index Data [RAPID3]) Achieving Low Disease Activity (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]≤3.2) at Week 52
Hide Description

For subjects randomized to CDAI, response is defined as CDAI ≤10 or 20% improvement from Baseline. For subjects randomized to RAPID3, response is defined as RAPID3 ≤6 or 20% improvement from Baseline.

DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56x√(TJC) + 0.28x√(SJC) + 0.70xlognat (ESR) + 0.014xGlobal Assessment of Arthritis where 28 joints are examined.

Time Frame Baseline (Week 0) to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).
Arm/Group Title RAPID3 to Assess Response to Cimzia CDAI to Assess Response to Cimzia
Hide Arm/Group Description:

RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points

CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)

Overall Number of Participants Analyzed 238 279
Measure Type: Number
Unit of Measure: percentage of participants
Yes 31.5 32.3
No 68.5 67.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RAPID3 to Assess Response to Cimzia, CDAI to Assess Response to Cimzia
Comments

The null hypothesis was: (Proportion of Rapid 3 responders)-(Proportion of CDAI responders) ≤ delta with a delta of -15 %.

A 2-sided 95 % Confidence Interval (CI) for the difference in proportion of responders was computed.

Type of Statistical Test Non-Inferiority or Equivalence
Comments If the lower bound of the 2-sided 95 % CI was greater than -15 %, the null hypothesis was rejected and RAPID3 was deemed comparable to CDAI in assessing percent of Week 12 responders achieving LDA at Week 52.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Study was intended to show the comparability of RAPID3 with CDAI. Assessment of whether the study objective was met was based on CIs rather than p-values. Both variables need to be significant to claim comparability between the two assessment tools.
Method ANCOVA
Comments Difference in proportions from ANCOVA with tool as factor & Baseline DAS28(ESR), gender, age, prior anti-TNF use & disease duration as covariates.
Method of Estimation Estimation Parameter Difference in proportion
Estimated Value -0.013
Confidence Interval (2-Sided) 95%
-0.093 to 0.066
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of All Subjects Who Are Both Responders at Week 12 and With Non-low Disease Activity (Disease Activity Score 28 [Erythrocyte Sedimentation Rate] > 3.2) at Week 52
Hide Description

For subjects randomized to CDAI, response is defined as CDAI ≤10 or 20% improvement from Baseline. For subjects randomized to RAPID3, response is defined as RAPID3 ≤6 or 20% improvement from Baseline.

DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56x√(TJC) + 0.28x√(SJC) + 0.70xlognat (ESR) + 0.014xGlobal Assessment of Arthritis where 28 joints are examined.

Time Frame Baseline (Week 0) to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).
Arm/Group Title RAPID3 to Assess Response to Cimzia CDAI to Assess Response to Cimzia
Hide Arm/Group Description:

RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points

CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)

Overall Number of Participants Analyzed 368 365
Measure Type: Number
Unit of Measure: percentage of participants
Yes 44.3 51.8
No 55.7 48.2
4.Secondary Outcome
Title Responders at Week 12 Achieving Remission (Disease Activity Score 28 [Erythrocyte Sedimentation Rate] < 2.6) at Week 52
Hide Description

For subjects randomized to CDAI, response is defined as CDAI ≤10 or 20% improvement from Baseline. For subjects randomized to RAPID3, response is defined as RAPID3 ≤6 or 20% improvement from Baseline.

DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56x√(TJC) + 0.28x√(SJC) + 0.70xlognat (ESR) + 0.014xGlobal Assessment of Arthritis where 28 joints are examined.

Time Frame Baseline (Week 0) to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description

The measurement only includes subjects that were responders at Week 12, and this is the denominator for the percentages.

The Full Analysis Set (FAS)-Nonresponse imputation (NRI) population set was used for this analysis.

