Phase 2
Completed N=135
Study of the Effect of Fostamatinib Twice Daily on Blood Pressure in Patients With Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT01563978 ↗Enrolled (actual)
135
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcomePrimary: Change From Baseline in 24-hour Mean Ambulatory SBP — 4.3; 1.3 mmHg — p=0.023
Summary
The purpose of this study is to evaluate the effect of fostamatinib compared to placebo on ambulatory blood pressure in patients with active rheumatoid arthritis who are taking a disease-modifying anti-rheumatic drug (DMARD).
The study will last for 57 days.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in 24-hour Mean Ambulatory SBP |
4.3; 1.3 | 0.023 sig |
| SECONDARY Change From Baseline in 24-hour Mean Ambulatory DBP |
4.4; 0.7 | <0.001 sig |
| SECONDARY Change From Baseline in Mean Daytime and Night-time SBP and DBP by Ambulatory Blood Pressure Monitoring |
4.9; 1.6; 4.7; 0.8; 3.0; 0.9 | 0.020 sig |
| SECONDARY Change From Baseline in Mean Awake SBP and DBP by Ambulatory Blood Pressure Monitoring |
4.8; 1.4; 4.8; 0.8 | 0.024 sig |
| SECONDARY Change From Baseline in Mean Sleeping SBP and DBP by Ambulatory Blood Pressure Monitoring |
2.4; 0.7; 2.8; 0.5 | 0.223 |
| SECONDARY Mean Change From Baseline in Clinic SBP and DBP |
3.8; 2.9; 2.7; 0.7 | 0.200 |
| SECONDARY Mean Change From Baseline in Morning Pre-dose Home SBP and DBP |
5.1; -1.3; 4.0; -0.4 | <0.001 sig |
| SECONDARY Mean Change From Baseline in Evening Post-dose Home SBP and DBP |
5.3; -1.6; 3.7; -1.0 | <0.001 sig |
| SECONDARY Mean Change From Completion/Discontinuation to Follow-up in Clinical Measurement of SBP and DBP |
-3.3; -0.5; -1.8; -0.6 | — |
| SECONDARY DAS28-CRP Improvement |
0.8; 0.3; 1.0; 0.3; 1.2; 0.5 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Male and female patients aged 18 or over diagnosed with rheumatoid arthritis after the age of 16
- Active rheumatoid arthritis defined as: ≥4 swollen joints and ≥4 tender/painful joints (from 28 joint count) and either erythrocyte sedimentation rate ≥28 mm/h, or C-reactive protein ≥10 mg/L.
- Currently taking one of the following disease-modifying anti-rheumatic drugs: methotrexate, sulfasalazine, hydroxychloroquine or chloroquine.
- Patients without essential hypertension or with essential hypertension if their blood pressure is controlled (<140/90 mmHg) with anti-hypertensive medications being stable at least 4 weeks prior to randomisation.
Exclusion Criteria
- Females who are pregnant or breastfeeding.
- Certain inflammatory conditions (other than rheumatoid arthritis), connective tissue diseases or chronic pain disorders
- History of liver problems that have required previous investigations
- Evidence of tuberculosis infection
- Conditions that preclude or render difficult the 24-hour ambulatory blood pressure monitoring technique.
Data sourced from ClinicalTrials.gov (NCT01563978). 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.