A Comparison of Two Assessment Tools in Predicting Treatment Success of Cimzia in Rheumatoid Arthritis Subjects (PREDICT)

• 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: UCB Pharma
• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia	Total
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
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)

Outcome Measures

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)]
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

Outcome Measure Data

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
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

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
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

Outcome Measure Data

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
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

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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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)

Adverse Events

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
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	--/--		--/--
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)
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)

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: (UCB) Study Director
• Organization: UCB Clinical Trial Call Center
• Phone: +1 887 822 9493

Publications of Results:

Curtis JR, Herrem C, Ndlovu 'N, O'Brien C, Yazici Y. A somatization comorbidity phenotype impacts response to therapy in rheumatoid arthritis: post-hoc results from the certolizumab pegol phase 4 PREDICT trial. Arthritis Res Ther. 2017 Sep 29;19(1):215. doi: 10.1186/s13075-017-1412-z.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Curtis JR, Churchill M, Kivitz A, Samad A, Gauer L, Gervitz L, Koetse W, Melin J, Yazici Y. A Randomized Trial Comparing Disease Activity Measures for the Assessment and Prediction of Response in Rheumatoid Arthritis Patients Initiating Certolizumab Pegol. Arthritis Rheumatol. 2015 Dec;67(12):3104-12. doi: 10.1002/art.39322.

• 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