Trial Outcomes & Findings for Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Not Responding. (NCT NCT01197521)

NCT ID: NCT01197521

Last Updated: 2014-04-07

Results Overview

ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DMARD=disease-modifying anti-rheumatic drug, PO=orally, QD=once a day.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

923 participants

Primary outcome timeframe

24 weeks

Results posted on

2014-04-07

Participant Flow

A total of 1475 patients were enrolled: 311, 306 \& 306 were randomised to Groups A, B \& C, respectively (310, 304 \& 304 received at least 1 dose of IP).

A total of 552 patients failed screening.

Participant milestones

Participant milestones
Measure	FOSTA 100 MG BID PO Dosing Group A	FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO Dosing Group B	PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO Dosing Group C
Overall Study STARTED	310	304	304
Overall Study Randomised But Did Not Receive Treatment	1	2	2
Overall Study COMPLETED	207	191	161
Overall Study NOT COMPLETED	103	113	143

Reasons for withdrawal

Reasons for withdrawal
Measure	FOSTA 100 MG BID PO Dosing Group A	FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO Dosing Group B	PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO Dosing Group C
Overall Study Not reported	24	25	21
Overall Study Enrolment in long term extension	42	36	87
Overall Study Severe non-compliance to protocol	1	3	3
Overall Study Lack of therapeutic response	2	3	4
Overall Study Dev. of study specific discont. criteria	6	16	2
Overall Study Lost to Follow-up	3	2	2
Overall Study Adverse Event	25	28	24

Baseline Characteristics

Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Not Responding.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FOSTA 100 MG BID PO n=310 Participants Dosing Group A	FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO n=304 Participants Dosing Group B	PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO n=304 Participants Dosing Group C	Total n=918 Participants Total of all reporting groups
Age, Continuous	52 years STANDARD_DEVIATION 12.2 • n=93 Participants	52 years STANDARD_DEVIATION 12.0 • n=4 Participants	53 years STANDARD_DEVIATION 11.9 • n=27 Participants	52 years STANDARD_DEVIATION 12.0 • n=483 Participants
Sex: Female, Male Female	263 Participants n=93 Participants	254 Participants n=4 Participants	253 Participants n=27 Participants	770 Participants n=483 Participants
Sex: Female, Male Male	47 Participants n=93 Participants	50 Participants n=4 Participants	51 Participants n=27 Participants	148 Participants n=483 Participants
Race/Ethnicity, Customized White	218 Participants n=93 Participants	213 Participants n=4 Participants	209 Participants n=27 Participants	640 Participants n=483 Participants
Race/Ethnicity, Customized Black or African American	9 Participants n=93 Participants	5 Participants n=4 Participants	11 Participants n=27 Participants	25 Participants n=483 Participants
Race/Ethnicity, Customized Asian	3 Participants n=93 Participants	10 Participants n=4 Participants	5 Participants n=27 Participants	18 Participants n=483 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	14 Participants n=93 Participants	12 Participants n=4 Participants	11 Participants n=27 Participants	37 Participants n=483 Participants
Race/Ethnicity, Customized Indian or Pakistani	20 Participants n=93 Participants	14 Participants n=4 Participants	19 Participants n=27 Participants	53 Participants n=483 Participants
Race/Ethnicity, Customized Other	46 Participants n=93 Participants	50 Participants n=4 Participants	49 Participants n=27 Participants	145 Participants n=483 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.

Outcome measures

Outcome measures
Measure	FOSTA 100 MG BID PO n=310 Participants Dosing Group A	FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO n=304 Participants Dosing Group B	PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO n=304 Participants Dosing Group C
Proportion of Patients With ACR20 at Week 24, Comparison Between Fostamatinib and Placebo.	49.0 Percentage of responders	44.4 Percentage of responders	34.2 Percentage of responders

PRIMARY outcome

Timeframe: Baseline and 24 weeks

Population: The full analysis set includes those patients who received at least 1 dose of IP. Patients were analysed by randomised treatment. Measurements at 2 timepoints are required in order for a patient to be included in the analysis; therefore patients with only 1 result have been excluded from the analysis population.

mTSS: modified total Sharp score, a measure of structural progression based upon X-rays. Hand and foot joints are scored for erosions and joint space narrowing and the results summed to give a value between 0 and 448. A higher value represents more serious progression of the disease. After disregarding ineligible records, patients with 2 or more non-missing values have had missing data imputed via linear extrapolation/interpolation methods. Patients with only 1 result have been excluded from the analysis. ANCOVA=analysis of covariance, BID=twice daily, DMARD=disease-modifying anti-rheumatic drug, IP=investigational product, PO=orally, QD=once a day.

