Trial Outcomes & Findings for Randomised Double-Blind, Placebo-Controlled, Parallel Group Study in Patients With Active Rheumatoid Arthritis:Magnetic Resonance Imaging Sub-Study (NCT NCT02092961)
NCT ID: NCT02092961
Last Updated: 2014-06-25
Results Overview
OMERACT RAMRIS synovitis score was based on 8 joints, scored from MRI images, and ranged from 0 to 24 with a smaller value indicating a better clinical condition. Median changes from baseline are shown at each visit (defined as post-baseline minus baseline) with negative values indicative of a better clinical condition. BID = twice daily, CI = confidence interval, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, MRI = magnetic resonance imaging, OMERACT = Outcome Measures in Rheumatoid Arthritis Clinical Trials, PO = orally, RAMRIS = Rheumatoid Arthritis Magnetic Resonance Image Scoring system, SC = subcutaneous.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
198 participants
Primary outcome timeframe
Baseline, 6 and 24 weeks
Results posted on
2014-06-25
Participant Flow
198 patients were enrolled: 34, 33 and 30 were randomised to Groups A, D and E (33, 28 and 29 received at least 1 dose of IP). Two of the randomised patients were in the main study (D4300C00004).
A total of 101 patients failed screening.
Participant milestones
| Measure |
FOSTA 100 MG PO BID
Dosing Group A
|
ADALIMUMAB 40 MG SC
Dosing Group D
|
PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID
Dosing Group E
|
|---|---|---|---|
|
Overall Study
STARTED
|
33
|
28
|
29
|
|
Overall Study
Randomised But Did Not Receive Treatment
|
1
|
5
|
1
|
|
Overall Study
COMPLETED
|
12
|
14
|
13
|
|
Overall Study
NOT COMPLETED
|
21
|
14
|
16
|
Reasons for withdrawal
| Measure |
FOSTA 100 MG PO BID
Dosing Group A
|
ADALIMUMAB 40 MG SC
Dosing Group D
|
PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID
Dosing Group E
|
|---|---|---|---|
|
Overall Study
Not reported
|
1
|
0
|
1
|
|
Overall Study
Study stopped
|
13
|
9
|
12
|
|
Overall Study
Lack of therapeutic response
|
2
|
1
|
3
|
|
Overall Study
Dev. of study specific discont. criteria
|
3
|
0
|
0
|
|
Overall Study
Adverse Event
|
2
|
4
|
0
|
Baseline Characteristics
Randomised Double-Blind, Placebo-Controlled, Parallel Group Study in Patients With Active Rheumatoid Arthritis:Magnetic Resonance Imaging Sub-Study
Baseline characteristics by cohort
| Measure |
FOSTA 100 MG PO BID
n=33 Participants
Dosing Group A
|
ADALIMUMAB 40 MG SC
n=28 Participants
Dosing Group D
|
PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID
n=29 Participants
Dosing Group E
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 11.3 • n=39 Participants
|
53 years
STANDARD_DEVIATION 12.5 • n=41 Participants
|
48 years
STANDARD_DEVIATION 14.7 • n=35 Participants
|
51 years
STANDARD_DEVIATION 12.9 • n=31 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=39 Participants
|
22 Participants
n=41 Participants
|
21 Participants
n=35 Participants
|
65 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
25 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
White
|
24 Participants
n=39 Participants
|
23 Participants
n=41 Participants
|
21 Participants
n=35 Participants
|
68 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
7 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Indian or Pakistani
|
5 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
9 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
6 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 and 24 weeksPopulation: The sub-study analysis set includes those patients who received at least 1 dose of investigational product in the MRI sub-study. Patients were analysed by randomised treatment, but only those with available images were included in the analysis.
OMERACT RAMRIS synovitis score was based on 8 joints, scored from MRI images, and ranged from 0 to 24 with a smaller value indicating a better clinical condition. Median changes from baseline are shown at each visit (defined as post-baseline minus baseline) with negative values indicative of a better clinical condition. BID = twice daily, CI = confidence interval, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, MRI = magnetic resonance imaging, OMERACT = Outcome Measures in Rheumatoid Arthritis Clinical Trials, PO = orally, RAMRIS = Rheumatoid Arthritis Magnetic Resonance Image Scoring system, SC = subcutaneous.
