Randomised Double-Blind, Placebo-Controlled, Parallel Group Study in Patients With Active Rheumatoid Arthritis:Magnetic Resonance Imaging Sub-Study

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT02092961

Run by

AstraZeneca

People needed

198

Starts

2011-02-01

Expected to finish

2013-07-01

Last updated by the study team

2014-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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