Very Early Versus Delayed Etanercept in Patients With RA

PHASE4CompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

July 31, 2011

Primary Completion Date

August 31, 2017

Study Completion Date

July 31, 2019

Conditions
Rheumatoid Arthritis
Interventions
DRUG

Etanercept

Etanercept will be administered subcutaneously at a dose of 50 mg weekly and will be discontinued at the primary endpoint (48 weeks).

DRUG

Methotrexate

Methotrexate will be administered orally at a starting dose of 15 mg and will be increased to 25mg weekly at 2 weeks.

DRUG

Sulfasalazine

Sulfasalazine will be added at weeks 8,12,16 or 20 if the subject fails to achieve low disease activity, administered orally at a dose of 1g twice daily. Will be discontinued if starting etanercept at 24 weeks.

DRUG

Hydroxychloroquine

Hydroxychloroquine will be added at weeks 8,12,16 or 20 if the subject fails to achieve low disease activity, administered at a dose of 200mg daily. Will be discontinued if starting etanercept at 24 weeks.

DRUG

Etanercept

Etanercept will be added at 24 weeks, if a subject fails to achieve clinical remission,at a dose of 50 mg weekly and will be discontinued at 48 weeks with the exception of those patients who are eligible to continue according to local prescribing guidelines (NICE guidelines)

DRUG

Methotrexate

Methotrexate will be administered orally at a starting dose of 15 mg weekly, increasing to 20mg and 25mg weekly at weeks 4 and 8 respectively.

Trial Locations (1)

LS7 4SA

Institute of Rheumatic & Musculoskeletal Medicine, Chapel Allerton Hospital, Leeds

All Listed Sponsors
lead

University of Leeds

OTHER

NCT02433184 - Very Early Versus Delayed Etanercept in Patients With RA | Biotech Hunter | Biotech Hunter