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

Rheumatoid Arthritis Clinical Trial

— PREDICT  

Official title:

Phase 4, Randomized, 52-Week Study To Evaluate Two Assessment Tools To Predict Treatment Success At 52 Weeks Based On A Treatment Decision At Week 12 In Subjects With Moderate To Severe Rheumatoid Arthritis Receiving Cimzia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01255761
• Other study ID #: RA0064
• Status: Completed
• Phase: Phase 4
• Start date: November 2010
• Est. completion date: December 2012

Study information

• Verified date: March 2018
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase 4 study to evaluate a routine patient completed assessment (RAPID3) compared to a physician completed assessment (CDAI) to predict treatment success with subjects with moderate to severe rheumatoid arthritis

Description:

RA0064 is a Phase 4, multicenter, randomized, 52-week study. All eligible subjects will receive open label Cimzia 400 mg at Weeks 0, 2 and 4, followed by Cimzia 200 mg every 2 weeks at Weeks 6 to 50 for the treatment of moderate to severe rheumatoid arthritis. All subjects will be assessed using the 2 assessment tools: the subject-based Routine Assessment of Patient Index (RAPID3) and the investigator-based Clinical Disease Activity Index (CDAI)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 736
• Est. completion date: December 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects 18 years of age or older

• Subjects with a diagnosis of Adult-onset Rheumatoid Arthritis of at least 3 months as defined by the 1987 American College of Rheumatology (ACR) classification criteria

• Subjects with active Rheumatoid Arthritis as defined by:

• 4 tender joints (28 joint count) at Screening and Baseline Visits; and

• 4 swollen joints (28 joint count) at Screening and Baseline Visits

• Subjects who have had an unsatisfactory response or intolerance to at least 1 traditional Disease-modifying Antirheumatic Drugs (DMARD)

Exclusion Criteria:

• Subjects must not have a diagnosis of any other inflammatory Arthritis

• Subjects must not have greater than 3 Arthroplasties due to Rheumatoid Arthritis and/or Steinbrocker IV Functional Capacity

• Subjects must not have a secondary non-inflammatory type of Arthritis that would interfere with study evaluation

• Subjects must not be diagnosed with Fibromyalgia with sufficient symptoms requiring treatment

• Subjects must not have a history of Infected Joint Prosthesis

• Subjects must not have discontinued biological therapy for their Rheumatoid Arthritis due to Severe Hypersensitivity Reaction or Anaphylactic Reaction

• Subjects must not have received more than 2 anti- Tumor Necrosis Factor (TNF) agents prior to enrollment

• Subjects must not have received treatment with Abatacept and/or Rituximab or have received any experimental or approved B cell therapeutic agent

• Subjects must not have a history of chronic alcohol or drug abuse

• Subjects must not have known hypersensitivity to any components of the investigational medicinal product

• Subjects must not have a history of chronic infections, recent serious or life-threatening infection within 6 months or any current sign or symptom that may indicate an infection

• Subjects must not have a history of a Blood Dyscrasias

• Subjects with known Tuberculosis (TB) Disease, high risk of acquiring TB or latent TB infection

• Subjects must not be at high risk of infection

• Subjects must not have a history of Lymphoproliferative Disorder including Lymphoma signs and symptoms suggestive of Lymphoproliferative Disease

• Subjects must not have concurrent acute or chronic Viral Hepatitis B or C

• Subjects must not have known Human Immunodeficiency Virus (HIV) infection

• Subject must not have concurrent Malignancy or history of Malignancy

• Subjects must not have a current or recent history of severe, progressive, and/or uncontrolled Renal, Hepatic, Hematological, Gastrointestinal, Endocrine, Pulmonary, Cardiac, Neurological or Cerebral Disease

• Subjects must not have Class III or IV Congestive Heart Failure

• Subjects must not have history of, or suspected Demyelinating Disease of the Central Nervous System

• Subjects must not have a history of adverse reaction to Polyethylene Glycol (PEG)

• Subjects must not have significant laboratory abnormalities which in the investigators judgment would make the subject unsuitable for inclusion

• Subjects must not have a known history or clinically active infection with Histoplasma, Coccidiodes, Paracoccidioides, Pneumocystis, Nontuberculous Mycobacteria, Blastomyces or Aspergillus

• Subject must not have a known history of or be currently diagnosed with Systemic Lupus Erythematosus

