Rheumatoid Arthritis
Conditions
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.
Interventions
100 mg tablet, orally, twice-a-day
DRUGPlacebo
Placebo, orally, either once a day, or twice a day
Sponsors
Rigel Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| American College of Rheumatology 20 (ACR20) Response at 6 Months | 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
| Measure | Time frame | Description |
|---|---|---|
| American College of Rheumatology 20 (ACR20) Response at 1 Week | 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 |
| American College of Rheumatology 20 (ACR20) Response at 2 Weeks | 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 |
| American College of Rheumatology 20 (ACR20) Response at 1 Month | 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 |
| American College of Rheumatology 20 (ACR20) Response at 6 Weeks | 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 |
| American College of Rheumatology 20 (ACR20) Response at 2 Months | 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 |
| American College of Rheumatology 20 (ACR20) Response at 3 Months | 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 |
| American College of Rheumatology 20 (ACR20) Response at 4 Months | 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 |
| American College of Rheumatology 20 (ACR20) Response at 5 Months | 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 |
| American College of Rheumatology 50 (ACR50) Response at 1 Week | 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 |
| American College of Rheumatology 50 (ACR50) Response at 1 Month | 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 |
| American College of Rheumatology 50 (ACR50) Response at 6 Weeks | 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 |
| American College of Rheumatology 50 (ACR50) Response at 2 Months | 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 |
| American College of Rheumatology 50 (ACR50) Response at 3 Months | 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 |
| American College of Rheumatology 50 (ACR50) Response at 4 Months | 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 |
| American College of Rheumatology 50 (ACR50) Response at 5 Months | 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 |
| American College of Rheumatology 50 (ACR50) Response at 6 Months | 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 |
| American College of Rheumatology 70 (ACR70) Response at 1 Week | 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 |
| American College of Rheumatology 70 (ACR70) Response at 2 Weeks | 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 |
| American College of Rheumatology 70 (ACR70) Response at 1 Month | 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 |
| American College of Rheumatology 70 (ACR70) Response at 6 Weeks | 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 |
| American College of Rheumatology 70 (ACR70) Response at 2 Months | 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 |
| American College of Rheumatology 70 (ACR70) Response at 3 Months | 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 |
| American College of Rheumatology 70 (ACR70) Response at 4 Months | 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 |
| American College of Rheumatology 70 (ACR70) Response at 5 Months | 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 |
| American College of Rheumatology 70 (ACR70) Response at 6 Months | 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 |
| American College of Rheumatology Index of Improvement (ACRn) at 1 Week | 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 |
| American College of Rheumatology Index of Improvement (ACRn) at 2 Weeks | 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 |
| American College of Rheumatology Index of Improvement (ACRn) at 1 Month | 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 |
| American College of Rheumatology Index of Improvement (ACRn) at 6 Weeks | 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 |
| American College of Rheumatology Index of Improvement (ACRn) at 2 Months | 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 |
| American College of Rheumatology Index of Improvement (ACRn) at 3 Months | 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 |
| American College of Rheumatology Index of Improvement (ACRn) at 4 Months | 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 |
| American College of Rheumatology Index of Improvement (ACRn) at 5 Months | 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 |
| American College of Rheumatology Index of Improvement (ACRn) at 6 Months | 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 |
| Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 1 Month | 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 |
| Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 2 Months | 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 |
| Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 3 Months | 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 |
| Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 4 Months | 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 |
| Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 5 Months | 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 |
| Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 6 Months | 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 |
| Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 1 Month | 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 |
| Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 2 Months | 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 |
| Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 3 Months | 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 |
| Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 4 Months | 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 |
| Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 5 Months | 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 |
| Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 6 Months | 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 |
| Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 1 Month | 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 |
| Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 2 Months | 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 |
| Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 3 Months | 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 |
| Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 4 Months | 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 |
| Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 5 Months | 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 |
| Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 6 Months | 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 |
| Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 1 Month | 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 |
| Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 2 Months | 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 |
| Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 3 Months | 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 |
| Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 4 Months | 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 |
| Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 5 Months | 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 |
| Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 6 Months | 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 |
| Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at 6 Months | 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. |
| Short Form Health Survey (SF-36) Physical Component Summary (PCS) at 6 Months | 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 |
| Short Form Health Survey (SF-36) Mental Component Summary (MCS) at 6 Months | 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 |
| Alanine Aminotransferase (ALT) >1.5x Upper Limit of Normal (ULN) | 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 |
| Alanine Aminotransferase (ALT) >1.5-2x Upper Limit of Normal (ULN) | 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 |
| Alanine Aminotransferase (ALT) >2-3x Upper Limit of Normal (ULN) | 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 |
| Alanine Aminotransferase (ALT) >3x Upper Limit of Normal (ULN) | 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 |
| Alanine Aminotransferase (ALT) >3-5x Upper Limit of Normal (ULN) | 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 |
| Alanine Aminotransferase (ALT) >5-10x Upper Limit of Normal (ULN) | 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 |
| Alanine Aminotransferase (ALT) >10x Upper Limit of Normal (ULN) | 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 |
| Aspartate Aminotransferase (AST) >1.5x Upper Limit of Normal (ULN) | 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 |
| American College of Rheumatology 50 (ACR50) Response at 2 Weeks | 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 |
| Aspartate Aminotransferase (AST) >2-3x Upper Limit of Normal (ULN) | 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 |
| Aspartate Aminotransferase (AST) >3x Upper Limit of Normal (ULN) | 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 |
| Aspartate Aminotransferase (AST) >3-5x Upper Limit of Normal (ULN) | 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 |
| Aspartate Aminotransferase (AST) >5-10 x Upper Limit of Normal (ULN) | 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 |
| Aspartate Aminotransferase (AST) >10 x Upper Limit of Normal (ULN) | 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 |
| Alkaline Phosphatase >1.5 x Upper Limit of Normal (ULN) and >1.5 Times Baseline | 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 |
| Bilirubin >1.5 x Upper Limit of Normal (ULN) | 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 |
| Bilirubin >2 x Upper Limit of Normal (ULN) | 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 |
| Absolute Neutrophil Count (ANC) <1500/mm3 | Any time between baseline and 6 months | The number of participants with ANC (a test of liver function) values lower than 1500/mm3 |
| Aspartate Aminotransferase (AST) >1.5-2x Upper Limit of Normal (ULN) | 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 |
Countries
Bulgaria, Colombia, Mexico, Poland, Romania, United States
Participant flow
Recruitment details
The first participant received the first dose of study drug on 19 May 2008; the last participant completed the study on 01 June 2009. Participants were recruited from centers in the United States, Europe and Latin America.
