A Phase 3 Study Comparing 2 Doses Of CP-690,550 And The Active Comparator, Humira (Adalimumab) Vs. Placebo For Treatment Of Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00853385
• Other study ID #: A3921064
• Status: Completed
• Phase: Phase 3
• First received: February 27, 2009
• Last updated: January 10, 2013
• Start date: May 2009
• Est. completion date: March 2011

Study information

• Verified date: January 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a comparative study of CP 690,550, Humira (adalimumab) and placebo on background methotrexate in patients with Rheumatoid Arthritis. The study is intended to provide evidence of the efficacy and safety of CP 690,550 when dosed 5 mg and 10 mg twice a day on background methotrexate in adult patients with moderate to severe 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 Rheumatoid Arthritis. An active comparator, adalimumab, is also included.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 717
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The patient has a diagnosis of RA based upon the American College of Rheumatology (ACR) 1987 Revised Criteria.

• The patient must have had an inadequate response to methotrexate and have active disease, as defined by both: =6 joints tender or painful on motion; and =6 joints swollen; and fulfills 1 of the following 2 criteria at Screening: 1.ESR (Westergren method) >28 mm in the local laboratory. 2. CRP >7 mg/L in the central laboratory.

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

• The patient must have been on a stable dose of 7.5 mg to 25 mg weekly of methotrexate and washed out of all other DMARDs.

Exclusion Criteria:

• Blood dyscrasias including confirmed: 1. Hemoglobin <9 g/dL or Hematocrit <30%; 2. White blood cell count <3,000 cu.mm. Absolute neutrophil count <1,200 cu.mm; 4. Platelet count <100,000/L

• History of any other autoimmune rheumatic 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

• Patients who have failed any TNFi for either lack of efficacy or a TNFi mechanism related adverse event.

• Patients who have previously received adalimumab therapy for any reason.

• Patients who are contraindicated for treatment with adalimumab in accordance with the approved local label.

• Patients meeting the New York Heart Association Class III and Class IV Congestive Heart failure

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
• Rheumatoid Arthritis

Intervention

Drug:
• CP 690,550
tablets 5 mg BID PO plus q2 week placebo SC injections for 12 months
• CP-690,550
tablets 10 mg BID PO plus q2 week placebo SC injections for 12 months

Other:
• Placebo
placebo tablets BID PO advance to 5mg CP 690,550 BID at Month 3 or 6 visit plus q2 week placebo SC injections for 12 months
• Placebo
tablets BID PO advance tablets to10mg CP 690,550 BID at Month 3 or 6 visit plus q2 week placebo SC injections for 12 months

Biological:
• Biologic TNFi
placebo tablets BID PO plus adalimumab 40 mg q2 week SC injections for 12 months