Outcome measures

Outcome measures
Measure	FOSTA 100 MG BID PO n=285 Participants Dosing Group A	FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO n=277 Participants Dosing Group B	PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO n=278 Participants Dosing Group C
Change From Baseline to Week 24 in mTSS, Comparison Between Fostamatinib and Placebo.	0.45 Units on a scale Standard Deviation 2.201	1.29 Units on a scale Standard Deviation 13.380	0.13 Units on a scale Standard Deviation 2.142

SECONDARY outcome

Timeframe: 1 week

Outcome measures

Outcome measures
Measure	FOSTA 100 MG BID PO n=614 Participants Dosing Group A	FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO n=304 Participants Dosing Group B	PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO Dosing Group C
ACR20 - Proportion of Patients Achieving ACR20, Comparison Between Fostamatinib and Placebo at Week 1	18.2 Percentage of responders	4.9 Percentage of responders	—

SECONDARY outcome

Timeframe: 24 weeks

ACR50: American College of Rheumatology 50% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, PO=orally, QD=once a day.

Outcome measures

Outcome measures
Measure	FOSTA 100 MG BID PO n=310 Participants Dosing Group A	FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO n=304 Participants Dosing Group B	PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO n=304 Participants Dosing Group C
Proportion of Patients Achieving ACR50 up to Week 24	26.1 Percentage of responders	18.4 Percentage of responders	9.9 Percentage of responders

SECONDARY outcome

Timeframe: 24 weeks

ACR70: American College of Rheumatology 70% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, PO=orally, QD=once a day.

Outcome measures

Outcome measures
Measure	FOSTA 100 MG BID PO n=310 Participants Dosing Group A	FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO n=304 Participants Dosing Group B	PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO n=304 Participants Dosing Group C
Proportion of Patients Achieving ACR70 up to Week 24	10.3 Percentage of responders	5.6 Percentage of responders	2.0 Percentage of responders

SECONDARY outcome

Timeframe: 24 weeks

ACRn: American College of Rheumatology index of RA improvement, based on smallest percentage improvement in the count of swollen joints (out of 28 joints), count of tender joints (out of 28 joints), or in blood test measures of inflammation (such as CRP) or the physician or patient's own assessments of disease activity, pain and physical function. Scores are reported as a percentage improvement on a scale of -100 to +100, with larger values representing a better clinical outcome. BID=twice daily, CI=confidence interval, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, PO=orally, QD=once a day, RA=rheumatoid arthritis. Mean refers to change at Week 24.

Outcome measures

Outcome measures
Measure	FOSTA 100 MG BID PO n=310 Participants Dosing Group A	FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO n=304 Participants Dosing Group B	PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO n=304 Participants Dosing Group C
ACRn - Comparison Between Fostamatinib and Placebo at Week 24	26.13 Percentage improvement from baseline Standard Deviation 30.833	20.06 Percentage improvement from baseline Standard Deviation 28.599	12.92 Percentage improvement from baseline Standard Deviation 26.611

SECONDARY outcome

Timeframe: 12 weeks

DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. A DAS28-CRP score of \<2.6 is indicative of remission of RA symptoms. BID=twice daily, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, OR=odds ratio, PO=orally, QD=once a day.

Outcome measures

Outcome measures
Measure	FOSTA 100 MG BID PO n=310 Participants Dosing Group A	FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO n=304 Participants Dosing Group B	PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO n=304 Participants Dosing Group C
Proportion of Patients Achieving DAS28-CRP <2.6 at Week 12	10.3 Percentage of responders	7.9 Percentage of responders	2.0 Percentage of responders

SECONDARY outcome

Timeframe: 24 weeks

Outcome measures

Outcome measures
Measure	FOSTA 100 MG BID PO n=310 Participants Dosing Group A	FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO n=304 Participants Dosing Group B	PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO n=304 Participants Dosing Group C
Proportion of Patients Achieving DAS28-CRP <2.6 at Week 24	13.2 Percentage of responders	8.6 Percentage of responders	4.9 Percentage of responders

SECONDARY outcome

Timeframe: 24 weeks

Change in DAS28 was derived for each post baseline scheduled assessment and categorised using the European League Against Rheumatism (EULAR) response criteria. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DAS28=Disease Activity Score based on a 28-joint count, DMARD=disease-modifying anti-rheumatic drug, OR=odds ratio, PO=orally, QD=once a day.

