Randomised Double-Blind, Placebo-Controlled, Parallel Group Study in Patients With Active Rheumatoid Arthritis:Magnetic Resonance Imaging Sub-Study
NCT ID: NCT02092961
Last Updated: 2014-06-25
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
198 participants
INTERVENTIONAL
2011-02-28
2013-07-31
Brief Summary
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This study will investigate the impact of treatment on joint activity and damage by assessing synovitis, osteitis, bone erosions and joint space narrowing.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dosing Group A
Oral treatment and subcutaneous injection.
Fostamatinib
Fostamatinib 100mg twice daily.
Placebo of Adalimumab
Placebo injection once every two weeks.
Dosing Group D
Oral treatment and subcutaneous injection.
Adalimumab
Adalimumab 40 mg by subcutaneous injection every 2 weeks for 24 weeks.
Placebo of Fostamatinib
Placebo bid for 6 weeks.
Dosing Group E
Placebo bid for 6 weeks followed by switch to 100 mg fostamatinib bid for 24 weeks, plus placebo subcutaneous injection every 2 weeks.
Fostamatinib
Fostamatinib 100mg twice daily.
Placebo of Fostamatinib
Placebo bid for 6 weeks.
Placebo of Adalimumab
Placebo injection once every two weeks.
Interventions
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Fostamatinib
Fostamatinib 100mg twice daily.
Adalimumab
Adalimumab 40 mg by subcutaneous injection every 2 weeks for 24 weeks.
Placebo of Fostamatinib
Placebo bid for 6 weeks.
Placebo of Adalimumab
Placebo injection once every two weeks.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Neil MacKillop, MD PhD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Glendale, Arizona, United States
Research Site
Paradise Valley, Arizona, United States
Research Site
Phoenix, Arizona, United States
Research Site
Brooklyn, New York, United States
Research Site
Jackson, Tennessee, United States
Research Site
Austin, Texas, United States
Research Site
Pleven, , Bulgaria
Research Site
Mississauga, Ontario, Canada
Research Site
Prague, , Czechia
Research Site
Hamburg, , Germany
Research Site
Munich, , Germany
Research Site
Balatonfüred, , Hungary
Research Site
Budapest, , Hungary
Research Site
Amsterdam, , Netherlands
Research Site
Warsaw, , Poland
Research Site
Yaroslavl, , Russia
Research Site
Durban, , South Africa
Research Site
Pretoria, , South Africa
Research Site
Stellenbosch, , South Africa
Research Site
Manchester, , United Kingdom
Research Site
Oxford, , United Kingdom
Countries
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Other Identifiers
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D4300C00004Sub
Identifier Type: -
Identifier Source: org_study_id
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