Phase 3
Completed N=322
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
Source: ClinicalTrials.gov NCT01197755 ↗Enrolled (actual)
322
Serious AEs
6.2%
Results posted
Apr 2014
Primary outcomePrimary: Proportion of Patients Achieving ACR20 at Week 24, Comparison Between Fostamatinib and Placebo — 36.2; 27.8; 21.1 Percentage of responders — p=0.004
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 methotrexate and have had an inadequate response to a single TNF-alpha antagonist. The study will last for approximately six months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients Achieving ACR20 at Week 24, Comparison Between Fostamatinib and Placebo |
36.2; 27.8; 21.1 | 0.004 sig |
| SECONDARY Proportion of Patients Achieving ACR20 at Week 1, Comparison Between Fostamatinib and Placebo |
3.7; 25.4 | <0.001 sig |
| SECONDARY Proportion of Patients Achieving ACR50 at Week 24, Comparison Between Fostamatinib and Placebo |
18.1; 13.0; 8.3 | 0.014 sig |
| SECONDARY Proportion of Patients Achieving ACR70 at Week 24, Comparison Between Fostamatinib and Placebo |
14.3; 2.8; 2.8 | <0.001 sig |
| SECONDARY ACRn - Comparison Between Fostamatinib and Placebo at Week 24 |
16.25; 13.00; 5.87 | 0.010 sig |
| SECONDARY Proportion of Patients Achieving DAS28-CRP <2.6 at Week 24, Comparison Between Fostamatinib and Placebo |
11.4; 7.4; 3.7 | 0.023 sig |
| SECONDARY Proportion of Patients Achieving DAS28-CRP <=3.2 at Week 12, Comparison Between Fostamatinib and Placebo |
18.1; 20.4; 5.5 | 0.005 sig |
| SECONDARY Proportion of Patients Achieving DAS28-CRP EULAR Response at Week 24, Comparison Between Fostamatinib and Placebo |
46.7; 54.6; 67.9; 29.5; 34.3; 26.6 | <0.001 sig |
| SECONDARY Proportion of Patients With a HAQ-DI Response at Week 24 - Comparison Between Fostamatinib and Placebo |
41.9; 31.5; 23.9 | 0.004 sig |
| SECONDARY Change From Baseline to Week 24 in mTSS Score, Comparison Between Fostamatinib and Placebo |
0.80; 0.18; 0.84 | 0.729 |
| SECONDARY SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Placebo at Week 24 |
5; 4; 2 | 0.009 sig |
| SECONDARY SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Placebo at Week 24 |
2; 2; 2 | 0.487 |
Eligibility Criteria
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 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 12months 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 anakinra or previous treatment with biological agent (other than TNF alpha antagonists including rituximab, abatacept and tocilizumab)
- Severe renal impairment
- Neutropenia
Data sourced from ClinicalTrials.gov (NCT01197755). 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.