Outcome measures

Outcome measures
Measure	FOSTA 100 MG BID PO n=310 Participants Dosing Group A	FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO n=304 Participants Dosing Group B	PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO n=304 Participants Dosing Group C
Proportion of Patients Achieving DAS28-CRP EULAR Response at Week 24 No response	34.8 Percentage of responders 1.46 • Interval 0.2 to 0.68	41.1 Percentage of responders 1.34 • Interval 0.26 to 0.89	53.0 Percentage of responders 1.30 • Interval 0.2 to 0.65
Proportion of Patients Achieving DAS28-CRP EULAR Response at Week 24 Moderate response	39.0 Percentage of responders	44.4 Percentage of responders	36.2 Percentage of responders
Proportion of Patients Achieving DAS28-CRP EULAR Response at Week 24 Good response	26.1 Percentage of responders	14.5 Percentage of responders	10.9 Percentage of responders

SECONDARY outcome

Timeframe: Baseline and 24 weeks

HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is calculated by summing scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygiene, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with higher score indicating greater disability. HAQ-DI response: a reduction from baseline in HAQ-DI greater than or equal to the minimally important difference (0.22). BID=twice daily, DMARD=disease-modifying anti-rheumatic drug, OR=odds ratio, PO=orally, QD=once a day.

Outcome measures

Outcome measures
Measure	FOSTA 100 MG BID PO n=310 Participants Dosing Group A	FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO n=304 Participants Dosing Group B	PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO n=304 Participants Dosing Group C
HAQ-DI Response - Comparison of the Change (>=0.22) From Baseline Between Fostamatinib and Placebo at Week 24	54.8 Percentage of responders	50.3 Percentage of responders	35.2 Percentage of responders

SECONDARY outcome

Timeframe: Baseline and 24 weeks

SF-36: 36 item Short Form Health Survey, a measure of health-related QoL. Scores for 8 sub-domains (Physical Functioning, Role-physical, Bodily Pain, General Health, Vitality, Social Function, Role-emotional \& Mental Health) are derived \& normalised to a scale of 0-100. Physical Component Scores (PCS) are derived by multiplying each of these 8 scores by a constant, summing them \& standardising against a population with mean of 50, standard deviation of 10. Higher scores represent a better QoL. Mean changes from baseline score are presented at each visit as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. ANCOVA=analysis of covariance, BID=twice daily, DMARD=disease modifying antirheumatic drug, PO=orally, QD=once daily, QoL=quality of life.

Outcome measures

Outcome measures
Measure	FOSTA 100 MG BID PO n=310 Participants Dosing Group A	FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO n=304 Participants Dosing Group B	PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO n=303 Participants Dosing Group C
SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Placebo at Week 24	6 Units on a scale Standard Deviation 8.0	5 Units on a scale Standard Deviation 6.7	3 Units on a scale Standard Deviation 6.2

SECONDARY outcome

Timeframe: Baseline and 24 weeks

SF-36: 36 item Short Form Health Survey, a measure of health-related QoL. Scores for 8 sub-domains (Physical Functioning, Role-physical, Bodily Pain, General Health, Vitality, Social Function, Role-emotional \& Mental Health) are derived \& normalised to a scale of 0-100. Mental Component Scores (MCS) are derived by multiplying each of these 8 scores by a constant, summing them \& standardising against a population with mean of 50, standard deviation of 10. Higher scores represent a better QoL. Mean changes from baseline score are presented at each visit as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. ANCOVA=analysis of covariance, BID=twice daily, DMARD=disease modifying antirheumatic drug, PO=orally, QD=once daily, QoL=quality of life.