Arm/Group Title RAPID3 to Assess Response to Cimzia CDAI to Assess Response to Cimzia
Hide Arm/Group Description:

RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points

CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)

Overall Number of Participants Analyzed 238 279
Measure Type: Number
Unit of Measure: percentage of participants
Yes 21.8 23.3
No 78.2 76.7
5.Secondary Outcome
Title Percentage of All Subjects Who Are Both Responders at Week 12 and With Non-remission (Disease Activity Score 28 [Erythrocyte Sedimentation Rate] > 2.6) at Week 52
Hide Description

For subjects randomized to CDAI, response is defined as CDAI ≤10 or 20% improvement from Baseline. For subjects randomized to RAPID3, response is defined as RAPID3 ≤6 or 20% improvement from Baseline.

DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56x√(TJC) + 0.28x√(SJC) + 0.70xlognat (ESR) + 0.014xGlobal Assessment of Arthritis where 28 joints are examined.

Time Frame Baseline (Week 0) to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).
Arm/Group Title RAPID3 to Assess Response to Cimzia CDAI to Assess Response to Cimzia
Hide Arm/Group Description:

RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points

CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)

Overall Number of Participants Analyzed 368 365
Measure Type: Number
Unit of Measure: percentage of participants
Yes 50.5 58.6
No 49.5 41.4
6.Secondary Outcome
Title Change From Baseline in the Disease Activity Score 28 Erythrocyte Sedimentation Rate [DAS28 (ESR)] Assessed at Week 12
Hide Description

The DAS28(ESR) score is a measure of the subject's disease activity.

DAS28(ESR) is calculated from the tender joint count (28 joints), swollen joint count (28 joints), erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this 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. Lower scores indicate less disease activity.

Time Frame Baseline (Week 0) to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. The Last Observation Carried Forward (LOCF) was used for this analysis.
Arm/Group Title RAPID3 to Assess Response to Cimzia CDAI to Assess Response to Cimzia
Hide Arm/Group Description:

RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points

CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)

Overall Number of Participants Analyzed 355 355
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.20  (1.33) -2.11  (1.39)
7.Secondary Outcome
Title Change From Baseline in Disease Activity Score 28 Erythrocyte Sedimentation Rate [DAS28 (ESR)] Assessed at Week 52
Hide Description

The DAS28(ESR) score is a measure of the subject's disease activity.

DAS28(ESR) is calculated from the tender joint count (28 joints), swollen joint count (28 joints), erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this 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. Lower scores indicate less disease activity.

Time Frame Baseline (Week 0) to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. The Last Observation Carried Forward (LOCF) was used for this analysis.
Arm/Group Title RAPID3 to Assess Response to Cimzia CDAI to Assess Response to Cimzia
Hide Arm/Group Description:

RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points

CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)

Overall Number of Participants Analyzed 355 355
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.26  (1.45) -2.14  (1.50)
8.Secondary Outcome
Title Change From Baseline in Clinical Disease Activity Index (CDAI) Assessed at Week 12
Hide Description

CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined.

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 0) to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. The Last Observation Carried Forward (LOCF) was used for this analysis.
Arm/Group Title RAPID3 to Assess Response to Cimzia CDAI to Assess Response to Cimzia
Hide Arm/Group Description:

RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points

CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)

Overall Number of Participants Analyzed 361 357
Mean (Standard Deviation)
Unit of Measure: units on a scale
-23.79  (14.35) -23.11  (14.57)
9.Secondary Outcome
Title Change From Baseline in Clinical Disease Activity Index (CDAI) Assessed at Week 52
Hide Description

CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined.

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 0) to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. The Last Observation Carried Forward (LOCF) was used for this analysis.
Arm/Group Title RAPID3 to Assess Response to Cimzia CDAI to Assess Response to Cimzia
Hide Arm/Group Description:

RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points

CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)

Overall Number of Participants Analyzed 361 357
Mean (Standard Deviation)
Unit of Measure: units on a scale
-24.55  (15.42) -23.16  (15.20)
10.Secondary Outcome
Title Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Assessed at Week 12
Hide Description

RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient's global status.

The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity.

