Efficacy and Safety Study of R935788 Tablets to Treat Rheumatoid Arthritis
- Conditions
- Rheumatoid Arthritis
- Interventions
- Drug: Placebo
- Registration Number
- NCT00665925
- Lead Sponsor
- Rigel Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 457
- 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.
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The patient has a history of, or a concurrent, clinically significant illness, medical condition (other than arthritis) or laboratory abnormality that, in the Investigator's opinion, could affect the conduct of the study. Specifically, excluded are patients with the following:
- uncontrolled or poorly controlled hypertension;
- other autoimmune disease (psoriatic arthritis, lupus, mixed connective disorder) or arthritis syndromes (gout, Lyme disease, Reiter's syndrome);
- recent (within past 2 months prior to Day 1 dosing) serious surgery or infectious disease;
- recent history (past 5 years prior to Day 1 dosing) of, or treatment for, a malignancy other than nonmelanomatous skin cancer, or any history of lymphoma;
- Hepatitis B ;
- Hepatitis C ;
- interstitial pneumonitis or active pulmonary infection on chest x-ray;
- Tuberculosis (TB): the TB skin test should be negative.
- known laboratory abnormalities.
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The patient has a history of substance abuse, drug addiction or alcoholism. Patients may consume up to 4 units of alcohol per week; however, alcohol should be avoided in the 72 hours prior to lab assessments. Patients who cannot reliably comply with this should be excluded. A unit of alcohol is defined as the following: Beer=12 oz or 355 mL; wine = 5 oz or 148 mL; sweet dessert wine=3 oz or 89 mL; 80 proof distilled spirits= 1.5 oz or 44 mL.
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The patient has been treated previously treated with R788 under a different protocol.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 Placebo Placebo, orally, either once a day, or twice a day 1 Fostamatinib disodium (R935788) R788, 100 mg tablet, orally, twice-a-day 2 Fostamatinib disodium (R935788) R788, 150 mg tablet, orally, once a day
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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) <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
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 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
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-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
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 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 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 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 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 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 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 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
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
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-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
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
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
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
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
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
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
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
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 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 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 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 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 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
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 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
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 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
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 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 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
Trial Locations
- Locations (64)
North Carolina Arthritis & Allergy Care Center
🇺🇸Raleigh, North Carolina, United States
DCC "Sv. Anna" Sofia
🇧🇬Sofia, Bulgaria
Unidad Medica Torre Plaza
🇨🇴Medellín, Antioquia, Colombia
Malopolskie Centrum Medyczne SC
🇵🇱Krakow, Poland
Synexus SCM
🇵🇱Wroclaw, Poland
Spitalul de Urgenta al MAI Dr. D. Gerota
🇷🇴Bucuresti, Romania
Rheumatology Associates, SC
🇺🇸Chicago, Illinois, United States
Arthritis Center of South Texas
🇺🇸San Antonio, Texas, United States
Divison of Rheumatology Allergy and Immunology
🇺🇸La Jolla, California, United States
Paddock Park Clinical Research
🇺🇸Ocala, Florida, United States
The Osteoporosis & Clinical Trials Center
🇺🇸Hagerstown, Maryland, United States
Fiechtner Research, Inc.
