Evaluation of Efficacy and Safety of Fostamatinib Monothe... | NCT01264770 | Trialant
NCT01264770
Sponsor
AstraZeneca
Status
Terminated
Last Update Posted
May 6, 2014Estimated
Enrollment
644Actual
Phase
Phase 2
Conditions
Rheumatoid Arthritis
Interventions
Fostamatinib and placebo injections
Fostamatinib and placebo injections
Fostamatinib and placebo injections
Adalimumab and placebo of fostamatinib
Placebo of fostamatinib, fostamatinib, and placebo injections
Countries
United States
Bulgaria
Canada
Czechia
Germany
Hungary
Netherlands
Poland
Russia
Slovakia
South Africa
Ukraine
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01264770
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
D4300C00004
Secondary IDs
ID
Type
Description
Link
2010-023692-26
EudraCT Number
Brief Title
Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA)
Official Title
(OSKIRA-4): A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared With Adalimumab Monotherapy in Patients With Active Rheumatoid Arthritis
Acronym
OSKIRA -4
Organization
AstraZenecaINDUSTRY
Status Module
Record Verification Date
Apr 2014
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
AZ decision to discontinue fostamatinib development in RA; rights to fostamatinib returned to Rigel Pharmaceuticals.
Expanded Access Info
No
Start Date
Jan 2011
Primary Completion Date
Oct 2012Actual
Completion Date
Aug 2013Actual
First Submitted Date
Dec 17, 2010
First Submission Date that Met QC Criteria
Dec 21, 2010
First Posted Date
Dec 22, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 22, 2013
Results First Submitted that Met QC Criteria
Apr 3, 2014
Results First Posted Date
May 6, 2014Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 3, 2014
Last Update Posted Date
May 6, 2014Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AstraZenecaINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of the study is to evaluate the improvements in signs and symptoms of rheumatoid arthritis (RA) for fostamatinib compared to placebo or adalimumab in patients who are Disease-Modifying anti-rheumatic drug (DMARD) naïve, DMARD intolerant or have had an inadequate response to DMARDs. The study will last for approximately six months
Detailed Description
Sub-study:
Full title: Optional Genetic Research
Date: 10 September 2010
Version: 1
Objectives: To collect and store, with appropriate consent , DNA samples for future exploratory research into genes/genetic variation that may influence response (ie, absorption, distribution, metabolism and excretion, safety, tolerability and efficacy) to fostamatinib disodium and/or adalimumab; and/or susceptibility to, progression of and prognosis of RA
The main study recruitment is complete, and sub study recruitment will continue until the target is reached, estimated to be June 2013
Sub-study:
Full title: (Sub-study to OSKIRA-4): A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared with Placebo or Adalimumab Monotherapy in Patients with Active Rheumatoid Arthritis: Magnetic Resonance Imaging Sub-Study
Date: 21 March 2011
Version: 1
Primary objective: Assess the efficacy of fostamatinib in reducing joint synovial disease activity as measured by:
Change from baseline to Week 6 (versus placebo) in OMERACT RAMRIS synovitis score.
Conditions Module
Conditions
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis
OSKIRA
fostamatinib
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
644Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Dosing Group A
Experimental
Oral treatment and subcutaneous injection
Drug: Fostamatinib and placebo injections
Dosing Group B
Experimental
Oral treatment and subcutaneous injection
Drug: Fostamatinib and placebo injections
Dosing Group C
Experimental
Oral treatment and subcutaneous injection
Drug: Fostamatinib and placebo injections
Dosing Group D
Active Comparator
Oral treatment and subcutaneous injection
Drug: Adalimumab and placebo of fostamatinib
Dosing Group E
Placebo Comparator
Oral treatment and subcutaneous injection
Drug: Placebo of fostamatinib, fostamatinib, and placebo injections
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Fostamatinib and placebo injections
Drug
Fostamatinib 100mg twice daily and placebo injection once every two weeks
Dosing Group A
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
DAS28-CRP Score - Change From Baseline to Week 6 Compared to Placebo
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, LS = least squares, n/a = not applicable, PO = orally, QD = once a day, SC = subcutaneous.
Baseline and 6 weeks
DAS28-CRP Score - Change From Baseline to Week 24 Compared to Adalimumab
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. Non-responder imputation has been applied by carrying the baseline observation forward. ANCOVA = analysis of covariance, BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, n/a = not applicable, PO = orally, QD = once a day, SC = subcutaneous.
Baseline and 24 weeks
Secondary Outcomes
Measure
Description
Time Frame
DAS28 EULAR Response at Week 6
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, 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, SC = subcutaneous.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male or female aged 18 and over
Active rheumatoid arthritis (RA) diagnosed after the age of 16 and diagnosis within 5 years prior to study visit 1 and inadequate response to treatment with a maximum 2 Disease-Modifying anti-rheumatic drug (DMARD) therapies, or diagnosis within 5 years prior to study visit 1 and intolerance to DMARD therapy, or diagnosis within 2 years prior to study visit 1 and no previous use of DMARDs
4 or more swollen joints and 4 or more tender/painful joints (from 28 joint count) and either Erythrocyte Sedimentation Rate (ESR) blood result of 28mm/h or more, or C-Reactive Protein (CRP) blood result of 10mg/L or more
At least 2 of the following: documented history or current presence of positive rheumatoid factor (blood test), radiographic erosion within 12 months prior to study enrolment, presence of serum anti-cyclic citrullinated peptide antibodies (blood test)
Exclusion Criteria:
Females who are pregnant or breast feeding
Poorly controlled hypertension
Liver disease or significant liver function test abnormalities
Certain inflammatory conditions (other than rheumatoid arthritis), connective tissue diseases or chronic pain disorders
Recent or significant cardiovascular disease
Significant active or recent infection including tuberculosis
Previously received treatment with a TNF alpha antagonist (including etanercept, certolizumab, adalimumab, infliximab, golimumab) or anakinra or previous treatment with other biological agent including rituximab, abatacept and tocilizumab
Use of any DMARDs within 6 weeks before first study visit
Taylor PC, Genovese MC, Greenwood M, Ho M, Nasonov E, Oemar B, Stoilov R, Vencovsky J, Weinblatt M. OSKIRA-4: a phase IIb randomised, placebo-controlled study of the efficacy and safety of fostamatinib monotherapy. Ann Rheum Dis. 2015 Dec;74(12):2123-9. doi: 10.1136/annrheumdis-2014-205361. Epub 2014 Jul 29.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
A total of 173 patients failed screening to the main study.
