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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 this study is to evaluate the long term safety and tolerability of fostamatinib in patients in Asia with rheumatoid arthritis (RA).
(OSKIRA-Asia-1X): A Long-term Study to Assess the Safety of Fostamatinib in the Treatment of Rheumatoid Arthritis in Asia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dosing regimen | Experimental | Open label Oral treatment 100mg once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fostamatinib | Drug | Fostamatinib 100mg once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Who Had at Least 1 Adverse Event in Any Category | AE = adverse event, IP = investigational product, PO = orally, QD = once daily, SAE = serious adverse event | Entry in extension to study termination (variable duration; maximum 52 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Components of ACR Response Criteria Over Time | ACR = American College of Rheumatology, n/a = not applicable, PO = orally, QD = once daily | Every 12 weeks for one year then every 24 weeks until study end |
| DAS28-CRP Score Over Time |
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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 | Hong Kong | Shatin | 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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No patients failed screening.
A total of 115 patients were enrolled; all received at least 1 dose of investigational product. This was an open-label study.
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| ID | Title | Description |
|---|---|---|
| FG000 | FOSTA 100 MG QD PO | Fostamatinib 100 mg qd |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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CRP = C-reactive protein, DAS28 = disease activity score based on a 28 joint count, n/a = not applicable, PO = orally, QD = once daily
| Every 12 weeks for one year then every 24 weeks until study end |
| HAQ-DI Score Over Time | HAQ-DI = health assessment questionnaire - disability index, n/a = not applicable, PO = orally, QD = once daily | Every 12 weeks for one year then every 24 weeks until study end |
| SF-36 Score Over Time | n/a = not applicable, PO = orally, QD = once daily, SF-36 = 36 item short form health survey | Every 12 weeks for one year then yearly until study end |
| Hong Kong |
| Hong Kong |
| Research Site | Fukuoka | Fukuoka | Japan |
| Research Site | Kitakyushu-shi | Fukuoka | Japan |
| Research Site | Sapporo | Hokkaido | Japan |
| Research Site | Kato-shi | Hyōgo | Japan |
| Research Site | Sendai | Miyagi | Japan |
| Research Site | Nagasaki | Nagasaki | Japan |
| Research Site | Omura-shi | Nagasaki | Japan |
| Research Site | Sasebo-shi | Nagasaki | Japan |
| Research Site | Okayama | Okayama-ken | Japan |
| Research Site | Tomigusuku-shi | Okinawa | Japan |
| Research Site | Hamamatsu | Shizuoka | Japan |
| Research Site | Itabashi-ku | Tokyo | Japan |
| Research Site | Shinjuku-ku | 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 | Kaohsiung City | Taiwan |
| Research Site | Taichung | Taiwan |
| Research Site | Taipei | Taiwan |
| Research Site | Singapore | Singapore | Thailand |
| Research Site | Bangkok | Thailand |
| Research Site | Hanoi | Vietnam |
| Research Site | Ho Chi Minh City | Vietnam |
| Did Not Receive Treatment |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | FOSTA 100 MG QD PO | Fostamatinib 100 mg qd |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| 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 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Components of ACR Response Criteria Over Time | ACR = American College of Rheumatology, n/a = not applicable, PO = orally, QD = once daily | Insufficient data were available for analysis due to sparse data collection and the early termination of the study. | Posted | Every 12 weeks for one year then every 24 weeks until study end |
|
| |||||||||||||||||||
| Secondary | DAS28-CRP Score Over Time | CRP = C-reactive protein, DAS28 = disease activity score based on a 28 joint count, n/a = not applicable, PO = orally, QD = once daily | Insufficient data were available for analysis due to sparse data collection and the early termination of the study. | Posted | Every 12 weeks for one year then every 24 weeks until study end |
|
| |||||||||||||||||||
| Secondary | HAQ-DI Score Over Time | HAQ-DI = health assessment questionnaire - disability index, n/a = not applicable, PO = orally, QD = once daily | Insufficient data were available for analysis due to sparse data collection and the early termination of the study. | Posted | Every 12 weeks for one year then every 24 weeks until study end |
|
| |||||||||||||||||||
| Secondary | SF-36 Score Over Time | n/a = not applicable, PO = orally, QD = once daily, SF-36 = 36 item short form health survey | Insufficient data were available for analysis due to sparse data collection and the early termination of the study. | Posted | Every 12 weeks for one year then yearly until study end |
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| Primary | Percentage of Patients Who Had at Least 1 Adverse Event in Any Category | AE = adverse event, IP = investigational product, PO = orally, QD = once daily, SAE = serious adverse event | The full analysis set was the primary population for reporting efficacy and safety data, and comprised all patients who received at least 1 dose of investigational product. | Posted | Number | Percentage of patients | Entry in extension to study termination (variable duration; maximum 52 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 QD PO | Fostamatinib 100 mg qd | 4 | 115 | 29 | 115 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PANCREATITIS ACUTE | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| ROAD TRAFFIC ACCIDENT | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| OSTEONECROSIS | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| SEBORRHOEIC KERATOSIS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
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| NASOPHARYNGITIS | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| RHEUMATOID ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| HYPERTENSION | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
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Insufficient efficacy data was available for analysis due to sparse data collection and the early termination of the study.
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| 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 |
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| ID | Term |
|---|---|
| C523665 | fostamatinib |
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| Asian |
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| American Indian or Alaska Native |
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| Indian or Pakistani |
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| Native Hawaiian or other Pacific Islander |
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