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

Summary

The principal aim of this study is to fill a clear knowledge gap and provide guidance for rheumatologists and reassurance to the patient group on a management challenge faced daily in rheumatology practice. Specifically, it aims to provide robust evidence on the optimal management of patients with established RA that have failed an anti-TNF therapy (the first of the biological therapies to be introduced); in particular, the investigators wish to address whether the currently licensed but non NICE-approved treatment options, TNF-blocking drug or abatacept, are equivalent to the NICE-approved treatment, rituximab. If so, the intention is to broaden treatment options and target these specific therapies to disease sub-groups.

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.

Sponsors & Collaborators

• Julia Brown

  lead OTHER

Principal Investigators

• Maya Buch · University of Leeds

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-08-31

Primary Completion

2015-11-30

Completion

2015-11-30

Countries

• United Kingdom

Study Locations