Recruitment Details
452 patients were enrolled into the main study, with 198 patients enrolled into a separate MRI sub-study. Synovitis results for the MRI sub-study were reported later due to study delays and so are presented entirely separately.
Fostamatinib 100mg twice daily / fostamatinib 150mg once daily and placebo injection once every two weeks
Dosing Group B
Fostamatinib and placebo injections
Drug
Fostamatinib 100mg twice daily / fostamatinib 100mg once daily and placebo injection once every two weeks.
Dosing Group C
Adalimumab and placebo of fostamatinib
Drug
Adalimumab 40mg injection once every two weeks and placebo to fostamatinib twice daily.
Dosing Group D
Humira®
Placebo of fostamatinib, fostamatinib, and placebo injections
Drug
Placebo injection once every two weeks. Placebo to fostamatinib for six weeks, followed by fostamatinib 100mg twice daily (Group F) / fostamatinib 100mg twice daily then 150mg once daily (Group G).
Dosing Group E
6 weeks
DAS28 EULAR Response at Week 24
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, 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, SC = subcutaneous.
24 weeks
Proportion of Patients Achieving ACR20 up to Week 24
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, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.
6 and 24 weeks
Proportion of Patients Achieving ACR50 up to Week 24
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, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.
6 and 24 weeks
Proportion of Patients Achieving ACR70 up to Week 24
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, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.
6 and 24 weeks
ACRn - Comparison Between Fostamatinib and Placebo at Week 6
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 and patient's own asessment 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. Non-responder imputation has been applied by carrying the baseline observation forward. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous. Mean refers to change at Week 6. Treatment difference: difference between fostamatinib and placebo groups.
Baseline and 6 weeks
ACRn - Comparison Between Fostamatinib and Adalimumab at Week 24
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 and patient's own asessment 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. 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, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous. Mean refers to change at Week 24. Treatment difference: difference between fostamatinib and adalimumab groups.
Baseline and 24 weeks
HAQ-DI - Comparison of the Change From Baseline Between Fostamatinib and Placebo at Week 6
HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is calculated by summing the category 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 a higher score indicating greater disability. Non-responder imputation has been applied by carrying the baseline observation forward. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.
Baseline and 6 weeks
HAQ-DI - Comparison of the Change From Baseline Between Fostamatinib and Adalimumab at Week 24
HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is calculated by summing the category 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 a higher score indicating greater disability. Non-responder imputation has been applied by carrying the baseline observation forward. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.
Baseline and 24 weeks
SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Adalimumab at Week 24
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 & Mental Component Scores (PCS & 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. Non-responder imputation applied by carrying the baseline observation forward. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, PO = orally, QD = once a day, QoL = quality of life, SC = subcutaneous.
Baseline and 24 weeks
SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Adalimumab at Week 24
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 & Mental Component Scores (PCS & 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. Non-responder imputation applied by carrying the baseline observation forward. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, PO = orally, QD = once a day, QoL = quality of life, SC = subcutaneous.
Baseline and 24 weeks
Glendale
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FG002
FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
Dosing Group C
FG003
ADALIMUMAB 40 MG SC
Dosing Group D
FG004
PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
Dosing Group F
FG005
PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
Dosing Group G
FG00054 subjectsPatients who received treatment
FG00148 subjectsPatients who received treatment
FG00257 subjectsPatients who received treatment
FG00354 subjectsPatients who received treatment
FG00427 subjectsPatients who received treatment
FG00525 subjectsPatients who received treatment
Randomised But Did Not Receive Treatment
FG0002 subjectsEligibility criteria not fulfilled/subject decision/other
FG0015 subjectsEligibility criteria not fulfilled/subject decision/other
FG0022 subjectsEligibility criteria not fulfilled/subject decision/other
FG0033 subjectsEligibility criteria not fulfilled/subject decision/other
FG0042 subjectsEligibility criteria not fulfilled/subject decision/other
FG0050 subjectsEligibility criteria not fulfilled/subject decision/other
COMPLETED
FG00036 subjectsNumber of patients who completed treatment includes patients who had a dose reduction.
FG00138 subjectsNumber of patients who completed treatment includes patients who had a dose reduction.
FG00241 subjectsNumber of patients who completed treatment includes patients who had a dose reduction.
FG00348 subjectsNumber of patients who completed treatment includes patients who had a dose reduction.
FG00419 subjectsNumber of patients who completed treatment includes patients who had a dose reduction.
FG00519 subjectsNumber of patients who completed treatment includes patients who had a dose reduction.
NOT COMPLETED
FG00018 subjects
FG00110 subjects
FG00216 subjects
FG0036 subjects
FG0048 subjects
FG0056 subjects
Type
Comment
Reasons
Not reported
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
e.g., change in circumstances
FG0008 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
FG004
Severe non-compliance to protocol
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Lack of therapeutic response
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG0031 subjects
FG004
Dev. of study specific discont. criteria
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Adverse Event
FG0007 subjects
FG0017 subjects
FG0028 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
FOSTA 100 MG BID PO
Dosing Group A
BG001
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
Dosing Group B
BG002
FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
Dosing Group C
BG003
ADALIMUMAB 40 MG SC
Dosing Group D
BG004
PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
Dosing Group F
BG005
PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
Dosing Group G
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00054
BG00148
BG00257
BG00354
BG00427
BG00525
BG006265
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00050± 11.5
BG00150± 12.6
BG00250± 11.0
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00038
BG00139
BG002
Race/Ethnicity, Customized
Number
Participants
Title
Denominators
Categories
White
Title
Measurements
BG00048
BG00147
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
DAS28-CRP Score - Change From Baseline to Week 6 Compared to Placebo
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, LS = least squares, n/a = not applicable, PO = orally, QD = once a day, SC = subcutaneous.
