A Study Comparing 2 Doses Of CP-690,550 Vs. Placebo For The Treatment Of Rheumatoid Arthritis In Patients On Other Background Arthritis Medications

Arthritis, Rheumatoid Clinical Trial

Official title:

Phase 3, Randomized, Double Blind, Placebo Controlled Study Of The Safety And Efficacy Of 2 Doses Of CP 690,550 In Patients With Active Rheumatoid Arthritis On Background DMARDS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00856544
• Other study ID #: A3921046
• Status: Completed
• Phase: Phase 3
• First received: March 3, 2009
• Last updated: December 6, 2012
• Start date: May 2009
• Est. completion date: January 2011

Study information

• Verified date: December 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This Phase 3 study is intended to provide evidence that CP-690,550 dosed 5 mg BID and 10 mg BID is safe and effective when used in combination with a variety of traditional disease modifying antirheumatic drugs in adult patients with rheumatoid arthritis. It is intended to confirm the benefits of CP-690,550 in improving signs and symptoms and physical function that were observed in the Phase 2 rheumatoid arthritis studies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 795
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The patient has a diagnosis of Rheumatoid Arthritis based on the American College of Rheumatology (ACR) 1987 Revised Criteria.

• The patient has active disease as defined by both >=4 tender or painful joints on motion and >= 4 joints swollen; and either an erythrocyte sedimentation rate (ESR) > 28 mm or a C-reactive protein (CRP) concentration > 7 mg/dL.

• Patient had an inadequate response to at least one disease modifying antirheumatic drug (traditional or biologic) due to lack of efficacy or toxicity.

• Patient must remain on at least one background traditional disease modifying antirheumatic drug.

• No evidence of inadequately treated latent or active infection with Mycobacterium tuberculosis.

Exclusion Criteria:

• Blood dyscrasias including confirmed: Hemoglobin <9 g/dL or Hematocrit <30%; White blood cell count <3.0 x 109/L; Absolute neutrophil count <1.2 x 109/L; Platelet count <100 x 109/L.

• History of any other rheumatic autoimmune disease other than Sjogren's syndrome.

• No malignancy or history of malignancy.

• History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

Drug:
• CP-690,550
Film coated tablet, 5 mg PO BID, 1 year
• CP-690,550
Film coated tablet, 10 mg PO BID, 1 year
• Placebo
Film coated tablet, 1 tablet PO BID, 3-6 months
• Placebo
Film coated tablet, 1 tablet PO BID, 3-6 months