Outcome measures

Outcome measures
Measure	FOSTA 100 MG BID PO n=310 Participants Dosing Group A	FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO n=304 Participants Dosing Group B	PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO n=303 Participants Dosing Group C
SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Placebo at Week 24	4 Units on a scale Standard Deviation 9.5	4 Units on a scale Standard Deviation 8.6	2 Units on a scale Standard Deviation 8.1

Adverse Events

FOSTA 100 MG BID

Serious events: 24 serious events

Other events: 169 other events

Deaths: 0 deaths

FOSTA 100 MG BID (4 WKS) THEN 150 MG QD

Serious events: 24 serious events

Other events: 191 other events

Deaths: 0 deaths

PLACEBO (24 WKS) THEN FOSTA 100 MG BID - FOSTA Period

Serious events: 12 serious events

Other events: 64 other events

Deaths: 0 deaths

PLACEBO (24 WKS) THEN FOSTA 100 MG BID - Placebo Period

Serious events: 5 serious events

Other events: 80 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	FOSTA 100 MG BID n=310 participants at risk Dosing Group A	FOSTA 100 MG BID (4 WKS) THEN 150 MG QD n=304 participants at risk Dosing Group B	PLACEBO (24 WKS) THEN FOSTA 100 MG BID - FOSTA Period n=304 participants at risk Dosing Group C	PLACEBO (24 WKS) THEN FOSTA 100 MG BID - Placebo Period n=304 participants at risk
Gastrointestinal disorders ABDOMINAL PAIN UPPER	3.9% 12/310 • Number of events 12 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.	5.3% 16/304 • Number of events 17 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.	0.99% 3/304 • Number of events 3 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.	3.3% 10/304 • Number of events 10 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.
Gastrointestinal disorders DIARRHOEA	19.4% 60/310 • Number of events 84 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.	20.7% 63/304 • Number of events 87 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.	5.9% 18/304 • Number of events 26 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.	3.9% 12/304 • Number of events 14 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.
Gastrointestinal disorders NAUSEA	6.1% 19/310 • Number of events 20 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.	8.9% 27/304 • Number of events 31 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.	2.6% 8/304 • Number of events 9 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.	3.6% 11/304 • Number of events 11 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.
Gastrointestinal disorders VOMITING	5.8% 18/310 • Number of events 18 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.	2.6% 8/304 • Number of events 9 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.	1.6% 5/304 • Number of events 6 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.	1.6% 5/304 • Number of events 5 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.
Infections and infestations NASOPHARYNGITIS	7.1% 22/310 • Number of events 29 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.	9.2% 28/304 • Number of events 34 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.	2.0% 6/304 • Number of events 7 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.	3.6% 11/304 • Number of events 14 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.
Infections and infestations URINARY TRACT INFECTION BACTERIAL	5.8% 18/310 • Number of events 23 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.	4.6% 14/304 • Number of events 19 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.	2.0% 6/304 • Number of events 6 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.	2.0% 6/304 • Number of events 6 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.
Investigations ALANINE AMINOTRANSFERASE INCREASED	7.1% 22/310 • Number of events 27 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.	7.2% 22/304 • Number of events 23 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.	2.6% 8/304 • Number of events 10 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.	1.6% 5/304 • Number of events 6 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	5.2% 16/310 • Number of events 18 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.	4.3% 13/304 • Number of events 15 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.	1.3% 4/304 • Number of events 7 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.	1.6% 5/304 • Number of events 7 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.
Investigations BLOOD PRESSURE INCREASED	5.5% 17/310 • Number of events 18 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.	5.3% 16/304 • Number of events 23 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.	1.3% 4/304 • Number of events 4 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.	1.6% 5/304 • Number of events 5 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.
Musculoskeletal and connective tissue disorders BACK PAIN	5.8% 18/310 • Number of events 19 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.	2.6% 8/304 • Number of events 8 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.	0.66% 2/304 • Number of events 3 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.	0.66% 2/304 • Number of events 2 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.
Musculoskeletal and connective tissue disorders RHEUMATOID ARTHRITIS	5.2% 16/310 • Number of events 18 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.	2.6% 8/304 • Number of events 9 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.	2.0% 6/304 • Number of events 6 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.	3.9% 12/304 • Number of events 13 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.
Nervous system disorders HEADACHE	4.8% 15/310 • Number of events 20 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.	6.6% 20/304 • Number of events 29 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.	2.3% 7/304 • Number of events 7 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.	3.9% 12/304 • Number of events 12 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.
Vascular disorders HYPERTENSION	19.0% 59/310 • Number of events 72 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.	19.1% 58/304 • Number of events 76 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.	3.6% 11/304 • Number of events 13 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.	3.9% 12/304 • Number of events 12 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 5 SAEs occurred during the 24 week placebo treated period.

Additional Information

Dave Goldstraw

AstraZeneca

Phone: +44 (0)1625 512415

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place