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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 4 November 2013
Main ID:  EUCTR2011-006070-73-CZ
Date of registration: 29/02/2012
Prospective Registration: Yes
Primary sponsor: AstraZeneca AB
Public title: 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
Scientific title: 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
Date of first enrolment: 16/05/2012
Target sample size: 130
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-006070-73
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2  
Phase: 
Countries of recruitment
Argentina Brazil Bulgaria Czech Republic Germany Mexico Peru Poland
South Africa Ukraine United States
Contacts
Name: Clinical Study Information Center   
Address:  NA NA NA
Telephone: NA
Email: information.center@astrazeneca.com
Affiliation:  AstraZeneca AB
Name: Clinical Study Information Center   
Address:  NA NA NA
Telephone: NA
Email: information.center@astrazeneca.com
Affiliation:  AstraZeneca AB
Key inclusion & exclusion 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 (<140/90 mmHg) with anti-hypertensive medications being stable at least 4 weeks prior to randomisation.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 117
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 13

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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Rheumatoid arthritis
MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Intervention(s)

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 Sponsor code: R935788 sodium
Other descriptive name: R788 sodium hexahydrate, RIG2-01, RIG-G
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)
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
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).

Timepoint(s) of evaluation of this end point: After 4 weeks of treatment with fostamatinib or placebo
Secondary Outcome(s)
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
Secondary ID(s)
2011-006070-73-DE
D4300C00033
Source(s) of Monetary Support
AstraZeneca AB
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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