Evaluation of the Effect of Fostamatinib Dosed at 100mg twice a Day on Blood Pressure when Walking, Moving Around and Living Normal Daily Life in Patients with Rheumatoid Arthritis

A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Effect of Fostamatinib 100 mg Twice Daily on 24-hour Ambulatory Blood Pressure in Patients with Rheumatoid Arthritis - Oskira ABPM

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-006070-73-DE

Enrollment

130

Registered

2012-02-24

Start date

2012-08-28

Completion date

Unknown

Last updated

2014-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis MedDRA version: 15.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Product Name: Fostamatinib 50 mg blue film-coated tablet Product Code: R935788 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Fostamatinib disodium CAS Number: 914295-16-2 Current Spons

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male and female patients aged 18 or over diagnosed with Rheumatoid Arthritis after the age of 16 2. Active Rheumatoid Arthritis 3. Currently taking one of the following DMARD treatments: methotrexate, sulfasalazine, hydroxychloroquine or chloroquine. 4. Patients with essential hypertension may be included provided that their BP is controlled (=65 years) yes F.1.3.1 Number of subjects for this age range 13

Exclusion criteria

Exclusion criteria: 1. Females who are pregnant or breast feeding 2. Certain inflammatory conditions (other than RA), connective tissue diseases or chronic pain disorders 3. History of liver problems that have required previous investigations 4. Evidence of TB infection 5. Conditions that preclude or render difficult the 24-hour ABPM technique. 6. Known secondary causes of hypertension. 7. Evidence of recent significant CV disease. 8. Severely impaired renal function. 9. Evidence of recent or active infection. 10. Absolute neutrophil count (ANC) <1500/mm3 or 1.5 x 109/L. 11. Any other clinically significant disease or disorder, which in the opinion of the investigator (by its nature or by being inadequately controlled) might put the patient at risk due to participation in the study

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to assess the effect of fostamatinib (100 mg twice daily [bid] taken in combination with a disease-modifying anti-rheumatic drug [DMARD]), relative to placebo plus a DMARD, on mean 24-hour ambulatory systolic blood pressure (SBP) at Week 4, in patients with active rheumatoid arthritis (RA).;Primary end point(s): Mean change from baseline in 24-hour mean ambulatory SBP ;Timepoint(s) of evaluation of this end point: After 4 weeks of treatment with fostamatinib or placebo;Secondary Objective: • To assess the effect of fostamatinib (100 mg bid taken in combination with a DMARD), relative to placebo plus a DMARD, on mean 24-hour ambulatory diastolic blood pressure (DBP) at Week 4, in patients with active RA. • To describe the effect of fostamatinib on blood pressure (BP) throughout the day by comparing daytime, night-time, awake and sleeping SBP and DBP between fostamatinib and placebo groups by ambulatory blood pressure monitoring (ABPM). • To describe the effects of fostamatinib on BP as determined by clinic and home BP measurements. • To describe the BP effects following discontinuation of fostamatinib (persistence and/or reversibility of any effect), including subjects who stopped the treatment prematurely due to BP elevation above the predefined threshold and for other safety reasons. • To evaluate the efficacy of fostamatinib as measured by Disease Activity Score based on a 28 joint count (DAS28).	—

Measure

Time frame

Main Objective: The primary objective of this study is to assess the effect of fostamatinib (100 mg twice daily [bid] taken in combination with a disease-modifying anti-rheumatic drug [DMARD]), relative to placebo plus a DMARD, on mean 24-hour ambulatory systolic blood pressure (SBP) at Week 4, in patients with active rheumatoid arthritis (RA).;Primary end point(s): Mean change from baseline in 24-hour mean ambulatory SBP ;Timepoint(s) of evaluation of this end point: After 4 weeks of treatment with fostamatinib or placebo;Secondary Objective: • To assess the effect of fostamatinib (100 mg bid taken in combination with a DMARD), relative to placebo plus a DMARD, on mean 24-hour ambulatory diastolic blood pressure (DBP) at Week 4, in patients with active RA. • To describe the effect of fostamatinib on blood pressure (BP) throughout the day by comparing daytime, night-time, awake and sleeping SBP and DBP between fostamatinib and placebo groups by ambulatory blood pressure monitoring (ABPM). • To describe the effects of fostamatinib on BP as determined by clinic and home BP measurements. • To describe the BP effects following discontinuation of fostamatinib (persistence and/or reversibility of any effect), including subjects who stopped the treatment prematurely due to BP elevation above the predefined threshold and for other safety reasons. • To evaluate the efficacy of fostamatinib as measured by Disease Activity Score based on a 28 joint count (DAS28).

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Secondary

Measure	Time frame
Secondary end point(s): Mean change from baseline in 24-hour mean ambulatory DBP Mean change from baseline in mean daytime (6am-10pm) SBP and DBP, night time (10pm-6am) SBP and DBP, awake and sleeping SBP and DBP Mean change from baseline in morning pre-dose and evening post-dose home SBP and DBP Mean change from completion/discontinuation to follow-up in clinical measurement of SBP and DBP; DAS28-CRP, DAS28-ESR, DAS28 EULAR response criteria, HAQ-DI, individual components of DAS28, patient’s global assessment of disease activity, physician’s global assessment of disease activity and patient’s assessment of pain, CRP, ESR. ;Timepoint(s) of evaluation of this end point: After 4 weeks of treatment with fostamatinib or placebo	—

Measure

Time frame

Secondary end point(s): Mean change from baseline in 24-hour mean ambulatory DBP Mean change from baseline in mean daytime (6am-10pm) SBP and DBP, night time (10pm-6am) SBP and DBP, awake and sleeping SBP and DBP Mean change from baseline in morning pre-dose and evening post-dose home SBP and DBP Mean change from completion/discontinuation to follow-up in clinical measurement of SBP and DBP; DAS28-CRP, DAS28-ESR, DAS28 EULAR response criteria, HAQ-DI, individual components of DAS28, patient’s global assessment of disease activity, physician’s global assessment of disease activity and patient’s assessment of pain, CRP, ESR. ;Timepoint(s) of evaluation of this end point: After 4 weeks of treatment with fostamatinib or placebo

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Countries

Argentina, Brazil, Bulgaria, Czech Republic, Germany, Mexico, Peru, Poland, South Africa, Ukraine, United States

Contacts

Public ContactClinical Study Information Center

AstraZeneca AB

information.center@astrazeneca.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026