Rheumatoid ArthritisPhase 4SWITCHNCT01295151
SWITCH Clinical Trial for Patients With Rheumatoid Arthritis Who Have Failed an Initial TNF-blocking Drug.
A Phase 4 study testing Etanercept, Abatacept and Rituximab in people with Rheumatoid Arthritis, run by Julia Brown at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Etanercept, Abatacept and Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2011to Nov 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects aged ≥18 years at the time of signing the Informed Consent Form.
- 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.
- Patients who have failed conventional DMARD therapy as per NICE/BSR Guidelines (49) i.e. failure of at least 2 DMARDS including MTX.
- 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*:
- 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
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- 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.
- MTX dose stable for 4 weeks prior to the screening visit and to be continued for the duration of the study.
- 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.
- Provided written informed consent prior to any trial-specific procedures.
Who cannot join
- Major surgery (including joint surgery) within 8 weeks prior to the screening visit or planned major surgery within 52 weeks following randomization.
- 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.
- Patients receiving doses of prednisolone > 10mg/day within the 4 weeks prior to the screening visit.
- Patients receiving intra-articular or intra-muscular steroid injections within 4 weeks prior to the screening visit.
- Patients who have previously received more than 1 TNFi drug OR any other biological therapy for the treatment of RA.
- 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.
Show all 23Show fewer
- Treatment with any investigational drug in the last 12 weeks prior the start of protocol treatment.
- 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.
- 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.
- 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)).
- 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.
- 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.
- 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.
- Primary or secondary immunodeficiency (history of or currently active) unless related to primary disease under investigation.
- 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.
- 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.
- 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
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Institute of Rheumatic & Musculoskeletal Medicine, Chapel Allerton Hospital
Leeds, West Yorkshire, LS7 4SA
About this study
Official 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
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
- Being tested
- Etanercept, Abatacept, Rituximab, Adalimumab, Certolizumab Pegol
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtanerceptDrug
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.
AbataceptDrug
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.
RituximabBiological
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.
AdalimumabDrug
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.
Certolizumab PegolDrug
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.
InfliximabDrug
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.
GolimumabDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| TNF-blocking drug | Experimental | Not described Receives: Drug: Etanercept; Drug: Adalimumab; Drug: Certolizumab Pegol; Drug: Infliximab; Drug: Golimumab |
| Abatacept | Experimental | Not described Receives: Drug: Abatacept |
| Rituximab | Active comparator | Not described Receives: Biological: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in disease activity.
Change in Disease Activity Score 28 (DAS28) at 6 months (24 weeks).
Measured: 6 months
Secondary outcomes (9)
Reduction in disease activity.
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.
Measured: Baseline and weeks 12, 24, 36 & 48.
EULAR & ACR Response Scores
EULAR Response Scores and American College of Rheumatology (ACR) Response Scores (evaluated at weeks 12, 24, 36, 48).
Measured: Baseline and weeks 12, 24, 36, 48
CDAI (Clinical disease activity index)
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.
Measured: Baseline and weeks 12, 24, 36 & 48.
SDAI (Simplified Disease Activity Index)
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.
Measured: Baseline and weeks 12, 24, 36 & 48.
ACR/EULAR Boolean remission rates
Proportion of participants that achieve Boolean remission rate at weeks 12, 24, 36 \& 48.
Measured: Baseline and weeks 12, 24, 36 & 48.
Quality of Life Assessments
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)
Measured: Baseline & weeks 12, 24, 36 & 48.
Safety & Toxicity
Toxicity Adverse Events \& Reactions
Measured: Baseline and weeks 12, 24, 36 & 48.
Economic Evaluation
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
Measured: Baseline & weeks 12, 24, 36 & 48
Imaging (at the discretion of individual sites)
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)
Measured: Baseline and week 48.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2011 (estimated)
- Study startAug 2011
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Julia Brown
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Julia Brown, University of Leeds
- Investigators
- Maya Buch, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01295151
- Sponsor's protocol ID
- RR10/9589
- Other IDs
- 2010-023880-17
- Acronym
- SWITCH
- Status last verified
- Nov 2016
- First submitted
- 11 Feb 2011
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Plein S, Erhayiem B, Fent G, Horton S, Dumitru RB, Andrews J, Greenwood JP, Emery P, Hensor EM, Baxter P, Pavitt S, Buch MH. Cardiovascular effects of biological versus conventional synthetic disease-modifying antirheumatic drug therapy in treatment-naive, early rheumatoid arthritis. Ann Rheum Dis. 2020 Nov;79(11):1414-1422. doi: 10.1136/annrheumdis-2020-217653. Epub 2020 Aug 28.
PubMed 32859608Brown S, Everett CC, Naraghi K, Davies C, Dawkins B, Hulme C, McCabe C, Pavitt S, Emery P, Sharples L, Buch MH. Alternative tumour necrosis factor inhibitors (TNFi) or abatacept or rituximab following failure of initial TNFi in rheumatoid arthritis: the SWITCH RCT. Health Technol Assess. 2018 Jun;22(34):1-280. doi: 10.3310/hta22340.