Pre-assignment details
Male/female participants who had active rheumatoid arthritis (RA) for a minimum of 6 months, and receiving a weekly methotrexate (MTX) dose for a minimum of 3 months were randomly assigned to receive R788 150 mg once daily, 100 mg twice daily, placebo once daily or placebo twice daily. It was planned to randomize approximately 420 participants.
Participants by arm
| Arm | Count |
|---|---|
| Placebo qd Placebo to R788, oral tablets, once daily, double-blind | 77 |
| Placebo Bid Placebo to R788, oral tablets, twice daily, double-blind | 76 |
| R788 150 mg qd R788 150 mg, oral tablets, once daily, double-blind | 152 |
| R788 100 mg Bid R788 100 mg, oral tablets, twice daily, double-blind | 152 |
| Total | 457 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 5 | 10 | 5 |
| Overall Study | Due to exclusion criteria | 1 | 0 | 0 | 0 |
| Overall Study | Enrolled by mistake | 0 | 0 | 0 | 1 |
| Overall Study | Lack of Efficacy | 10 | 8 | 9 | 8 |
| Overall Study | Lost to Follow-up | 1 | 2 | 2 | 2 |
| Overall Study | Physician Decision | 0 | 0 | 1 | 2 |
| Overall Study | Severe Non-Compliance to Protocol | 0 | 0 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 2 | 3 | 2 |
Baseline characteristics
| Characteristic | Placebo qd | Placebo Bid | R788 150 mg qd | R788 100 mg Bid | Total |
|---|---|---|---|---|---|
| Age, Continuous | 51.3 Years STANDARD_DEVIATION 13.68 | 53.4 Years STANDARD_DEVIATION 12.66 | 52.6 Years STANDARD_DEVIATION 12.31 | 52.5 Years STANDARD_DEVIATION 12.97 | 52.5 Years STANDARD_DEVIATION 12.8 |
| Sex: Female, Male Female | 67 Participants | 64 Participants | 128 Participants | 131 Participants | 390 Participants |
| Sex: Female, Male Male | 10 Participants | 12 Participants | 24 Participants | 21 Participants | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 26 / 77 | 20 / 76 | 62 / 152 | 73 / 152 |
| serious Total, serious adverse events | 2 / 77 | 4 / 76 | 5 / 152 | 1 / 152 |
Outcome results
Primary
American College of Rheumatology 20 (ACR20) Response at 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
Time frame: 6 months
Population: Intent-to-treat population includes all subjects that received study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | American College of Rheumatology 20 (ACR20) Response at 6 Months | 53 Participants |
| Arm 4 - R788 150 mg qd | American College of Rheumatology 20 (ACR20) Response at 6 Months | 87 Participants |
| Arm 5 - R788 100 mg Bid | American College of Rheumatology 20 (ACR20) Response at 6 Months | 101 Participants |
Secondary
Absolute Neutrophil Count (ANC) <1500/mm3
The number of participants with ANC (a test of liver function) values lower than 1500/mm3
Time frame: Any time between baseline and 6 months
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1 - Placebo qd | Absolute Neutrophil Count (ANC) <1500/mm3 | 1 Participants |
| Arm 2 - Placebo Bid | Absolute Neutrophil Count (ANC) <1500/mm3 | 0 Participants |
| Arm 4 - R788 150 mg qd | Absolute Neutrophil Count (ANC) <1500/mm3 | 10 Participants |
| Arm 5 - R788 100 mg Bid | Absolute Neutrophil Count (ANC) <1500/mm3 | 9 Participants |
Secondary
Alanine Aminotransferase (ALT) >10x Upper Limit of Normal (ULN)
The number of participants with ALT (a test of liver function) values greater than 10 times the ULN
Time frame: Any time between baseline and 6 months
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1 - Placebo qd | Alanine Aminotransferase (ALT) >10x Upper Limit of Normal (ULN) | 0 Participants |
| Arm 2 - Placebo Bid | Alanine Aminotransferase (ALT) >10x Upper Limit of Normal (ULN) | 0 Participants |
| Arm 4 - R788 150 mg qd | Alanine Aminotransferase (ALT) >10x Upper Limit of Normal (ULN) | 0 Participants |
| Arm 5 - R788 100 mg Bid | Alanine Aminotransferase (ALT) >10x Upper Limit of Normal (ULN) | 0 Participants |
Secondary
Alanine Aminotransferase (ALT) >1.5-2x Upper Limit of Normal (ULN)
The number of participants with ALT (a test of liver function) values greater than 1.5 to 2 times the ULN
Time frame: Any time between baseline and 6 months
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1 - Placebo qd | Alanine Aminotransferase (ALT) >1.5-2x Upper Limit of Normal (ULN) | 1 Participants |
| Arm 2 - Placebo Bid | Alanine Aminotransferase (ALT) >1.5-2x Upper Limit of Normal (ULN) | 5 Participants |
| Arm 4 - R788 150 mg qd | Alanine Aminotransferase (ALT) >1.5-2x Upper Limit of Normal (ULN) | 14 Participants |
| Arm 5 - R788 100 mg Bid | Alanine Aminotransferase (ALT) >1.5-2x Upper Limit of Normal (ULN) | 15 Participants |
Secondary
Alanine Aminotransferase (ALT) >1.5x Upper Limit of Normal (ULN)
The number of participants with ALT (a test of liver function) values greater than 1.5 times the ULN
Time frame: Any time between baseline and 6 months
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1 - Placebo qd | Alanine Aminotransferase (ALT) >1.5x Upper Limit of Normal (ULN) | 3 Participants |
| Arm 2 - Placebo Bid | Alanine Aminotransferase (ALT) >1.5x Upper Limit of Normal (ULN) | 11 Participants |
| Arm 4 - R788 150 mg qd | Alanine Aminotransferase (ALT) >1.5x Upper Limit of Normal (ULN) | 28 Participants |
| Arm 5 - R788 100 mg Bid | Alanine Aminotransferase (ALT) >1.5x Upper Limit of Normal (ULN) | 31 Participants |
Secondary
Alanine Aminotransferase (ALT) >2-3x Upper Limit of Normal (ULN)
The number of participants with ALT (a test of liver function) values greater than 2 to 3 times the ULN
Time frame: Any time between baseline and 6 months
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1 - Placebo qd | Alanine Aminotransferase (ALT) >2-3x Upper Limit of Normal (ULN) | 1 Participants |
| Arm 2 - Placebo Bid | Alanine Aminotransferase (ALT) >2-3x Upper Limit of Normal (ULN) | 4 Participants |
| Arm 4 - R788 150 mg qd | Alanine Aminotransferase (ALT) >2-3x Upper Limit of Normal (ULN) | 8 Participants |
| Arm 5 - R788 100 mg Bid | Alanine Aminotransferase (ALT) >2-3x Upper Limit of Normal (ULN) | 10 Participants |
Secondary
Alanine Aminotransferase (ALT) >3-5x Upper Limit of Normal (ULN)
The number of participants with ALT (a test of liver function) values greater than 3 to 5 times the ULN
Time frame: Any time between baseline and 6 months
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1 - Placebo qd | Alanine Aminotransferase (ALT) >3-5x Upper Limit of Normal (ULN) | 1 Participants |
| Arm 2 - Placebo Bid | Alanine Aminotransferase (ALT) >3-5x Upper Limit of Normal (ULN) | 1 Participants |
| Arm 4 - R788 150 mg qd | Alanine Aminotransferase (ALT) >3-5x Upper Limit of Normal (ULN) | 3 Participants |
| Arm 5 - R788 100 mg Bid | Alanine Aminotransferase (ALT) >3-5x Upper Limit of Normal (ULN) | 3 Participants |