Time Frame Baseline (Week 0) to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. The Last Observation Carried Forward (LOCF) was used for this analysis.
Arm/Group Title RAPID3 to Assess Response to Cimzia CDAI to Assess Response to Cimzia
Hide Arm/Group Description:

RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points

CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)

Overall Number of Participants Analyzed 361 357
Mean (Standard Deviation)
Unit of Measure: units on a scale
-6.78  (5.94) -6.47  (6.69)
11.Secondary Outcome
Title Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Assessed at Week 52
Hide Description

RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient's global status.

The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity.

Time Frame Baseline (Week 0) to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. The Last Observation Carried Forward (LOCF) was used for this analysis.
Arm/Group Title RAPID3 to Assess Response to Cimzia CDAI to Assess Response to Cimzia
Hide Arm/Group Description:

RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points

CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)

Overall Number of Participants Analyzed 361 357
Mean (Standard Deviation)
Unit of Measure: units on a scale
-6.36  (6.48) -6.65  (6.99)
12.Secondary Outcome
Title Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Low Disease Activity (DAS28[ESR] ≤ 3.2) at Week 12
Hide Description DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, using this 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. Lower scores indicate less disease activity.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).
Arm/Group Title RAPID3 to Assess Response to Cimzia CDAI to Assess Response to Cimzia
Hide Arm/Group Description:

RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points

CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)

Overall Number of Participants Analyzed 368 365
Measure Type: Number
Unit of Measure: percentage of subjects
Yes 25.0 28.2
No 75.0 71.8
13.Secondary Outcome
Title Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Low Disease Activity (DAS28[ESR] ≤ 3.2) at Week 52
Hide Description DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, using this 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. Lower scores indicate less disease activity.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).
Arm/Group Title RAPID3 to Assess Response to Cimzia CDAI to Assess Response to Cimzia
Hide Arm/Group Description:

RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points

CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)

Overall Number of Participants Analyzed 368 365
Measure Type: Number
Unit of Measure: percentage of subjects
Yes 21.5 24.9
No 78.5 75.1
14.Secondary Outcome
Title Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS [ESR] < 2.6) at Week 12
Hide Description DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this 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. Lower scores indicate less disease activity.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).
Arm/Group Title RAPID3 to Assess Response to Cimzia CDAI to Assess Response to Cimzia
Hide Arm/Group Description:

RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points

CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)

Overall Number of Participants Analyzed 368 365
Measure Type: Number
Unit of Measure: percentage of subjects
Yes 12.8 15.6
No 87.2 84.4
15.Secondary Outcome
Title Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS28[ESR] < 2.6) at Week 52
Hide Description DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this 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. Lower scores indicate less disease activity.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).
Arm/Group Title RAPID3 to Assess Response to Cimzia CDAI to Assess Response to Cimzia
Hide Arm/Group Description:

RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points

CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)

Overall Number of Participants Analyzed 368 365
Measure Type: Number
Unit of Measure: percentage of subjects
Yes 14.9 17.8
No 85.1 82.2
16.Secondary Outcome
Title Percentage of Subjects With CDAI (Clinical Disease Activity Index) Low Disease Activity (CDAI ≤ 10) at Week 12
Hide Description

CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined.

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 Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).
Arm/Group Title RAPID3 to Assess Response to Cimzia CDAI to Assess Response to Cimzia
Hide Arm/Group Description:

RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points

CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)

Overall Number of Participants Analyzed 368 365
Measure Type: Number
Unit of Measure: percentage of subjects
Yes 34.8 38.1
No 65.2 61.9
17.Secondary Outcome
Title Percentage of Subjects With CDAI (Clinical Disease Activity Index) Low Disease Activity (CDAI ≤ 10) at Week 52
Hide Description

CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined.

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 Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).
Arm/Group Title RAPID3 to Assess Response to Cimzia CDAI to Assess Response to Cimzia
Hide Arm/Group Description:

RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points

CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)

Overall Number of Participants Analyzed 368 365
Measure Type: Number
Unit of Measure: percentage of subjects
Yes 30.2 33.4
No 69.8 66.6
18.Secondary Outcome
Title Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤ 2.8) at Week 12
Hide Description

CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined.

