Randomised Double-Blind, Placebo-Controlled, Parallel Group Study in Patients with Active Rheumatoid Arthritis:Magnetic Resonance Imaging Sub-Study - OSKIRA 4 SS

Study identifier:D4300C00004Sub

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Terminated/Withdrawn

Official Title

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

Medical condition

Rheumatoid Arthritis

Phase

Phase 2

Healthy volunteers

Study drug

Fostamatinib, Adalimumab, Placebo of Fostamatinib, Placebo of Adalimumab

Sex

All

Actual Enrollment

198

Study type

Interventional

Age

18 Years - 150 Years

Date

Study Start Date: 01 Feb 2011

Primary Completion Date: 01 Jul 2013

Study Completion Date: 01 Jul 2013

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Jul 2014 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

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:
o documented history or current presence of positive rheumatoid factor (blood test),
o radiographic erosion within 12 months prior to study enrolment,
o presence of serum anti-cyclic citrullinated peptide antibodies (blood test)
o Presence of at least one swollen hand or wrist joint.
o 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

No locations available

Arms	Assigned Interventions
Experimental: Dosing Group A Oral treatment and subcutaneous injection.	Drug: Fostamatinib Fostamatinib 100mg twice daily. Drug: Placebo of Adalimumab Placebo injection once every two weeks.
Active Comparator: Dosing Group D Oral treatment and subcutaneous injection.	Drug: Adalimumab Adalimumab 40 mg by subcutaneous injection every 2 weeks for 24 weeks. Drug: Placebo of Fostamatinib Placebo bid for 6 weeks.
Placebo Comparator: 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.	Drug: Fostamatinib Fostamatinib 100mg twice daily. Drug: Placebo of Fostamatinib Placebo bid for 6 weeks. Drug: Placebo of Adalimumab Placebo injection once every two weeks.

Documents available

CSR Synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

800-236-9933

[email protected]

Investigators

Principal Investigator

Neil MacKillop

AstraZeneca