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• Certolizumab Pegol (CZP)
400 mg subcutaneous injection at Weeks 0, 2 and 4 200 mg subcutaneous injection every two weeks, Week 6 through Week 52

Locations

Country	Name	City	State
United States	175	Albany	New York
United States	125	Albuquerque	New Mexico
United States	162	Amarillo	Texas
United States	146	Arlington	Virginia
United States	144	Atlanta	Georgia
United States	232	Atlanta	Georgia
United States	110	Austin	Texas
United States	156	Austin	Texas
United States	108	Aventura	Florida
United States	152	Bethlehem	Pennsylvania
United States	139	Binghamton	New York
United States	137	Birmingham	Alabama
United States	121	Bridgeport	Connecticut
United States	200	Bridgeport	Connecticut
United States	188	Bridgeton	Missouri
United States	116	Brooklyn	New York
United States	167	Brooklyn	New York
United States	136	Burlington	Vermont
United States	198	Charleston	South Carolina
United States	178	Charlotte	North Carolina
United States	150	Chesapeake	Virginia
United States	221	Clarksburg	West Virginia
United States	143	Clifton	New Jersey
United States	217	Coeur d'Alene	Idaho
United States	228	Columbia	South Carolina
United States	111	Covina	California
United States	149	Cumberland	Maryland
United States	192	Dallas	Texas
United States	107	Danbury	Connecticut
United States	195	Danbury	Connecticut
United States	112	Duncansville	Pennsylvania
United States	120	Dunedin	Florida
United States	210	Durham	North Carolina
United States	185	El Paso	Texas
United States	186	Elizabethtown	Kentucky
United States	219	Erie	Pennsylvania
United States	208	Escondido	California
United States	103	Fullerton	California
United States	194	Glendale	Wisconsin
United States	237	Hagerstown	Maryland
United States	138	Hamden	Connecticut
United States	130	Hendersonville	Tennessee
United States	234	Hickory	North Carolina
United States	168	Hot Springs	Arkansas
United States	122	Houston	Texas
United States	170	Houston	Texas
United States	155	Huntington Beach	California
United States	166	Huntsville	Alabama
United States	206	Idaho Falls	Idaho
United States	129	Jackson	Tennessee
United States	196	Johnson City	New York
United States	241	Jonesboro	Arkansas
United States	223	Kennewick	Washington
United States	202	La Mesa	California
United States	140	Lansing	Michigan
United States	157	Lawrenceville	Georgia
United States	159	Lebanon	New Hampshire
United States	218	Lewes	Delaware
United States	204	Lexington	Kentucky
United States	124	Lincoln	Nebraska
United States	153	Little Rock	Arkansas
United States	203	Loma Linda	California
United States	233	Los Angeles	California
United States	230	Louisville	Kentucky
United States	118	Mansfield	Massachusetts
United States	123	Mesquite	Texas
United States	102	Monroe	North Carolina
United States	189	Nashua	New Hampshire
United States	115	Nassau Bay	Texas
United States	174	New York	New York
United States	101	Ocala	Florida
United States	225	Orange Park	Florida
United States	104	Orchard Park	New York
United States	227	Ormond Beach	Florida
United States	105	Palm Desert	California
United States	184	Palm Harbor	Florida
United States	165	Peoria	Arizona
United States	226	Petoskey	Michigan
United States	128	Philadelphia	Pennsylvania
United States	135	Plainview	New York
United States	205	Reno	Nevada
United States	215	Rochester	New York
United States	193	Rock Island	Illinois
United States	229	Roseville	California
United States	113	Sacramento	California
United States	114	Saint Clair Shores	Michigan
United States	109	Saint Louis	Missouri
United States	133	Saint Louis	Missouri
United States	117	San Antonio	Texas
United States	119	San Antonio	Texas
United States	161	San Antonio	Texas
United States	127	San Diego	California
United States	106	Santa Maria	California
United States	172	Santa Monica	California
United States	145	Sarasota	Florida
United States	147	Sellersville	Pennsylvania
United States	134	Spokane	Washington
United States	207	Springfield	Illinois
United States	191	Tampa	Florida
United States	216	Tucson	Arizona
United States	212	Upland	California
United States	231	Van Nuys	California
United States	236	Vero Beach	Florida
United States	190	Victoria	Texas
United States	142	Waco	Texas
United States	197	Wheaton	Maryland
United States	158	Whittier	California
United States	213	Willow Grove	Pennsylvania
United States	132	Worcester	Massachusetts
United States	235	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response at Week 12 as Assessed by Randomized Tool [Clinical Disease Activity Index (CDAI) or Routine Assessment of Patient Index Data 3 (RAPID3)]	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.	Baseline (Week 0) to Week 12
Primary	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	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: 0.56xv(TJC) + 0.28xv(SJC) + 0.70xlognat (ESR) + 0.014xGlobal Assessment of Arthritis where 28 joints are examined.	Baseline (Week 0) to Week 52
Secondary	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	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: 0.56xv(TJC) + 0.28xv(SJC) + 0.70xlognat (ESR) + 0.014xGlobal Assessment of Arthritis where 28 joints are examined.	Baseline (Week 0) to Week 52
Secondary	Responders at Week 12 Achieving Remission (Disease Activity Score 28 [Erythrocyte Sedimentation Rate] < 2.6) at Week 52	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: 0.56xv(TJC) + 0.28xv(SJC) + 0.70xlognat (ESR) + 0.014xGlobal Assessment of Arthritis where 28 joints are examined.	Baseline (Week 0) to Week 52
Secondary	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	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: 0.56xv(TJC) + 0.28xv(SJC) + 0.70xlognat (ESR) + 0.014xGlobal Assessment of Arthritis where 28 joints are examined.	Baseline (Week 0) to Week 52
