Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, OSKIRA, fostamatinib, CE-MRI, DCE-MRI
Brief summary
This is a sub-study of the OSKIRA-4 study, (D4300C0004, NCT01264770) to explore alternative and more sensitive modalities for measuring the beneficial effects of syk inhibition with fostamatinib in patients with active RA. This MRI sub-study was reported later than the main study due to recruitment delays at specialist imaging sites and so is registered and presented entirely separately to the main study results. This study will investigate the impact of treatment on joint activity and damage by assessing synovitis, osteitis, bone erosions and joint space narrowing.
Detailed description
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.
Interventions
DRUGFostamatinib
Fostamatinib 100mg twice daily.
DRUGAdalimumab
Adalimumab 40 mg by subcutaneous injection every 2 weeks for 24 weeks.
DRUGPlacebo of Fostamatinib
Placebo bid for 6 weeks.
DRUGPlacebo of Adalimumab
Placebo injection once every two weeks.
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- * Male or female aged 18 and over * Active rheumatoid arthritis (RA) diagnosed after the age of 16 * 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) * 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) * Presence of at least one swollen hand or wrist joint. * Presence of synovitis on baseline MRI scan, defined as at least 1 joint with RAMRIS synovitis score of +1 or greater.
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 * Severe renal impairment * Neutropenia * Unable to undergo an MRI examination (e.g. presence of a pacemaker, defibrillator, or other implanted metallic device such as anterior interbody cages, aneurysm clip or pedicle screws) * Known allergy to Gadolinium-based contrast agent, * Tattoos \[in area of examination if contains metallic pigment\] * Likely to require sedation for the procedure * eGFR less than 55 mL/min
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OMERACT RAMRIS Synovitis Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab (Van Elteren) | Baseline, 6 and 24 weeks | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| OMERACT RAMRIS Osteitis Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab (Van Elteren) | Baseline, 6 and 24 weeks | 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. |
| Joint Space Narrowing - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab (Van Elteren) | Baseline, 6 and 24 weeks | 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. |
| OMERACT RAMRIS Erosions Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab (Van Elteren) | Baseline, 6 and 24 weeks | 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. |
| DAS-CRP Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab | Baseline, 6 and 24 weeks | DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. 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. |
Countries
Bulgaria, Canada, Czechia, Germany, Hungary, Netherlands, Poland, Russia, South Africa, United Kingdom, United States
Participant flow
Recruitment details
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).
Pre-assignment details
A total of 101 patients failed screening.
Participants by arm
| Arm | Count |
|---|---|
| FOSTA 100 MG PO BID Dosing Group A | 33 |
| ADALIMUMAB 40 MG SC Dosing Group D | 28 |
| PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID Dosing Group E | 29 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 4 | 0 |
| Overall Study | Dev. of study specific discont. criteria | 3 | 0 | 0 |
| Overall Study | Lack of therapeutic response | 2 | 1 | 3 |
| Overall Study | Not reported | 1 | 0 | 1 |
| Overall Study | Study stopped | 13 | 9 | 12 |
Baseline characteristics
| Characteristic | FOSTA 100 MG PO BID | ADALIMUMAB 40 MG SC | PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID | Total |
|---|---|---|---|---|
| Age, Continuous | 52 years STANDARD_DEVIATION 11.3 | 53 years STANDARD_DEVIATION 12.5 | 48 years STANDARD_DEVIATION 14.7 | 51 years STANDARD_DEVIATION 12.9 |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 1 Participants | 4 Participants | 7 Participants |
| Race/Ethnicity, Customized Indian or Pakistani | 5 Participants | 4 Participants | 0 Participants | 9 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 0 Participants | 4 Participants | 6 Participants |
| Race/Ethnicity, Customized White | 24 Participants | 23 Participants | 21 Participants | 68 Participants |
| Sex: Female, Male Female | 22 Participants | 22 Participants | 21 Participants | 65 Participants |
| Sex: Female, Male Male | 11 Participants | 6 Participants | 8 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 7 / 28 | 17 / 33 | 7 / 22 | 4 / 29 |
| serious Total, serious adverse events | 3 / 28 | 3 / 33 | 0 / 22 | 1 / 29 |
Outcome results
Primary
OMERACT RAMRIS Synovitis Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab (Van Elteren)
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.