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. In line with the study objectives, fostamatinib was compared with placebo (not adalimumab) at Week 6.
Posted
Mean
Standard Deviation
Units on a scale
Baseline and 6 weeks
ID
Title
Description
OG000
Dosing Group A
FOSTA 100 MG BID PO
OG001
Dosing Group B
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
OG002
Dosing Group C
FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
OG003
Dosing Group E
PLACEBO (COMBINED)
Units
Counts
Participants
OG00054
OG00148
OG00257
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.1± 0.92(0.23 to )
OG0011.1± 1.01
OG0020.8± 0.96
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
Change from baseline at Week 6. Non-responder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data.
ANCOVA
Includes terms for baseline as a continuous covariate and treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country as factors.
0.006
Treatment difference
0.56
2-Sided
90
0.23
0.90
No
Superiority or Other
Primary
DAS28-CRP Score - Change From Baseline to Week 24 Compared to Adalimumab
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. Non-responder imputation has been applied by carrying the baseline observation forward. ANCOVA = analysis of covariance, BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, n/a = not applicable, PO = orally, QD = once a day, SC = subcutaneous.
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. In line with the study objectives, fostamatinib was compared with adalimumab (not placebo) at Week 24.
Posted
Mean
Standard Deviation
Units on a scale
Baseline and 24 weeks
ID
Title
Description
OG000
Dosing Group A
FOSTA 100 MG BID PO
OG001
Dosing Group B
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
Secondary
DAS28 EULAR Response at Week 6
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, 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, SC = subcutaneous.
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. In line with the study objectives, fostamatinib was compared with placebo (not adalimumab) at Week 6.
Posted
Number
Percentage of responders
6 weeks
ID
Title
Description
OG000
Dosing Group A
FOSTA 100 MG BID PO
OG001
Dosing Group B
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
OG002
Dosing Group C
FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
OG003
Dosing Group D
Secondary
DAS28 EULAR Response at Week 24
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, 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, SC = subcutaneous.
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. In line with the study objectives, fostamatinib was compared with adalimumab (not placebo) at Week 24.
Posted
Number
Percentage of responders
24 weeks
ID
Title
Description
OG000
Dosing Group A
FOSTA 100 MG BID PO
OG001
Dosing Group B
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
OG002
Dosing Group C
FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
OG003
Dosing Group D
Secondary
Proportion of Patients Achieving ACR20 up to Week 24
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, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.
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. In line with the study objectives, fostamatinib was compared with placebo (not adalimumab) at Week 6 and with adalimumab (not placebo) at Week 24.
Posted
Number
Percentage of responders
6 and 24 weeks
ID
Title
Description
OG000
Dosing Group A
FOSTA 100 MG BID PO
OG001
Dosing Group B
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
OG002
Dosing Group C
FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
Secondary
Proportion of Patients Achieving ACR50 up to Week 24
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, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.
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. In line with the study objectives, fostamatinib was compared with placebo (not adalimumab) at Week 6 and with adalimumab (not placebo) at Week 24.
Posted
Number
Percentage of responders
6 and 24 weeks
ID
Title
Description
OG000
Dosing Group A
FOSTA 100 MG BID PO
OG001
Dosing Group B
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
OG002
Dosing Group C
FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
Secondary
Proportion of Patients Achieving ACR70 up to Week 24
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, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.
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. In line with the study objectives, fostamatinib was compared with placebo (not adalimumab) at Week 6 and with adalimumab (not placebo) at Week 24.
Posted
Number
Percentage of responders
6 and 24 weeks
ID
Title
Description
OG000
Dosing Group A
FOSTA 100 MG BID PO
OG001
Dosing Group B
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
OG002
Dosing Group C
FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
Secondary
ACRn - Comparison Between Fostamatinib and Placebo at Week 6
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 and patient's own asessment 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. Non-responder imputation has been applied by carrying the baseline observation forward. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous. Mean refers to change at Week 6. Treatment difference: difference between fostamatinib and placebo groups.
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. In line with the study objectives, fostamatinib was compared with placebo (not adalimumab) at Week 6.
Posted
Mean
Standard Deviation
Percentage improvement from baseline
Baseline and 6 weeks
ID
Title
Description
OG000
Dosing Group A
FOSTA 100 MG BID PO
OG001
Dosing Group B
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
Secondary
ACRn - Comparison Between Fostamatinib and Adalimumab at Week 24
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 and patient's own asessment 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. 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, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous. Mean refers to change at Week 24. Treatment difference: difference between fostamatinib and adalimumab groups.
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.In line with the study objectives, fostamatinib was compared with adalimumab (not placebo) at Week 24.
Posted
Mean
Standard Deviation
Percentage improvement from baseline
Baseline and 24 weeks
ID
Title
Description
OG000
Dosing Group A
FOSTA 100 MG BID PO
OG001
Dosing Group B
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
Secondary
HAQ-DI - Comparison of the Change From Baseline Between Fostamatinib and Placebo at Week 6
HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is calculated by summing the category 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 a higher score indicating greater disability. Non-responder imputation has been applied by carrying the baseline observation forward. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.
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. In line with the study objectives, fostamatinib was compared with placebo (not adalimumab) at Week 6.
Posted
Mean
Standard Deviation
Units on a scale
Baseline and 6 weeks
ID
Title
Description
OG000
Dosing Group A
FOSTA 100 MG BID PO
OG001
Dosing Group B
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
Secondary
HAQ-DI - Comparison of the Change From Baseline Between Fostamatinib and Adalimumab at Week 24
HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is calculated by summing the category 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 a higher score indicating greater disability. Non-responder imputation has been applied by carrying the baseline observation forward. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.
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. In line with the study objectives, fostamatinib was compared with adalimumab (not placebo) at Week 24.
Posted
Mean
Standard Deviation
Units on a scale
Baseline and 24 weeks
ID
Title
Description
OG000
Dosing Group A
FOSTA 100 MG BID PO
OG001
Dosing Group B
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
Secondary
SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Adalimumab at Week 24
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 & Mental Component Scores (PCS & 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. Non-responder imputation applied by carrying the baseline observation forward. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, PO = orally, QD = once a day, QoL = quality of life, SC = subcutaneous.
