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AZ decision to discontinue fostamatinib development in RA; rights to fostamatinib returned to Rigel Pharmaceuticals.
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The purpose of the study is to evaluate the effectiveness of four dosing regimens of fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking methotrexate but not responding. The study will last for 12 weeks.
(OSKIRA-Asia-1): A Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Dose Ranging Study in Asia Evaluating Efficacy and Safety of Fostamatinib in Patients with Active Rheumatoid Arthritis who are Inadequate Responders to Methotrexate Therapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dosing A regimen | Experimental | Oral treatment |
|
| Dosing B regimen | Experimental | Oral treatment |
|
| Dosing C regimen | Experimental | Oral treatment |
|
| Dosign D regimen | Experimental | Oral treatment |
|
| Dosing E regimen | Placebo Comparator | Oral treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fostamatinib | Drug | Fostamatinib 100mg twice daily for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Achieving ACR20 at Week 12, Comparison Between Fostamatinib and Placebo | ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as C-Reactive Protein) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Achieving ACR20 at Week 1, Comparison Between Fostamatinib and Placebo | ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as C-Reactive Protein) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neil - Mackillop, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | New Territories | HK | Hong Kong | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33254235 | Derived | Tanaka Y, Millson D, Iwata S, Nakayamada S. Safety and efficacy of fostamatinib in rheumatoid arthritis patients with an inadequate response to methotrexate in phase II OSKIRA-ASIA-1 and OSKIRA-ASIA-1X study. Rheumatology (Oxford). 2021 Jun 18;60(6):2884-2895. doi: 10.1093/rheumatology/keaa732. |
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A total of 135 patients failed screening.
A total of 298 patients were enrolled: 31, 33, 33, 33 & 33 were randomised to Groups A, B, C, D & E respectively (all received at least 1 dose of investigational product).
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| ID | Title | Description |
|---|---|---|
| FG000 | FOSTA 100 MG BID PO | Dosing Group A |
| FG001 | FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO | Dosing Group B |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Fostamatinib |
| Drug |
Fostamatinib 100mg twice daily for 4 weeks, followed by150mg once daily up to Week 12 |
|
| Fostamatinib | Drug | Fostamatinib 75mg twice daily for 12 weeks |
|
| Fostamatinib | Drug | Fostamatinib 50mg twice daily for 12 weeks |
|
| Placebo | Drug | Placebo twice daily for 12 weeks |
|
| 1 week |
| Proportion of Patients Achieving ACR50 at Week 12, Comparison Between Fostamatinib and Placebo | ACR50: American College of Rheumatology 50% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as C-Reactive Protein) and the physician and patient's own assessments of disease activity, pain and physical function, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day. | 12 weeks |
| Proportion of Patients Achieving ACR70 at Week 12, Comparison Between Fostamatinib and Placebo | ACR70: American College of Rheumatology 70% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as C-Reactive Protein) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day. | 12 weeks |
| ACRn - Comparison Between Fostamatinib and Placebo at Week 12 | ACRn: American College of Rheumatology index of RA improvement, based on smallest percentage improvement in the count of swollen joints (out of 28 joints), count of tender joints (out of 28 joints), or in blood test measures of inflammation (such as C-Reactive Protein) or the physician or patient's own assessments of disease activity, pain and physical function. Scores are reported as a percentage improvement on a scale of -100 to +100, with larger values representing a better clinical outcome. Mean refers to change at Week 12. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day. | Baseline and 12 weeks |
| Proportion of Patients Achieving DAS28-CRP<=3.2 at Week 12, Comparison Between Fostamatinib and Placebo | DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. DAS28-CRP score of <=3.2 indicates low disease activity. BID = twice daily, CRP = C-reactive protein, , DMARD = disease modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once daily. | 12 weeks |
| Proportion of Patients With DAS28-CRP EULAR Response at Week 12, Comparison Between Fostamatinib and Placebo | Change from baseline in DAS28-CRP at Week 12 was derived and categorised using the European League Against Rheumatism (EULAR) response criteria. BID = twice a day, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once a day. | 12 weeks |
| Proportion of Patients With HAQ-DI Response at Week 12, Comparison Between Fostamatinib and Placebo | HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is calculated by summing scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygiene, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with higher score indicating greater disability. HAQ-DI response is a reduction from baseline in HAQ-DI greater than or equal to the minimally important difference (0.22). BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once a day. | 12 weeks |
| SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Placebo at Week 12 | SF-36 = 36-item Short Form Health Survey, as a measure of health related quality of life. Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional and Mental Health) are derived and normalised to a scale of 0 to 100. The physical and mental component scores (PCS and MCS) are derived by multiplying each of these 8 scores by a constant, summing them and standardising against a population with mean of 50, standard deviation of 10. A higher score represents better quality of life. Mean changes from baseline are presented as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. Mean refers to change in scores at Week 12. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day. | Baseline and 12 weeks |
| SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Placebo at Week 12 | SF-36 = 36-item Short Form Health Survey, as a measure of health related quality of life. Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional and Mental Health) are derived and normalised to a scale of 0 to 100. The physical and mental component scores (PCS and MCS) are derived by multiplying each of these 8 scores by a constant, summing them and standardising against a population with mean of 50, standard deviation of 10. A higher score represents better quality of life. Mean changes from baseline are presented as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. Mean refers to change in scores at Week 12. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day. | Baseline and 12 weeks |
| Hong Kong |
| Hong Kong |
| Research Site | Matsuyama | Ehime | Japan |
| Research Site | Fukuoka | Fukuoka | Japan |
| Research Site | Kitakyushu-shi | Fukuoka | Japan |
| Research Site | Kurume | Fukuoka | Japan |
| Research Site | Sapporo | Hokkaido | Japan |
| Research Site | Kato-shi | Hyōgo | Japan |
| Research Site | Kasama-shi | Ibaraki | Japan |
| Research Site | Kumamoto | Kumamoto | Japan |
| Research Site | Sendai | Miyagi | Japan |
| Research Site | Isahaya | Nagasaki | Japan |
| Research Site | Nagasaki | Nagasaki | Japan |
| Research Site | Omura-shi | Nagasaki | Japan |
| Research Site | Sasebo-shi | Nagasaki | Japan |
| Research Site | Shibata | Niigata | Japan |
| Research Site | Okayama | Okayama-ken | Japan |
| Research Site | Tomigusuku-shi | Okinawa | Japan |
| Research Site | Matsue | Shimane | Japan |
| Research Site | Hamamatsu | Shizuoka | Japan |
| Research Site | Shinjuku | Tokyo | Japan |
| Research Site | tabashi City | Tokyo | Japan |
| Research Site | Anyang-si | Gyeonggi-do | South Korea |
| Research Site | Gwangju | South Korea |
| Research Site | Incheon | South Korea |
| Research Site | Seoul | South Korea |
| Research Site | Chiayi City | Taiwan |
| Research Site | Kaohsiung City | Taiwan |
| Research Site | Taichung | Taiwan |
| Research Site | Taipei | Taiwan |
| Research Site | Bangkok | Thailand |
| Research Site | Singapore | Thailand |
| Research Site | Hanoi | Vietnam |
| Research Site | Ho Chi Minh City | Vietnam |
| FG002 |
| FOSTA 75 MG BID PO |
Dosing Group C |
| FG003 | FOSTA 50 MG BID PO | Dosing Group D |
| FG004 | PLACEBO PO | Dosing Group E |
| Randomised But Did Not Receive Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | FOSTA 100 MG BID PO | Dosing Group A |
| BG001 | FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO | Dosing Group B |
| BG002 | FOSTA 75 MG BID PO | Dosing Group C |
| BG003 | FOSTA 50 MG BID PO | Dosing Group D |
| BG004 | PLACEBO PO | Dosing Group E |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Patients Achieving ACR20 at Week 12, Comparison Between Fostamatinib and Placebo | ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as C-Reactive Protein) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day. | The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. | Posted | Number | Percentage of responders | 12 weeks |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Patients Achieving ACR20 at Week 1, Comparison Between Fostamatinib and Placebo | ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as C-Reactive Protein) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally. | The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. The fostamatinib 100 mg BID combined group contains 31 patients from Dosing Group A and 33 patients from Dosing Group B. | Posted | Number | Percentage of responders | 1 week |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Patients Achieving ACR50 at Week 12, Comparison Between Fostamatinib and Placebo | ACR50: American College of Rheumatology 50% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as C-Reactive Protein) and the physician and patient's own assessments of disease activity, pain and physical function, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day. | The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. | Posted | Number | Percentage of responders | 12 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Patients Achieving ACR70 at Week 12, Comparison Between Fostamatinib and Placebo | ACR70: American College of Rheumatology 70% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as C-Reactive Protein) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day. | The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. | Posted | Number | Percentage of responders | 12 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | ACRn - Comparison Between Fostamatinib and Placebo at Week 12 | ACRn: American College of Rheumatology index of RA improvement, based on smallest percentage improvement in the count of swollen joints (out of 28 joints), count of tender joints (out of 28 joints), or in blood test measures of inflammation (such as C-Reactive Protein) or the physician or patient's own assessments of disease activity, pain and physical function. Scores are reported as a percentage improvement on a scale of -100 to +100, with larger values representing a better clinical outcome. Mean refers to change at Week 12. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day. | The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. | Posted | Mean | Standard Deviation | Percentage improvement from baseline | Baseline and 12 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Patients Achieving DAS28-CRP<=3.2 at Week 12, Comparison Between Fostamatinib and Placebo | DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. DAS28-CRP score of <=3.2 indicates low disease activity. BID = twice daily, CRP = C-reactive protein, , DMARD = disease modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once daily. | The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. | Posted | Number | Percentage of responders | 12 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Patients With DAS28-CRP EULAR Response at Week 12, Comparison Between Fostamatinib and Placebo | Change from baseline in DAS28-CRP at Week 12 was derived and categorised using the European League Against Rheumatism (EULAR) response criteria. BID = twice a day, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once a day. | The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. | Posted | Number | Percentage of responders | 12 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Patients With HAQ-DI Response at Week 12, Comparison Between Fostamatinib and Placebo | HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is calculated by summing scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygiene, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with higher score indicating greater disability. HAQ-DI response is a reduction from baseline in HAQ-DI greater than or equal to the minimally important difference (0.22). BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once a day. | The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. | Posted | Number | Percentage of responders | 12 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Placebo at Week 12 | SF-36 = 36-item Short Form Health Survey, as a measure of health related quality of life. Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional and Mental Health) are derived and normalised to a scale of 0 to 100. The physical and mental component scores (PCS and MCS) are derived by multiplying each of these 8 scores by a constant, summing them and standardising against a population with mean of 50, standard deviation of 10. A higher score represents better quality of life. Mean changes from baseline are presented as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. Mean refers to change in scores at Week 12. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day. | The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and 12 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Placebo at Week 12 | SF-36 = 36-item Short Form Health Survey, as a measure of health related quality of life. Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional and Mental Health) are derived and normalised to a scale of 0 to 100. The physical and mental component scores (PCS and MCS) are derived by multiplying each of these 8 scores by a constant, summing them and standardising against a population with mean of 50, standard deviation of 10. A higher score represents better quality of life. Mean changes from baseline are presented as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. Mean refers to change in scores at Week 12. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day. | The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and 12 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FOSTA 100 MG BID PO | Dosing Group A | 1 | 31 | 21 | 31 | ||
| EG001 | FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO | Dosing Group B | 1 | 33 | 17 | 33 | ||
| EG002 | FOSTA 50 MG BID PO | Dosing Group D | 3 | 33 | 17 | 33 | ||
| EG003 | FOSTA 75 MG BID PO | Dosing Group C | 0 | 33 | 16 | 33 | ||
| EG004 | PLACEBO PO | Dosing Group E | 1 | 33 | 15 | 33 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| LARYNGITIS VIRAL | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| OSTEOPOROSIS | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| RHEUMATOID ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| CARPAL TUNNEL SYNDROME | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| PALPITATIONS | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| GASTRITIS | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dave Goldstraw | AstraZeneca Pharmaceuticals | +44 (0)1625 512415 | dave.goldstraw@astrazeneca.com |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C523665 | fostamatinib |
Not provided
Not provided
Not provided
| Male |
|
| White |
|
| Black or African American |
|
| American Indian or Alaska Native |
|
| Indian or Pakistani |
|
| Native Hawaiian or Other Pacific Islander |
|
| Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied | Mantel Haenszel | Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country. | 0.054 | Week 12 | Weighted difference in proportions | 0.24 | 2-Sided | 80 | 0.08 | 0.39 | No | Superiority or Other |
| Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied | Mantel Haenszel | Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country. | 0.570 | Week 12 | Weighted difference in proportions | -0.06 | 2-Sided | 80 | -0.20 | 0.08 | No | Superiority or Other |
| Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied | Mantel Haenszel | Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country. | 0.262 | Week 12 | Weighted difference in proportions | 0.14 | 2-Sided | 80 | -0.02 | 0.29 | No | Superiority or Other |
Dosing Group A |
|
|
|
| OG004 | PLACEBO PO | Dosing Group E |
|
|
|
| OG004 | PLACEBO PO | Dosing Group E |
|
|
|
| OG003 | FOSTA 50 MG BID PO | Dosing Group D |
| OG004 | PLACEBO PO | Dosing Group E |
|
|
|
Dosing Group D |
| OG004 | PLACEBO PO | Dosing Group E |
|
|
|
| OG004 |
| PLACEBO PO |
Dosing Group E |
|
|
|
| OG003 | FOSTA 50 MG BID PO | Dosing Group D |
| OG004 | PLACEBO PO | Dosing Group E |
|
|
|
| OG002 | FOSTA 75 MG BID PO | Dosing Group C |
| OG003 | FOSTA 50 MG BID PO | Dosing Group D |
| OG004 | PLACEBO PO | Dosing Group E |
|
|
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| OG002 | FOSTA 75 MG BID PO | Dosing Group C |
| OG003 | FOSTA 50 MG BID PO | Dosing Group D |
| OG004 | PLACEBO PO | Dosing Group E |
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