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A Study of ARRY-438162 in Patients With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Array BioPharma
ClinicalTrials.gov Identifier:
NCT00650767
First received: March 31, 2008
Last updated: September 20, 2016
Last verified: September 2016
  Purpose
This is a Phase 2 study, involving a 12-week treatment period, designed to evaluate the effectiveness of investigational study drug ARRY-438162 in treating rheumatoid arthritis in patients on stable doses of methotrexate, and to further evaluate the safety of the study drug. Approximately 200 patients from the US, Argentina, Brazil, Hungary, Peru, Poland and Romania will be enrolled in this study.

Condition Intervention Phase
Rheumatoid Arthritis
Drug: ARRY-438162, MEK inhibitor; oral
Drug: Placebo; oral
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Array BioPharma:

Primary Outcome Measures:
  • American College of Rheumatology 20% (ACR20) Response Rate at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • American College of Rheumatology 20% (ACR20) Response Rate at Week 1 [ Time Frame: Week 1 ] [ Designated as safety issue: No ]

    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.


  • American College of Rheumatology 20% (ACR20) Response Rate at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]

    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.


  • American College of Rheumatology 20% (ACR20) Response Rate at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

    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.


  • American College of Rheumatology 20% (ACR20) Response Rate at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

    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.


  • American College of Rheumatology 20% (ACR20) Response Rate at Week 16 (Follow-up) [ Time Frame: Week 16 (Follow-up) ] [ Designated as safety issue: No ]

    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.


  • American College of Rheumatology 50% (ACR50) Response Rate at Week 1 [ Time Frame: Week 1 ] [ Designated as safety issue: No ]

    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.


  • American College of Rheumatology 50% (ACR50) Response Rate at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]

    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.


  • American College of Rheumatology 50% (ACR50) Response Rate at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

    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.


  • American College of Rheumatology 50% (ACR50) Response Rate at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

    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.


  • American College of Rheumatology 50% (ACR50) Response Rate at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

    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.


  • American College of Rheumatology 50% (ACR50) Response Rate at Week 16 (Follow-up) [ Time Frame: Week 16 (Follow-up) ] [ Designated as safety issue: No ]

    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.


  • American College of Rheumatology 70% (ACR70) Response Rate at Week 1 [ Time Frame: Week 1 ] [ Designated as safety issue: No ]

    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.


  • American College of Rheumatology 70% (ACR70) Response Rate at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]

    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.


  • American College of Rheumatology 70% (ACR70) Response Rate at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

    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.


  • American College of Rheumatology 70% (ACR70) Response Rate at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

    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.


  • American College of Rheumatology 70% (ACR70) Response Rate at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

    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.


  • American College of Rheumatology 70% (ACR70) Response Rate at Week 16 (Follow-up) [ Time Frame: Week 16 (Follow-up) ] [ Designated as safety issue: No ]

    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.


  • American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28) [ Time Frame: Baseline ] [ Designated as safety issue: No ]

    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.


  • American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28) [ Time Frame: Week 1 ] [ Designated as safety issue: No ]

    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.


  • American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28) [ Time Frame: Week 2 ] [ Designated as safety issue: No ]

    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.


  • American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

    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.


  • American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

    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.


  • American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

    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.


  • American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28) [ Time Frame: Week 16 (Follow-up) ] [ Designated as safety issue: No ]

    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.


  • American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28) [ Time Frame: Baseline ] [ Designated as safety issue: No ]

    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.


  • American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28) [ Time Frame: Week 1 ] [ Designated as safety issue: No ]

    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.


  • American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28) [ Time Frame: Week 2 ] [ Designated as safety issue: No ]

    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.


  • American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

    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.


  • American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

    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.


  • American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

    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.


  • American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28) [ Time Frame: Week 16 (Follow-up) ] [ Designated as safety issue: No ]

    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.


  • Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS) [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
    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.

  • Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS) [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    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.

  • Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    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.

  • Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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.

  • Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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.

  • Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS) [ Time Frame: Week 16 (Follow-up) ] [ Designated as safety issue: No ]
    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.

  • Patient's Global Assessment of Arthritis - Visual Analog Score (VAS) [ Time Frame: Baseline ] [ Designated as safety issue: No ]

    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).


  • Patient's Global Assessment of Arthritis - Visual Analog Score (VAS) [ Time Frame: Week 1 ] [ Designated as safety issue: No ]

    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).


  • Patient's Global Assessment of Arthritis - Visual Analog Score (VAS) [ Time Frame: Week 2 ] [ Designated as safety issue: No ]

    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).


  • Patient's Global Assessment of Arthritis - Visual Analog Score (VAS) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

    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).


  • Patient's Global Assessment of Arthritis - Visual Analog Score (VAS) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

    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).


  • Patient's Global Assessment of Arthritis - Visual Analog Score (VAS) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

    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).


  • Patient's Global Assessment of Arthritis - Visual Analog Score (VAS) [ Time Frame: Week 16 (Follow-up) ] [ Designated as safety issue: No ]

    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).