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. In line with the study objectives, fostamatinib was compared with adalimumab (not placebo) at Week 24.
Posted
Mean
Standard Deviation
Units on a scale
Baseline and 24 weeks
ID
Title
Description
OG000
Dosing Group A
FOSTA 100 MG BID PO
OG001
Dosing Group B
Secondary
SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Adalimumab at Week 24
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 & Mental Component Scores (PCS & 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. Non-responder imputation applied by carrying the baseline observation forward. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, PO = orally, QD = once a day, QoL = quality of life, SC = subcutaneous.
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. In line with the study objectives, fostamatinib was compared with adalimumab (not placebo) at Week 24.
Posted
Mean
Standard Deviation
Units on a scale
Baseline and 24 weeks
ID
Title
Description
OG000
Dosing Group A
FOSTA 100 MG BID PO
OG001
Dosing Group B
Time Frame
24 weeks
Description
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
PLACEBO (6 WKS) THEN FOSTA 100 MG BID - FOSTA Period
0
27
11
27
EG007
PLACEBO (6 WKS) THEN FOSTA 100 MG BID - Placebo Period
0
27
3
27
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
LIGAMENT RUPTURE
Injury, poisoning and procedural complications
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected57 at risk
EG0031 events1 affected48 at risk
EG004
ANGINA UNSTABLE
Cardiac disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0011 events1 affected54 at risk
EG0021 events1 affected57 at risk
EG003
BUNDLE BRANCH BLOCK LEFT
Cardiac disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected54 at risk
EG0021 events1 affected57 at risk
EG003
CARDIAC FAILURE CONGESTIVE
Cardiac disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected54 at risk
EG0021 events1 affected57 at risk
EG003
COR PULMONALE ACUTE
Cardiac disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected54 at risk
EG0021 events1 affected57 at risk
EG003
PERICARDITIS
Cardiac disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected54 at risk
EG0021 events1 affected57 at risk
EG003
HYPERADRENALISM
Endocrine disorders
MedDRA 15.1
Systematic Assessment
EG0001 events1 affected54 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected57 at risk
EG003
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected54 at risk
EG0021 events1 affected57 at risk
EG003
INGUINAL HERNIA
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0001 events1 affected54 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected57 at risk
EG003
CHRONIC SINUSITIS
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0011 events1 affected54 at risk
EG0020 events0 affected57 at risk
EG003
GASTROENTERITIS
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0011 events1 affected54 at risk
EG0020 events0 affected57 at risk
EG003
PYELONEPHRITIS CHRONIC
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0011 events1 affected54 at risk
EG0020 events0 affected57 at risk
EG003
CONCUSSION
Injury, poisoning and procedural complications
MedDRA 15.1
Systematic Assessment
EG0001 events1 affected54 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected57 at risk
EG003
MENISCUS LESION
Injury, poisoning and procedural complications
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected57 at risk
EG003
CARDIAC MYXOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected57 at risk
EG003
MULTIPLE MYELOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected57 at risk
EG003
ASTHMA
Respiratory, thoracic and mediastinal disorders
MedDRA 15.1
Systematic Assessment
EG0001 events1 affected54 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected57 at risk
EG003
PULMONARY EMBOLISM
Respiratory, thoracic and mediastinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected54 at risk
EG0021 events1 affected57 at risk
EG003
ESSENTIAL HYPERTENSION
Vascular disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0011 events1 affected54 at risk
EG0020 events0 affected57 at risk
EG003
HYPERTENSIVE CRISIS
Vascular disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0011 events1 affected54 at risk
EG0020 events0 affected57 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
DIARRHOEA
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0001 events1 affected54 at risk
EG0019 events9 affected54 at risk
EG00212 events12 affected57 at risk
EG00313 events13 affected48 at risk
EG0044 events4 affected25 at risk
EG0050 events0 affected25 at risk
EG0063 events3 affected27 at risk
EG0070 events0 affected27 at risk
LEUKOPENIA
Blood and lymphatic system disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0013 events3 affected54 at risk
EG0020 events0 affected57 at risk
EG003
NEUTROPENIA
Blood and lymphatic system disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0013 events3 affected54 at risk
EG0020 events0 affected57 at risk
EG003
DYSPEPSIA
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0003 events3 affected54 at risk
EG0010 events0 affected54 at risk
EG0021 events1 affected57 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0001 events1 affected54 at risk
EG0012 events2 affected54 at risk
EG0020 events0 affected57 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0013 events3 affected54 at risk
EG0020 events0 affected57 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0011 events1 affected54 at risk
EG0020 events0 affected57 at risk
EG003
INFLUENZA
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0011 events1 affected54 at risk
EG0020 events0 affected57 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0004 events4 affected54 at risk
EG0011 events1 affected54 at risk
EG0021 events1 affected57 at risk
EG003
ALANINE AMINOTRANSFERASE INCREASED
Investigations
MedDRA 15.1
Systematic Assessment
EG0001 events1 affected54 at risk
EG0013 events3 affected54 at risk
EG0022 events2 affected57 at risk
EG003
HEPATIC ENZYME INCREASED
Investigations
MedDRA 15.1
Systematic Assessment
EG0001 events1 affected54 at risk
EG0013 events3 affected54 at risk
EG0022 events2 affected57 at risk
EG003
RHEUMATOID ARTHRITIS
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Systematic Assessment
EG0002 events2 affected54 at risk
EG0013 events3 affected54 at risk