Locations

Country	Name	City	State
Australia	Pfizer Investigational Site	Cairns	Queensland
Australia	Pfizer Investigational Site	Malvern East	Victoria
Australia	Pfizer Investigational Site	Maroochydore	Queensland
Australia	Pfizer Investigational Site	St Leonards	New South Wales
Bosnia and Herzegovina	Pfizer Investigational Site	Sarajevo
Bulgaria	Pfizer Investigational Site	Pleven
Bulgaria	Pfizer Investigational Site	Plovdiv
Bulgaria	Pfizer Investigational Site	Plovdiv
Bulgaria	Pfizer Investigational Site	Sevlievo
Bulgaria	Pfizer Investigational Site	Sofia
Bulgaria	Pfizer Investigational Site	Sofia
Canada	Pfizer Investigational Site	London	Ontario
Canada	Pfizer Investigational Site	Lunenburg	Nova Scotia
Canada	Pfizer Investigational Site	Mississauga	Ontario
Canada	Pfizer Investigational Site	Quebec
Canada	Pfizer Investigational Site	Saskatoon	Saskatchewan
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Trois-Rivieres	Quebec
Canada	Pfizer Investigational Site	Vancouver	British Columbia
Chile	Pfizer Investigational Site	Providencia	Santiago, RM
Chile	Pfizer Investigational Site	Rancagua	VI Region
Chile	Pfizer Investigational Site	Santiago	RM
Chile	Pfizer Investigational Site	Santiago	RM
Costa Rica	Pfizer Investigational Site	Cartago
Costa Rica	Pfizer Investigational Site	San Jose
Costa Rica	Pfizer Investigational Site	San Jose
Croatia	Pfizer Investigational Site	Osijek
Croatia	Pfizer Investigational Site	Split
Croatia	Pfizer Investigational Site	Zagreb
Czech Republic	Pfizer Investigational Site	Brno
Czech Republic	Pfizer Investigational Site	Brno
Czech Republic	Pfizer Investigational Site	Brno
Czech Republic	Pfizer Investigational Site	Brno - Zidenice
Czech Republic	Pfizer Investigational Site	Hlucin
Czech Republic	Pfizer Investigational Site	Pardubice
Czech Republic	Pfizer Investigational Site	Praha 11
Czech Republic	Pfizer Investigational Site	Praha 11 - Chodov
Czech Republic	Pfizer Investigational Site	Praha 2
Czech Republic	Pfizer Investigational Site	Praha 4
Czech Republic	Pfizer Investigational Site	Zlin
Denmark	Pfizer Investigational Site	Frederiksberg
Denmark	Pfizer Investigational Site	Randers NOE
Dominican Republic	Pfizer Investigational Site	Santo Domingo
Finland	Pfizer Investigational Site	Hyvinkaa
Germany	Pfizer Investigational Site	Aachen
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Frankfurt am Main
Germany	Pfizer Investigational Site	Halle
Germany	Pfizer Investigational Site	Halle
Germany	Pfizer Investigational Site	Herne
Germany	Pfizer Investigational Site	Ratingen
Germany	Pfizer Investigational Site	Wuerzburg
Korea, Republic of	Pfizer Investigational Site	Daegu
Korea, Republic of	Pfizer Investigational Site	Gwangju
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Mexico	Pfizer Investigational Site	Guadalajara	Jalisco
Mexico	Pfizer Investigational Site	Mexico	DF
Mexico	Pfizer Investigational Site	Morelia	Michoacan
Mexico	Pfizer Investigational Site	San Luis Potosi	SLP
Philippines	Pfizer Investigational Site	Angeles City	Pampanga
Philippines	Pfizer Investigational Site	Cebu City
Philippines	Pfizer Investigational Site	Lipa City	Batangas
Poland	Pfizer Investigational Site	Bialystok
Poland	Pfizer Investigational Site	Cieszyn
Poland	Pfizer Investigational Site	Koscian
Poland	Pfizer Investigational Site	Krakow
Poland	Pfizer Investigational Site	Sopot
Poland	Pfizer Investigational Site	Torun
Poland	Pfizer Investigational Site	Warszawa
Slovakia	Pfizer Investigational Site	Bratislava
Slovakia	Pfizer Investigational Site	Dunajska Streda
Slovakia	Pfizer Investigational Site	Kosice
Slovakia	Pfizer Investigational Site	Nove Zamky
Slovakia	Pfizer Investigational Site	Povazska Dystrica
Slovakia	Pfizer Investigational Site	Zilina
Spain	Pfizer Investigational Site	A Coruña
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Santiago de Compostela	A Coruña
Spain	Pfizer Investigational Site	Sevilla
Spain	Pfizer Investigational Site	Valencia
Spain	Pfizer Investigational Site	Vigo	Pontevedra
Thailand	Pfizer Investigational Site	Amphoe Muang	Chiang Mai
Thailand	Pfizer Investigational Site	Rajathevee	Bangkok
United Kingdom	Pfizer Investigational Site	Cannock	Staffs
United Kingdom	Pfizer Investigational Site	Dudley, West Midlands
United Kingdom	Pfizer Investigational Site	Wirral	Merseyside
United States	Pfizer Investigational Site	Austin	Texas
United States	Pfizer Investigational Site	Baton Rouge	Louisiana
United States	Pfizer Investigational Site	Boulder	Colorado
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Clarksburg	West Virginia
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Decatur	Georgia
United States	Pfizer Investigational Site	Evansville	Indiana
United States	Pfizer Investigational Site	Fair Oaks	California
United States	Pfizer Investigational Site	Gilbert	Arizona
United States	Pfizer Investigational Site	Glendale	Arizona
United States	Pfizer Investigational Site	Grand Rapids	Michigan
United States	Pfizer Investigational Site	Greenville	South Carolina
United States	Pfizer Investigational Site	Haverhill	Massachusetts
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Jonesboro	Arkansas
United States	Pfizer Investigational Site	Largo	Florida
United States	Pfizer Investigational Site	Lexington	Kentucky
United States	Pfizer Investigational Site	Lexington	Kentucky
United States	Pfizer Investigational Site	Lubbock	Texas
United States	Pfizer Investigational Site	Marietta	Georgia
United States	Pfizer Investigational Site	Mesa	Arizona
United States	Pfizer Investigational Site	Mesquite	Texas
United States	Pfizer Investigational Site	Naples	Florida
United States	Pfizer Investigational Site	Oklahoma City	Oklahoma
United States	Pfizer Investigational Site	Palm Harbor	Florida
United States	Pfizer Investigational Site	Paradise Valley	Arizona
United States	Pfizer Investigational Site	Phoenix	Arizona
United States	Pfizer Investigational Site	Pinellas Park	Florida
United States	Pfizer Investigational Site	Plantation	Florida
United States	Pfizer Investigational Site	Rockford	Illinois
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	Seattle	Washington
United States	Pfizer Investigational Site	Seattle	Washington
United States	Pfizer Investigational Site	St. Petersburg	Florida
United States	Pfizer Investigational Site	Tampa	Florida
United States	Pfizer Investigational Site	Wichita	Kansas
United States	Pfizer Investigational Site	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Bosnia and Herzegovina,  Bulgaria,  Canada,  Chile,  Costa Rica,  Croatia,  Czech Republic,  Denmark,  Dominican Republic,  Finland,  Germany,  Korea, Republic of,  Mexico,  Philippines,  Poland,  Slovakia,  Spain,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6	ACR20 response: greater than or equal to (>=) 20% 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 the Health Assessment Questionnaire-Disability Index (HAQ-DI) 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 With 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) calculated from SJC and TJC using 28-joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (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) less than or equal to (<=) 3.2 implied low disease activity and > 3.2 to 5.1 implied moderate to high disease activity, and < 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) Response at Month 1 and 3	ACR20 response: >=20% improvement in TJC; >= 20% improvement in 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 HAQ); and CRP.	Month 1, 3	No
