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Efficacy and Safety Study of R935788 Tablets to Treat Rheumatoid Arthritis (Taski-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00665925
Recruitment Status : Completed
First Posted : April 24, 2008
Results First Posted : June 13, 2016
Last Update Posted : September 16, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine whether the Spleen Tyrosine Kinase (Syk) inhibitor, R935788 (R788), at a dose of 100 mg, orally, twice-a-day, and/or a dose of of 150 mg, orally, once-a-day is effective in the treatment of Rheumatoid Arthrits in patients who have had an inadequate clinical response to methotrexate.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Fostamatinib disodium (R935788) Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 457 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of Two Doses of R935788 in Rheumatoid Arthritis Patients Failing to Respond to Methotrexate
Study Start Date : May 2008
Primary Completion Date : June 2009
Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
R788, 100 mg tablet, orally, twice-a-day
Drug: Fostamatinib disodium (R935788)
100 mg tablet, orally, twice-a-day
Other Name: R935788
Experimental: 2
R788, 150 mg tablet, orally, once a day
Drug: Fostamatinib disodium (R935788)
150 mg tablet, orally, once a day
Other Name: R935788
Placebo Comparator: 3
Placebo, orally, either once a day, or twice a day
Drug: Placebo
Placebo, orally, either once a day, or twice a day


Outcome Measures

Primary Outcome Measures :
  1. American College of Rheumatology 20 (ACR20) Response at 6 Months [ Time Frame: 6 months ]
    The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 6 months


Secondary Outcome Measures :
  1. American College of Rheumatology 20 (ACR20) Response at 1 Week [ Time Frame: 1 week ]
    The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 1 week

  2. American College of Rheumatology 20 (ACR20) Response at 2 Weeks [ Time Frame: 2 weeks ]
    The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 2 weeks

  3. American College of Rheumatology 20 (ACR20) Response at 1 Month [ Time Frame: 1 month ]
    The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 1 month

  4. American College of Rheumatology 20 (ACR20) Response at 6 Weeks [ Time Frame: 6 weeks ]
    The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 6 weeks

  5. American College of Rheumatology 20 (ACR20) Response at 2 Months [ Time Frame: 2 months ]
    The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 2 months

  6. American College of Rheumatology 20 (ACR20) Response at 3 Months [ Time Frame: 3 months ]
    The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 3 months

  7. American College of Rheumatology 20 (ACR20) Response at 4 Months [ Time Frame: 4 months ]
    The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 4 months

  8. American College of Rheumatology 20 (ACR20) Response at 5 Months [ Time Frame: 5 months ]
    The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 5 months

  9. American College of Rheumatology 50 (ACR50) Response at 1 Week [ Time Frame: 1 week ]
    The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 1 week

  10. American College of Rheumatology 50 (ACR50) Response at 2 Weeks [ Time Frame: 2 weeks ]
    The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 2 weeks

  11. American College of Rheumatology 50 (ACR50) Response at 1 Month [ Time Frame: 1 month ]
    The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 1 month

  12. American College of Rheumatology 50 (ACR50) Response at 6 Weeks [ Time Frame: 6 weeks ]
    The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 6 weeks

  13. American College of Rheumatology 50 (ACR50) Response at 2 Months [ Time Frame: 2 months ]
    The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 2 months

  14. American College of Rheumatology 50 (ACR50) Response at 3 Months [ Time Frame: 3 months ]
    The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 3 months

  15. American College of Rheumatology 50 (ACR50) Response at 4 Months [ Time Frame: 4 months ]
    The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 4 months

  16. American College of Rheumatology 50 (ACR50) Response at 5 Months [ Time Frame: 5 months ]
    The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 5 months

  17. American College of Rheumatology 50 (ACR50) Response at 6 Months [ Time Frame: 6 months ]
    The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 6 months

  18. American College of Rheumatology 70 (ACR70) Response at 1 Week [ Time Frame: 1 week ]
    The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 1 week

  19. American College of Rheumatology 70 (ACR70) Response at 2 Weeks [ Time Frame: 2 weeks ]
    The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 2 weeks

  20. American College of Rheumatology 70 (ACR70) Response at 1 Month [ Time Frame: 1 month ]
    The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 1 month