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 Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).
Arm/Group Title RAPID3 to Assess Response to Cimzia CDAI to Assess Response to Cimzia
Hide Arm/Group Description:

RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points

CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)

Overall Number of Participants Analyzed 368 365
Measure Type: Number
Unit of Measure: percentage of subjects
Yes 10.1 10.1
No 89.9 89.9
19.Secondary Outcome
Title Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤ 2.8) at Week 52
Hide Description

CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined.

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 Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).
Arm/Group Title RAPID3 to Assess Response to Cimzia CDAI to Assess Response to Cimzia
Hide Arm/Group Description:

RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points

CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)

Overall Number of Participants Analyzed 368 365
Measure Type: Number
Unit of Measure: percentage of subjects
Yes 12.2 15.6
No 87.8 84.4
20.Secondary Outcome
Title Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Low Disease Activity (RAPID3 ≤ 6.0) at Week 12
Hide Description

RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient's global status.

The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity.

Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).
Arm/Group Title RAPID3 to Assess Response to Cimzia CDAI to Assess Response to Cimzia
Hide Arm/Group Description:

RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points

CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)

Overall Number of Participants Analyzed 368 365
Measure Type: Number
Unit of Measure: percentage of subjects
Yes 33.7 33.4
No 66.3 66.6
21.Secondary Outcome
Title Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Low Disease Activity (RAPID3 ≤ 6.0) at Week 52
Hide Description

RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient's global status.

The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity.

Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).
Arm/Group Title RAPID3 to Assess Response to Cimzia CDAI to Assess Response to Cimzia
Hide Arm/Group Description:

RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points

CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)

Overall Number of Participants Analyzed 368 365
Measure Type: Number
Unit of Measure: percentage of subjects
Yes 27.7 28.8
No 72.3 71.2
22.Secondary Outcome
Title Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Remission (RAPID3 ≤ 3.0) at Week 12
Hide Description

RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient's global status.

The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity.

Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).
Arm/Group Title RAPID3 to Assess Response to Cimzia CDAI to Assess Response to Cimzia
Hide Arm/Group Description:

RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points

CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)

Overall Number of Participants Analyzed 368 365
Measure Type: Number
Unit of Measure: percentage of subjects
Yes 14.9 18.9
No 85.1 81.1
23.Secondary Outcome
Title Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Remission (RAPID3 ≤ 3.0) at Week 52
Hide Description

RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient's global status.

The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity.

Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).
Arm/Group Title RAPID3 to Assess Response to Cimzia CDAI to Assess Response to Cimzia
Hide Arm/Group Description:

RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points

CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)

Overall Number of Participants Analyzed 368 365
Measure Type: Number
Unit of Measure: percentage of subjects
Yes 18.8 20.8
No 81.3 79.2
24.Secondary Outcome
Title Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
Hide Description Number of work days missed in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.
Arm/Group Title RAPID3 to Assess Response to Cimzia CDAI to Assess Response to Cimzia
Hide Arm/Group Description:

RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points

CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)

Overall Number of Participants Analyzed 149 134
Mean (Standard Deviation)
Unit of Measure: Number of work days missed in last month
0.7  (3.6) 0.7  (3.1)
25.Secondary Outcome
Title Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
Hide Description Number of work days with reduced productivity in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.
Arm/Group Title RAPID3 to Assess Response to Cimzia CDAI to Assess Response to Cimzia
Hide Arm/Group Description:

RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points

CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)

Overall Number of Participants Analyzed 149 134
Mean (Standard Deviation)
Unit of Measure: Work days with reduced work productivity
1.1  (3.5) 1.2  (3.5)
26.Secondary Outcome
Title Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
Hide Description The arthritis interference in the last month with work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference) The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.
Arm/Group Title RAPID3 to Assess Response to Cimzia CDAI to Assess Response to Cimzia
Hide Arm/Group Description:

RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points

CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)