EG0020 events0 affected57 at risk
EG003
NEPHROLITHIASIS
Renal and urinary disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0013 events3 affected54 at risk
EG0020 events0 affected57 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA 15.1
Systematic Assessment
EG0005 events5 affected54 at risk
EG0017 events7 affected54 at risk
EG0025 events5 affected57 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
Point of Contact
Title
Organization
Phone
Extension
Email
Dave Goldstraw
AstraZeneca Pharmaceuticals
+44 (0)1625 512415
dave.goldstraw@astrazeneca.com
ID
Term
D001172
Arthritis, Rheumatoid
Ancestor Terms
ID
Term
D001168
Arthritis
D007592
Joint Diseases
D009140
Musculoskeletal Diseases
D012216
Rheumatic Diseases
D003240
Connective Tissue Diseases
D017437
Skin and Connective Tissue Diseases
D001327
Autoimmune Diseases
D007154
Immune System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C523665
fostamatinib
D000068879
Adalimumab
Ancestor Terms
ID
Term
D061067
Antibodies, Monoclonal, Humanized
D000911
Antibodies, Monoclonal
D000906
Antibodies
D007136
Immunoglobulins
D007162
Immunoproteins
D001798
Blood Proteins
D011506
Proteins
D000602
Amino Acids, Peptides, and Proteins
D012712
Serum Globulins
D005916
Globulins
Browse Leaves
Not provided
Browse Branches
Not provided
4 subjects
FG0054 subjects
0 subjects
FG0050 subjects
1 subjects
FG0050 subjects
1 subjects
FG0051 subjects
0 subjects
FG0050 subjects
2 subjects
FG0051 subjects
48
± 12.4
BG00450± 12.7
BG00553± 10.8
BG00650± 11.8
48
BG00345
BG00420
BG00520
BG006210
Male
BG00016
BG0019
BG0029
BG0039
BG0047
BG0055
BG00655
48
BG00351
BG00423
BG00523
BG006240
Black or African American
Title
Measurements
BG0005
BG0010
BG0026
BG0031
BG0043
BG0051
BG00616
Asian
Title
Measurements
BG0001
BG0011
BG0020
BG0031
BG0040
BG0051
BG0064
American Indian or Alaska Native
Title
Measurements
BG0000
BG0010
BG0021
BG0030
BG0040
BG0050
BG0061
Indian or Pakistani
Title
Measurements
BG0000
BG0010
BG0021
BG0031
BG0040
BG0050
BG0062
Other
Title
Measurements
BG0000
BG0010
BG0021
BG0030
BG0041
BG0050
BG0062
52
0.6
± 1.14
OG001
OG003
Change from baseline at Week 6. Non-responder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data.
ANCOVA
Includes terms for baseline as a continuous covariate and treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country as factors.
0.022
Treatment difference
0.49
2-Sided
90
0.14
0.84
No
Superiority or Other
OG002
OG003
Change from baseline at Week 6. Non-responder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data.
ANCOVA
Includes terms for baseline as a continuous covariate and treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country as factors.
0.280
Treatment difference
0.22
2-Sided
90
-0.12
0.56
No
Superiority or Other
OG002
Dosing Group C
FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
OG003
Dosing Group D
ADALIMUMAB 40 MG SC
OG004
Dosing Group F
PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
OG005
Dosing Group G
PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
Units
Counts
Participants
OG00054
OG00148
OG00257
OG00354
OG00427
OG00525
Title
Denominators
Categories
Title
Measurements
OG0001.0± 1.31
OG0011.1± 1.22
OG0021.0± 1.25
OG0031.8± 1.45
OG0041.1± 1.26
OG0051.4± 1.26
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
Change from baseline at Week 24. Non-responder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data.
ANCOVA
Includes terms for baseline as a continuous covariate and treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country as factors.
0.005
Treatment difference
-0.72
2-Sided
80
-1.04
-0.40
Yes
Non-Inferiority or Equivalence
For the comparison with adalimumab a non-inferiority margin of -0.6 in the mean change from baseline in DAS28-CRP at Week 24 was defined. The lower 80% confidence interval for treatment difference was below this value so non-inferiority could not be concluded. A p-value is also provided for a 2-sided test of superiority.
OG001
OG003
Change from baseline at Week 24. Non-responder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data.
ANCOVA
Includes terms for baseline as a continuous covariate and treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country as factors.
0.020
Treatment difference
-0.61
2-Sided
80
-0.94
-0.27
Yes
Non-Inferiority or Equivalence
For the comparison with adalimumab a non-inferiority margin of -0.6 in the mean change from baseline in DAS28-CRP at Week 24 was defined. The lower 80% confidence interval for treatment difference was below this value so non-inferiority could not be concluded. A p-value is also provided for a 2-sided test of superiority.
OG002
OG003
Change from baseline at Week 24. Non-responder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data.
ANCOVA
Includes terms for baseline as a continuous covariate and treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country as factors.
0.004
Treatment difference
-0.72
2-Sided
80
-1.04
-0.40
Yes
Non-Inferiority or Equivalence
For the comparison with adalimumab a non-inferiority margin of -0.6 in the mean change from baseline in DAS28-CRP at Week 24 was defined. The lower 80% confidence interval for treatment difference was below this value so non-inferiority could not be concluded. A p-value is also provided for a 2-sided test of superiority.
ADALIMUMAB 40 MG SC
OG004
Dosing Group E
PLACEBO (COMBINED)
Units
Counts
Participants
OG00054
OG00148
OG00257
OG00354
OG00452
Title
Denominators
Categories
No response
Title
Measurements
OG00037.0± 1.46(0.20 to 0.68)
OG00133.3± 1.34(0.26 to 0.89)
OG00257.9± 1.30(0.20 to 0.65)
OG00340.7± 1.58
OG00467.3± 1.33
Moderate response
Title
Measurements
OG00053.7
OG00147.9
OG00235.1
OG003
Good response
Title
Measurements
OG0009.3
OG00118.8
OG0027.0
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.
Proportional odds model
0.005
Odds Ratio (OR)
3.05
2-Sided
90
1.59
5.86
An odds ratio >1 indicates a benefit towards fostamatinib.
No
Superiority or Other
OG001
OG004
Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.
Proportional odds model
<0.001
Odds Ratio (OR)
4.11
2-Sided
90
2.10
8.05
An odds ratio >1 indicates a benefit towards fostamatinib.
No
Superiority or Other
OG002
OG004
Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.
Proportional odds model
0.335
Odds Ratio (OR)
1.47
2-Sided
90
0.76
2.83
An odds ratio >1 indicates a benefit towards fostamatinib.
