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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rigel Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00665925
First received: April 22, 2008
Last updated: June 21, 2016
Last verified: June 2016
  Purpose
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 Intervention Phase
Rheumatoid Arthritis
Drug: Fostamatinib disodium (R935788)
Drug: Placebo
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
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

Resource links provided by NLM:


Further study details as provided by Rigel Pharmaceuticals:

Primary Outcome Measures:
  • American College of Rheumatology 20 (ACR20) Response at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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:
  • American College of Rheumatology 20 (ACR20) Response at 1 Week [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    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

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

  • American College of Rheumatology 20 (ACR20) Response at 1 Month [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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

  • American College of Rheumatology 20 (ACR20) Response at 6 Weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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

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

  • American College of Rheumatology 20 (ACR20) Response at 3 Months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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

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

  • American College of Rheumatology 20 (ACR20) Response at 5 Months [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    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

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

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

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

  • American College of Rheumatology 50 (ACR50) Response at 6 Weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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

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

  • American College of Rheumatology 50 (ACR50) Response at 3 Months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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

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

  • American College of Rheumatology 50 (ACR50) Response at 5 Months [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    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

  • American College of Rheumatology 50 (ACR50) Response at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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

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

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

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

  • American College of Rheumatology 70 (ACR70) Response at 6 Weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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

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

  • American College of Rheumatology 70 (ACR70) Response at 3 Months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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

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

  • American College of Rheumatology 70 (ACR70) Response at 5 Months [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    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

  • American College of Rheumatology 70 (ACR70) Response at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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

  • American College of Rheumatology Index of Improvement (ACRn) at 1 Week [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    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

  • American College of Rheumatology Index of Improvement (ACRn) at 2 Weeks [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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

  • American College of Rheumatology Index of Improvement (ACRn) at 1 Month [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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

  • American College of Rheumatology Index of Improvement (ACRn) at 6 Weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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

  • American College of Rheumatology Index of Improvement (ACRn) at 2 Months [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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

  • American College of Rheumatology Index of Improvement (ACRn) at 3 Months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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

  • American College of Rheumatology Index of Improvement (ACRn) at 4 Months [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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

  • American College of Rheumatology Index of Improvement (ACRn) at 5 Months [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    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

  • American College of Rheumatology Index of Improvement (ACRn) at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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

  • Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 1 Month [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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

  • Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 2 Months [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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

  • Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 3 Months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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

  • Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 4 Months [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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

  • Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 5 Months [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    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

  • Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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

  • Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 1 Month [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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

  • Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 2 Months [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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

  • Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 3 Months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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

  • Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 4 Months [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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

  • Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 5 Months [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    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

  • Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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

  • Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 1 Month [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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

  • Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 2 Months [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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

  • Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 3 Months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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

  • Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 4 Months [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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

  • Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 5 Months [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    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

  • Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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

  • Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 1 Month [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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

  • Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 2 Months [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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

  • Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 3 Months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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

  • Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 4 Months [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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

  • Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 5 Months [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    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

  • Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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

  • Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at 6 Months [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    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.

  • Short Form Health Survey (SF-36) Physical Component Summary (PCS) at 6 Months [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    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

  • Short Form Health Survey (SF-36) Mental Component Summary (MCS) at 6 Months [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

  • Alkaline Phosphatase >1.5 x Upper Limit of Normal (ULN) and >1.5 Times Baseline [ Time Frame: Any time between baseline and 6 months ] [ Designated as safety issue: Yes ]
    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

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

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

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


Enrollment: 457
Study Start Date: May 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
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: 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 
Study First Received: April 22, 2008
Results First Received: May 3, 2016
Last Updated: June 21, 2016
Health Authority: United States: Food and Drug Administration
Argentina: Ministry of Health
Argentina: Human Research Bioethics Committee
Argentina: National Committee of Ethics in Science and Technology
Brazil: Ethics Committee
Brazil: Ministry of Health
Brazil: National Committee of Ethics in Research
Brazil: National Health Surveillance Agency
Bulgaria: Bulgarian Drug Agency
Colombia: Ministry of Health and Social Protection
Colombia: Ethics Committee
Hungary: National Institute of Pharmacy
Israel: Ethics Commission
Israel: Israeli Health Ministry Pharmaceutical Administration
Mexico: Ethics Committee
Mexico: Federal Commission for Protection Against Health Risks
Mexico: Federal Commission for Sanitary Risks Protection
Mexico: Ministry of Health
Peru: Ethics Committee
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Peru: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Individual Participant Data  
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

ClinicalTrials.gov processed this record on July 21, 2016