Overall Number of Participants Analyzed 149 134
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.7  (2.3) 1.6  (2.5)
27.Secondary Outcome
Title Number of Days With No Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
Hide Description Number of days with no household work in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.
Arm/Group Title RAPID3 to Assess Response to Cimzia CDAI to Assess Response to Cimzia
Hide Arm/Group Description:

RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points

CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)

Overall Number of Participants Analyzed 321 314
Mean (Standard Deviation)
Unit of Measure: Days with no household work
3.2  (5.9) 3.1  (5.8)
28.Secondary Outcome
Title Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
Hide Description Number of days with reduced household work productivity in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.
Arm/Group Title RAPID3 to Assess Response to Cimzia CDAI to Assess Response to Cimzia
Hide Arm/Group Description:

RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points

CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)

Overall Number of Participants Analyzed 320 312
Mean (Standard Deviation)
Unit of Measure: Days with reduced household work
3.1  (5.7) 3.1  (5.6)
29.Secondary Outcome
Title Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
Hide Description Number of days missed of family/social/leisure activities in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.
Arm/Group Title RAPID3 to Assess Response to Cimzia CDAI to Assess Response to Cimzia
Hide Arm/Group Description:

RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points

CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)

Overall Number of Participants Analyzed 321 314
Mean (Standard Deviation)
Unit of Measure: Activity days missed
0.7  (2.4) 0.9  (3.5)
30.Secondary Outcome
Title Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
Hide Description Number of days with hired outside help in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.
Arm/Group Title RAPID3 to Assess Response to Cimzia CDAI to Assess Response to Cimzia
Hide Arm/Group Description:

RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points

CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)

Overall Number of Participants Analyzed 321 314
Mean (Standard Deviation)
Unit of Measure: Days with hired outside help
0.4  (2.2) 0.5  (2.5)
31.Secondary Outcome
Title Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
Hide Description

The arthritis interference in the last month with household work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference).

The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.

Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.
Arm/Group Title RAPID3 to Assess Response to Cimzia CDAI to Assess Response to Cimzia
Hide Arm/Group Description:

RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points

CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)

Overall Number of Participants Analyzed 321 314
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.7  (2.7) 2.4  (2.8)
32.Secondary Outcome
Title Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Hide Description Number of work days missed in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.
Arm/Group Title RAPID3 to Assess Response to Cimzia CDAI to Assess Response to Cimzia
Hide Arm/Group Description:

RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points

CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)

Overall Number of Participants Analyzed 88 84
Mean (Standard Deviation)
Unit of Measure: Number of work days missed in last month
0.2  (0.9) 0.1  (0.4)
33.Secondary Outcome
Title Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Hide Description Number of work days with reduced productivity in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.
Arm/Group Title RAPID3 to Assess Response to Cimzia CDAI to Assess Response to Cimzia
Hide Arm/Group Description:

RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points

CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)

Overall Number of Participants Analyzed 88 84
Mean (Standard Deviation)
Unit of Measure: Work days with reduced work productivity
0.6  (2.1) 0.3  (1.1)
34.Secondary Outcome
Title Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Hide Description

The arthritis interference in the last month with work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference).

The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.

Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.
Arm/Group Title RAPID3 to Assess Response to Cimzia CDAI to Assess Response to Cimzia
Hide Arm/Group Description:

RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points

CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)

Overall Number of Participants Analyzed 88 83
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.7  (1.4) 0.5  (1.1)
35.Secondary Outcome
Title Number of Days With No Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Hide Description Number of days with no household work in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.
Arm/Group Title RAPID3 to Assess Response to Cimzia CDAI to Assess Response to Cimzia
Hide Arm/Group Description:

RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points

CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)

Overall Number of Participants Analyzed 172 180
Mean (Standard Deviation)
Unit of Measure: Days with no household work
1.1  (3.1) 1.3  (3.4)
36.Secondary Outcome
Title Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Hide Description Number of days with reduced household work productivity in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.
Arm/Group Title RAPID3 to Assess Response to Cimzia CDAI to Assess Response to Cimzia
Hide Arm/Group Description:

RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points

CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)

