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

NCT02092961 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2014-06-25

Study results available
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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.

Conditions

Interventions

DRUG

Fostamatinib

Fostamatinib 100mg twice daily.

DRUG

Adalimumab

Adalimumab 40 mg by subcutaneous injection every 2 weeks for 24 weeks.

DRUG

Placebo of Fostamatinib

Placebo bid for 6 weeks.

DRUG

Placebo of Adalimumab

Placebo injection once every two weeks.

Sponsors & Collaborators

Principal Investigators

  • Neil MacKillop, MD PhD · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • United States
  • Bulgaria
  • Canada
  • Czechia
  • Germany
  • Hungary
  • Netherlands
  • Poland
  • Russia
  • South Africa
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02092961 on ClinicalTrials.gov