Outcome measures
| Measure |
FOSTA 100 MG PO BID
n=33 Participants
Dosing Group A
|
ADALIMUMAB 40 MG SC
n=28 Participants
Dosing Group D
|
PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID
n=29 Participants
Dosing Group E
|
|---|---|---|---|
|
OMERACT RAMRIS Synovitis Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab (Van Elteren)
6 weeks (n=25, 22, 20)
|
-1.50 Units on a scale
Interval -3.0 to 0.0
|
-0.50 Units on a scale
Interval -1.0 to 0.0
|
0.00 Units on a scale
Interval -0.5 to 1.63
|
|
OMERACT RAMRIS Synovitis Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab (Van Elteren)
24 weeks (n=18, 16, 18)
|
-0.25 Units on a scale
Interval -3.0 to 1.0
|
-1.03 Units on a scale
Interval -2.0 to 0.0
|
0.00 Units on a scale
Interval -2.75 to 1.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 and 24 weeksPopulation: The sub-study analysis set includes those patients who received at least 1 dose of investigational product in the MRI sub-study. Patients were analysed by randomised treatment, but only those with available images were included in the analysis.
OMERACT RAMRIS osteitis score was based on 25 joints, scored from MRI images, and ranged from 0 to 75 with a smaller value indicating a better clinical condition. Median changes from baseline are shown at each visit (defined as post-baseline minus baseline) with negative values indicative of a better clinical condition. BID = twice daily, CI = confidence interval, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, MRI = magnetic resonance imaging, OMERACT = Outcome Measures in Rheumatoid Arthritis Clinical Trials, PO = orally, RAMRIS = Rheumatoid Arthritis Magnetic Resonance Image Scoring system, SC = subcutaneous.
Outcome measures
| Measure |
FOSTA 100 MG PO BID
n=33 Participants
Dosing Group A
|
ADALIMUMAB 40 MG SC
n=28 Participants
Dosing Group D
|
PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID
n=29 Participants
Dosing Group E
|
|---|---|---|---|
|
OMERACT RAMRIS Osteitis Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab (Van Elteren)
24 weeks (n=18, 16, 18)
|
0.00 Units on a scale
Interval -3.5 to 6.0
|
0.00 Units on a scale
Interval -1.67 to 1.25
|
0.00 Units on a scale
Interval -1.0 to 2.0
|
|
OMERACT RAMRIS Osteitis Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab (Van Elteren)
6 weeks (n=25, 22, 20)
|
0.00 Units on a scale
Interval -0.5 to 0.5
|
0.00 Units on a scale
Interval -1.0 to 0.0
|
0.00 Units on a scale
Interval -0.5 to 1.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 and 24 weeksPopulation: The sub-study analysis set includes those patients who received at least 1 dose of investigational product in the MRI sub-study. Patients were analysed by randomised treatment, but only those with available images were included in the analysis.
Joint space narrowing score was based on 20 joints, scored from MRI images and ranged from 0 to 80 with a smaller value indicating a better clinical condition. Median changes from baseline are shown at each visit (defined as post-baseline minus baseline) with negative values indicative of a better clinical condition. BID = twice daily, CI = confidence interval, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, JSN = joint space narrowing, MRI = magnetic resonance imaging, PO = orally, SC = subcutaneous.
