Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01197521 | Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Not Responding. | PHASE3 | COMPLETED | 923 | — | — | Sep 1, 2010 | Nov 1, 2012 | Apr 7, 2014 | 127 | United States, Argentina +15 |
| NCT01197534 | Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding. | PHASE3 | COMPLETED | 913 | — | — | Sep 1, 2010 | Mar 1, 2013 | Apr 17, 2014 | 149 | United States, Canada +14 |
| NCT01197755 | Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate and Have Had Inadequate Response to Single TNF-alpha Antagonist | PHASE3 | COMPLETED | 323 | — | — | Sep 1, 2010 | Feb 1, 2013 | Apr 7, 2014 | 135 | United States, Argentina +14 |
| NCT01563978 | Study of the Effect of Fostamatinib Twice Daily on Blood Pressure in Patients With Rheumatoid Arthritis | PHASE2 | COMPLETED | 266 | — | — | Apr 1, 2012 | Jan 1, 2013 | May 8, 2014 | 56 | United States, Bulgaria +5 |
| NCT01725230 | Assess the Pharmacokinetics of Rosuvastatin and Simvastatin When Administered Alone or in Combination With Fostamatinib | PHASE1 | COMPLETED | 42 | — | — | Nov 1, 2012 | Jan 1, 2013 | Feb 4, 2013 | 1 | United States |
| NCT01336218 | Effects of Administration of Fostamatinib on Blood Concentrations of Rifampicin in Healthy Subjects. | PHASE1 | COMPLETED | 15 | — | — | Apr 1, 2011 | Jul 1, 2011 | Jul 22, 2011 | 1 | United States |
| NCT01309854 | Effects of Administration of Fostamatinib on Blood Concentrations of Pioglitazone in Healthy Subjects | PHASE1 | COMPLETED | 15 | — | — | Mar 1, 2011 | May 1, 2011 | Jul 7, 2011 | 1 | United States |
| NCT01311622 | Effects of Administration of Fostamatinib on Blood Concentrations of Warfarin in Healthy Subjects | PHASE1 | COMPLETED | 15 | — | — | Mar 1, 2011 | May 1, 2011 | Jan 31, 2013 | 1 | United Kingdom |
| NCT01245790 | A Study of Fostamatinib in Subjects With Impaired Kidney Function | PHASE1 | COMPLETED | 24 | — | — | Nov 1, 2010 | Jun 1, 2011 | Jun 16, 2011 | 1 | United States |
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 CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DMARD=disease-modifying anti-rheumatic drug, PO=orally, QD=once a day.
mTSS: modified total Sharp score, a measure of structural progression based upon X-rays. Hand and foot joints are scored for erosions and joint space narrowing and the results summed to give a value between 0 and 448. A higher value represents more serious progression of the disease. After disregarding ineligible records, patients with 2 or more non-missing values have had missing data imputed via linear extrapolation/interpolation methods. Patients with only 1 result have been excluded from the analysis. ANCOVA=analysis of covariance, BID=twice daily, DMARD=disease-modifying anti-rheumatic drug, IP=investigational product, PO=orally, QD=once a day.
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 CRP) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.
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 daily.
ANCOVA=analysis of covariance, BID=twice daily, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.
* Pharmacokinetics of warfarin measured by AUC * Pharmacokinetics of warfarin measured Cmax
Parameters include: AUC, Cmax
| Arm | Type | Description |
|---|---|---|
| Dosing Regimen A | EXPERIMENTAL | Oral Treatment |
| Dosing Regimen B | EXPERIMENTAL | Oral Treatment |
| Dosing Regimen C | PLACEBO_COMPARATOR | Oral Treatment |
| Rosuvastatin | EXPERIMENTAL | Single, oral dose of rosuvastatin 20mg in first period and in second period (after wash out) fostamatinib 100 mg twice daily, then single oral dose of rosuvastatin 20 mg plus continued oral dosing of fostamatinib 100 mg twice daily, then continue fostamatinib 100 mg twice daily |
| Simvastatin | EXPERIMENTAL | Single, oral dose of simvastatin 40 mg in first period and in second period (after wash out) fostamatinib 100 mg twice daily, then single oral dose of simvastatin 40 mg plus continued oral dosing of fostamatinib 100 mg twice daily, then continue fostamatinib 100 mg twice daily |
| 1 | EXPERIMENTAL | Fostamatinib |
| 2 | EXPERIMENTAL | Rifampicin |
| pioglitazone | EXPERIMENTAL | - |
| pioglitazone and fostamatinib | EXPERIMENTAL | - |
| warfarin | EXPERIMENTAL | - |
| warfarin and fostamatinib | EXPERIMENTAL | - |
| 3 | EXPERIMENTAL | Moderate renal impairment (Stage 2) |
| 4 | EXPERIMENTAL | Severe renal impairment (Stage 2) |
| 5 | EXPERIMENTAL | End stage renal disease (Stage 1) |
| Name | Type | Description |
|---|---|---|
| fostamatinib | DRUG | fostamatinib 100 mg twice daily |
| placebo, fostamatinib | DRUG | Placebo for 24 weeks followed by fostamatinib 100 mg twice daily |
| placebo | DRUG | Placebo twice daily |
| Rosuvastatin | DRUG | 20-mg tablet |
| Simvastatin | DRUG | 40-mg tablet |
| rifampicin | DRUG | oral tablets, 600mg (2 X 300mg) 8 doses over 8 days |
| pioglitazone | DRUG | oral tablets, 30mg single dose per period |
| warfarin | DRUG | 2 single 25 mg doses of Warfarin (5 x 5 mg tablets) administered 14 days apart |
Inclusion Criteria: * Active rheumatoid arthritis (RA) diagnosed after the age of 16 * Currently taking methotrexate * 6 or more swollen joints and 6 or more tender/painful joints (from 28 joint count) and either Erythrocyte Sedimentation Rate (ESR) blood result of 28mm/h or more, or C-Reactive Pro...