World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 14 November 2016
Main ID:  NCT01295151
Date of registration: 11/02/2011
Prospective Registration: Yes
Primary sponsor: Julia Brown
Public title: SWITCH Clinical Trial for Patients With Rheumatoid Arthritis Who Have Failed an Initial TNF-blocking Drug. SWITCH
Scientific title: Randomised-controlled Trial of Switching to Alternative Tumour-necrosis Factor (TNF)-Blocking Drugs or Abatacept or Rituximab in Patients With Rheumatoid Arthritis Who Have Failed an Initial TNF-blocking Drug
Date of first enrolment: August 2011
Target sample size: 122
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01295151
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 4
Countries of recruitment
United Kingdom
Contacts
Name:     Maya Buch
Address: 
Telephone:
Email:
Affiliation:  University of Leeds
Key inclusion & exclusion criteria

Inclusion Criteria

1. Male and female subjects aged =18 years at the time of signing the Informed Consent
Form.

2. Patients with a diagnosis of rheumatoid arthritis as per the ACR/EULAR 2010
classification criteria (Appendix 7) confirmed at least 24 weeks prior to the
screening visit.

3. Patients who have failed conventional DMARD therapy as per NICE/BSR Guidelines (49)
i.e. failure of at least 2 DMARDS including MTX.

4. Patients with persistent RA disease activity despite having been treated with a
current initial TNFi agent for at least 12 weeks. Active RA defined as*:

1. Primary non-response: failing to improve DAS28 by > 1.2 (Appendix 6) or failing
to achieve DAS28 = 3.2 within the first 12 to 24 weeks of starting the initial
TNFi.

• This may include patients that have shown a reduction in DAS28 of > 1.2 but
still demonstrate unacceptably high disease activity in the physician's
judgement with evidence of an overall DAS28 of = 3.2 OR

2. Secondary non-response: defined as inefficacy to first TNFi (having demonstrated
prior satisfactory response) as per clinician judgement; with intolerance not
the reason for cessation of first TNFi.

5. MTX dose stable for 4 weeks prior to the screening visit and to be continued for the
duration of the study.

6. Patients on NSAIDs and / or corticosteroids (oral prednisolone not exceeding 10mg
daily) who have been on an unchanged regimen for at least 4 weeks prior to the
screening visit and are expected to remain on a stable dose until the baseline
assessments have been completed.

7. Provided written informed consent prior to any trial-specific procedures.

Exclusion Criteria

1. Major surgery (including joint surgery) within 8 weeks prior to the screening visit
or planned major surgery within 52 weeks following randomization.

2. Patients with inflammatory joint disease of different origin, mixed connective tissue
disease, Reiter's syndrome, psoriatic arthritis, systemic lupus erythematosus, or any
arthritis with onset prior to 16 years of age.

3. Patients receiving doses of prednisolone > 10mg/day within the 4 weeks prior to the
screening visit.

4. Patients receiving intra-articular or intra-muscular steroid injections within 4
weeks prior to the screening visit.

5. Patients who have previously received more than 1 TNFi drug OR any other biological
therapy for the treatment of RA.

6. Patients unable or unwilling to stop treatment with a prohibited DMARD (i.e synthetic
DMARD aside from MTX e.g. oral or injectable gold, chloroquine, hydroxychloroquine,
cyclosporine, azathioprine, leflunomide, sulphasalazine) prior to the start of
protocol treatment.

7. Treatment with any investigational drug in the last 12 weeks prior the start of
protocol treatment.

8. Patients with other co-morbidity including acute, severe infections, uncontrolled
diabetes, uncontrolled hypertension, unstable ischaemic heart disease,
moderate/severe heart failure (Class III/IV of the New York Heart Association (NYHA)
functional classification system (79)), active bowel disease, active peptic ulcer
disease, recent stroke (within 12 weeks before the screening visit), or any other
condition which, in the opinion of the investigator, would put the patient at risk to
participate in the study or would make implementation of the protocol difficult.

9. Patients with any major episode of infection requiring hospitalisation or treatment
with IV antibiotics within 12 weeks of start of treatment protocol or oral
antibiotics within 4 weeks of start of protocol treatment.

10. Patients at significant risk of infection, which in the opinion of the investigator
would put the patient at risk to participate in the study (e.g. leg ulceration,
indwelling urinary catheter, septic joint within 52 weeks (or ever if prosthetic
joint still in situ)).

11. Patients with known active current or history of recurrent bacterial, viral, fungal,
mycobacterial or other infections including herpes zoster (for tuberculosis and
Hepatitis B and C see below), but excluding fungal infections of nail beds as per
clinical judgment.

12. Patients with untreated active current or latent tuberculosis (TB). Patients should
have been screened for latent TB (as per BSR guidelines) within 24 weeks prior to the
screening visit and, if positive, treated following local practice guidelines prior
to the start of protocol treatment.

13. Patients with active current hepatitis B and/or C infection. Patients should have
been screened for hepatitis B and C within 24 weeks prior to the screening visit and
if positive, excluded from the study.

14. Primary or secondary immunodeficiency (history of or currently active) unless related
to primary disease under investigation.

15. Pregnancy, lactation or women of child-bearing potential (WCBP) unwilling to use an
effective birth control measure (Appendix 2) whilst receiving treatment and after the
last dose of protocol treatment as indicated in the relevant SmPC/IB.

16. Men whose partners are of child-bearing potential but who are unwilling to use an
effective birth control measure (Appendix 2) whilst receiving treatment and after the
last dose of protocol treatment as indicated in the relevant SmPC/IB.

17. Patients with known significantly impaired bone marrow function as for example
significant anaemia, leukopaenia, neutropaenia or thrombocytopaenia as shown by the
following laboratory values at the time of the screening visit:

- Haemoglobin < 8.5 g/dl

- Platelet count < 100 x 109 / L

- White blood cell count < 2.0 x 109 / L

- Neutrophil count < 1 x 109 / L

18. Patients with known severe hypoproteinaemia at the time of the screening visit, e.g.
in nephrotic syndrome or impaired renal function, as shown by:

- Serum Creatinine > 150 umol / L



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Biological: Rituximab
Drug: Abatacept
Drug: Adalimumab
Drug: Certolizumab Pegol
Drug: Etanercept
Drug: Golimumab
Drug: Infliximab
Primary Outcome(s)
Change in disease activity. [Time Frame: 6 months]
Secondary Outcome(s)
ACR/EULAR Boolean remission rates [Time Frame: Baseline and weeks 12, 24, 36 & 48.]
CDAI (Clinical disease activity index) [Time Frame: Baseline and weeks 12, 24, 36 & 48.]
Economic Evaluation [Time Frame: Baseline & weeks 12, 24, 36 & 48]
EULAR & ACR Response Scores [Time Frame: Baseline and weeks 12, 24, 36, 48]
Imaging (at the discretion of individual sites) [Time Frame: Baseline and week 48.]
Quality of Life Assessments [Time Frame: Baseline & weeks 12, 24, 36 & 48.]
Reduction in disease activity. [Time Frame: Baseline and weeks 12, 24, 36 & 48.]
Safety & Toxicity [Time Frame: Baseline and weeks 12, 24, 36 & 48.]
SDAI (Simplified Disease Activity Index) [Time Frame: Baseline and weeks 12, 24, 36 & 48.]
Secondary ID(s)
2010-023880-17
RR10/9589
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history