Outcome measures
| Measure |
FOSTA 100 MG PO BID
n=33 Participants
Dosing Group A
|
ADALIMUMAB 40 MG SC
n=28 Participants
Dosing Group D
|
PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID
n=29 Participants
Dosing Group E
|
|---|---|---|---|
|
Joint Space Narrowing - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab (Van Elteren)
24 weeks (n=18, 16, 18)
|
0.00 Units on a scale
Interval 0.0 to 0.0
|
0.00 Units on a scale
Interval 0.0 to 0.0
|
0.00 Units on a scale
Interval 0.0 to 1.0
|
|
Joint Space Narrowing - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab (Van Elteren)
6 weeks (n=25, 22, 20)
|
0.00 Units on a scale
Interval 0.0 to 0.0
|
0.00 Units on a scale
Interval 0.0 to 0.0
|
0.00 Units on a scale
Interval 0.0 to 0.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 and 24 weeksPopulation: The sub-study analysis set includes those patients who received at least 1 dose of investigational product in the MRI sub-study. Patients were analysed by randomised treatment, but only those with available images were included in the analysis.
OMERACT RAMRIS erosions score was based on 25 joints and ranged from 0 to 250 with a smaller value indicating a better clinical condition. Median changes from baseline are shown at each visit (defined as post-baseline minus baseline) with negative values indicative of a better clinical condition. BID = twice daily, CI = confidence interval, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, MRI = magnetic resonance imaging, OMERACT = Outcome Measures in Rheumatoid Arthritis Clinical Trials, PO = orally, RAMRIS = Rheumatoid Arthritis Magnetic Resonance Image Scoring system, SC = subcutaneous.
Outcome measures
| Measure |
FOSTA 100 MG PO BID
n=33 Participants
Dosing Group A
|
ADALIMUMAB 40 MG SC
n=28 Participants
Dosing Group D
|
PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID
n=29 Participants
Dosing Group E
|
|---|---|---|---|
|
OMERACT RAMRIS Erosions Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab (Van Elteren)
6 weeks (n=25, 22, 20)
|
0.00 Units on a scale
Interval 0.0 to 1.0
|
0.00 Units on a scale
Interval -0.5 to 0.75
|
0.50 Units on a scale
Interval 0.0 to 1.0
|
|
OMERACT RAMRIS Erosions Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab (Van Elteren)
24 weeks (n=18, 16, 18)
|
1.00 Units on a scale
Interval 0.0 to 3.0
|
0.00 Units on a scale
Interval -0.75 to 0.5
|
1.25 Units on a scale
Interval 0.0 to 4.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 and 24 weeksPopulation: The sub-study analysis set includes those patients who received at least 1 dose of investigational product in the MRI sub-study. Patients were analysed by randomised treatment in accordance with the intention to treat principle.
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. Mean changes from baseline in DAS28-CRP score are shown at each visit and are presented as decreases from baseline (defined as baseline minus post-baseline) with larger changes indicative of a better clinical condition. ANCOVA = analysis of covariance, BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, MRI = magnetic resonance imaging, PO = orally, SC = subcutaneous.
Outcome measures
| Measure |
FOSTA 100 MG PO BID
n=33 Participants
Dosing Group A
|
ADALIMUMAB 40 MG SC
n=28 Participants
Dosing Group D
|
PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID
n=29 Participants
Dosing Group E
|
|---|---|---|---|
|
DAS-CRP Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab
6 weeks (n=32, 27, 27)
|
1.4 Units on a scale
Standard Deviation 1.35 • Interval 0.0 to 1.0
|
1.1 Units on a scale
Standard Deviation 1.16 • Interval -0.5 to 0.75
|
0.5 Units on a scale
Standard Deviation 1.06 • Interval 0.0 to 1.5
|
|
DAS-CRP Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab
24 weeks (n=20, 19, 17)
|
1.1 Units on a scale
Standard Deviation 1.61 • Interval 0.0 to 3.0
|
1.5 Units on a scale
Standard Deviation 1.44 • Interval -0.75 to 0.5
|
1.6 Units on a scale
Standard Deviation 1.39 • Interval 0.0 to 4.5
|
Adverse Events
ADALIMUMAB 40 MG
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
FOSTA 100 MG BID
Serious events: 3 serious events
Other events: 17 other events
Deaths: 0 deaths
PLACEBO (6 WKS) THEN FOSTA 100 MG BID - FOSTA Period
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
PLACEBO (6 WKS) THEN FOSTA 100 MG BID - Placebo Period
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ADALIMUMAB 40 MG
n=28 participants at risk
Dosing Group D
|
FOSTA 100 MG BID
n=33 participants at risk
Dosing Group A
|
PLACEBO (6 WKS) THEN FOSTA 100 MG BID - FOSTA Period
n=22 participants at risk
|
PLACEBO (6 WKS) THEN FOSTA 100 MG BID - Placebo Period
n=29 participants at risk
|
|---|---|---|---|---|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/28 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
3.0%
1/33 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/22 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/29 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Injury, poisoning and procedural complications
FEMORAL NECK FRACTURE
|
0.00%
0/28 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
3.0%
1/33 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/22 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/29 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMORRHAGE
|
0.00%
0/28 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
3.0%
1/33 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/22 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/29 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Musculoskeletal and connective tissue disorders
EXOSTOSIS
|
0.00%
0/28 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/33 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/22 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
3.4%
1/29 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.00%
0/28 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/33 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/22 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
