A Study of ARRY-438162 in Patients With Rheumatoid Arthritis

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.

Time frame: Week 12

Population: Analysis group is comprised of the Intent-to-Treat (ITT) population, which is all patients who were randomized to a treatment group.

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.

Time frame: Week 1

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.

Time frame: Week 16 (Follow-up)

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.

Time frame: Week 2

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.

Time frame: Week 4

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.

Time frame: Week 8

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria.

Time frame: Week 1

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria.

Time frame: Week 12

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria.

Time frame: Week 16 (Follow-up)

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria.

Time frame: Week 2

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria.

Time frame: Week 4

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria.

Time frame: Week 8

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria.

Time frame: Week 1

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria.

Time frame: Week 12

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria.

Time frame: Week 16 (Follow-up)

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria.

Time frame: Week 2

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria.

Time frame: Week 4

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria.

Time frame: Week 8

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.

Time frame: Week 16 (Follow-up)

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.

Time frame: Baseline

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.

Time frame: Week 1

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.

Time frame: Week 2

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.

Time frame: Week 4

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.

Time frame: Week 8

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.

Time frame: Week 12

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.

Time frame: Baseline

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.

Time frame: Week 1

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.

Time frame: Week 2

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.

Time frame: Week 4

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.

Time frame: Week 8

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.

Time frame: Week 12

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.

Time frame: Week 16 (Follow-up)

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

Time frame: Baseline

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

Time frame: Week 1

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

Time frame: Week 12

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

Time frame: Week 16 (Follow-up)

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

Time frame: Week 2

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

Time frame: Week 4

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

Time frame: Week 8

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.

Time frame: Baseline

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.

Time frame: Week 16 (Follow-up)

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.

Time frame: Week 12

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.

Time frame: Week 8

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.

Time frame: Week 4

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.

Time frame: Week 2

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.

Time frame: Week 1

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to without difficulty, 1 equal to with some difficulty, 2 equal to with much difficulty and 3 equal to unable to do. Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.

Time frame: Week 16 (Follow-up)

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to without difficulty, 1 equal to with some difficulty, 2 equal to with much difficulty and 3 equal to unable to do. Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.

Time frame: Baseline

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to without difficulty, 1 equal to with some difficulty, 2 equal to with much difficulty and 3 equal to unable to do. Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.

Time frame: Week 1

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to without difficulty, 1 equal to with some difficulty, 2 equal to with much difficulty and 3 equal to unable to do. Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.

Time frame: Week 2

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to without difficulty, 1 equal to with some difficulty, 2 equal to with much difficulty and 3 equal to unable to do. Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.

Time frame: Week 4

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to without difficulty, 1 equal to with some difficulty, 2 equal to with much difficulty and 3 equal to unable to do. Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.

Time frame: Week 8

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to without difficulty, 1 equal to with some difficulty, 2 equal to with much difficulty and 3 equal to unable to do. Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.

Time frame: Week 12

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.

Time frame: Week 2

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.

Time frame: Week 1

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.

Time frame: Baseline

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.

Time frame: Week 8

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.

Time frame: Week 4

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.

Time frame: Week 16 (Follow-up)

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.

Time frame: Week 12

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS). Patients answered the following: Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing. The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).

Time frame: Baseline

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS). Patients answered the following: Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing. The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).

Time frame: Week 1

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS). Patients answered the following: Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing. The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).

Time frame: Week 2

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS). Patients answered the following: Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing. The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).

Time frame: Week 4

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS). Patients answered the following: Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing. The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).

Time frame: Week 8

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS). Patients answered the following: Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing. The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).

Time frame: Week 12

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS). Patients answered the following: Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing. The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).

Time frame: Week 16 (Follow-up)

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS). The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).

Time frame: Week 1

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS). The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).

Time frame: Baseline

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS). The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).

Time frame: Week 2

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS). The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).

Time frame: Week 4

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS). The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).

Time frame: Week 8

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS). The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).

Time frame: Week 12

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS). The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).

Time frame: Week 16 (Follow-up)

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.

Time frame: Baseline

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.

Time frame: Week 4

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.

Time frame: Week 8

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.

Time frame: Week 12

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.

Time frame: Week 16 (Follow-up)

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.

Time frame: Week 16 (Follow-up)

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.

Time frame: Week 12

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.

Time frame: Week 8

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.

Time frame: Week 4

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.

Time frame: Baseline

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.

Time frame: Week 16 (Follow-up)

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.

Time frame: Week 12

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.

Time frame: Week 8

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.

Time frame: Week 4

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.

Time frame: Baseline

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

SF-36V2 is a generic 36-item generic health status measure covering 2 summary measures: physical component summary (PCS) and mental health component score (MCS); it consists of 8 subscales. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have choices per item. Scoring is done for both MCS subscale scores and summary scores; for each, the range is 0 (worst) to 100 (best).

Time frame: Baseline

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.

Time frame: Week 16 (Follow-up)

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.

Time frame: Week 12

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.

Time frame: Week 8

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.

Time frame: Week 4

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.

Time frame: Baseline

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.

Time frame: Week 4

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.

Time frame: Week 8

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.

Time frame: Week 12

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.

Time frame: Week 16 (Follow-up)

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.

Time frame: Baseline

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.

Time frame: Week 4

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.

Time frame: Week 8

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.

Time frame: Week 12

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.

Time frame: Week 16 (Follow-up)

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.

Time frame: Baseline

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.

Time frame: Week 4

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.

Time frame: Week 8

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.

Time frame: Week 12

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.

Time frame: Week 16 (Follow-up)

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.

Time frame: Baseline

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.

Time frame: Week 16 (Follow-up)

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.

Time frame: Week 12

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.

Time frame: Week 8

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.

Time frame: Week 4

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.

Time frame: Baseline

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.

Time frame: Week 16 (Follow-up)

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.

Time frame: Week 12

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.

Time frame: Week 8

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.

Time frame: Week 4

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.

Time frame: Week 16 (Follow-up)

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.

Time frame: Week 12

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.

Time frame: Week 8

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.

Time frame: Week 4

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.

Time frame: Baseline

Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.