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A 2-Year Phase 3 Study Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate

Primary Purpose

Arthritis, Rheumatoid

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

CP-690,550

Placebo

CP-690,550

Placebo

CP-690,550

About this trial

This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring double-blind placebo-controlled investigational drug oral therapy safety and efficacy hand and feet x-rays

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adults with moderate to severe rheumatoid arthritis on a stable dose of methotrexate

Exclusion Criteria:

Pregnancy, severe acute or chronic medical conditions, including serious infections or clinically significant laboratory abnormalities.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Sequence 1

Sequence 2

Sequence 3

Sequence 4

Arm Description

Outcomes

Primary Outcome Measures

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; >=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 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.

Changes From Baseline in Modified Total Sharp Score (mTSS) at Month 6

mTSS = sum of erosion and Joint Space Narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change: scores at observation minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.

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 and common activities over past week. Each item scored on 4-point scale, 0 to 3: 0=no difficulty; 1=some difficulty;2=much difficulty; 3=unable to do. Overall score was computed as sum of domain sc ores 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.

Percentage of Participant 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 swollen joint count (SJC) and tender/painful joint count (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, greater than (>) 3.2 to 5.1 implied moderate to high disease activity and 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.

Secondary Outcome Measures

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 1 and 3

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.

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9, 12, 15, 18, 21 and 24

Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 1, 3 and 6

ACR50 response: greater than or equal to >=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.

Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9, 12, 15, 18, 21 and 24

Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) 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 HAQ); and CRP.

Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9, 12, 15, 18, 21 and 24

Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6

Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9, 12, 15, 18, 21 and 24

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 indicated low disease activity, >3.2 to 5.1 indicated moderate to high disease activity and <2.6 = remission.

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.

Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9, 12, 15, 18, 21 and 24

DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PtGA 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.

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.

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.

Modified Total Sharp Scores (mTSS) at Baseline

mTSS = sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.

Modified Total Sharp Scores (mTSS) at Month 12 and 24

Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, 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; 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.

Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9, 12, 15, 18, 21 and 24

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.

Patient Assessment of Arthritis Pain at Month 9, 12, 15, 18, 21 and 24

Participants rated the severity of arthritis pain on a 0 to 100 mm visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.

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 = very well and 100 = very poorly.

Patient Global Assessment (PtGA) of Arthritis Pain at Month 9, 12, 15, 18, 21 and 24

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.

Physician Global Assessment (PGA) of Arthritis 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.

Physician Global Assessment (PGA) of Arthritis at Month 9, 12, 15, 18, 21 and 24

Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.

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.

36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24

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.

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.

Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24

Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24

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.

Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 12, 18 and 24

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.

Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 12, 18 and 24

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]).

Work Limitations Questionnaire (WLQ) Score at Month 12, 18 and 24

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 or housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.

Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24

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.

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.

Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24

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.

Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24

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.

Number of Hours Per Day as Assessed RA-HCRU at Month 12, 18 and 24

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.

Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12, 18 and 24

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.

Full Information

NCT ID

NCT00847613

First Posted

February 17, 2009

Last Updated

January 14, 2013

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00847613

Brief Title

A 2-Year Phase 3 Study Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

March 2009 (undefined)

Primary Completion Date

April 2011 (Actual)

Study Completion Date

February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study is designed to provide safety and efficacy data to support the development of CP-690,550 in patients with moderate to severe rheumatoid arthritis on background of methotrexate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arthritis, Rheumatoid

Keywords

double-blind placebo-controlled investigational drug oral therapy safety and efficacy hand and feet x-rays

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

800 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sequence 1

Arm Type

Experimental

Arm Title

Sequence 2

Arm Type

Experimental

Arm Title

Sequence 3

Arm Type

Placebo Comparator

Arm Title

Sequence 4

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

CP-690,550

Other Intervention Name(s)

Double-blind, placebo-controlled period

Intervention Description

Oral tablets administered at 5 mg BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.

Intervention Type

Drug

Intervention Name(s)

CP-690,550

Other Intervention Name(s)

Double-blind, Active Extension Period

Intervention Description

Oral tablets administered at 5 mg BID daily through the end of the study during the double-blind, active-extension period.

Intervention Type

Drug

Intervention Name(s)

CP-690,550

Other Intervention Name(s)

Double-blind, placebo-controlled period

Intervention Description

Oral tablets administered at 10 mg BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.

Intervention Type

Drug

Intervention Name(s)

CP-690,550

Other Intervention Name(s)

Double-blind, Active Extension Period

Intervention Description

Oral tablets administered at 10 mg BID daily through the end of the study during the double-blind, active-extension period.

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Double-blind, placebo-controlled period

Intervention Description

Oral placebo tablets administered BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.

Intervention Type

Drug

Intervention Name(s)

CP-690,550

Other Intervention Name(s)

Double-blind, Active Extension Period

Intervention Description

Oral tablets administered at 5 mg BID daily through the end of the study during the double-blind, active-extension period.

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Double-blind, Active Extension Period

Intervention Description

Oral placebo tablets administered BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.

Intervention Type

Drug

Intervention Name(s)

CP-690,550

Other Intervention Name(s)

Double-blind, placebo-controlled period

Intervention Description

Oral tablets administered at 10 mg BID daily through the end of the study during the double-blind, active-extension period.