Secondary
Alanine Aminotransferase (ALT) >3x Upper Limit of Normal (ULN)
The number of participants with ALT (a test of liver function) values greater than 3 times the ULN
Time frame: Any time between baseline and 6 months
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1 - Placebo qd | Alanine Aminotransferase (ALT) >3x Upper Limit of Normal (ULN) | 1 Participants |
| Arm 2 - Placebo Bid | Alanine Aminotransferase (ALT) >3x Upper Limit of Normal (ULN) | 2 Participants |
| Arm 4 - R788 150 mg qd | Alanine Aminotransferase (ALT) >3x Upper Limit of Normal (ULN) | 6 Participants |
| Arm 5 - R788 100 mg Bid | Alanine Aminotransferase (ALT) >3x Upper Limit of Normal (ULN) | 6 Participants |
Secondary
Alanine Aminotransferase (ALT) >5-10x Upper Limit of Normal (ULN)
The number of participants with ALT (a test of liver function) values greater than 5 to 10 times the ULN
Time frame: Any time between baseline and 6 months
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1 - Placebo qd | Alanine Aminotransferase (ALT) >5-10x Upper Limit of Normal (ULN) | 0 Participants |
| Arm 2 - Placebo Bid | Alanine Aminotransferase (ALT) >5-10x Upper Limit of Normal (ULN) | 1 Participants |
| Arm 4 - R788 150 mg qd | Alanine Aminotransferase (ALT) >5-10x Upper Limit of Normal (ULN) | 3 Participants |
| Arm 5 - R788 100 mg Bid | Alanine Aminotransferase (ALT) >5-10x Upper Limit of Normal (ULN) | 3 Participants |
Secondary
Alkaline Phosphatase >1.5 x Upper Limit of Normal (ULN) and >1.5 Times Baseline
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
Time frame: Any time between baseline and 6 months
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1 - Placebo qd | Alkaline Phosphatase >1.5 x Upper Limit of Normal (ULN) and >1.5 Times Baseline | 0 Participants |
| Arm 2 - Placebo Bid | Alkaline Phosphatase >1.5 x Upper Limit of Normal (ULN) and >1.5 Times Baseline | 1 Participants |
| Arm 4 - R788 150 mg qd | Alkaline Phosphatase >1.5 x Upper Limit of Normal (ULN) and >1.5 Times Baseline | 1 Participants |
| Arm 5 - R788 100 mg Bid | Alkaline Phosphatase >1.5 x Upper Limit of Normal (ULN) and >1.5 Times Baseline | 6 Participants |
Secondary
American College of Rheumatology 20 (ACR20) Response at 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
Time frame: 1 month
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | American College of Rheumatology 20 (ACR20) Response at 1 Month | 48 Participants |
| Arm 4 - R788 150 mg qd | American College of Rheumatology 20 (ACR20) Response at 1 Month | 72 Participants |
| Arm 5 - R788 100 mg Bid | American College of Rheumatology 20 (ACR20) Response at 1 Month | 89 Participants |
Secondary
American College of Rheumatology 20 (ACR20) Response at 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
Time frame: 1 week
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | American College of Rheumatology 20 (ACR20) Response at 1 Week | 21 Participants |
| Arm 4 - R788 150 mg qd | American College of Rheumatology 20 (ACR20) Response at 1 Week | 34 Participants |
| Arm 5 - R788 100 mg Bid | American College of Rheumatology 20 (ACR20) Response at 1 Week | 53 Participants |
Secondary
American College of Rheumatology 20 (ACR20) Response at 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
Time frame: 2 months
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | American College of Rheumatology 20 (ACR20) Response at 2 Months | 58 Participants |
| Arm 4 - R788 150 mg qd | American College of Rheumatology 20 (ACR20) Response at 2 Months | 81 Participants |
| Arm 5 - R788 100 mg Bid | American College of Rheumatology 20 (ACR20) Response at 2 Months | 95 Participants |
Secondary
American College of Rheumatology 20 (ACR20) Response at 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
Time frame: 2 weeks
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | American College of Rheumatology 20 (ACR20) Response at 2 Weeks | 29 Participants |
| Arm 4 - R788 150 mg qd | American College of Rheumatology 20 (ACR20) Response at 2 Weeks | 47 Participants |
| Arm 5 - R788 100 mg Bid | American College of Rheumatology 20 (ACR20) Response at 2 Weeks | 67 Participants |
Secondary
American College of Rheumatology 20 (ACR20) Response at 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
Time frame: 3 months
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | American College of Rheumatology 20 (ACR20) Response at 3 Months | 64 Participants |
| Arm 4 - R788 150 mg qd | American College of Rheumatology 20 (ACR20) Response at 3 Months | 79 Participants |
| Arm 5 - R788 100 mg Bid | American College of Rheumatology 20 (ACR20) Response at 3 Months | 97 Participants |
Secondary
American College of Rheumatology 20 (ACR20) Response at 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
Time frame: 4 months
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | American College of Rheumatology 20 (ACR20) Response at 4 Months | 57 Participants |
| Arm 4 - R788 150 mg qd | American College of Rheumatology 20 (ACR20) Response at 4 Months | 71 Participants |
| Arm 5 - R788 100 mg Bid | American College of Rheumatology 20 (ACR20) Response at 4 Months | 100 Participants |
Secondary
American College of Rheumatology 20 (ACR20) Response at 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
Time frame: 5 months
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | American College of Rheumatology 20 (ACR20) Response at 5 Months | 61 Participants |
| Arm 4 - R788 150 mg qd | American College of Rheumatology 20 (ACR20) Response at 5 Months | 84 Participants |
| Arm 5 - R788 100 mg Bid | American College of Rheumatology 20 (ACR20) Response at 5 Months | 97 Participants |
Secondary
American College of Rheumatology 20 (ACR20) Response at 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
Time frame: 6 weeks
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | American College of Rheumatology 20 (ACR20) Response at 6 Weeks | 55 Participants |
| Arm 4 - R788 150 mg qd | American College of Rheumatology 20 (ACR20) Response at 6 Weeks | 75 Participants |
| Arm 5 - R788 100 mg Bid | American College of Rheumatology 20 (ACR20) Response at 6 Weeks | 84 Participants |
Secondary
American College of Rheumatology 50 (ACR50) Response at 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
Time frame: 1 month
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | American College of Rheumatology 50 (ACR50) Response at 1 Month | 11 Participants |
| Arm 4 - R788 150 mg qd | American College of Rheumatology 50 (ACR50) Response at 1 Month | 24 Participants |
| Arm 5 - R788 100 mg Bid | American College of Rheumatology 50 (ACR50) Response at 1 Month | 45 Participants |