Locations

Country	Name	City	State
Australia	Pfizer Investigational Site	Cairns	Queensland
Australia	Pfizer Investigational Site	Campsie	New South Wales
Australia	Pfizer Investigational Site	Malvern East	Victoria
Australia	Pfizer Investigational Site	Maroochydore	Queensland
Australia	Pfizer Investigational Site	Shenton Park	Western Australia
Australia	Pfizer Investigational Site	Woodville	South Australia
Chile	Pfizer Investigational Site	Providencia	Santiago, RM
Chile	Pfizer Investigational Site	Santiago	RM
Chile	Pfizer Investigational Site	Santiago	RM
Chile	Pfizer Investigational Site	Vina del Mar	V Region
Chile	Pfizer Investigational Site	Vina del Mar
China	Pfizer Investigational Site	Beijing
China	Pfizer Investigational Site	Beijing
China	Pfizer Investigational Site	Beijing
China	Pfizer Investigational Site	Changsha	Hunan
China	Pfizer Investigational Site	Chengdu	Sichuan
China	Pfizer Investigational Site	Guangzhou	Guangdong
China	Pfizer Investigational Site	Guangzhou	Guangdong
China	Pfizer Investigational Site	Hangzhou	Zhejiang
China	Pfizer Investigational Site	Hefei	Anhui
China	Pfizer Investigational Site	Hefei	Anhui
China	Pfizer Investigational Site	Jinan	Shandong
China	Pfizer Investigational Site	Nanjing	Jiangsu
China	Pfizer Investigational Site	Qingdao	Shandong
China	Pfizer Investigational Site	Shanghai
China	Pfizer Investigational Site	Shanghai
China	Pfizer Investigational Site	Shanghai
China	Pfizer Investigational Site	Suzhou	Jiangsu
China	Pfizer Investigational Site	Tianjin
China	Pfizer Investigational Site	Wuhan	Hubei
China	Pfizer Investigational Site	Xi'an	Shanxi
Colombia	Pfizer Investigational Site	Barranquilla	Atlantico
Colombia	Pfizer Investigational Site	Bogota	Cundinamarca
Colombia	Pfizer Investigational Site	Bucaramanga	Santander
Croatia	Pfizer Investigational Site	Opatija
Croatia	Pfizer Investigational Site	Zagreb
Denmark	Pfizer Investigational Site	Frederiksberg
Finland	Pfizer Investigational Site	Helsinki
Finland	Pfizer Investigational Site	Hyvinkaa
Finland	Pfizer Investigational Site	Tampere
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Dresden
Germany	Pfizer Investigational Site	Hamburg
Germany	Pfizer Investigational Site	Leipzig
Germany	Pfizer Investigational Site	Nuernberg
Germany	Pfizer Investigational Site	Rheine
Greece	Pfizer Investigational Site	Maroussi Athens
Malaysia	Pfizer Investigational Site	Batu Caves	Selangor
Malaysia	Pfizer Investigational Site	Putrajaya	Wilayah Persekutuan
Malaysia	Pfizer Investigational Site	Seremban	Negeri Sembilan
Malaysia	Pfizer Investigational Site	Subang Jaya	Selangor
Mexico	Pfizer Investigational Site	Cuernavaca	Morelos
Mexico	Pfizer Investigational Site	Merida	Yucatan
Mexico	Pfizer Investigational Site	Mexico	Queretaro
Mexico	Pfizer Investigational Site	Morelia	Michoacan
Mexico	Pfizer Investigational Site	Torreon	Coahuila
Poland	Pfizer Investigational Site	Bialystok
Poland	Pfizer Investigational Site	Bialystok
Poland	Pfizer Investigational Site	Koscian
Poland	Pfizer Investigational Site	Poznan
Poland	Pfizer Investigational Site	Torun
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Petrozavodsk
Slovakia	Pfizer Investigational Site	Nove Zamky
Slovakia	Pfizer Investigational Site	Poprad
Slovakia	Pfizer Investigational Site	Povazska Bystrica
Slovakia	Pfizer Investigational Site	Rimavska Sobota
Slovakia	Pfizer Investigational Site	Senica
Slovakia	Pfizer Investigational Site	Zilina
Spain	Pfizer Investigational Site	A Coruña
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Malaga
Spain	Pfizer Investigational Site	Santiago de Compostela	A Coruña