Primary Outcome Measure Information:

Title

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6

Description

Time Frame

Month 6

Title

Changes From Baseline in Modified Total Sharp Score (mTSS) at Month 6

Description

Time Frame

Baseline, Month 6

Title

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3

Description

Time Frame

Baseline, Month 3

Title

Percentage of Participant With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6

Description

Time Frame

Month 6

Secondary Outcome Measure Information:

Title

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 1 and 3

Description

Time Frame

Month 1, 3

Title

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9, 12, 15, 18, 21 and 24

Description

Time Frame

Month 9, 12, 15, 18, 21, 24

Title

Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 1, 3 and 6

Description

Time Frame

Month 1, 3, 6

Title

Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9, 12, 15, 18, 21 and 24

Description

Time Frame

Month 9, 12, 15, 18, 21, 24

Title

Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 1, 3 and 6

Description

Time Frame

Month 1, 3, 6

Title

Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9, 12, 15, 18, 21 and 24

Description

Time Frame

Month 9, 12, 15, 18, 21, 24

Title

Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6

Description

Time Frame

Baseline, Month 1, 3, 6

Title

Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9, 12, 15, 18, 21 and 24

Description

Time Frame

Month 9, 12, 15, 18, 21, 24

Title

Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6

Description

Time Frame

Baseline, Month 1, 3, 6

Title

Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9, 12, 15, 18, 21 and 24

Description

Time Frame

Month 9, 12, 15, 18, 21, 24

Title

Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])

Description

Time Frame

Baseline, Month 1, 3, 6, 9, 12, 15, 18, 21, 24

Title

Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])

Description

Time Frame

Baseline, Month 1, 3, 6, 9, 12, 15, 18, 21, 24

Title

Modified Total Sharp Scores (mTSS) at Baseline

Description

Time Frame

Baseline

Title

Modified Total Sharp Scores (mTSS) at Month 12 and 24

Description

Time Frame

Month 12, 24

Title

Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Month 1, 3 and 6

Description

Time Frame

Baseline, Month 1, 3, 6

Title

Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9, 12, 15, 18, 21 and 24

Description

Time Frame

Month 9, 12, 15, 18, 21, 24

Title

Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6

Description

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.

Time Frame

Baseline, Month 1, 3, 6

Title

Patient Assessment of Arthritis Pain at Month 9, 12, 15, 18, 21 and 24

Description

Participants rated the severity of arthritis pain on a 0 to 100 mm visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.

Time Frame

Month 9, 12, 15, 18, 21, 24

Title

Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3, and 6

Description

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.

Time Frame

Baseline, Month 1, 3, 6

Title

Patient Global Assessment (PtGA) of Arthritis Pain at Month 9, 12, 15, 18, 21 and 24

Description

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.

Time Frame

Month 9, 12, 15, 18, 21, 24

Title

Physician Global Assessment (PGA) of Arthritis at Baseline, Month 1, 3 and 6

Description

Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.

Time Frame

Baseline, Month 1, 3, 6

Title

Physician Global Assessment (PGA) of Arthritis at Month 9, 12, 15, 18, 21 and 24

Description

Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.

Time Frame

Month 9, 12, 15, 18, 21, 24

Title

36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6

Description

Time Frame

Baseline, Month 1, 3, 6

Title

36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24

Description

Time Frame

Month 9, 12, 15, 18, 21, 24

Title

Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6

Description

Time Frame

Baseline, Month 1, 3, 6

Title

Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6

Description

Time Frame

Baseline, Month 1, 3, 6

Title

Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24

Description

Time Frame

Month 12, 18, 24

Title

Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24

Description

Time Frame

Month 12, 18, 24

Title

Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6

Description

Time Frame

Baseline, Month 1, 3, 6

Title

Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 12, 18 and 24

Description

Time Frame

Month 12, 18, 24

Title

Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline, Month 3 and 6

Description

Time Frame

Baseline, Month 3, 6

Title

Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 12, 18 and 24

Description

Time Frame

Month 12, 18, 24

Title

Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6

Description

Time Frame

Baseline, Month 3, 6

Title

Work Limitations Questionnaire (WLQ) Score at Month 12, 18 and 24

Description

Time Frame

Month 12, 18, 24

Title

Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6

Description

Time Frame

Baseline, Month 3, 6

Title

Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24

Description

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.

Time Frame

Month 12, 18, 24

Title

Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6

Description

Time Frame

Baseline, Month 3, 6

Title

Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24

Description

Time Frame

Month 12, 18, 24

Title

Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6

Description

Time Frame

Baseline, Month 1, 3, 6

Title

Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24

Description

Time Frame

Month 12, 18, 24

Title

Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6

Description

Time Frame

Baseline, Month 1, 3, 6

Title

Number of Hours Per Day as Assessed RA-HCRU at Month 12, 18 and 24

Description

Time Frame

Month 12, 18, 24

Title

Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6

Description

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.

Time Frame

Baseline, Month 1, 3, 6

Title

Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12, 18 and 24

Description

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.

Time Frame

Month 12, 18, 24

Other Pre-specified Outcome Measures:

Title

Percentage of Participants With Sustained American College of Rheumatology 20% (ACR20) Response

Description

Time Frame