Secondary
American College of Rheumatology 50 (ACR50) Response at 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
Time frame: 1 week
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | American College of Rheumatology 50 (ACR50) Response at 1 Week | 4 Participants |
| Arm 4 - R788 150 mg qd | American College of Rheumatology 50 (ACR50) Response at 1 Week | 7 Participants |
| Arm 5 - R788 100 mg Bid | American College of Rheumatology 50 (ACR50) Response at 1 Week | 10 Participants |
Secondary
American College of Rheumatology 50 (ACR50) Response at 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
Time frame: 2 months
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | American College of Rheumatology 50 (ACR50) Response at 2 Months | 22 Participants |
| Arm 4 - R788 150 mg qd | American College of Rheumatology 50 (ACR50) Response at 2 Months | 34 Participants |
| Arm 5 - R788 100 mg Bid | American College of Rheumatology 50 (ACR50) Response at 2 Months | 51 Participants |
Secondary
American College of Rheumatology 50 (ACR50) Response at 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
Time frame: 2 weeks
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | American College of Rheumatology 50 (ACR50) Response at 2 Weeks | 7 Participants |
| Arm 4 - R788 150 mg qd | American College of Rheumatology 50 (ACR50) Response at 2 Weeks | 15 Participants |
| Arm 5 - R788 100 mg Bid | American College of Rheumatology 50 (ACR50) Response at 2 Weeks | 21 Participants |
Secondary
American College of Rheumatology 50 (ACR50) Response at 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
Time frame: 3 months
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | American College of Rheumatology 50 (ACR50) Response at 3 Months | 23 Participants |
| Arm 4 - R788 150 mg qd | American College of Rheumatology 50 (ACR50) Response at 3 Months | 43 Participants |
| Arm 5 - R788 100 mg Bid | American College of Rheumatology 50 (ACR50) Response at 3 Months | 58 Participants |
Secondary
American College of Rheumatology 50 (ACR50) Response at 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
Time frame: 4 months
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | American College of Rheumatology 50 (ACR50) Response at 4 Months | 25 Participants |
| Arm 4 - R788 150 mg qd | American College of Rheumatology 50 (ACR50) Response at 4 Months | 34 Participants |
| Arm 5 - R788 100 mg Bid | American College of Rheumatology 50 (ACR50) Response at 4 Months | 62 Participants |
Secondary
American College of Rheumatology 50 (ACR50) Response at 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
Time frame: 5 months
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | American College of Rheumatology 50 (ACR50) Response at 5 Months | 25 Participants |
| Arm 4 - R788 150 mg qd | American College of Rheumatology 50 (ACR50) Response at 5 Months | 41 Participants |
| Arm 5 - R788 100 mg Bid | American College of Rheumatology 50 (ACR50) Response at 5 Months | 62 Participants |
Secondary
American College of Rheumatology 50 (ACR50) Response at 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
Time frame: 6 months
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | American College of Rheumatology 50 (ACR50) Response at 6 Months | 29 Participants |
| Arm 4 - R788 150 mg qd | American College of Rheumatology 50 (ACR50) Response at 6 Months | 49 Participants |
| Arm 5 - R788 100 mg Bid | American College of Rheumatology 50 (ACR50) Response at 6 Months | 65 Participants |
Secondary
American College of Rheumatology 50 (ACR50) Response at 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
Time frame: 6 weeks
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | American College of Rheumatology 50 (ACR50) Response at 6 Weeks | 19 Participants |
| Arm 4 - R788 150 mg qd | American College of Rheumatology 50 (ACR50) Response at 6 Weeks | 30 Participants |
| Arm 5 - R788 100 mg Bid | American College of Rheumatology 50 (ACR50) Response at 6 Weeks | 43 Participants |
Secondary
American College of Rheumatology 70 (ACR70) Response at 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
Time frame: 1 month
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | American College of Rheumatology 70 (ACR70) Response at 1 Month | 7 Participants |
| Arm 4 - R788 150 mg qd | American College of Rheumatology 70 (ACR70) Response at 1 Month | 13 Participants |
| Arm 5 - R788 100 mg Bid | American College of Rheumatology 70 (ACR70) Response at 1 Month | 14 Participants |
Secondary
American College of Rheumatology 70 (ACR70) Response at 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
Time frame: 1 week
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | American College of Rheumatology 70 (ACR70) Response at 1 Week | 1 Participants |
| Arm 4 - R788 150 mg qd | American College of Rheumatology 70 (ACR70) Response at 1 Week | 1 Participants |
| Arm 5 - R788 100 mg Bid | American College of Rheumatology 70 (ACR70) Response at 1 Week | 2 Participants |
Secondary
American College of Rheumatology 70 (ACR70) Response at 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
Time frame: 2 months
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | American College of Rheumatology 70 (ACR70) Response at 2 Months | 4 Participants |
| Arm 4 - R788 150 mg qd | American College of Rheumatology 70 (ACR70) Response at 2 Months | 15 Participants |
| Arm 5 - R788 100 mg Bid | American College of Rheumatology 70 (ACR70) Response at 2 Months | 20 Participants |
Secondary
American College of Rheumatology 70 (ACR70) Response at 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
Time frame: 2 weeks
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | American College of Rheumatology 70 (ACR70) Response at 2 Weeks | 1 Participants |
| Arm 4 - R788 150 mg qd | American College of Rheumatology 70 (ACR70) Response at 2 Weeks | 5 Participants |
| Arm 5 - R788 100 mg Bid | American College of Rheumatology 70 (ACR70) Response at 2 Weeks | 7 Participants |
Secondary
American College of Rheumatology 70 (ACR70) Response at 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
Time frame: 3 months
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | American College of Rheumatology 70 (ACR70) Response at 3 Months | 10 Participants |
| Arm 4 - R788 150 mg qd | American College of Rheumatology 70 (ACR70) Response at 3 Months | 19 Participants |
| Arm 5 - R788 100 mg Bid | American College of Rheumatology 70 (ACR70) Response at 3 Months | 30 Participants |
Secondary
American College of Rheumatology 70 (ACR70) Response at 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
