Phase 3
Completed N=908
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.
Source: ClinicalTrials.gov NCT01197534 ↗Enrolled (actual)
908
Serious AEs
6.2%
Results posted
Apr 2014
Primary outcomePrimary: Proportion of Patients With ACR20 at Week 24, Comparison Between Fostamatinib and Placebo — 39.6; 39.6; 24.5 Percentage of responders — p=<0.001
Summary
The purpose of the study is to evaluate the 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. The study will last for 1 year.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients With ACR20 at Week 24, Comparison Between Fostamatinib and Placebo |
39.6; 39.6; 24.5 | <0.001 sig |
| SECONDARY Proportion of Patients Achieving ACR20, Comparison Between Fostamatinib and Placebo at Week 1 |
16.0; 8.3 | <0.001 sig |
| SECONDARY Proportion of Patients Achieving ACR50, Comparison Between Fostamatinib and Placebo at Week 24 |
20.8; 18.1; 8.3 | <0.001 sig |
| SECONDARY Proportion of Patients Achieving ACR70, Comparison Between Fostamatinib and Placebo at Week 24 |
9.1; 6.0; 2.6 | <0.001 sig |
| SECONDARY ACRn - Comparison Between Fostamatinib and Placebo at Week 24 |
20.75; 18.31; 9.84 | <0.001 sig |
| SECONDARY Proportion of Patients Achieving DAS28-CRP <2.6 at Week 12, Comparison Between Fostamatinib and Placebo |
17.2; 10.7; 3.0 | <0.001 sig |
| SECONDARY Proportion of Patients Achieving DAS28-CRP <2.6 at Week 24, Comparison Between Fostamatinib and Placebo |
41.3; 12.8; 2.3 | <0.001 sig |
| SECONDARY Proportion of Patients Achieving DAS28 EULAR Response at Week 24 |
42.9; 45.3; 64.6; 33.8; 34.9; 29.1 | <0.001 sig |
| SECONDARY HAQ-DI Response - Comparison of the Change(>=0.22) From Baseline Between Fostamatinib and Placebo at Week 24 |
46.1; 42.3; 26.5 | <0.001 sig |
| SECONDARY Change From Baseline to Week 24 in mTSS, Comparison Between Fostamatinib and Placebo |
0.64; 0.37; 1.16 | 0.904 |
| SECONDARY SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Placebo at Week 24 |
5; 4; 2 | <0.001 sig |
| SECONDARY SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Placebo at Week 24 |
3; 3; 1 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Active rheumatoid arthritis (RA) diagnosed after the age of 16
- Treatment with one the following disease modifying anti-rheumatic drug: methotrexate, sulfasalazine, hydroxychloroquine or chloroquine
- 4 or more swollen joints and 4 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 Protein (CRP) blood result of 10mg/L or more
- At least one of the following: documented history of positive rheumatoid factor (blood test), current presence of rheumatoid factor (blood test), radiographic erosion within 12 months prior to study enrolment, presence of serum anti-cyclic citrullinated peptide antibodies (blood test)
Exclusion Criteria
- Females who are pregnant or breast feeding
- Poorly controlled hypertension
- Liver disease or significant liver function test abnormalities
- Certain inflammatory conditions (other than rheumatoid arthritis), connective tissue diseases or chronic pain disorders
- Recent or significant cardiovascular disease
- Significant active or recent infection including tuberculosis
- Previous failure to respond to a TNF alpha antagonist, anakinra or previous treatment with other biological agent
- Severe renal impairment
- Neutropenia
Data sourced from ClinicalTrials.gov (NCT01197534). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.