SWITCH Clinical Trial for Patients With Rheumatoid Arthritis Who Have Failed an Initial TNF-blocking Drug.

PHASE4CompletedINTERVENTIONAL
Enrollment

122

Participants

Timeline

Start Date

August 31, 2011

Primary Completion Date

November 30, 2015

Study Completion Date

November 30, 2015

Conditions
Rheumatoid Arthritis
Interventions
DRUG

Etanercept

"Etanercept will be administered at a dose of 50mg by subcutaneous injection per week for a total of 12 weeks. Further treatment will be prescribed at the discretion of the treating clinician.~The patient will be taught how to administer the subcutaneous injection and injections will be monitored by the hospital until the patient is proficient with the technique."

DRUG

Abatacept

"Abatacept will be administered at a dose determined by body weight:~Body Weight (kg) Dose (mg) \< 60kg = 500 mg~\> or equal to 60kg and \< or equal to 100kg = 750 mg \> 100 kg = 1000mg~The intravenous infusions will be administered in clinic on days 1, 15, 29 and every 28 days thereafter for a minimum of 24 weeks. Further treatment will be prescribed at the discretion of the treating clinician."

BIOLOGICAL

Rituximab

"Rituximab will be given at a dose of 1000mg; 2 intravenous infusions will be administered at days 0 (week 0) and 15 (week 2).~In line with standard practice, a patient who loses an initial response with a DAS28 increase of at least 0.6 may receive a further cycle of rituximab at the discretion of the treating clinician.~Prior to receiving rituximab, intravenous methylprednisolone 100mg will also be given."

DRUG

Adalimumab

"Adalimumab will be given at a dose of 40mg by subcutaneous injection every two weeks for a minimum of 12 weeks. Further treatment will be prescribed at the discretion of the treating clinician.~The patient will be taught how to administer the subcutaneous injection and injections will be monitored by the hospital until the patient is proficient with the technique."

DRUG

Certolizumab Pegol

"Certolizumab Pegol will be given at a dose of 400mg by subcutaneous injection at weeks 0, 2, 4and then at a dose of 200mg every two weeks thereafter for a minimum of 12 weeks. Further treatment will be prescribed at the discretion of the treating clinician.~The patient will be taught how to administer the subcutaneous injection and injections will be monitored by the hospital until the patient is proficient with the technique."

DRUG

Infliximab

"Infliximab will be given at a dose of 3mg/kg per intravenous infusion in clinic.~The intravenous infusions will be administered at week 0, 2, 6 and then 8-weekly thereafter for a minimum of 12 weeks.~Further treatment will be prescribed at the discretion of the treating clinician."

DRUG

Golimumab

"Golimumab will be given at a dose of 50mg by subcutaneous injection every 4 weeks for a minimum of 24 weeks.~Further treatment will be prescribed in line with the study protocol and following week 48, at the discretion of the treating clinician.~The participant will be taught how to administer the subcutaneous injection and injections will be monitored according to local arrangements until the participant is proficient with the technique according to local practice."

Trial Locations (1)

LS7 4SA

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

All Listed Sponsors
lead

Julia Brown

OTHER

NCT01295151 - SWITCH Clinical Trial for Patients With Rheumatoid Arthritis Who Have Failed an Initial TNF-blocking Drug. | Biotech Hunter | Biotech Hunter