No
Superiority or Other
ADALIMUMAB 40 MG SC
OG004
Dosing Group F
PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
OG005
Dosing Group G
PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
Units
Counts
Participants
OG00054
OG00148
OG00257
OG00354
OG00427
OG00525
Title
Denominators
Categories
No response
Title
Measurements
OG00051.9± 1.46(0.20 to 0.68)
OG00141.7± 1.34(0.26 to 0.89)
OG00252.6± 1.30(0.20 to 0.65)
OG00331.5± 1.58
OG00455.6± 1.33
OG00540.0± 1.48
Moderate response
Title
Measurements
OG00029.6
OG00139.6
OG00229.8
OG003
Good response
Title
Measurements
OG00018.5
OG00118.8
OG00217.5
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.
Proportional odds model
0.007
Odds Ratio (OR)
0.37
2-Sided
90
0.20
0.68
An odds ratio >1 indicates a benefit towards fostamatinib.
No
Superiority or Other
OG001
OG003
Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.
Proportional odds model
0.051
Odds Ratio (OR)
0.48
2-Sided
90
0.26
0.89
An odds ratio >1 indicates a benefit towards fostamatinib.
No
Superiority or Other
OG002
OG003
Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.
Proportional odds model
0.004
Odds Ratio (OR)
0.36
2-Sided
90
0.20
0.65
An odds ratio >1 indicates a benefit towards fostamatinib.
No
Superiority or Other
OG003
Dosing Group D
ADALIMUMAB 40 MG SC
OG004
Dosing Group E
PLACEBO (COMBINED)
OG005
Dosing Group F
PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
OG006
Dosing Group G
PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
Units
Counts
Participants
OG00054
OG00148
OG00257
OG00354
OG00452
OG00527
OG00625
Title
Denominators
Categories
Week 6
Title
Measurements
OG00048.1
OG00147.9
OG00238.6
OG00353.7
OG00419.2
OG005NAData appears under Group E at Week 6.
OG006NAData appears under Group E at Week 6.
Week 24
Title
Measurements
OG00040.7
OG00156.3
OG00235.1
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.
Mantel Haenszel
p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.
<0.001
Week 6
Weighted difference in proportions
0.29
2-Sided
90
0.17
0.40
90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.
No
Superiority or Other
OG001
OG004
Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.
Mantel Haenszel
p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.
<0.001
Week 6
Weighted difference in proportions
0.30
2-Sided
90
0.18
0.43
90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.
No
Superiority or Other
OG002
OG004
Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.
Mantel Haenszel
p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.
0.007
Week 6
Weighted difference in proportions
0.19
2-Sided
90
0.07
0.31
90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.
No
Superiority or Other
OG000
OG003
Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.
Mantel Haenszel
p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.
0.049
Week 24
Weighted difference in proportions
-0.16
2-Sided
90
-0.30
-0.03
90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.
No
Superiority or Other
OG001
OG003
Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.
Mantel Haenszel
p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.
0.803
Week 24
Weighted difference in proportions
-0.02
2-Sided
90
-0.16
0.12
90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.
No
Superiority or Other
OG002
OG003
Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.
Mantel Haenszel
p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.
0.003
Week 24
Weighted difference in proportions
-0.24
2-Sided
90
-0.37
-0.10
90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.
No
Superiority or Other
OG003
Dosing Group D
ADALIMUMAB 40 MG SC
OG004
Dosing Group E
PLACEBO (COMBINED)
OG005
Dosing Group F
PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
OG006
Dosing Group G
PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
Units
Counts
Participants
OG00054
OG00148
OG00257
OG00354
OG00452
OG00527
OG00625
Title
Denominators
Categories
Week 6
Title
Measurements
OG00013.0
OG00112.5
OG0027.0
OG00325.9
OG0043.8
OG005NAData appears under Group E at Week 6.
OG006NAData appears under Group E at Week 6.
Week 24
Title
Measurements
OG00020.4
OG00118.8
OG00212.3
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.
Mantel Haenszel
p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.
0.059
Week 6
Weighted difference in proportions
0.09
2-Sided
90
0.01
0.18
90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.
No
Superiority or Other
OG001
OG004
Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.
Mantel Haenszel
p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.
0.071
Week 6
Weighted difference in proportions
0.09
2-Sided
90
0.01
0.17
90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.
No
Superiority or Other
OG002
OG004
Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.
Mantel Haenszel
p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.
0.758
Week 6
Weighted difference in proportions
0.01
2-Sided
90
-0.05
0.07
90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.
No
Superiority or Other
OG000
OG003
Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.
Mantel Haenszel
p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.
0.114
Week 24
Weighted difference in proportions
-0.12
2-Sided
90
-0.24
0.00
90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.
No
Superiority or Other
OG001
OG003
Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.
Mantel Haenszel
p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.
0.078
Week 24
Weighted difference in proportions
-0.14
2-Sided
90
-0.26
-0.01
90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.
No
Superiority or Other
OG002
OG003
Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.
Mantel Haenszel
p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.
0.003
Week 24
Weighted difference in proportions
-0.21
2-Sided
90
-0.32
-0.09
90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.
No
Superiority or Other
OG003
Dosing Group D
ADALIMUMAB 40 MG SC
OG004
Dosing Group E
PLACEBO (COMBINED)
OG005
Dosing Group F
PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
OG006
Dosing Group G
PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
Units
Counts
Participants
OG00054
OG00148
OG00257
OG00354
OG00452
OG00527
OG00625
Title
Denominators
Categories
Week 6
Title
Measurements
OG0001.9
OG0014.2
OG0021.8
OG0037.4
OG0043.8
OG005NAData appears under Group E at Week 6.
OG006NAData appears under Group E at Week 6.
Week 24
Title
Measurements
OG0009.3
OG00110.4
OG0023.5
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.
Mantel Haenszel
p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.
0.460
Week 6
Weighted difference in proportions
-0.02
2-Sided
90
-0.07
0.03
90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.
No
Superiority or Other
OG001
OG004
Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.
Mantel Haenszel
p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.
0.903
Week 6
Weighted difference in proportions
0.00
2-Sided
90
-0.05
0.06
90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.
No
Superiority or Other
OG002
OG004
Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.
Mantel Haenszel
p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.