3.4%
1/29 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
3.6%
1/28 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/33 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/22 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/29 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
3.6%
1/28 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/33 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/22 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/29 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Vascular disorders
ORTHOSTATIC HYPOTENSION
|
3.6%
1/28 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/33 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/22 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/29 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
Other adverse events
| Measure |
ADALIMUMAB 40 MG
n=28 participants at risk
Dosing Group D
|
FOSTA 100 MG BID
n=33 participants at risk
Dosing Group A
|
PLACEBO (6 WKS) THEN FOSTA 100 MG BID - FOSTA Period
n=22 participants at risk
|
PLACEBO (6 WKS) THEN FOSTA 100 MG BID - Placebo Period
n=29 participants at risk
|
|---|---|---|---|---|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/28 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
9.1%
3/33 • Number of events 3 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/22 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/29 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Gastrointestinal disorders
DIARRHOEA
|
3.6%
1/28 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
9.1%
3/33 • Number of events 3 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
4.5%
1/22 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
3.4%
1/29 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/28 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/33 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
9.1%
2/22 • Number of events 2 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/29 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Infections and infestations
NASOPHARYNGITIS
|
3.6%
1/28 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
9.1%
3/33 • Number of events 3 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
9.1%
2/22 • Number of events 2 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/29 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.00%
0/28 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
9.1%
3/33 • Number of events 3 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/22 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/29 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Musculoskeletal and connective tissue disorders
RHEUMATOID ARTHRITIS
|
3.6%
1/28 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
6.1%
2/33 • Number of events 2 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
9.1%
2/22 • Number of events 2 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
3.4%
1/29 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/28 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/33 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/22 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
6.9%
2/29 • Number of events 2 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/28 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
12.1%
4/33 • Number of events 4 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
4.5%
1/22 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
3.4%
1/29 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Gastrointestinal disorders
NAUSEA
|
3.6%
1/28 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
6.1%
2/33 • Number of events 2 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/22 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/29 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
7.1%
2/28 • Number of events 2 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/33 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
4.5%
1/22 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/29 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.00%
0/28 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
6.1%
2/33 • Number of events 2 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/22 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/29 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
0.00%
0/28 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
6.1%
2/33 • Number of events 2 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/22 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/29 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Nervous system disorders
DIZZINESS
|
3.6%
1/28 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
6.1%
2/33 • Number of events 2 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/22 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/29 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Nervous system disorders
DYSGEUSIA
|
0.00%
0/28 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
6.1%
2/33 • Number of events 2 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/22 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/29 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Skin and subcutaneous tissue disorders
RASH MACULAR
|
0.00%
0/28 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
6.1%
2/33 • Number of events 2 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/22 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/29 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The disclosure restriction on the PI is that the sponsor can review and comment on results communications prior to publication. Sponsor will be allowed a review period of at least 60 days from submission but can request that publication be delayed for a period up to 6 months. Any reasonable comments made by the sponsor will be incorporated by the PI into the publication.
- Publication restrictions are in place
Restriction type: OTHER