Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Fostamatinib disodium · 8 trials · 4 indications
Incidence, frequency, seriousness, and severity of adverse events that occurred during the current study
Change from baseline in blood pressure over time
Change from baseline in absolute neutrophil count (ANC) over time
Proportion of subjects achieving a hemoglobin level ≥ 10 g/dL with an increase from Baseline in hemoglobin level of ≥ 2 g/dL on 3 consecutive available visits during the 24-week treatment period.
Stable platelet response by Week 24 defined as a platelet count of at least 50,000/µL on at least 4 of the 6 visits between Weeks 14-24
Percentage of subjects who achieved platelet count of at least 50,000/µL within 12 Weeks of beginning treatment up to 12 months was analyzed among all subjects who received active treatment in one of the prior studies (C788-047 or C788-048), in the current extension study (C788-049), or in both prior and current studies. Treated Population was defined as all enrolled and treated subjects.
A within-subject, between-study comparison of platelet counts for subjects who were previously treated with placebo in one of the prior studies (C788-047 or C788-048) was prospectively defined in the protocol (version 2). Achievement of platelet response by 12 weeks and maintenance of platelet response for 12 weeks was analyzed among subjects who had been randomized to placebo in one of the prior studies (C788-047 or C788-048). Treated Population was defined as all enrolled and treated subjects.
A stable platelet response by Week 24 defined as a platelet count of at least 50,000/μL on at least 4 of the last 6 scheduled visits between Weeks 14 and 24
Overall regressive response rate (ORRR) is the proportion of patients with a best response of Complete Response (CR), Partial Response (PR) (per Cheson 2007), or Regressive Stable Disease (RSD) defined as regressive disease that does not meet the criteria for partial response.
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, Health Assessment Questionnaire-Disability Index (HAQ-DI); and CRP or ESR, after 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 6 months
| Arm | Type | Description |
|---|---|---|
| Fostamatinib | EXPERIMENTAL | Subjects who at any time during the C-935788-057 study achieved a hemoglobin response will continue at their dose and regimen from the Week 22 visit in the C-935788-057 study. All other subjects who enter the extension study will initially receive fostamatinib 100 mg PO bid. Starting at Week 4, the initial fostamatinib dose of 100 mg PO bid will be increased to fostamatinib 150 mg PO bid if subjects have adequately tolerated the study drug, based on the Investigator's judgment. |
| Placebo | PLACEBO_COMPARATOR | Initial dose is 100 mg by mouth (PO) twice a day (bid). At week 4 dose will be increased to placebo 150 mg PO bid if subjects have adequately tolerated the study drug in the opinion of the Investigator. |
| Fostamatinib Disodium | EXPERIMENTAL | Fostamatinib Disodium tablet 100 mg or 150 mg PO bid (morning and evening) over the course of 24 weeks. |
| 1 | EXPERIMENTAL | - |
| Arm 1 | EXPERIMENTAL | Fostamatinib disodium (R935788) 100 mg tablet, orally, twice-a-day |
| Arm 2 | PLACEBO_COMPARATOR | Placebo, orally, twice-a-day |
| 2 | EXPERIMENTAL | R788, 150 mg tablet, orally, once a day |
| 3 | PLACEBO_COMPARATOR | Placebo, orally, either once a day, or twice a day |
| Name | Type | Description |
|---|---|---|
| Fostamatinib disodium | DRUG | Fostamatinib is supplied in two (2) dosage strengths: 100 mg and 150 mg. |
| Placebo | DRUG | Placebo |
| Fostamatinib disodium (R935788) | DRUG | R935788 100 mg tablet, orally, twice-a-day |
Inclusion Criteria: 1. Subject must be willing and able to give written informed consent by signing an IRB approved Informed Consent Form prior to undergoing any study-specific procedures. 2. Subject must have completed all 24 weeks of participation in the study C-935788-057. Exclusion Criteria: ...