0.172
Week 6
Weighted difference in proportions
-0.03
2-Sided
90
-0.08
0.01
90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.
No
Superiority or Other
OG000
OG003
Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.
Mantel Haenszel
p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.
0.082
Week 24
Weighted difference in proportions
-0.11
2-Sided
90
-0.21
-0.01
90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.
No
Superiority or Other
OG001
OG003
Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.
Mantel Haenszel
p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.
0.092
Week 24
Weighted difference in proportions
-0.11
2-Sided
90
-0.21
-0.00
90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.
No
Superiority or Other
OG002
OG003
Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.
Mantel Haenszel
p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.
0.002
Week 24
Weighted difference in proportions
-0.17
2-Sided
90
-0.27
-0.08
90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.
No
Superiority or Other
OG002
Dosing Group C
FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
OG003
Dosing Group D
ADALIMUMAB 40 MG SC
OG004
Dosing Group E
PLACEBO (COMBINED)
Units
Counts
Participants
OG00054
OG00148
OG00257
OG00354
OG00452
Title
Denominators
Categories
Title
Measurements
OG00016.60± 30.682
OG00115.07± 33.334
OG0026.48± 32.237
OG00315.53± 43.015
OG004-6.49± 35.159
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.
Van Elteren
Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.
<0.001
Treatment difference
23.39
2-Sided
90
9.57
40.00
No
Superiority or Other
OG001
OG004
Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.
Van Elteren
Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.
0.006
Treatment difference
22.97
2-Sided
90
7.84
38.34
No
Superiority or Other
OG002
OG004
Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.
Van Elteren
Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.
0.234
Treatment difference
5.72
2-Sided
90
-3.20
21.68
No
Superiority or Other
OG002
Dosing Group C
FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
OG003
Dosing Group D
ADALIMUMAB 40 MG SC
Units
Counts
Participants
OG00054
OG00148
OG00257
OG00354
Title
Denominators
Categories
Title
Measurements
OG00018.35± 34.355
OG00122.03± 32.361
OG00211.49± 26.916
OG00331.21± 39.187
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.
Van Elteren
Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.
0.030
Treatment difference
-13.72
2-Sided
90
-25.01
0.00
No
Superiority or Other
OG001
OG003
Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.
Van Elteren
Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.
0.207
Treatment difference
-9.49
2-Sided
90
-25.00
6.96
No
Superiority or Other
OG002
OG003
Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.
Van Elteren
Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.
0.002
Treatment difference
-19.53
2-Sided
90
-30.01
-6.25
No
Superiority or Other
OG002
Dosing Group C
FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
OG003
Dosing Group D
ADALIMUMAB 40 MG SC
OG004
Dosing Group E
PLACEBO (COMBINED)
Units
Counts
Participants
OG00054
OG00148
OG00257
OG00354
OG00452
Title
Denominators
Categories
Title
Measurements
OG0000.3± 0.35
OG0010.3± 0.54
OG0020.2± 0.43
OG0030.3± 0.45
OG0040.1± 0.52
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.
ANCOVA
Including terms for baseline as a continuous covariate & treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) & pooled country as factors.
0.007
Treatment difference
0.24
2-Sided
90
0.09
0.38
No
Superiority or Other
OG001
OG004
Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.
ANCOVA
Including terms for baseline as a continuous covariate & treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) & pooled country as factors.
0.016
Treatment difference
0.22
2-Sided
90
0.07
0.37
No
Superiority or Other
OG002
OG004
Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.
ANCOVA
Includes terms for baseline as a continuous covariate & treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) & pooled country as factors.
0.094
Treatment difference
0.14
2-Sided
90
0.00
0.29
No
Superiority or Other
OG002
Dosing Group C
FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
OG003
Dosing Group D
ADALIMUMAB 40 MG SC
OG004
Dosing Group F
PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
OG005
Dosing Group G
PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
Units
Counts
Participants
OG00054
OG00148
OG00257
OG00354
OG00427
OG00525
Title
Denominators
Categories
Title
Measurements
OG0000.3± 0.57
OG0010.4± 0.56
OG0020.2± 0.45
OG0030.5± 0.53
OG0040.3± 0.47
OG0050.1± 0.35
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.
ANCOVA
Including terms for baseline as a continuous covariate & treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) & pooled country as factors.
0.043
Treatment difference
-0.20
2-Sided
90
-0.36
-0.04
No
Superiority or Other
OG001
OG003
Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.
ANCOVA
Including terms for baseline as a continuous covariate & treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) & pooled country as factors.
0.158
Treatment difference
-0.14
2-Sided
90
-0.31
0.02
No
Superiority or Other
OG002
OG003
Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.
ANCOVA
Includes terms for baseline as a continuous covariate & treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) & pooled country as factors.
0.001
Treatment difference
-0.32
2-Sided
90
-0.47
-0.16
No
Superiority or Other
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
OG002
Dosing Group C
FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
OG003
Dosing Group D
ADALIMUMAB 40 MG SC
OG004
Dosing Group F
PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
OG005
Dosing Group G
PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
Units
Counts
Participants
OG00054
OG00148
OG00257
OG00354
OG00427
OG00525
Title
Denominators
Categories
Title
Measurements
OG0004± 7.3
OG0015± 7.2
OG0024± 7.4
OG0037± 8.4
OG0044± 8.7
OG0053± 5.0
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.
ANCOVA
Including terms for baseline as a continuous covariate & treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) & pooled country as factors.
0.050
Treatment difference
-2.77
2-Sided
90
-5.08
-0.45
No
Superiority or Other
OG001
OG003
Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.
ANCOVA
Including terms for baseline as a continuous covariate & treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) & pooled country as factors.
0.360
Treatment difference
-1.33
2-Sided
90
-3.73
1.06
No
Superiority or Other
OG002
OG003
Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.
ANCOVA
Includes terms for baseline as a continuous covariate & treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) & pooled country as factors.