Secondary	Change From Baseline in the Disease Activity Score 28 Erythrocyte Sedimentation Rate [DAS28 (ESR)] Assessed at Week 12	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 v(TJC) + 0.28 x v(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity.	Baseline (Week 0) to Week 12
Secondary	Change From Baseline in Disease Activity Score 28 Erythrocyte Sedimentation Rate [DAS28 (ESR)] Assessed at Week 52	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 v(TJC) + 0.28 x v(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity.	Baseline (Week 0) to Week 52
Secondary	Change From Baseline in Clinical Disease Activity Index (CDAI) Assessed at Week 12	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.	Baseline (Week 0) to Week 12
Secondary	Change From Baseline in Clinical Disease Activity Index (CDAI) Assessed at Week 52	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.	Baseline (Week 0) to Week 52
Secondary	Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Assessed at Week 12	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.	Baseline (Week 0) to Week 12
Secondary	Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Assessed at Week 52	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.	Baseline (Week 0) to Week 52
Secondary	Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Low Disease Activity (DAS28[ESR] = 3.2) at Week 12	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 v(TJC) + 0.28 x v(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity.	Week 12
Secondary	Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Low Disease Activity (DAS28[ESR] = 3.2) at Week 52	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 v(TJC) + 0.28 x v(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity.	Week 52
Secondary	Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS [ESR] < 2.6) at Week 12	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 v(TJC) + 0.28 x v(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity.	Week 12
Secondary	Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS28[ESR] < 2.6) at Week 52	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 v(TJC) + 0.28 x v(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity.	Week 52
Secondary	Percentage of Subjects With CDAI (Clinical Disease Activity Index) Low Disease Activity (CDAI = 10) at Week 12	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.	Week 12
Secondary	Percentage of Subjects With CDAI (Clinical Disease Activity Index) Low Disease Activity (CDAI = 10) at Week 52	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.	Week 52
Secondary	Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI = 2.8) at Week 12	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.	Week 12
Secondary	Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI = 2.8) at Week 52	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.	Week 52
Secondary	Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Low Disease Activity (RAPID3 = 6.0) at Week 12	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.	Week 12
Secondary	Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Low Disease Activity (RAPID3 = 6.0) at Week 52	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.	Week 52
Secondary	Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Remission (RAPID3 = 3.0) at Week 12	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.	Week 12
Secondary	Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Remission (RAPID3 = 3.0) at Week 52	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.	Week 52
Secondary	Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12	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.	Week 12
Secondary	Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12	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.	Week 12
Secondary	Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12	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.	Week 12
Secondary	Number of Days With No Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12	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.	Week 12
Secondary	Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12	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.	Week 12
Secondary	Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12	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.	Week 12
Secondary	Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12	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.	Week 12
Secondary	Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12	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.	Week 12
Secondary	Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52	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.	Week 52
Secondary	Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52	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.	Week 52
Secondary	Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52	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.	Week 52
Secondary	Number of Days With No Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52	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.	Week 52
Secondary	Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52	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.	Week 52
Secondary	Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52	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.	Week 52
Secondary	Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52	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.	Week 52
Secondary	Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52	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.	Week 52

External Links

•   Cimzia