Time frame: 4 months
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | American College of Rheumatology 70 (ACR70) Response at 4 Months | 8 Participants |
| Arm 4 - R788 150 mg qd | American College of Rheumatology 70 (ACR70) Response at 4 Months | 17 Participants |
| Arm 5 - R788 100 mg Bid | American College of Rheumatology 70 (ACR70) Response at 4 Months | 32 Participants |
Secondary
American College of Rheumatology 70 (ACR70) Response at 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
Time frame: 5 months
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | American College of Rheumatology 70 (ACR70) Response at 5 Months | 8 Participants |
| Arm 4 - R788 150 mg qd | American College of Rheumatology 70 (ACR70) Response at 5 Months | 20 Participants |
| Arm 5 - R788 100 mg Bid | American College of Rheumatology 70 (ACR70) Response at 5 Months | 33 Participants |
Secondary
American College of Rheumatology 70 (ACR70) Response at 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
Time frame: 6 months
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | American College of Rheumatology 70 (ACR70) Response at 6 Months | 16 Participants |
| Arm 4 - R788 150 mg qd | American College of Rheumatology 70 (ACR70) Response at 6 Months | 21 Participants |
| Arm 5 - R788 100 mg Bid | American College of Rheumatology 70 (ACR70) Response at 6 Months | 43 Participants |
Secondary
American College of Rheumatology 70 (ACR70) Response at 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
Time frame: 6 weeks
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | American College of Rheumatology 70 (ACR70) Response at 6 Weeks | 5 Participants |
| Arm 4 - R788 150 mg qd | American College of Rheumatology 70 (ACR70) Response at 6 Weeks | 13 Participants |
| Arm 5 - R788 100 mg Bid | American College of Rheumatology 70 (ACR70) Response at 6 Weeks | 16 Participants |
Secondary
American College of Rheumatology Index of Improvement (ACRn) at 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
Time frame: 1 month
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 3 - Placebo Pooled | American College of Rheumatology Index of Improvement (ACRn) at 1 Month | 14.65 Score | Standard Deviation 20.537 |
| Arm 4 - R788 150 mg qd | American College of Rheumatology Index of Improvement (ACRn) at 1 Month | 24.14 Score | Standard Deviation 25.428 |
| Arm 5 - R788 100 mg Bid | American College of Rheumatology Index of Improvement (ACRn) at 1 Month | 32.23 Score | Standard Deviation 26.304 |
Secondary
American College of Rheumatology Index of Improvement (ACRn) at 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
Time frame: 1 week
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 3 - Placebo Pooled | American College of Rheumatology Index of Improvement (ACRn) at 1 Week | 7.07 Score | Standard Deviation 13.677 |
| Arm 4 - R788 150 mg qd | American College of Rheumatology Index of Improvement (ACRn) at 1 Week | 10.75 Score | Standard Deviation 15.788 |
| Arm 5 - R788 100 mg Bid | American College of Rheumatology Index of Improvement (ACRn) at 1 Week | 16.22 Score | Standard Deviation 19.564 |
Secondary
American College of Rheumatology Index of Improvement (ACRn) at 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
Time frame: 2 months
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 3 - Placebo Pooled | American College of Rheumatology Index of Improvement (ACRn) at 2 Months | 20.12 Score | Standard Deviation 23.179 |
| Arm 4 - R788 150 mg qd | American College of Rheumatology Index of Improvement (ACRn) at 2 Months | 29.11 Score | Standard Deviation 26.827 |
| Arm 5 - R788 100 mg Bid | American College of Rheumatology Index of Improvement (ACRn) at 2 Months | 36.73 Score | Standard Deviation 28.254 |
Secondary
American College of Rheumatology Index of Improvement (ACRn) at 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
Time frame: 2 weeks
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 3 - Placebo Pooled | American College of Rheumatology Index of Improvement (ACRn) at 2 Weeks | 9.74 Score | Standard Deviation 16.987 |
| Arm 4 - R788 150 mg qd | American College of Rheumatology Index of Improvement (ACRn) at 2 Weeks | 16.27 Score | Standard Deviation 20.899 |
| Arm 5 - R788 100 mg Bid | American College of Rheumatology Index of Improvement (ACRn) at 2 Weeks | 21.62 Score | Standard Deviation 23.491 |
Secondary
American College of Rheumatology Index of Improvement (ACRn) at 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
Time frame: 3 months
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 3 - Placebo Pooled | American College of Rheumatology Index of Improvement (ACRn) at 3 Months | 22.11 Score | Standard Deviation 25.904 |
| Arm 4 - R788 150 mg qd | American College of Rheumatology Index of Improvement (ACRn) at 3 Months | 31.79 Score | Standard Deviation 27.959 |
| Arm 5 - R788 100 mg Bid | American College of Rheumatology Index of Improvement (ACRn) at 3 Months | 39.04 Score | Standard Deviation 30.059 |
Secondary
American College of Rheumatology Index of Improvement (ACRn) at 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
Time frame: 4 months
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 3 - Placebo Pooled | American College of Rheumatology Index of Improvement (ACRn) at 4 Months | 22.61 Score | Standard Deviation 25.661 |
| Arm 4 - R788 150 mg qd | American College of Rheumatology Index of Improvement (ACRn) at 4 Months | 30.24 Score | Standard Deviation 28.347 |
| Arm 5 - R788 100 mg Bid | American College of Rheumatology Index of Improvement (ACRn) at 4 Months | 44.70 Score | Standard Deviation 29.729 |
Secondary
American College of Rheumatology Index of Improvement (ACRn) at 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
Time frame: 5 months
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 3 - Placebo Pooled | American College of Rheumatology Index of Improvement (ACRn) at 5 Months | 25.66 Score | Standard Deviation 25.734 |
| Arm 4 - R788 150 mg qd | American College of Rheumatology Index of Improvement (ACRn) at 5 Months | 35.35 Score | Standard Deviation 27.683 |
| Arm 5 - R788 100 mg Bid | American College of Rheumatology Index of Improvement (ACRn) at 5 Months | 44.76 Score | Standard Deviation 29.972 |
Secondary
American College of Rheumatology Index of Improvement (ACRn) at 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
Time frame: 6 months
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 3 - Placebo Pooled | American College of Rheumatology Index of Improvement (ACRn) at 6 Months | 26.00 Score | Standard Deviation 29.402 |
