SWITCH Clinical Trial for Patients With Rheumatoid Arthritis Who Have Failed an Initial TNF-blocking Drug.
- Conditions
- Rheumatoid Arthritis
- Interventions
- Registration Number
- NCT01295151
- Lead Sponsor
- Julia Brown
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 122
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TNF-blocking drug Certolizumab Pegol - TNF-blocking drug Golimumab - Rituximab Rituximab - TNF-blocking drug Etanercept - TNF-blocking drug Adalimumab - TNF-blocking drug Infliximab - Abatacept Abatacept -
- Primary Outcome Measures
Name Time Method Change in disease activity. 6 months Change in Disease Activity Score 28 (DAS28) at 6 months (24 weeks).
- Secondary Outcome Measures
Name Time Method Reduction in disease activity. Baseline and weeks 12, 24, 36 & 48. Proportion of participants who achieve a reduction in DAS28 score of greater than 1.2 from baseline at weeks 12, 24, 36 and 48 with no toxicity.
CDAI (Clinical disease activity index) Baseline and weeks 12, 24, 36 & 48. Change in CDAI score from baseline at weeks 12, 24, 36 and 48. Proportion of participants in each CDAI category at weeks 12, 24, 36 \& 48.
SDAI (Simplified Disease Activity Index) Baseline and weeks 12, 24, 36 & 48. Change in SDAI score from baseline at weeks 12, 24, 36 \& 48. Proportion of participants in each SDAI category at weeks 12, 24, 36 \& 48.
ACR/EULAR Boolean remission rates Baseline and weeks 12, 24, 36 & 48. Proportion of participants that achieve Boolean remission rate at weeks 12, 24, 36 \& 48.
Economic Evaluation Baseline & weeks 12, 24, 36 & 48 EuroQol 5-dimensions (EQ-5D) (also evaluated at weeks 60, 72, 84 \& 96) Health Utilities Index (also evaluated at weeks 60, 72, 84 \& 96) Health and Social Care Use \& Expenditure due to Rheumatoid Arthritis (evaluated at weeks 12, 24, 36 \& 48) Incremental Cost Effectiveness
EULAR & ACR Response Scores Baseline and weeks 12, 24, 36, 48 EULAR Response Scores and American College of Rheumatology (ACR) Response Scores (evaluated at weeks 12, 24, 36, 48).
Imaging (at the discretion of individual sites) Baseline and week 48. Change in plain x-ray score of hands and feet (Modified Genant score - evaluated at baseline and week 48) Bone densitometry scan scores (T-scores unilateral neck of femur and lumbar spine - evaluated at baseline and week 48)
Quality of Life Assessments Baseline & weeks 12, 24, 36 & 48. RA Quality of Life (RAQoL) score Health Assessment Questionnaire Disability Index (HAQ-DI) (also evaluated at weeks 60, 72, 84 \& 96) Hospital Anxiety and Depression Scale (HADS)
Safety & Toxicity Baseline and weeks 12, 24, 36 & 48. Toxicity Adverse Events \& Reactions
Trial Locations
- Locations (1)
Institute of Rheumatic & Musculoskeletal Medicine, Chapel Allerton Hospital
🇬🇧Leeds, West Yorkshire, United Kingdom