  21. American College of Rheumatology 70 (ACR70) Response at 6 Weeks [ Time Frame: 6 weeks ]
    The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 6 weeks

  22. American College of Rheumatology 70 (ACR70) Response at 2 Months [ Time Frame: 2 months ]
    The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 2 months

  23. American College of Rheumatology 70 (ACR70) Response at 3 Months [ Time Frame: 3 months ]
    The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 3 months

  24. American College of Rheumatology 70 (ACR70) Response at 4 Months [ Time Frame: 4 months ]
    The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 4 months

  25. American College of Rheumatology 70 (ACR70) Response at 5 Months [ Time Frame: 5 months ]
    The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 5 months

  26. American College of Rheumatology 70 (ACR70) Response at 6 Months [ Time Frame: 6 months ]
    The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 6 months

  27. American College of Rheumatology Index of Improvement (ACRn) at 1 Week [ Time Frame: 1 week ]
    The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 1 week of treatment

  28. American College of Rheumatology Index of Improvement (ACRn) at 2 Weeks [ Time Frame: 2 weeks ]
    The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 2 weeks of treatment

  29. American College of Rheumatology Index of Improvement (ACRn) at 1 Month [ Time Frame: 1 month ]
    The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 1 month of treatment

  30. American College of Rheumatology Index of Improvement (ACRn) at 6 Weeks [ Time Frame: 6 weeks ]
    The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 6 weeks of treatment

  31. American College of Rheumatology Index of Improvement (ACRn) at 2 Months [ Time Frame: 2 months ]
    The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 2 months of treatment

  32. American College of Rheumatology Index of Improvement (ACRn) at 3 Months [ Time Frame: 3 months ]
    The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 3 months of treatment

  33. American College of Rheumatology Index of Improvement (ACRn) at 4 Months [ Time Frame: 4 months ]
    The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 4 months of treatment

  34. American College of Rheumatology Index of Improvement (ACRn) at 5 Months [ Time Frame: 5 months ]
    The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 5 months of treatment

  35. American College of Rheumatology Index of Improvement (ACRn) at 6 Months [ Time Frame: 6 months ]
    The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 6 months of treatment

  36. Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 1 Month [ Time Frame: 1 month ]
    Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms

  37. Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 2 Months [ Time Frame: 2 months ]
    Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms

  38. Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 3 Months [ Time Frame: 3 months ]
    Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms

  39. Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 4 Months [ Time Frame: 4 months ]
    Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms

  40. Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 5 Months [ Time Frame: 5 months ]
    Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms

  41. Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 6 Months [ Time Frame: 6 months ]
    Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms

  42. Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 1 Month [ Time Frame: 1 month ]
    Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity

  43. Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 2 Months [ Time Frame: 2 months ]
    Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity

  44. Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 3 Months [ Time Frame: 3 months ]
    Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity

  45. Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 4 Months [ Time Frame: 4 months ]
    Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity

  46. Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 5 Months [ Time Frame: 5 months ]
    Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity

  47. Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 6 Months [ Time Frame: 6 months ]
    Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity

  48. Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 1 Month [ Time Frame: 1 month ]
    Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms

  49. Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 2 Months [ Time Frame: 2 months ]
    Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms

  50. Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 3 Months [ Time Frame: 3 months ]
    Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms

  51. Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 4 Months [ Time Frame: 4 months ]
    Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms

  52. Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 5 Months [ Time Frame: 5 months ]
    Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms

  53. Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 6 Months [ Time Frame: 6 months ]
    Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms

  54. Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 1 Month [ Time Frame: 1 month ]
    Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity

  55. Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 2 Months [ Time Frame: 2 months ]
    Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity

  56. Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 3 Months [ Time Frame: 3 months ]
    Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity

  57. Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 4 Months [ Time Frame: 4 months ]
    Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity

  58. Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 5 Months [ Time Frame: 5 months ]
    Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity

  59. Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 6 Months [ Time Frame: 6 months ]
    Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity

  60. Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at 6 Months [ Time Frame: Baseline to 6 months ]
    Change from baseline in FACIT-F, which is a patient-reported 13-item questionnaire that assesses fatigue, calculated as the score at 6 months minus the score at baseline. The FACIT-F runs from 0 to 52 with lower scores indicating higher fatigue. A positive change from baseline indicates an improvement in fatigue after treatment.