0.032
Treatment difference
-2.99
2-Sided
90
-5.29
-0.70
No
Superiority or Other
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
OG002
Dosing Group C
FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
OG003
Dosing Group D
ADALIMUMAB 40 MG SC
OG004
Dosing Group F
PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
OG005
Dosing Group G
PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
Units
Counts
Participants
OG00054
OG00148
OG00257
OG00354
OG00427
OG00525
Title
Denominators
Categories
Title
Measurements
OG0003± 9.3
OG0013± 11.5
OG0022± 10.0
OG0034± 9.8
OG0043± 5.9
OG0050± 10.1
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.
ANCOVA
Including terms for baseline as a continuous covariate & treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) & pooled country as factors.
0.568
Treatment difference
-1.02
2-Sided
90
-3.95
1.92
No
Superiority or Other
OG001
OG003
Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.
ANCOVA
Including terms for baseline as a continuous covariate & treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) & pooled country as factors.
0.368
Treatment difference
-1.66
2-Sided
90
-4.69
1.38
No
Superiority or Other
OG002
OG003
Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.
ANCOVA
Includes terms for baseline as a continuous covariate & treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) & pooled country as factors.
0.160
Treatment difference
-2.48
2-Sided
90
-5.38
0.43
No
Superiority or Other
0 events
0 affected
25 at risk
EG0050 events0 affected25 at risk
EG0060 events0 affected27 at risk
EG0070 events0 affected27 at risk
0 events
0 affected
48 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected25 at risk
EG0060 events0 affected27 at risk
EG0070 events0 affected27 at risk
0 events
0 affected
48 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected25 at risk
EG0060 events0 affected27 at risk
EG0070 events0 affected27 at risk
0 events
0 affected
48 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected25 at risk
EG0060 events0 affected27 at risk
EG0070 events0 affected27 at risk
0 events
0 affected
48 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected25 at risk
EG0060 events0 affected27 at risk
EG0070 events0 affected27 at risk
0 events
0 affected
48 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected25 at risk
EG0060 events0 affected27 at risk
EG0070 events0 affected27 at risk
0 events
0 affected
48 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected25 at risk
EG0060 events0 affected27 at risk
EG0070 events0 affected27 at risk
0 events
0 affected
48 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected25 at risk
EG0060 events0 affected27 at risk
EG0070 events0 affected27 at risk
0 events
0 affected
48 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected25 at risk
EG0060 events0 affected27 at risk
EG0070 events0 affected27 at risk
0 events
0 affected
48 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected25 at risk
EG0060 events0 affected27 at risk
EG0070 events0 affected27 at risk
0 events
0 affected
48 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected25 at risk
EG0060 events0 affected27 at risk
EG0070 events0 affected27 at risk
0 events
0 affected
48 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected25 at risk
EG0060 events0 affected27 at risk
EG0070 events0 affected27 at risk
0 events
0 affected
48 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected25 at risk
EG0060 events0 affected27 at risk
EG0070 events0 affected27 at risk
1 events
1 affected
48 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected25 at risk
EG0060 events0 affected27 at risk
EG0070 events0 affected27 at risk
1 events
1 affected
48 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected25 at risk
EG0060 events0 affected27 at risk
EG0070 events0 affected27 at risk
0 events
0 affected
48 at risk
EG0040 events0 affected25 at risk
EG0051 events1 affected25 at risk
EG0060 events0 affected27 at risk
EG0070 events0 affected27 at risk
0 events
0 affected
48 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected25 at risk
EG0060 events0 affected27 at risk
EG0070 events0 affected27 at risk
0 events
0 affected
48 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected25 at risk
EG0060 events0 affected27 at risk
EG0070 events0 affected27 at risk
0 events
0 affected
48 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected25 at risk
EG0060 events0 affected27 at risk
EG0070 events0 affected27 at risk
0 events
0 affected
48 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected25 at risk
EG0060 events0 affected27 at risk
EG0070 events0 affected27 at risk
0 events
0 affected
48 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected25 at risk
EG0060 events0 affected27 at risk
EG0070 events0 affected27 at risk
0 events
0 affected
48 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected25 at risk
EG0062 events2 affected27 at risk
EG0070 events0 affected27 at risk
0 events
0 affected
48 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected25 at risk
EG0060 events0 affected27 at risk
EG0070 events0 affected27 at risk
2 events
2 affected
48 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected25 at risk
EG0062 events2 affected27 at risk
EG0070 events0 affected27 at risk
0 events
0 affected
48 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected25 at risk
EG0061 events1 affected27 at risk
EG0070 events0 affected27 at risk
0 events
0 affected
48 at risk
EG0042 events2 affected25 at risk
EG0050 events0 affected25 at risk
EG0060 events0 affected27 at risk
EG0070 events0 affected27 at risk
0 events
0 affected
48 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected25 at risk
EG0060 events0 affected27 at risk
EG0072 events2 affected27 at risk
2 events
2 affected
48 at risk
EG0041 events1 affected25 at risk
EG0050 events0 affected25 at risk
EG0060 events0 affected27 at risk
EG0071 events1 affected27 at risk
1 events
1 affected
48 at risk
EG0040 events0 affected25 at risk
EG0051 events1 affected25 at risk
EG0060 events0 affected27 at risk
EG0070 events0 affected27 at risk
1 events
1 affected
48 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected25 at risk
EG0060 events0 affected27 at risk
EG0070 events0 affected27 at risk
2 events
2 affected
48 at risk
EG0041 events1 affected25 at risk
EG0050 events0 affected25 at risk
EG0064 events4 affected27 at risk
EG0070 events0 affected27 at risk
0 events
0 affected
48 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected25 at risk
EG0060 events0 affected27 at risk
EG0070 events0 affected27 at risk
3 events
3 affected
48 at risk
EG0047 events7 affected25 at risk
EG0050 events0 affected25 at risk
EG0064 events4 affected27 at risk
EG0070 events0 affected27 at risk
38.9
OG00425.0
20.4
OG0047.7
27.8
OG00433.3
OG00536.0
40.7
OG00411.1
OG00524.0
59.3
OG004NAData appears under Groups F and G at Week 24.
OG00544.4
OG00644.0
31.5
OG004NAData appears under Groups F and G at Week 24.
OG00522.2
OG00624.0
20.4
OG004NAData appears under Groups F and G at Week 24.