  • Physician's Global Assessment of Arthritis - Visual Analog Score (VAS) [ Time Frame: Baseline ] [ Designated as safety issue: No ]

    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).


  • Physician's Global Assessment of Arthritis - Visual Analog Score (VAS) [ Time Frame: Week 1 ] [ Designated as safety issue: No ]

    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).


  • Physician's Global Assessment of Arthritis - Visual Analog Score (VAS) [ Time Frame: Week 2 ] [ Designated as safety issue: No ]

    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).


  • Physician's Global Assessment of Arthritis - Visual Analog Score (VAS) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

    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).


  • Physician's Global Assessment of Arthritis - Visual Analog Score (VAS) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

    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).


  • Physician's Global Assessment of Arthritis - Visual Analog Score (VAS) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

    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).


  • Physician's Global Assessment of Arthritis - Visual Analog Score (VAS) [ Time Frame: Week 16 (Follow-up) ] [ Designated as safety issue: No ]

    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).


  • Health Assessment Questionnaire - Disability Index (HAQ-DI) [ Time Frame: Baseline ] [ Designated as safety issue: No ]

    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.


  • Health Assessment Questionnaire - Disability Index (HAQ-DI) [ Time Frame: Week 1 ] [ Designated as safety issue: No ]

    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.


  • Health Assessment Questionnaire - Disability Index (HAQ-DI) [ Time Frame: Week 2 ] [ Designated as safety issue: No ]

    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.


  • Health Assessment Questionnaire - Disability Index (HAQ-DI) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

    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.


  • Health Assessment Questionnaire - Disability Index (HAQ-DI) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

    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.


  • Health Assessment Questionnaire - Disability Index (HAQ-DI) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

    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.


  • Health Assessment Questionnaire - Disability Index (HAQ-DI) [ Time Frame: Week 16 (Follow-up) ] [ Designated as safety issue: No ]

    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.


  • C-Reactive Protein (CRP) at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • C-Reactive Protein (CRP) at Week 1 [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
  • C-Reactive Protein (CRP) at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • C-Reactive Protein (CRP) at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • C-Reactive Protein (CRP) at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • C-Reactive Protein (CRP) at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • C-Reactive Protein (CRP) at Week 16 (Follow-up) [ Time Frame: Week 16 (Follow-up) ] [ Designated as safety issue: No ]
  • Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP]) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP]) [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
    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.

  • Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP]) [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    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.

  • Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP]) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    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.

  • Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP]) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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.

  • Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP]) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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.

  • Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP]) [ Time Frame: Week 16 (Follow-up) ] [ Designated as safety issue: No ]
    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.

  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning [ Time Frame: Baseline ] [ Designated as safety issue: No ]

    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.


  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

    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.


  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

    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.


  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

    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.


  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning [ Time Frame: Week 16 (Follow-up) ] [ Designated as safety issue: No ]

    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.


  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical [ Time Frame: Baseline ] [ Designated as safety issue: No ]

    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.


  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

    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.


  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

    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.


  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

    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.


  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical [ Time Frame: Week 16 (Follow-up) ] [ Designated as safety issue: No ]

    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.


  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain [ Time Frame: Baseline ] [ Designated as safety issue: No ]

    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.


  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

    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.


  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

    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.


  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

    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.


  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain [ Time Frame: Week 16 (Follow-up) ] [ Designated as safety issue: No ]

    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.


  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health [ Time Frame: Baseline ] [ Designated as safety issue: No ]

    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.


  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

    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.


  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

    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.


  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

    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.


  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health [ Time Frame: Week 16 (Follow-up) ] [ Designated as safety issue: No ]

    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.


  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality [ Time Frame: Baseline ] [ Designated as safety issue: No ]

    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.


  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

    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.


  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

    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.


  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

    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.


  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality [ Time Frame: Week 16 (Follow-up) ] [ Designated as safety issue: No ]

    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.


  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning [ Time Frame: Baseline ] [ Designated as safety issue: No ]

    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.


  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

    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.


  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

    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.


  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

    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.


  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning [ Time Frame: Week 16 (Follow-up) ] [ Designated as safety issue: No ]

    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.


  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional [ Time Frame: Baseline ] [ Designated as safety issue: No ]

    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.


  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

    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.


  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

    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.


  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

    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.


  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional [ Time Frame: Week 16 (Follow-up) ] [ Designated as safety issue: No ]

    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.


  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health [ Time Frame: Baseline ] [ Designated as safety issue: No ]

    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.


  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

    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.


  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

    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.


  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

    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.


  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health [ Time Frame: Week 16 (Follow-up) ] [ Designated as safety issue: No ]

    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.


  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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).

  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    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.

  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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.

  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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.

  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score [ Time Frame: Week 16 (Follow-up) ] [ Designated as safety issue: No ]
    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.

  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    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.

  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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.

  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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.

  • SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score [ Time Frame: Week 16 (Follow-up) ] [ Designated as safety issue: No ]
    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.