  61. Short Form Health Survey (SF-36) Physical Component Summary (PCS) at 6 Months [ Time Frame: Baseline to 6 months ]
    Change from baseline in the PCS of the SF-36 (which assesses health and wellbeing), calculated as the score at 6 months minus the score at baseline. The PCS ranges from 0 to 100 with 100 indicating the highest level of functioning possible. A positive change indicates an improvement in PCS after treatment

  62. Short Form Health Survey (SF-36) Mental Component Summary (MCS) at 6 Months [ Time Frame: Baseline to 6 months ]
    Change from baseline in the MCS of the SF-36 (which assesses health and wellbeing), calculated as the score at 6 months minus the score at baseline. The MCS ranges from 0 to 100 with 100 indicating the highest level of functioning possible. A positive change indicates an improvement in MCS after treatment

  63. Alanine Aminotransferase (ALT) >1.5x Upper Limit of Normal (ULN) [ Time Frame: Any time between baseline and 6 months ]
    The number of participants with ALT (a test of liver function) values greater than 1.5 times the ULN

  64. Alanine Aminotransferase (ALT) >1.5-2x Upper Limit of Normal (ULN) [ Time Frame: Any time between baseline and 6 months ]
    The number of participants with ALT (a test of liver function) values greater than 1.5 to 2 times the ULN

  65. Alanine Aminotransferase (ALT) >2-3x Upper Limit of Normal (ULN) [ Time Frame: Any time between baseline and 6 months ]
    The number of participants with ALT (a test of liver function) values greater than 2 to 3 times the ULN

  66. Alanine Aminotransferase (ALT) >3x Upper Limit of Normal (ULN) [ Time Frame: Any time between baseline and 6 months ]
    The number of participants with ALT (a test of liver function) values greater than 3 times the ULN

  67. Alanine Aminotransferase (ALT) >3-5x Upper Limit of Normal (ULN) [ Time Frame: Any time between baseline and 6 months ]
    The number of participants with ALT (a test of liver function) values greater than 3 to 5 times the ULN

  68. Alanine Aminotransferase (ALT) >5-10x Upper Limit of Normal (ULN) [ Time Frame: Any time between baseline and 6 months ]
    The number of participants with ALT (a test of liver function) values greater than 5 to 10 times the ULN

  69. Alanine Aminotransferase (ALT) >10x Upper Limit of Normal (ULN) [ Time Frame: Any time between baseline and 6 months ]
    The number of participants with ALT (a test of liver function) values greater than 10 times the ULN

  70. Aspartate Aminotransferase (AST) >1.5x Upper Limit of Normal (ULN) [ Time Frame: Any time between baseline and 6 months ]
    The number of participants with AST (a test of liver function) values greater than 1.5 times the ULN

  71. Aspartate Aminotransferase (AST) >1.5-2x Upper Limit of Normal (ULN) [ Time Frame: Any time between baseline and 6 months ]
    The number of participants with AST (a test of liver function) values greater than 1.5-2 times the ULN

  72. Aspartate Aminotransferase (AST) >2-3x Upper Limit of Normal (ULN) [ Time Frame: Any time between baseline and 6 months ]
    The number of participants with AST (a test of liver function) values greater than 2 to 3 times the ULN

  73. Aspartate Aminotransferase (AST) >3x Upper Limit of Normal (ULN) [ Time Frame: Any time between baseline and 6 months ]
    The number of participants with AST (a test of liver function) values greater than 3 times the ULN

  74. Aspartate Aminotransferase (AST) >3-5x Upper Limit of Normal (ULN) [ Time Frame: Any time between baseline and 6 months ]
    The number of participants with AST (a test of liver function) values greater than 3 to 5 times the ULN

  75. Aspartate Aminotransferase (AST) >5-10 x Upper Limit of Normal (ULN) [ Time Frame: Any time between baseline and 6 months ]
    The number of participants with AST (a test of liver function) values greater than 5 to 10 times the ULN

  76. Aspartate Aminotransferase (AST) >10 x Upper Limit of Normal (ULN) [ Time Frame: Any time between baseline and 6 months ]
    The number of participants with AST (a test of liver function) values greater than 10 times the ULN