| Arm 4 - R788 150 mg qd | American College of Rheumatology Index of Improvement (ACRn) at 6 Months | 38.45 Score | Standard Deviation 29.108 |
| Arm 5 - R788 100 mg Bid | American College of Rheumatology Index of Improvement (ACRn) at 6 Months | 49.55 Score | Standard Deviation 30.189 |
Secondary
American College of Rheumatology Index of Improvement (ACRn) at 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
Time frame: 6 weeks
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 3 - Placebo Pooled | American College of Rheumatology Index of Improvement (ACRn) at 6 Weeks | 18.05 Score | Standard Deviation 22.904 |
| Arm 4 - R788 150 mg qd | American College of Rheumatology Index of Improvement (ACRn) at 6 Weeks | 26.87 Score | Standard Deviation 26.893 |
| Arm 5 - R788 100 mg Bid | American College of Rheumatology Index of Improvement (ACRn) at 6 Weeks | 31.08 Score | Standard Deviation 27.789 |
Secondary
Aspartate Aminotransferase (AST) >10 x Upper Limit of Normal (ULN)
The number of participants with AST (a test of liver function) values greater than 10 times the ULN
Time frame: Any time between baseline and 6 months
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1 - Placebo qd | Aspartate Aminotransferase (AST) >10 x Upper Limit of Normal (ULN) | 0 Participants |
| Arm 2 - Placebo Bid | Aspartate Aminotransferase (AST) >10 x Upper Limit of Normal (ULN) | 0 Participants |
| Arm 4 - R788 150 mg qd | Aspartate Aminotransferase (AST) >10 x Upper Limit of Normal (ULN) | 0 Participants |
| Arm 5 - R788 100 mg Bid | Aspartate Aminotransferase (AST) >10 x Upper Limit of Normal (ULN) | 0 Participants |
Secondary
Aspartate Aminotransferase (AST) >1.5-2x Upper Limit of Normal (ULN)
The number of participants with AST (a test of liver function) values greater than 1.5-2 times the ULN
Time frame: Any time between baseline and 6 months
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1 - Placebo qd | Aspartate Aminotransferase (AST) >1.5-2x Upper Limit of Normal (ULN) | 0 Participants |
| Arm 2 - Placebo Bid | Aspartate Aminotransferase (AST) >1.5-2x Upper Limit of Normal (ULN) | 1 Participants |
| Arm 4 - R788 150 mg qd | Aspartate Aminotransferase (AST) >1.5-2x Upper Limit of Normal (ULN) | 13 Participants |
| Arm 5 - R788 100 mg Bid | Aspartate Aminotransferase (AST) >1.5-2x Upper Limit of Normal (ULN) | 5 Participants |
Secondary
Aspartate Aminotransferase (AST) >1.5x Upper Limit of Normal (ULN)
The number of participants with AST (a test of liver function) values greater than 1.5 times the ULN
Time frame: Any time between baseline and 6 months
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1 - Placebo qd | Aspartate Aminotransferase (AST) >1.5x Upper Limit of Normal (ULN) | 1 Participants |
| Arm 2 - Placebo Bid | Aspartate Aminotransferase (AST) >1.5x Upper Limit of Normal (ULN) | 4 Participants |
| Arm 4 - R788 150 mg qd | Aspartate Aminotransferase (AST) >1.5x Upper Limit of Normal (ULN) | 19 Participants |
| Arm 5 - R788 100 mg Bid | Aspartate Aminotransferase (AST) >1.5x Upper Limit of Normal (ULN) | 11 Participants |
Secondary
Aspartate Aminotransferase (AST) >2-3x Upper Limit of Normal (ULN)
The number of participants with AST (a test of liver function) values greater than 2 to 3 times the ULN
Time frame: Any time between baseline and 6 months
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1 - Placebo qd | Aspartate Aminotransferase (AST) >2-3x Upper Limit of Normal (ULN) | 0 Participants |
| Arm 2 - Placebo Bid | Aspartate Aminotransferase (AST) >2-3x Upper Limit of Normal (ULN) | 2 Participants |
| Arm 4 - R788 150 mg qd | Aspartate Aminotransferase (AST) >2-3x Upper Limit of Normal (ULN) | 4 Participants |
| Arm 5 - R788 100 mg Bid | Aspartate Aminotransferase (AST) >2-3x Upper Limit of Normal (ULN) | 1 Participants |
Secondary
Aspartate Aminotransferase (AST) >3-5x Upper Limit of Normal (ULN)
The number of participants with AST (a test of liver function) values greater than 3 to 5 times the ULN
Time frame: Any time between baseline and 6 months
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1 - Placebo qd | Aspartate Aminotransferase (AST) >3-5x Upper Limit of Normal (ULN) | 0 Participants |
| Arm 2 - Placebo Bid | Aspartate Aminotransferase (AST) >3-5x Upper Limit of Normal (ULN) | 1 Participants |
| Arm 4 - R788 150 mg qd | Aspartate Aminotransferase (AST) >3-5x Upper Limit of Normal (ULN) | 2 Participants |
| Arm 5 - R788 100 mg Bid | Aspartate Aminotransferase (AST) >3-5x Upper Limit of Normal (ULN) | 5 Participants |
Secondary
Aspartate Aminotransferase (AST) >3x Upper Limit of Normal (ULN)
The number of participants with AST (a test of liver function) values greater than 3 times the ULN
Time frame: Any time between baseline and 6 months
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1 - Placebo qd | Aspartate Aminotransferase (AST) >3x Upper Limit of Normal (ULN) | 1 Participants |
| Arm 2 - Placebo Bid | Aspartate Aminotransferase (AST) >3x Upper Limit of Normal (ULN) | 1 Participants |
| Arm 4 - R788 150 mg qd | Aspartate Aminotransferase (AST) >3x Upper Limit of Normal (ULN) | 2 Participants |
| Arm 5 - R788 100 mg Bid | Aspartate Aminotransferase (AST) >3x Upper Limit of Normal (ULN) | 5 Participants |
Secondary
Aspartate Aminotransferase (AST) >5-10 x Upper Limit of Normal (ULN)
The number of participants with AST (a test of liver function) values greater than 5 to 10 times the ULN
Time frame: Any time between baseline and 6 months
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1 - Placebo qd | Aspartate Aminotransferase (AST) >5-10 x Upper Limit of Normal (ULN) | 1 Participants |
| Arm 2 - Placebo Bid | Aspartate Aminotransferase (AST) >5-10 x Upper Limit of Normal (ULN) | 0 Participants |
| Arm 4 - R788 150 mg qd | Aspartate Aminotransferase (AST) >5-10 x Upper Limit of Normal (ULN) | 0 Participants |
| Arm 5 - R788 100 mg Bid | Aspartate Aminotransferase (AST) >5-10 x Upper Limit of Normal (ULN) | 0 Participants |
Secondary
Bilirubin >1.5 x Upper Limit of Normal (ULN)
The number of participants with bilirubin (a test of liver function) values greater than 1.5 times the ULN
Time frame: Any time between baseline and 6 months
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1 - Placebo qd | Bilirubin >1.5 x Upper Limit of Normal (ULN) | 0 Participants |
| Arm 2 - Placebo Bid | Bilirubin >1.5 x Upper Limit of Normal (ULN) | 2 Participants |
| Arm 4 - R788 150 mg qd | Bilirubin >1.5 x Upper Limit of Normal (ULN) | 4 Participants |
| Arm 5 - R788 100 mg Bid | Bilirubin >1.5 x Upper Limit of Normal (ULN) | 4 Participants |
Secondary
Bilirubin >2 x Upper Limit of Normal (ULN)