Spain	Pfizer Investigational Site	Sevilla
Sweden	Pfizer Investigational Site	Falun
Sweden	Pfizer Investigational Site	Goteborg
Sweden	Pfizer Investigational Site	Uppsala
Thailand	Pfizer Investigational Site	Amphoe Muang	Chiang Mai
Thailand	Pfizer Investigational Site	Muang District	Khonkaen
Thailand	Pfizer Investigational Site	Rajathevee	Bangkok
United Kingdom	Pfizer Investigational Site	Cannock	Staffs
United Kingdom	Pfizer Investigational Site	Newcastle Upon Tyne
United Kingdom	Pfizer Investigational Site	Solihull	West Midlands
United Kingdom	Pfizer Investigational Site	Wirral	Merseyside
United States	Pfizer Investigational Site	Albany	New York
United States	Pfizer Investigational Site	Asheville	North Carolina
United States	Pfizer Investigational Site	Austin	Texas
United States	Pfizer Investigational Site	Bethlehem	Pennsylvania
United States	Pfizer Investigational Site	Boulder	Colorado
United States	Pfizer Investigational Site	Charlotte	North Carolina
United States	Pfizer Investigational Site	Clarksburg	West Virginia
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Danbury	Connecticut
United States	Pfizer Investigational Site	Decatur	Georgia
United States	Pfizer Investigational Site	Denver	Colorado
United States	Pfizer Investigational Site	Edina	Minnesota
United States	Pfizer Investigational Site	Evansville	Indiana
United States	Pfizer Investigational Site	Greenville	South Carolina
United States	Pfizer Investigational Site	Hamden	Connecticut
United States	Pfizer Investigational Site	Huntsville	Alabama
United States	Pfizer Investigational Site	Indianapolis	Indiana
United States	Pfizer Investigational Site	Jonesboro	Arkansas
United States	Pfizer Investigational Site	Knoxville	Tennessee
United States	Pfizer Investigational Site	Leominster	Massachusetts
United States	Pfizer Investigational Site	Lexington	Kentucky
United States	Pfizer Investigational Site	Lincoln	Nebraska
United States	Pfizer Investigational Site	Marietta	Georgia
United States	Pfizer Investigational Site	Maywood	Illinois
United States	Pfizer Investigational Site	New Port Richey	Florida
United States	Pfizer Investigational Site	Oakbrook Terrace	Illinois
United States	Pfizer Investigational Site	Ocala	Florida
United States	Pfizer Investigational Site	Orchard Park	New York
United States	Pfizer Investigational Site	Palo Alto	California
United States	Pfizer Investigational Site	Plantation	Florida
United States	Pfizer Investigational Site	Port Richey	Florida
United States	Pfizer Investigational Site	Rochester	New York
United States	Pfizer Investigational Site	Rockford	Illinois
United States	Pfizer Investigational Site	Seattle	Washington
United States	Pfizer Investigational Site	Springfield	Illinois
United States	Pfizer Investigational Site	Springfield	Illinois
United States	Pfizer Investigational Site	Stanford	California
United States	Pfizer Investigational Site	Tacoma	Washington
United States	Pfizer Investigational Site	Tacoma	Washington
United States	Pfizer Investigational Site	Tamarac	Florida
United States	Pfizer Investigational Site	Tampa	Florida
United States	Pfizer Investigational Site	Trumbull	Connecticut
United States	Pfizer Investigational Site	Vernon Hills	Illinois
United States	Pfizer Investigational Site	Wichita	Kansas
United States	Pfizer Investigational Site	Worcester	Massachusetts
United States	Pfizer Investigational Site	Wyomissing	Pennsylvania
Venezuela	Pfizer Investigational Site	Caracas	DC/ Municipio Libertados
Venezuela	Pfizer Investigational Site	Caracas	Distrito Capital