  77. Alkaline Phosphatase >1.5 x Upper Limit of Normal (ULN) and >1.5 Times Baseline [ Time Frame: Any time between baseline and 6 months ]
    The number of participants with alkaline phosphatase (a test of liver function) values greater than 1.5 times the ULN and greater than 1.5 times baseline

  78. Bilirubin >1.5 x Upper Limit of Normal (ULN) [ Time Frame: Any time between baseline and 6 months ]
    The number of participants with bilirubin (a test of liver function) values greater than 1.5 times the ULN

  79. Bilirubin >2 x Upper Limit of Normal (ULN) [ Time Frame: Any time between baseline and 6 months ]
    The number of participants with bilirubin (a test of liver function) values greater than 2 times the ULN

  80. Absolute Neutrophil Count (ANC) <1500/mm3 [ Time Frame: Any time between baseline and 6 months ]
    The number of participants with ANC (a test of liver function) values lower than 1500/mm3


Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patients must give written informed consent by signing an IRB/EC-approved Informed Consent Form (ICF) prior to admission to this study.
  • Males and females, 18 years of age or older, with active RA for at least 6 months prior to Day 1 dosing.
  • Patients must have been receiving weekly methotrexate doses (7.5-25 mg/week) for a minimum of 3 months prior to Day 1 dosing and must be receiving a stable MTX dose, with no change in route, for the previous 6 weeks prior to Day 1 dosing.

    `Patients must be receiving a folic or folinic acid supplementation at a stable dose for at least 6 weeks prior to Day 1 dosing.

  • Females of childbearing potential must be fully informed of the potential for R788 to adversely affect the fetus and, if sexually active, must agree to use a well established method of birth control during the study (oral contraceptive, mechanical barrier, long acting hormonal agent). These patients must not be lactating and must have a negative urine pregnancy test at the time of randomization and at each laboratory determination.
  • The patient must otherwise be in good health as determined by the Investigator on the basis of medical history, physical examination, and laboratory screening tests during the screening period. See exclusion criteria for specific exclusions.
  • In the Investigator's opinion, the patient has the ability to understand the nature of the study and any hazards of participation, and to communicate satisfactorily with the Investigator and to participate in, and to comply with, the requirements of the entire protocol.

Exclusion Criteria:

  • The patient has a history of, or a concurrent, clinically significant illness, medical condition (other than arthritis) or laboratory abnormality that, in the Investigator's opinion, could affect the conduct of the study. Specifically, excluded are patients with the following:

    1. uncontrolled or poorly controlled hypertension;
    2. other autoimmune disease (psoriatic arthritis, lupus, mixed connective disorder) or arthritis syndromes (gout, Lyme disease, Reiter's syndrome);
    3. recent (within past 2 months prior to Day 1 dosing) serious surgery or infectious disease;
    4. recent history (past 5 years prior to Day 1 dosing) of, or treatment for, a malignancy other than nonmelanomatous skin cancer, or any history of lymphoma;
    5. Hepatitis B ;
    6. Hepatitis C ;
    7. interstitial pneumonitis or active pulmonary infection on chest x-ray;
    8. Tuberculosis (TB): the TB skin test should be negative.
    9. known laboratory abnormalities.
  • The patient has a history of substance abuse, drug addiction or alcoholism. Patients may consume up to 4 units of alcohol per week; however, alcohol should be avoided in the 72 hours prior to lab assessments. Patients who cannot reliably comply with this should be excluded. A unit of alcohol is defined as the following: Beer=12 oz or 355 mL; wine = 5 oz or 148 mL; sweet dessert wine=3 oz or 89 mL; 80 proof distilled spirits= 1.5 oz or 44 mL.
  • The patient has been treated previously treated with R788 under a different protocol.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00665925


  Show 65 Study Locations
Sponsors and Collaborators
Rigel Pharmaceuticals
Investigators
Study Director: Daniel B Magilavy, MD Rigel Pharmaceuticals
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rigel Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00665925     History of Changes
Other Study ID Numbers: C-935788-010
First Posted: April 24, 2008    Key Record Dates
Results First Posted: June 13, 2016
Last Update Posted: September 16, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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