A Study of Tocilizumab (RoActemra/Actemra) in Monotherapy or in Combination With Methotrexate or Other Non-Biologic DMARDs in Participants With Active Rheumatoid Arthritis and an Inadequate Response to Current Non-Biologic DMARD Therapy or the First Anti-TNF Biologic Agent

PHASE3CompletedINTERVENTIONAL
Enrollment

162

Participants

Timeline

Start Date

March 4, 2014

Primary Completion Date

August 4, 2016

Study Completion Date

August 4, 2016

Conditions
Rheumatoid Arthritis
Interventions
DRUG

Tocilizumab

Tocilizumab 162 mg will be administered once a week by SC injection and as a single fixed dose, irrespective of body weight, for the treatment duration of 52 weeks.

DRUG

DMARDs

Treatment with non-biologic DMARDs, at a stable dose that was initiated at least 4 weeks prior to baseline, is permitted during the study. The study protocol does not specify any particular therapy.

DRUG

Oral Corticosteroids

Stable oral corticosteroids doses (≤10 mg/day prednisone or equivalent) are allowed. The study protocol does not specify any additional detail on types of oral corticosteroids.

DRUG

Methotrexate

Methotrexate per investigator's discretion.

Trial Locations (38)

AB25 2ZN

Aberdeen Royal Infirmary, Aberdeen

BH23 2JX

Christchurch Hospital; Rheumatology, Bournemouth

BN2 5BE

Royal Sussex County Hospital; Clinical Investigation Research Unit, Brighton

DE13 0RB

Queens Hospital, Burton-on-Trent

IP33 2QZ

West Suffolk Hospital, Bury Saint Edmonds

CB2 2QQ

Addenbrooke'S Hospital; Rheumatology Research Unit, Cambridge

WS11 5XY

Cannock Chase Hospital; Rheumatology, Cannock

CF14 4XW

University Hospital of Wales; Dept of Rhematology, Cardiff

CM1 7ET

Broomfield Hospital, Chelmsford

CH2 1UL

Countess of Chester Hospital; Dept of Rheumatology, Chester

WF13 4HS

Dewsbury & District Hospital; Dept of Rheumatology, Dewsbury

DY1 2HQ

Russells Hall Hospital; Rheumatology Department, Dudley

DD12 9SY

Ninewells Hospital, Dundee

BN21 2UD

Eastbourne District General Hospital; Dept of Rheumatology, Eastbourne

EH4 2XU

Western General Hospital; Pharmacy Department, Edinburgh

G12 0YN

Gartnavel General Hospital; Rheumatology, Glasgow

DN33 2BA

Diana Princess of Wales Hosp., Grimsby

CM20 1QX

Princess Alexandra Hospital, Harlow

HA1 3UJ

Northwick Park Hospital, Harrow

HP2 4AD

Hemel Hempstead General Hospital; Rheumatology Dept, Hemel Hempstead

HU3 3JZ

Hull Royal Infirmary; Rheumatology Department, Hull

LL30 1LB

Llandudno General Hospital, Llandudno

E11 1NR

Whipps Cross Hospital; Rheumatology Dept, London

NW3 2QG

Royal Free Hospital; Department of Rheumatology, London

ME16 9QQ

Maidstone Hospital; Dept of Rheumatology, Maidstone

M23 9QZ

Wythenshawe Hospital, Manchester

NE7 7DN

Freeman Hospital; Dept of Rheumatology, Newcastle upon Tyne

NE29 8NH

North Tyneside General Hospital, North Shields

NR4 7UY

Norfolk & Norwich Hospital; Rheumatology, Norwich

OL1 1NL

Integrated Care Centre, Oldham

B91 2JL

Solihull Hospital, Solihull

ST6 7AG

Haywood Hospital; Staffordshire Rheumatology Centre, Stoke-on-Trent

SN3 6BB

Great Western Hospital; Dept of Rheumatology, Swindon

TQ2 7AA

Torbay Hospital; Dept of Rhematology, Torquay

TR1 3LJ

Royal Cornwall Hospital; Rhuematololgy Dept, Truro

WA5 1QG

Warrington Hospital, Warrington

WN6 9EW

Wrightington Hospital; Rheumatology, Wigan

ML2 0DP

Wishaw General Hospital, Wishaw

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02046603 - A Study of Tocilizumab (RoActemra/Actemra) in Monotherapy or in Combination With Methotrexate or Other Non-Biologic DMARDs in Participants With Active Rheumatoid Arthritis and an Inadequate Response to Current Non-Biologic DMARD Therapy or the First Anti-TNF Biologic Agent | Biotech Hunter | Biotech Hunter