Time frame: Baseline, 6 and 24 weeks
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FOSTA 100 MG PO BID | 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 |
| FOSTA 100 MG PO BID | 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 |
| ADALIMUMAB 40 MG SC | OMERACT RAMRIS Synovitis Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab (Van Elteren) | 6 weeks (n=25, 22, 20) | -0.50 Units on a scale |
| ADALIMUMAB 40 MG SC | OMERACT RAMRIS Synovitis Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab (Van Elteren) | 24 weeks (n=18, 16, 18) | -1.03 Units on a scale |
| PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID | OMERACT RAMRIS Synovitis 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 |
| PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID | OMERACT RAMRIS Synovitis 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 |
Comparison: 6 weeksp-value: 0.02290% CI: [-2.75, -0.42]Van Elteren
Comparison: 24 weeksp-value: 0.40290% CI: [-1, 2]Van Elteren
Other Pre-specified
DAS-CRP Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or 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. 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.
Time frame: Baseline, 6 and 24 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FOSTA 100 MG PO BID | 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 |
| FOSTA 100 MG PO BID | 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 |
| ADALIMUMAB 40 MG SC | DAS-CRP Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab | 6 weeks (n=32, 27, 27) | 1.1 Units on a scale | Standard Deviation 1.16 |
| ADALIMUMAB 40 MG SC | DAS-CRP Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab | 24 weeks (n=20, 19, 17) | 1.5 Units on a scale | Standard Deviation 1.44 |
| PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID | DAS-CRP Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab | 24 weeks (n=20, 19, 17) | 1.6 Units on a scale | Standard Deviation 1.39 |
| PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID | DAS-CRP Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab | 6 weeks (n=32, 27, 27) | 0.5 Units on a scale | Standard Deviation 1.06 |
Comparison: Change from baseline at Week 6. Nonresponder 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. Patients who prematurely withdrew due to project closure have no imputation applied.p-value: 0.00690% CI: [0.36, 1.41]ANCOVA
Comparison: Change from baseline at Week 24. Nonresponder 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. Patients who prematurely withdrew due to project closure have no imputation applied.p-value: 0.49690% CI: [-1.16, 0.49]ANCOVA
Other Pre-specified
Joint Space Narrowing - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab (Van Elteren)
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.
Time frame: Baseline, 6 and 24 weeks
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FOSTA 100 MG PO BID | 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 |
| FOSTA 100 MG PO BID | 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 |
| ADALIMUMAB 40 MG SC | 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 |
| ADALIMUMAB 40 MG SC | 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 |
| PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID | 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 |
| PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID | 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 |
Comparison: 6 weeksp-value: 0.49190% CI: [0, 0]Van Elteren
Comparison: 24 weeksp-value: 0.34190% CI: [0, 0]Van Elteren
Other Pre-specified
OMERACT RAMRIS Erosions Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab (Van Elteren)
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.
Time frame: Baseline, 6 and 24 weeks
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FOSTA 100 MG PO BID | 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 |
| FOSTA 100 MG PO BID | 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 |
| ADALIMUMAB 40 MG SC | 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 |
| ADALIMUMAB 40 MG SC | OMERACT RAMRIS Erosions 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 |
| PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID | OMERACT RAMRIS Erosions Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab (Van Elteren) | 6 weeks (n=25, 22, 20) | 0.50 Units on a scale |
| PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID | OMERACT RAMRIS Erosions Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab (Van Elteren) | 24 weeks (n=18, 16, 18) | 1.25 Units on a scale |
Comparison: 6 weeksp-value: 0.36690% CI: [-0.5, 0]Van Elteren
Comparison: 24 weeksp-value: 0.05390% CI: [0.5, 2.5]Van Elteren
Other Pre-specified
OMERACT RAMRIS Osteitis Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab (Van Elteren)
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.
Time frame: Baseline, 6 and 24 weeks
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FOSTA 100 MG PO BID | 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 |
| FOSTA 100 MG PO BID | 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 |
| ADALIMUMAB 40 MG SC | 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 |
| ADALIMUMAB 40 MG SC | 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 |
| PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID | 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 |
| PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID | 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 |
Comparison: 6 weeksp-value: 0.74690% CI: [-1, 0.5]Van Elteren
Comparison: 24 weeksp-value: 0.41390% CI: [-1.5, 3.5]Van Elteren