The number of participants with bilirubin (a test of liver function) values greater than 2 times the ULN
Time frame: Any time between baseline and 6 months
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1 - Placebo qd | Bilirubin >2 x Upper Limit of Normal (ULN) | 0 Participants |
| Arm 2 - Placebo Bid | Bilirubin >2 x Upper Limit of Normal (ULN) | 0 Participants |
| Arm 4 - R788 150 mg qd | Bilirubin >2 x Upper Limit of Normal (ULN) | 0 Participants |
| Arm 5 - R788 100 mg Bid | Bilirubin >2 x Upper Limit of Normal (ULN) | 3 Participants |
Secondary
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 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
Time frame: 1 month
Population: Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 1 Month | 2 Participants |
| Arm 4 - R788 150 mg qd | Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 1 Month | 10 Participants |
| Arm 5 - R788 100 mg Bid | Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 1 Month | 4 Participants |
Secondary
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 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
Time frame: 2 months
Population: Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 2 Months | 3 Participants |
| Arm 4 - R788 150 mg qd | Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 2 Months | 8 Participants |
| Arm 5 - R788 100 mg Bid | Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 2 Months | 8 Participants |
Secondary
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 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
Time frame: 3 months
Population: Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 3 Months | 5 Participants |
| Arm 4 - R788 150 mg qd | Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 3 Months | 7 Participants |
| Arm 5 - R788 100 mg Bid | Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 3 Months | 11 Participants |
Secondary
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 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
Time frame: 4 months
Population: Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 4 Months | 4 Participants |
| Arm 4 - R788 150 mg qd | Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 4 Months | 10 Participants |
| Arm 5 - R788 100 mg Bid | Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 4 Months | 15 Participants |
Secondary
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 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
Time frame: 5 months
Population: Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 5 Months | 5 Participants |
| Arm 4 - R788 150 mg qd | Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 5 Months | 8 Participants |
| Arm 5 - R788 100 mg Bid | Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 5 Months | 24 Participants |
Secondary
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 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
Time frame: 6 months
Population: Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 6 Months | 6 Participants |
| Arm 4 - R788 150 mg qd | Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 6 Months | 17 Participants |
| Arm 5 - R788 100 mg Bid | Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 6 Months | 20 Participants |
Secondary
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 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
Time frame: 1 month
Population: Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 1 Month | 6 Participants |
| Arm 4 - R788 150 mg qd | Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 1 Month | 15 Participants |
| Arm 5 - R788 100 mg Bid | Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 1 Month | 15 Participants |
Secondary
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 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
Time frame: 2 months
Population: Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 2 Months | 9 Participants |
| Arm 4 - R788 150 mg qd | Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 2 Months | 19 Participants |
| Arm 5 - R788 100 mg Bid | Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 2 Months | 21 Participants |
Secondary
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 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
Time frame: 3 months
Population: Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 3 Months | 8 Participants |
| Arm 4 - R788 150 mg qd | Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 3 Months | 25 Participants |
| Arm 5 - R788 100 mg Bid | Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 3 Months | 21 Participants |
Secondary
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 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
Time frame: 4 months
Population: Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 4 Months | 9 Participants |
| Arm 4 - R788 150 mg qd | Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 4 Months | 20 Participants |
| Arm 5 - R788 100 mg Bid | Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 4 Months | 28 Participants |
Secondary
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 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
Time frame: 5 months
Population: Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 5 Months | 8 Participants |
| Arm 4 - R788 150 mg qd | Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 5 Months | 21 Participants |
| Arm 5 - R788 100 mg Bid | Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 5 Months | 34 Participants |
Secondary
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 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
Time frame: 6 months
Population: Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 6 Months | 7 Participants |
| Arm 4 - R788 150 mg qd | Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 6 Months | 26 Participants |
| Arm 5 - R788 100 mg Bid | Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 6 Months | 30 Participants |
Secondary
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 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
Time frame: 1 month
Population: Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 1 Month | 2 Participants |
| Arm 4 - R788 150 mg qd | Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 1 Month | 3 Participants |
| Arm 5 - R788 100 mg Bid | Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 1 Month | 12 Participants |
Secondary
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 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
Time frame: 2 months
Population: Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 2 Months | 4 Participants |
| Arm 4 - R788 150 mg qd | Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 2 Months | 4 Participants |