Overall Number of Participants Analyzed 172 180
Mean (Standard Deviation)
Unit of Measure: Days with reduced household work
1.3  (3.3) 1.1  (2.9)
37.Secondary Outcome
Title Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Hide Description Number of days missed of family/social/leisure activities in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.
Arm/Group Title RAPID3 to Assess Response to Cimzia CDAI to Assess Response to Cimzia
Hide Arm/Group Description:

RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points

CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)

Overall Number of Participants Analyzed 172 180
Mean (Standard Deviation)
Unit of Measure: Activity days missed
0.4  (2.5) 0.2  (0.9)
38.Secondary Outcome
Title Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Hide Description Number of days with hired outside help in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.
Arm/Group Title RAPID3 to Assess Response to Cimzia CDAI to Assess Response to Cimzia
Hide Arm/Group Description:

RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points

CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)

Overall Number of Participants Analyzed 172 180
Mean (Standard Deviation)
Unit of Measure: Days with hired outside help
0.1  (0.6) 0.3  (2.1)
39.Secondary Outcome
Title Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Hide Description

The arthritis interference in the last month with household work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference).

The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.

Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.
Arm/Group Title RAPID3 to Assess Response to Cimzia CDAI to Assess Response to Cimzia
Hide Arm/Group Description:

RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points

CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)

Overall Number of Participants Analyzed 172 180
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.4  (2.0) 1.2  (2.0)
Time Frame Adverse Events were collected from November 2010 through December 2012.
Adverse Event Reporting Description Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
 
Arm/Group Title RAPID3 to Assess Response to Cimzia CDAI to Assess Response to Cimzia
Hide Arm/Group Description

RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points

CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)