🇺🇸Lansing, Michigan, United States
Arthritis & Osteoporosis Center, PC
🇺🇸Hamden, Connecticut, United States
Lovelace Scientific Resources
🇺🇸Sarasota, Florida, United States
Memorial Medical Group Clinical Research Inst
🇺🇸South Bend, Indiana, United States
Center for Arthritis & Osteoporosis
🇺🇸Elizabethtown, Kentucky, United States
Health Research of Oklahoma
🇺🇸Oklahoma, Oklahoma, United States
Rheumatic Disease Associates
🇺🇸Willow Grove, Pennsylvania, United States
CIREEM
🇨🇴Bogota, Cundinamarca, Colombia
Fundación Instituto de Reumatología
🇨🇴Bogota, Cundinamarca, Colombia
Reumatologos del Caribe
🇨🇴Barranquilla, Atlántico, Colombia
MHAT "Kaspela"
🇧🇬Plovdiv, PLO, Bulgaria
MHAT Ruse
🇧🇬Ruse, Bulgaria
Riesgo de Fractura S.A
🇨🇴Bogota, Cundinamarca, Colombia
Private Office
🇨🇴Bogotá, Cundinamarca, Colombia
Hospital Aranda de la Parra
🇲🇽Leon, Guanajuato, Mexico
Hospital Ángeles Metropolitano
🇲🇽Mexico, D.f., Mexico
Instituto Jalisciense de Investigación Clínica
🇲🇽Guadalajara, Jalisco, Mexico
Centro de Investigacion Clinical de Morelia
🇲🇽Morelia, Michoacan, Mexico
Christus Muguerza del Parque
🇲🇽Chihuahua, Mexico
Wojewodzki Szpital Zespolony Oddzial Reumatol
🇵🇱Elblag, Poland
ZOZ w Zyradowie Oddzial Reumatologii
🇵🇱Zyradow, Poland
Krakowskie Centrum Medyczne NZOZ
🇵🇱Krakow, Poland
NZOZ Reumed
🇵🇱Lublin, Poland
NZOZ "Nasz Lekarz"
🇵🇱Torun, Poland
Spitalul Judetean "Dr. Fogolyan Kristol"
🇷🇴Sf. Gheorghe, Romania
Spitalul Clinic Judetean Sibiu
🇷🇴Sibiu, Romania
Spitalul Clinic Judetean de Urgenta Cluj Reum
🇷🇴Cluj-Napoca, Cluj, Romania
Florida Medical Research Institute
🇺🇸Gainsville, Florida, United States
Westroads Medical Group
🇺🇸Omaha, Nebraska, United States
Cynthia Morgan
🇺🇸Washington, District of Columbia, United States
MNTranspH "Tsar Boris Treti"
🇧🇬Sofia, Gsof, Bulgaria
Arthritis Northwest, PLLC
🇺🇸Spokane, Washington, United States
Centro Medico Carlos Ardila Lulle
🇨🇴Bucaramanga, Santander, Colombia
Szpit. Spec.Nr 1, Odz. Reumatol. i Reh.
🇵🇱Bytom, Poland
SERVIMED
🇨🇴Bucaramanga, Santander, Colombia
Hospital General de México
🇲🇽Mexico, D.f., Mexico
NZOZ Centrum Medyczne Artur Racewicz
🇵🇱Bialystok, Poland
ASK Klinika Reumatologii i Chor. Wewn.
🇵🇱Wroclaw, Poland
Spitalul Clinic "Sf. Maria" Med Int si Reumat
🇷🇴Bucuresti, Sector 1, Romania
Desert Medical Advances
🇺🇸Palm Desert, California, United States
Jeffrey Poiley, MD
🇺🇸Orlando, Florida, United States
Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Rheumatology Associates
🇺🇸Charleston, South Carolina, United States
Arké Estudios Clínicos S.A de C.V
🇲🇽Mexico, D.f., Mexico
Clínica para el Diagnostico y Tratamiento de
🇲🇽Mexico, D.f., Mexico
Centro Médico DALINDE
🇲🇽Mexico, Distrito Federal, Mexico
Mazowieckie Centrum Badan Klinicznych
🇵🇱Grodzisk Mazowiecki, Poland
CMI "Cristei R. Dorica"
🇷🇴Braila, Romania
Hospital Civil de Guadalajara "Fray Antonio A
🇲🇽Guadalajara, Jalisco, Mexico
Austin Rheumatology & Research
🇺🇸Austin, Texas, United States
Centro de Reumatologia y Ortopedia
🇨🇴Barranquilla, Atlántico, Colombia
Clinical Research Center of Reading, LLP
🇺🇸West Reading, Pennsylvania, United States
Hospital Inovamed , Torre Médica
🇲🇽Cuernavaca, Morelos, Mexico