| Arm 5 - R788 100 mg Bid | Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 2 Months | 13 Participants |
Secondary
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 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
Time frame: 3 months
Population: Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 3 Months | 4 Participants |
| Arm 4 - R788 150 mg qd | Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 3 Months | 3 Participants |
| Arm 5 - R788 100 mg Bid | Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 3 Months | 19 Participants |
Secondary
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 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
Time frame: 4 months
Population: Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 4 Months | 5 Participants |
| Arm 4 - R788 150 mg qd | Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 4 Months | 3 Participants |
| Arm 5 - R788 100 mg Bid | Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 4 Months | 15 Participants |
Secondary
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 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
Time frame: 5 months
Population: Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 5 Months | 3 Participants |
| Arm 4 - R788 150 mg qd | Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 5 Months | 7 Participants |
| Arm 5 - R788 100 mg Bid | Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 5 Months | 12 Participants |
Secondary
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 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
Time frame: 6 months
Population: Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 6 Months | 3 Participants |
| Arm 4 - R788 150 mg qd | Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 6 Months | 9 Participants |
| Arm 5 - R788 100 mg Bid | Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 6 Months | 21 Participants |
Secondary
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 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
Time frame: 1 month
Population: Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 1 Month | 3 Participants |
| Arm 4 - R788 150 mg qd | Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 1 Month | 6 Participants |
| Arm 5 - R788 100 mg Bid | Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 1 Month | 18 Participants |
Secondary
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 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
Time frame: 2 months
Population: Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 2 Months | 9 Participants |
| Arm 4 - R788 150 mg qd | Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 2 Months | 7 Participants |
| Arm 5 - R788 100 mg Bid | Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 2 Months | 23 Participants |
Secondary
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 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
Time frame: 3 months
Population: Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 3 Months | 7 Participants |
| Arm 4 - R788 150 mg qd | Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 3 Months | 8 Participants |
| Arm 5 - R788 100 mg Bid | Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 3 Months | 22 Participants |
Secondary
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 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
Time frame: 4 months
Population: Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 4 Months | 8 Participants |
| Arm 4 - R788 150 mg qd | Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 4 Months | 6 Participants |
| Arm 5 - R788 100 mg Bid | Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 4 Months | 23 Participants |
Secondary
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 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
Time frame: 5 months
Population: Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 5 Months | 7 Participants |
| Arm 4 - R788 150 mg qd | Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 5 Months | 8 Participants |
| Arm 5 - R788 100 mg Bid | Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 5 Months | 24 Participants |
Secondary
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 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
Time frame: 6 months
Population: Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 3 - Placebo Pooled | Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 6 Months | 8 Participants |
| Arm 4 - R788 150 mg qd | Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 6 Months | 11 Participants |
| Arm 5 - R788 100 mg Bid | Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 6 Months | 29 Participants |
Secondary
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at 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.
Time frame: Baseline to 6 months
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 3 - Placebo Pooled | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at 6 Months | 4.5 Score | Standard Deviation 9.79 |
| Arm 4 - R788 150 mg qd | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at 6 Months | 5.7 Score | Standard Deviation 10.28 |
| Arm 5 - R788 100 mg Bid | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at 6 Months | 7.4 Score | Standard Deviation 10.87 |
Secondary
Short Form Health Survey (SF-36) Mental Component Summary (MCS) at 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
Time frame: Baseline to 6 months
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 3 - Placebo Pooled | Short Form Health Survey (SF-36) Mental Component Summary (MCS) at 6 Months | 3.711 Score | Standard Deviation 10.7098 |
| Arm 4 - R788 150 mg qd | Short Form Health Survey (SF-36) Mental Component Summary (MCS) at 6 Months | 2.033 Score | Standard Deviation 10.7089 |
| Arm 5 - R788 100 mg Bid | Short Form Health Survey (SF-36) Mental Component Summary (MCS) at 6 Months | 3.990 Score | Standard Deviation 10.5129 |
Secondary
Short Form Health Survey (SF-36) Physical Component Summary (PCS) at 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
Time frame: Baseline to 6 months
Population: Intent-to-treat population with available data and received study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 3 - Placebo Pooled | Short Form Health Survey (SF-36) Physical Component Summary (PCS) at 6 Months | 4.902 Score | Standard Deviation 8.4808 |
| Arm 4 - R788 150 mg qd | Short Form Health Survey (SF-36) Physical Component Summary (PCS) at 6 Months | 5.903 Score | Standard Deviation 8.9541 |
| Arm 5 - R788 100 mg Bid | Short Form Health Survey (SF-36) Physical Component Summary (PCS) at 6 Months | 8.524 Score | Standard Deviation 8.7068 |