All-Cause Mortality
RAPID3 to Assess Response to Cimzia CDAI to Assess Response to Cimzia
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
RAPID3 to Assess Response to Cimzia CDAI to Assess Response to Cimzia
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   32/369 (8.67%)      39/367 (10.63%)    
Blood and lymphatic system disorders     
Anaemia * 1  1/369 (0.27%)  1 2/367 (0.54%)  2
Cardiac disorders     
Cardiomyopathy * 1  1/369 (0.27%)  1 0/367 (0.00%)  0
Cardiac failure congestive * 1  0/369 (0.00%)  0 1/367 (0.27%)  1
Acute myocardial infarction * 1  0/369 (0.00%)  0 1/367 (0.27%)  1
Myocardial infarction * 1  1/369 (0.27%)  1 0/367 (0.00%)  0
Left ventricular dysfunction * 1  1/369 (0.27%)  1 0/367 (0.00%)  0
Bradycardia * 1  0/369 (0.00%)  0 1/367 (0.27%)  1
Atrial fibrillation * 1  0/369 (0.00%)  0 3/367 (0.82%)  3
Gastrointestinal disorders     
Diarrhoea * 1  0/369 (0.00%)  0 1/367 (0.27%)  1
Small intestinal obstruction * 1  0/369 (0.00%)  0 2/367 (0.54%)  2
Intestinal perforation * 1  0/369 (0.00%)  0 1/367 (0.27%)  1
Oesophageal ulcer * 1  0/369 (0.00%)  0 1/367 (0.27%)  1
General disorders     
Asthenia * 1  1/369 (0.27%)  1 0/367 (0.00%)  0
Chest pain * 1  1/369 (0.27%)  1 2/367 (0.54%)  2
Non-cardiac chest pain * 1  3/369 (0.81%)  3 0/367 (0.00%)  0
Spinal pain * 1  1/369 (0.27%)  1 0/367 (0.00%)  0
Hepatobiliary disorders     
Cholecystitis * 1  1/369 (0.27%)  1 0/367 (0.00%)  0
Immune system disorders     
Drug hypersensitivity * 1  0/369 (0.00%)  0 1/367 (0.27%)  1
Infections and infestations     
Cellulitis * 1  2/369 (0.54%)  2 1/367 (0.27%)  1
Escherichia urinary tract infection * 1  0/369 (0.00%)  0 1/367 (0.27%)  1
Helicobacter infection * 1  0/369 (0.00%)  0 1/367 (0.27%)  1
Postoperative wound infection * 1  0/369 (0.00%)  0 1/367 (0.27%)  1
Pneumonia * 1  1/369 (0.27%)  1 3/367 (0.82%)  4
Lobar pneumonia * 1  1/369 (0.27%)  1 0/367 (0.00%)  0
Sepsis * 1  0/369 (0.00%)  0 1/367 (0.27%)  1
Septic shock * 1  0/369 (0.00%)  0 1/367 (0.27%)  1
Staphylococcal infection * 1  1/369 (0.27%)  1 1/367 (0.27%)  1
Staphylococcal sepsis * 1  0/369 (0.00%)  0 1/367 (0.27%)  1
Urinary tract infection * 1  1/369 (0.27%)  1 1/367 (0.27%)  1
Emphysematous cystitis * 1  0/369 (0.00%)  0 1/367 (0.27%)  1
Injury, poisoning and procedural complications     
Femur fracture * 1  0/369 (0.00%)  0 1/367 (0.27%)  1
Hip fracture * 1  0/369 (0.00%)  0 1/367 (0.27%)  1
Overdose * 1  1/369 (0.27%)  1 0/367 (0.00%)  0
Pelvic fracture * 1  1/369 (0.27%)  1 0/367 (0.00%)  0
Alcohol poisoning * 1  0/369 (0.00%)  0 1/367 (0.27%)  1
Head injury * 1  1/369 (0.27%)  1 0/367 (0.00%)  0
Wrist fracture * 1  1/369 (0.27%)  1 0/367 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration * 1  1/369 (0.27%)  1 0/367 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Intervertebral disc degeneration * 1  0/369 (0.00%)  0 1/367 (0.27%)  1
Intervertebral disc protrusion * 1  1/369 (0.27%)  1 0/367 (0.00%)  0
Lupus-like syndrome * 1  0/369 (0.00%)  0 2/367 (0.54%)  2
Fibromyalgia * 1  0/369 (0.00%)  0 1/367 (0.27%)  1
Muscle tightness * 1  1/369 (0.27%)  1 0/367 (0.00%)  0
Back pain * 1  0/369 (0.00%)  0 1/367 (0.27%)  1
Neck pain * 1  1/369 (0.27%)  1 0/367 (0.00%)  0
Critical illness myopathy * 1  0/369 (0.00%)  0 1/367 (0.27%)  1
Osteoarthritis * 1  1/369 (0.27%)  1 0/367 (0.00%)  0
Rheumatoid arthritis * 1  1/369 (0.27%)  1 1/367 (0.27%)  1
Cervical spinal stenosis * 1  1/369 (0.27%)  1 0/367 (0.00%)  0
Lumbar spinal stenosis * 1  0/369 (0.00%)  0 1/367 (0.27%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer in situ * 1  0/369 (0.00%)  0 1/367 (0.27%)  1
