Efficacy and Safety Study of R935788 Tablets to Treat Rheumatoid Arthritis

Phase 2

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: Placebo
Drug: Fostamatinib disodium (R935788)

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

Inclusion Criteria

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

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

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

Exclusion Criteria

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

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
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
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
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
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): Divison of Rheumatology Allergy and Immunology
🇺🇸
La Jolla, California, United States
Desert Medical Advances
🇺🇸
Palm Desert, California, United States
Arthritis & Osteoporosis Center, PC
🇺🇸
Hamden, Connecticut, United States
Cynthia Morgan
🇺🇸
Washington, District of Columbia, United States
Florida Medical Research Institute
🇺🇸
Gainsville, Florida, United States
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Jeffrey Poiley, MD
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Sarasota, Florida, United States
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South Bend, Indiana, United States
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Divison of Rheumatology Allergy and Immunology
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