Secondary	Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response 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 the HAQ); and CRP.	Month 9, 12	No
Secondary	Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 1, 3 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 the HAQ); and CRP.	Month 1, 3, 6	No
Secondary	Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response 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 the HAQ); and CRP.	Month 9, 12	No
Secondary	Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 1, 3 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 the HAQ); and CRP.	Month 1, 3, 6	No
Secondary	Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response 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 the 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, Month 1, 3 and 6	DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (milligram per liter [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.	Baseline, Month 1, 3, 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 1, 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 1, 3, 6	No
Secondary	Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9 and 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 9, 12	No
Secondary	Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])	DAS28-4 [CRP] calculated from SJC and TJC using 28 joint count, CRP (mg/L) 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 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.	Baseline, Month 1, 3, 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 SJC and TJC using 28 joint count and ESR (mm/hour). 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 1, 3, 6, 9, 12	No
Secondary	Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 1, 3 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; 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.	Month 1, 3, 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; 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.	Month 9, 12	No
Secondary	Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 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, Month 1, 3, 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, Month 1, 3 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 mm = very well and 100 mm = very poorly.	Baseline, Month 1, 3, 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 mm = very well and 100 mm = very poorly.	Month 9, 12	No
Secondary	Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Month 1, 3 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, Month 1, 3, 6	No
Secondary	Physician Global Assessment (PGA) of Arthritis Pain 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 was reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0-100 where higher scores represented 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 was reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0-100 where higher scores represented higher level of functioning.	Month 9, 12	No
Secondary	Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Baseline, Month 1, 3 and 6	FACIT-Fatigue scale 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-Fatigue (FACIT)-Fatigue Scale at Month 12	FACIT-Fatigue scale 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	Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6	Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 sub scales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range:0-100); sleep quantity (Qua)(range:0-24), and optimal (Opt) sleep (yes: 1, no: 0) and nine item index measures of sleep disturbance were constructed to provide composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute.	Baseline, Month 1, 3, 6	No
Secondary	Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12	Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 sub scales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range:0-100); sleep quantity (Qua)(range:0-24), and optimal (Opt) sleep (yes: 1, no: 0) and nine item index measures of sleep disturbance were constructed to provide composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute.	Month 12	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	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	Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Baseline, Month 1, 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 1, 3, 6	No
Secondary	Euro Quality of Life-5 Dimension (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 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: 5-items Time Management scale (TMS); 6-items Physical Demands scale (PDS); 9-items Mental-Interpersonal Demands Scale (MIDS); 5-items Output Demands scale (ODS). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), 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 3, 6	No
Secondary	Work Limitations Questionnaire (WLQ) Score at Baseline and 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: 5-items Time Management scale (TMS); 6-items Physical Demands scale (PDS); 9-items Mental-Interpersonal Demands Scale (MIDS); 5-items Output Demands scale (ODS). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), 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 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: any RA/non-RA related medical/non-medical (NM) practitioner visit, nursing home, hospital, surgery, emergency room (ER) treatment, diagnostic tests, over-night stay, home healthcare (HC) 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 indicated higher medical cost.	Baseline, Month 3, 6	No
Secondary	Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12	RA-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, NM practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, over-night stay, home HC services, and 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 indicated 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, hours affected per day and average number of hours missed work per day 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, hours affected per day and average number of hours missed work per day 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 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 10-point scale, where higher score indicated lower work performance.	Month 12	No

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