Squamous cell carcinoma * 1  0/369 (0.00%)  0 1/367 (0.27%)  1
Non-small cell lung cancer * 1  0/369 (0.00%)  0 1/367 (0.27%)  1
Basal cell carcinoma * 1  1/369 (0.27%)  1 0/367 (0.00%)  0
Nervous system disorders     
Ischaemic stroke * 1  0/369 (0.00%)  0 1/367 (0.27%)  1
Syncope * 1  1/369 (0.27%)  1 0/367 (0.00%)  0
Amnesia * 1  1/369 (0.27%)  1 0/367 (0.00%)  0
Transient global amnesia * 1  1/369 (0.27%)  1 0/367 (0.00%)  0
Multiple sclerosis * 1  1/369 (0.27%)  1 0/367 (0.00%)  0
Dizziness * 1  0/369 (0.00%)  0 1/367 (0.27%)  1
Optic neuritis * 1  1/369 (0.27%)  1 0/367 (0.00%)  0
Convulsion * 1  0/369 (0.00%)  0 1/367 (0.27%)  1
Hypoaesthesia * 1  0/369 (0.00%)  0 1/367 (0.27%)  1
Myelopathy * 1  1/369 (0.27%)  1 0/367 (0.00%)  0
Transient ischaemic attack * 1  1/369 (0.27%)  1 0/367 (0.00%)  0
Pregnancy, puerperium and perinatal conditions     
Ectopic pregnancy * 1  0/369 (0.00%)  0 1/367 (0.27%)  1
Pregnancy on contraceptive * 1  1/369 (0.27%)  1 0/367 (0.00%)  0
Pregnancy on oral contraceptive * 1  0/369 (0.00%)  0 1/367 (0.27%)  1
Psychiatric disorders     
Anxiety * 1  1/369 (0.27%)  2 0/367 (0.00%)  0
Depression * 1  0/369 (0.00%)  0 1/367 (0.27%)  1
Renal and urinary disorders     
Bladder perforation * 1  0/369 (0.00%)  0 1/367 (0.27%)  1
Renal mass * 1  0/369 (0.00%)  0 1/367 (0.27%)  1
Renal failure acute * 1  0/369 (0.00%)  0 1/367 (0.27%)  1
Nephrolithiasis * 1  0/369 (0.00%)  0 1/367 (0.27%)  1
Reproductive system and breast disorders     
Cervical dysplasia * 1  0/369 (0.00%)  0 1/367 (0.27%)  1
Uterine haemorrhage * 1  0/369 (0.00%)  0 1/367 (0.27%)  1
Uterine polyp * 1  0/369 (0.00%)  0 1/367 (0.27%)  1
Respiratory, thoracic and mediastinal disorders     
Dyspnoea * 1  1/369 (0.27%)  1 0/367 (0.00%)  0
Status asthmaticus * 1  1/369 (0.27%)  1 0/367 (0.00%)  0
Epistaxis * 1  1/369 (0.27%)  1 0/367 (0.00%)  0
Respiratory failure * 1  0/369 (0.00%)  0 1/367 (0.27%)  1
Skin and subcutaneous tissue disorders     
Drug eruption * 1  0/369 (0.00%)  0 1/367 (0.27%)  1
Erythema * 1  1/369 (0.27%)  1 0/367 (0.00%)  0
Pruritus * 1  1/369 (0.27%)  2 0/367 (0.00%)  0
Dermal cyst * 1  1/369 (0.27%)  1 0/367 (0.00%)  0
Surgical and medical procedures     
Abortion induced * 1  0/369 (0.00%)  0 1/367 (0.27%)  1
Knee arthroplasty * 1  0/369 (0.00%)  0 1/367 (0.27%)  1
Spinal laminectomy * 1  1/369 (0.27%)  1 0/367 (0.00%)  0
Vascular disorders     
Flushing * 1  1/369 (0.27%)  1 0/367 (0.00%)  0
Hypertension * 1  1/369 (0.27%)  1 0/367 (0.00%)  0
Hypotension * 1  1/369 (0.27%)  1 0/367 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (15.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
RAPID3 to Assess Response to Cimzia CDAI to Assess Response to Cimzia
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   126/369 (34.15%)      115/367 (31.34%)    
Infections and infestations     
Bronchitis * 1  10/369 (2.71%)  10 22/367 (5.99%)  23
Sinusitis * 1  28/369 (7.59%)  34 20/367 (5.45%)  24
Upper respiratory tract infection * 1  37/369 (10.03%)  39 38/367 (10.35%)  41
Urinary tract infection * 1  39/369 (10.57%)  53 38/367 (10.35%)  46
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  24/369 (6.50%)  33 10/367 (2.72%)  11
Rheumatoid arthritis * 1  19/369 (5.15%)  21 5/367 (1.36%)  5
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (15.1)
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: NCT01255761    
Other Study ID Numbers: RA0064
First Submitted: December 6, 2010
First Posted: December 7, 2010
Results First Submitted: October 7, 2013
Results First Posted: March 7, 2014
Last Update Posted: July 31, 2018