Enrollment: 201
Study Start Date: March 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ARRY-438162 (Schedule 1) Drug: ARRY-438162, MEK inhibitor; oral
multiple dose, single schedule
Experimental: ARRY-438162 (Schedule 2) Drug: ARRY-438162, MEK inhibitor; oral
multiple dose, single schedule
Experimental: ARRY-438162 (Schedule 3) Drug: ARRY-438162, MEK inhibitor; oral
multiple dose, single schedule
Placebo Comparator: Placebo Drug: Placebo; oral
matching placebo

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Diagnosis of rheumatoid arthritis, based on the American College of Rheumatology (ACR) 1987 Revised Criteria, prior to first dose of study drug.
  • Patient has received a stable dose of methotrexate for ≥ 6 weeks prior to first dose of study drug and is willing to continue on this regimen for the duration of the study.
  • Patient has received a stable dose of folate for ≥ 6 weeks and is willing to continue on this regimen for the duration of the study.
  • No prior use of biological agents for the treatment of rheumatoid arthritis.
  • Additional criteria exist.

Key Exclusion Criteria:

  • Diagnosis of any other inflammatory or non-inflammatory arthritis that may interfere with disease activity assessments or clinically apparent osteoarthritis which would affect subsequent efficacy measures.
  • A history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological disease or severe systemic involvement with rheumatoid arthritis.
  • Additional criteria exist.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00650767

Locations
United States, South Carolina
Spartanburg Medical Research
Spartanburg, South Carolina, United States, 29303
Argentina
Asistencia Integral en Reumatologia
Buenos Aires, Argentina
CEMIC
Buenos Aires, Argentina
Hospital Britanico
Buenos Aires, Argentina
CER San Juan
San Juan, Argentina
Centro Medico Privado de Reumatologia
San Miguel de Tucumán, Argentina
Centro de Investigaciones Clinicas del Litoral SRL
Santa Fe, Argentina
Brazil
Médicos Unidos Ltda.
Goiânia, GO, Brazil, 74110-120
CETI - Hospital das Clínicas da Universidade Federal do Paraná
Curitiba, PR, Brazil, 80060
Hospital de Clínicas de Porto Alegre
Porto Alegre, RS, Brazil, 90035-003
Hospital São Lucas da da Pontifícia Universidade Católica do Rio Grande do Sul
Porto Alegre, RS, Brazil, 90610-000
Hospital São Paulo / Instituto Paulista de Reumatologia
São Paulo, SP, Brazil, 04026-000
Hospital Heliópolis
São Paulo, SP, Brazil, 04230-000
Instituto de Medicina Avançada (IMA Brasil)
São Paulo, SP, Brazil, 05437-010
Hungary
Budai Irgalmasrendi Kórház - Allergólógia és Immunológia
Budapest, Hungary
Synexus Ltd Hungary
Budapest, Hungary
Békés Megyei Pándy Kálmán Kórház - Rheumatology
Gyula, Hungary
Mozgasszervi Rehabilitacios Kozpont
Mezőkövesd, Hungary
MÁV Kórház - Clinical Pharmacology
Szolnok, Hungary
Vas Megyei Markusovszky Korhaz Lajos Általános, Rehabilitációs és Gyógyfürdő Kórház, Egyetemi Oktató Kórház, Zártkörűen Működő Nonprofit Részvénytársaság - Rheumatology
Szombathely, Hungary
Fejér Megyei Szent György Kórház - Rheumatology
Székesfehérvár, Hungary
Peru
Instituto de Investigacion y Seguridad Medica EIRL
Arequipa, Peru
Clinica San Felipe - Centro de Estudios Clinicos CGYM
Lima, Peru
Clínica Ricardo Palma- Sitio de Investigacion de Reumatologia
Lima, Peru
Hospital Maria Auxiliadora - Centro de Investigaciones Medicas
Lima, Peru
Poland
Centrum Osteoporozy i Chorób Kostno-Stawowych
Bialystok, Poland
Wojewódzki Szpital Zespolony - Oddział Reumatologiczny
Elblag, Poland
Centrum Leczenia Chorob Cywilizacyjnych
Gdynia, Poland
NZOZ Reumed
Lublin, Poland
Centrum Leczenia Chorob Cywilizacyjnych
Warszawa, Poland
Synexus SCM Sp. z o.o.
Wroclaw, Poland
Romania
Spitalul Clinic "Sf, Maria"
Bucuresti, Romania
Spitalul Clinic Judetean de Urgenta
Cluj-Napoca, Romania
Spitalul Clinic Judetean de Urgenta
Targu Mures, Romania
Cabinet Medical "Prof. Dr. Miorara Banciu"
Timisoara, Romania
Sponsors and Collaborators
Array BioPharma
  More Information

Responsible Party: Array BioPharma
ClinicalTrials.gov Identifier: NCT00650767     History of Changes
Other Study ID Numbers: ARRAY-162-201 
Study First Received: March 31, 2008
Results First Received: July 21, 2016
Last Updated: September 20, 2016
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: National Health Surveillance Agency
Brazil: Ethics Committee
Brazil: National Committee of Ethics in Research
Hungary: National Institute of Pharmacy
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Peru: Ethics Committee
Peru: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Romania: Ministry of Public Health

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on December 02, 2016