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Venezuela,  Australia,  Chile,  China,  Colombia,  Croatia,  Denmark,  Finland,  Germany,  Greece,  Malaysia,  Mexico,  Poland,  Russian Federation,  Slovakia,  Spain,  Sweden,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Global Assessment of Arthritis	Patient global assessment of arthritis: participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly.	2 weeks	No
Other	Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Assessment of Arthritis Pain	Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.	2 weeks	No
Primary	Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6	ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count (TJC); >= 20% improvement in swollen joint count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.	Month 6	No
Primary	Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3	HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities:dress/groom;arise;eat; walk;reach;grip; hygiene;common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3:0=least difficulty and 3=extreme difficulty. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.	Baseline, Month 3	No
Primary	Percentage of Participants Achieving Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])Less Than 2.6 at Month 6	DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeters/hour[mm/hour]) and patient's global assessment (PtGA) of disease activity(participant rated arthritis activity assessment). Total score range:0-9.4, higher score=more disease activity. DAS28-4 (ESR) less than or equal to (<=)3.2 implied low disease activity, greater than (>)3.2 to 5.1 implied moderate to high disease activity, less than (<)2.6=remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.	Month 6	No
Secondary	Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Week 2, Month 1, 2, 3, 4.5 and 6	ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.	Week 2, Month 1, 2, 3, 4.5, 6	No
Secondary	Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9 and 12	ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.	Month 9, 12	No
Secondary	Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Week 2, Month 1, 2, 3, 4.5 and 6	ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.	Week 2, Month 1, 2, 3, 4.5, 6	No
Secondary	Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9 and 12	ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.	Month 9, 12	No
Secondary	Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Week 2, Month 1, 2, 3, 4.5 and 6	ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.	Week 2, Month 1, 2, 3, 4.5, 6	No
Secondary	Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9 and 12	ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.	Month 9, 12	No
Secondary	Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6	DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.	Week 2, Month 1, 2, 3, 4.5, 6	No
Secondary	Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 12	DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.	Month 9, 12	No
Secondary	Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 3 and 6	DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.	Baseline, Month 3, 6	No
Secondary	Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 12	DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.	Month 12	No
Secondary	Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])	DAS28-4 (CRP) was calculated from SJC and TJC using the 28 joints count, CRP [mg/L] and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 [CRP] <=3.2 implied low disease activity, DAS28-4 [CRP] >3.2 to 5.1 implied moderate to high disease activity and DAS28 <2.6 implied remission.	Baseline, Week 2, Month 1, 2, 3, 4.5, 6, 9, 12	No
Secondary	Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])	DAS28-3 (ESR) was calculated from the number of SJC and TJC using the 28 joints count and ESR (mm/hr). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (ESR) <=3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.	Baseline, Month 3, 6, 12	No
Secondary	Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6	HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty.	Baseline, Week 2, Month 1, 2, 3, 4.5, 6	No
Secondary	Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9 and 12	HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty.	Month 9, Month 12	No
Secondary	Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6	Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.	Baseline, Week 2, Month 1, 2, 3, 4.5, 6	No
Secondary	Patient Assessment of Arthritis Pain at Month 9 and 12	Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.	Month 9, 12	No
Secondary	Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6	Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly.	Baseline, Week 2, Month 1, 2, 3, 4.5, 6	No
Secondary	Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12	Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly.	Month 9, 12	No
Secondary	Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6	Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.	Baseline, Week 2, Month 1, 2, 3, 4.5, 6	No
Secondary	Physician Global Assessment (PGA) of Arthritis at Month 9 and 12	Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.	Month 9, 12	No
Secondary	36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6	SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.	Baseline, Month 1, 3, 6	No
Secondary	36-Item Short-Form Health Survey (SF-36) at Month 9 and 12	SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.	Month 9, 12	No
Secondary	Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6	Participant-rated 12 item questionnaire to assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score(RS) minus lowest possible score divided by possible RS range*100);total score range:0-100,higher score=more intensity of attribute.	Baseline, Month 1, 3, 6	No
Secondary	Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6	MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.	Baseline, Month 1, 3, 6	No
Secondary	Medical Outcome Study (MOS) Sleep Scale at Month 12	Participant-rated 12 item questionnaire to assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score(RS) minus lowest possible score divided by possible RS range*100);total score range:0-100,higher score=more intensity of attribute.	Month 12	No
Secondary	Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12	MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.	Month 12	No
Secondary	Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6	FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.	Baseline, Month 1, 3, 6	No
Secondary	Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 12	FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.	Month 12	No
Secondary	Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline, Month 3 and 6	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.	Baseline, Month 3, 6	No
Secondary	Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 12	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.	Month 12	No
Secondary	Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6	WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: time management scale (5-items); physical demands scale (6-item); mental-interpersonal demands Scale (9-items); output demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work loss index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0[no loss] to 100[complete loss of work]).	Baseline, Month 3, 6	No
Secondary	Work Limitations Questionnaire (WLQ) Score at Month 12	WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: time management scale (5-items); physical demands scale (6-item); mental-interpersonal demands scale (9-items); output demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work loss index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0[no loss] to 100[complete loss of work]).	Month 12	No
Secondary	Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6	Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor, non-medical practitioner, nursing home, hospital, surgery, emergency room(ER) treatment, diagnostic tests, over-night stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status, willingness to work, work disability due to RA, sick leave,part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost.	Baseline, Month 3, 6	No
Secondary	Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12	Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor,non-medical practitioner,nursing home,hospital,surgery,emergency room(ER) treatment,diagnostic tests, over-night stay,home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status,willingness to work,work disability due to RA,sick leave,part time work,ability to perform chores,chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost.	Month 12	No
Secondary	Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6	RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.	Baseline, Month 3, 6	No
Secondary	Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12	RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.	Month 12	No
Secondary	Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6	RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.	Baseline, Month 3, 6	No
Secondary	Number of Days as Assessed Using RA-HCRU at Month 12	RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.	Month 12	No
Secondary	Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6	RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.	Baseline, Month 3, 6	No
Secondary	Number of Hours Per Day as Assessed RA-HCRU at Month 12	RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.	Month 12	No
Secondary	Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6	Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.	Baseline, Month 3, 6	No
Secondary	Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12	Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.	Month 12	No

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