PubMed 29900829Navarro Coy NC, Brown S, Bosworth A, Davies CT, Emery P, Everett CC, Fernandez C, Gray JC, Hartley S, Hulme C, Keenan AM, McCabe C, Redmond A, Reynolds C, Scott D, Sharples LD, Pavitt S, Buch MH. The 'Switch' study protocol: a randomised-controlled trial of switching to an alternative tumour-necrosis factor (TNF)-inhibitor drug or abatacept or rituximab in patients with rheumatoid arthritis who have failed an initial TNF-inhibitor drug. BMC Musculoskelet Disord. 2014 Dec 23;15:452. doi: 10.1186/1471-2474-15-452.
PubMed 25539805
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01295151
- Acronym / sponsor ID
- SWITCH / RR10/9589
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Julia BrownUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 14 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TNF-blocking drug | Experimental | Drug: Etanercept, Drug: Adalimumab, Drug: Certolizumab Pegol, Drug: Infliximab, Drug: Golimumab |
| Abatacept | Experimental | Drug: Abatacept |
| Rituximab | Active comparator | Biological: Rituximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male and female subjects aged ≥18 years at the time of signing the Informed Consent Form.
- 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.
- Patients who have failed conventional DMARD therapy as per NICE/BSR Guidelines (49) i.e. failure of at least 2 DMARDS including MTX.
- 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*:
- MTX dose stable for 4 weeks prior to the screening visit and to be continued for the duration of the study.
Key exclusion criteria (23 listed)
- Major surgery (including joint surgery) within 8 weeks prior to the screening visit or planned major surgery within 52 weeks following randomization.
- 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.
- Patients receiving doses of prednisolone > 10mg/day within the 4 weeks prior to the screening visit.
- Patients receiving intra-articular or intra-muscular steroid injections within 4 weeks prior to the screening visit.
- Patients who have previously received more than 1 TNFi drug OR any other biological therapy for the treatment of RA.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EtanerceptEtanercept 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 | TNF-blocking drug |
| AbataceptAbatacept 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. | Drug | Abatacept |
| RituximabRituximab 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. | Biological | Rituximab |
| AdalimumabAdalimumab 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 | TNF-blocking drug |
| Certolizumab PegolCertolizumab 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 | TNF-blocking drug |
| InfliximabInfliximab 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 | TNF-blocking drug |
| GolimumabGolimumab 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. | Drug | TNF-blocking drug |
Primary outcome
Change in disease activity.
Time frame: 6 months
Change in Disease Activity Score 28 (DAS28) at 6 months (24 weeks).
9 secondary outcomes
Reduction in disease activity.
Time frame: Baseline and weeks 12, 24, 36 & 48.
EULAR & ACR Response Scores
Time frame: Baseline and weeks 12, 24, 36, 48
CDAI (Clinical disease activity index)
Time frame: Baseline and weeks 12, 24, 36 & 48.
SDAI (Simplified Disease Activity Index)
Time frame: Baseline and weeks 12, 24, 36 & 48.
ACR/EULAR Boolean remission rates
Time frame: Baseline and weeks 12, 24, 36 & 48.
Quality of Life Assessments
Time frame: Baseline & weeks 12, 24, 36 & 48.
Safety & Toxicity
Time frame: Baseline and weeks 12, 24, 36 & 48.
Economic Evaluation
Time frame: Baseline & weeks 12, 24, 36 & 48
Imaging (at the discretion of individual sites)
Time frame: Baseline and week 48.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
- Derived from this study: PubMed 32859608Plein S, Erhayiem B, Fent G, Horton S, Dumitru RB, Andrews J, Greenwood JP, Emery P, Hensor EM, Baxter P, Pavitt S, Buch MH. Cardiovascular effects of biological versus conventional synthetic disease-modifying antirheumatic drug therapy in treatment-naive, early rheumatoid arthritis. Ann Rheum Dis. 2020 Nov;79(11):1414-1422. doi: 10.1136/annrheumdis-2020-217653. Epub 2020 Aug 28.
- Derived from this study: PubMed 29900829Brown S, Everett CC, Naraghi K, Davies C, Dawkins B, Hulme C, McCabe C, Pavitt S, Emery P, Sharples L, Buch MH. Alternative tumour necrosis factor inhibitors (TNFi) or abatacept or rituximab following failure of initial TNFi in rheumatoid arthritis: the SWITCH RCT. Health Technol Assess. 2018 Jun;22(34):1-280. doi: 10.3310/hta22340.
- Derived from this study: PubMed 25539805Navarro Coy NC, Brown S, Bosworth A, Davies CT, Emery P, Everett CC, Fernandez C, Gray JC, Hartley S, Hulme C, Keenan AM, McCabe C, Redmond A, Reynolds C, Scott D, Sharples LD, Pavitt S, Buch MH. The 'Switch' study protocol: a randomised-controlled trial of switching to an alternative tumour-necrosis factor (TNF)-inhibitor drug or abatacept or rituximab in patients with rheumatoid arthritis who have failed an initial TNF-inhibitor drug. BMC Musculoskelet Disord. 2014 Dec 23;15:452. doi: 10.1186/1471-2474-15-452.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maya Buch principal investigator
University of Leeds
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Etanercept, Abatacept and Rituximab in people with Rheumatoid Arthritis, run by Julia Brown at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in disease activity. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01295151, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.