Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis
Brief summary
The purpose of this study is to evaluate the long term safety and tolerability of fostamatinib in patients in Asia with rheumatoid arthritis (RA).
Detailed description
(OSKIRA-Asia-1X): A Long-term Study to Assess the Safety of Fostamatinib in the Treatment of Rheumatoid Arthritis in Asia
Interventions
DRUGFostamatinib
Fostamatinib 100mg once daily
Sponsors
AstraZeneca
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provision of informed consent prior to any study-specific procedures. * Patients who have successfully completed study D4300C00008 and whose disease is adequately controlled, in the opinion of the Investigator.
Exclusion criteria
* Premature withdrawal from study D4300C00008 or in the opinion of the Investigator the patient's disease is not adequately controlled on current treatment. * Development of any of the withdrawal criteria from study D4300C00008 * Females who are pregnant or breast feeding * Any other clinically significant disease or disorder, which in the opinion of the Investigator might put the patient at risk due to participation in the study, or may influence the results of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Who Had at Least 1 Adverse Event in Any Category | Entry in extension to study termination (variable duration; maximum 52 weeks) | AE = adverse event, IP = investigational product, PO = orally, QD = once daily, SAE = serious adverse event |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Components of ACR Response Criteria Over Time | Every 12 weeks for one year then every 24 weeks until study end | ACR = American College of Rheumatology, n/a = not applicable, PO = orally, QD = once daily |
| DAS28-CRP Score Over Time | Every 12 weeks for one year then every 24 weeks until study end | CRP = C-reactive protein, DAS28 = disease activity score based on a 28 joint count, n/a = not applicable, PO = orally, QD = once daily |
| HAQ-DI Score Over Time | Every 12 weeks for one year then every 24 weeks until study end | HAQ-DI = health assessment questionnaire - disability index, n/a = not applicable, PO = orally, QD = once daily |
| SF-36 Score Over Time | Every 12 weeks for one year then yearly until study end | n/a = not applicable, PO = orally, QD = once daily, SF-36 = 36 item short form health survey |
Countries
Hong Kong, Japan, South Korea, Taiwan, Thailand, Vietnam
Participant flow
Recruitment details
A total of 115 patients were enrolled; all received at least 1 dose of investigational product. This was an open-label study.
Pre-assignment details
No patients failed screening.
Participants by arm
| Arm | Count |
|---|---|
| FOSTA 100 MG QD PO Fostamatinib 100 mg qd | 115 |
| Total | 115 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Lack of Efficacy | 3 |
| Overall Study | Study-specific disc criteria | 1 |
Baseline characteristics
| Characteristic | FOSTA 100 MG QD PO |
|---|---|
| Age, Continuous | 53 years STANDARD_DEVIATION 11.3 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 115 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants |
| Race/Ethnicity, Customized Indian or Pakistani | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized White | 0 Participants |
| Sex: Female, Male Female | 101 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 29 / 115 |
| serious Total, serious adverse events | 4 / 115 |
Outcome results
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
Time frame: Entry in extension to study termination (variable duration; maximum 52 weeks)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FOSTA 100 MG QD PO | Percentage of Patients Who Had at Least 1 Adverse Event in Any Category | Any AE | 62.6 Percentage of patients |
| FOSTA 100 MG QD PO | Percentage of Patients Who Had at Least 1 Adverse Event in Any Category | Any AE with outcome of death | 0 Percentage of patients |
| FOSTA 100 MG QD PO | Percentage of Patients Who Had at Least 1 Adverse Event in Any Category | Any SAE (including events with outcome of death) | 3.5 Percentage of patients |
| FOSTA 100 MG QD PO | Percentage of Patients Who Had at Least 1 Adverse Event in Any Category | Any AE leading to discontinuation of IP | 2.6 Percentage of patients |
Secondary
Components of ACR Response Criteria Over Time
ACR = American College of Rheumatology, n/a = not applicable, PO = orally, QD = once daily
Time frame: Every 12 weeks for one year then every 24 weeks until study end
Population: Insufficient data were available for analysis due to sparse data collection and the early termination of the study.
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
Time frame: Every 12 weeks for one year then every 24 weeks until study end
Population: Insufficient data were available for analysis due to sparse data collection and the early termination of the study.
Secondary
HAQ-DI Score Over Time
HAQ-DI = health assessment questionnaire - disability index, n/a = not applicable, PO = orally, QD = once daily
Time frame: Every 12 weeks for one year then every 24 weeks until study end
Population: Insufficient data were available for analysis due to sparse data collection and the early termination of the study.
Secondary
SF-36 Score Over Time
n/a = not applicable, PO = orally, QD = once daily, SF-36 = 36 item short form health survey
Time frame: Every 12 weeks for one year then yearly until study end
Population: Insufficient data were available for analysis due to sparse data collection and the early termination of the study.