Rheumatoid ArthritisPhase 4TEEMSNCT03813771
Targeted Treatment Early With Etanercept + Methotrexate vs.T2T Care for DMARD-naïve Early RA Patients Based on naïve T-cell Stratification
A Phase 4 study testing Benepali, Sulfasalazine and Methotrexate in people with Rheumatoid Arthritis, run by University of Leeds at 1 site in United Kingdom.
Trial summary
The main aim of the study is to determine the clinical utility of naive T-cell stratification for rationalising treatment with methotrexate (MTX), for DMARD-naive early RA patients. 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?
- Benepali, Sulfasalazine and Methotrexate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2019to Feb 2023
- 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
- Subject has a diagnosis of RA as defined by the new ACR/EULAR 2010 classification criteria
- Newly diagnosed (within 12 weeks)
- Active disease at screening (DAS28ESR ≥3.2 or clinical evidence of synovitis)
- Anti-citrillunated protein antibody (ACPA) positive
- Male \& female subjects ≥18 years old
- DMARD (disease modifying anti-rheumatic drug) naïve
Show all 10Show fewer
- No use of intra-muscular, intra-articular or oral corticosteroids 4 weeks days prior to screening
- All male and female subjects biologically capable of having children must agree to use a reliable method of contraception for the duration of the study and 24 weeks after the end of the study period. Acceptable methods of contraception are surgical sterilisation, oral, implantable or injectable hormonal methods, intrauterine devices or barrier contraceptives.
- Patients must have the capacity and be willing to provide written informed consent and comply with the requirements of the protocol
- Subjects should be deemed to be in good health with respect to clinical examination and screening blood tests, including full blood count (FBC), urea and electrolytes (U\&E), and liver functions tests (LFT) - see exclusion criteria for further details
Who cannot join
- Use of any additional investigational medications or products within 28 days of screening (including prior to screening)
- Use of intra-muscular/intra-articular or oral corticosteroids within 28 days prior to screening
- Use (including use as required) of more than one NSAID, change in NSAID or change in dose of NSAID within 28 days of the baseline visit.
- Live vaccine within <28 days prior to screening
- Pregnant/lactating women or planning pregnancy within 24 weeks of last protocol treatment
- Planned surgery within the study period (requiring omission of study medication > 28 days
Show all 17Show fewer
- The presence of other comorbidities, which the physician deems as significant to interfere with evaluation (musculoskeletal condition such as osteoarthritis \& fibromyalgia)
- Diagnosis of another inflammatory arthritis or connective tissue disease (e.g. psoriatic arthritis or Ankylosing spondylitis, primary Sjogren's syndrome, systemic sclerosis, systemic lupus erythematosus, polymyositis)
- Concomitant severe infection requiring intravenous therapy 4 weeks (28) days prior to screening
- Any contraindication to conventional DMARD's/anti-TNF therapy
- Patients with abnormal liver function at the time of screening or abnormal blood tests as shown by:
- Aminotransferase (AST) / alanine aminotransferase (ALT) > 3x upper limit of normal (ULN) OR Bilirubin > 50µmol/L
- Serum Creatinine > 175 umol/L
- eGFR below 30ml/L/min/1.73m2
- neutrophils < 2000 x 106/L
- Platelets < 125 x 109/L
- Haemoglobin < 90 g/L for males and < 85 g/L for females
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
Paul Emery, Professor, p.emery@leeds.ac.uk
About this study
Official title: Targeted Treatment Early With Etanercept Plus Methotrexate Versus T2T Care for DMARD-naïve Early RA Patients. A Prospective, Longitudinal Cohort Study With Embedded Pilot Randomised Controlled Trial to Assess Treatment Rationalisation Based on naïve T-cell Stratification.
The main aim of the study is to determine the clinical utility of naive T-cell stratification for rationalising treatment with methotrexate (MTX), for DMARD-naive early RA patients. Thus, it aims to determine whether TNFi therapy (Benepali) instituted as first-line therapy in DMARD-naive early RA patients with poor T-cell prognostication confers better outcomes (clinical, structural and immunological). Hence, this would enable early targeted treatment for those with a poorer prognosis based on their immunological status.
Read the detailed description
The current optimal therapeutic approach in early RA is to start MTX to target inflammation and induce remission.Prediction of MTX therapy response remains a key clinical need to enable the identification of patients who would benefit from an alternative, more aggressive treatment strategy. Multiple predictors of remission with MTX have been reported over the years but none have entered routine clinical practice.
We previously reported that T-cell phenotyping at baseline could predict remission in DMARD-naïve early RA treated with MTX. Reduced naïve CD4+ T-cell frequency was the most predictive factor, using both a pilot and a replication cohort.These data confirmed the potential value of using naïve CD4+ T-cells as a biomarker of MTX induced remission in early RA.
The clinical utility of measuring T-cell subsets is therefore strongly indicated by these data and suggests that measurement of T- cell subsets can be used to rationalise the use of MTX as first-line therapy.Predicting response to MTX has important clinical value to identify patients who will do well on MTX but furthermore for directing those who will have a sub-optimal response to MTX to receive alternative therapy without any harmful delay and in line with the treat to target principle.
The current study aims to confirm/validate the clinical value of T-cell subset quantification for the prediction of MTX response in early RA, by stratified interventions based on baseline naïve CD4+ T-cell status.
This is a Single centre, phase IV, open-label, prospective, longitudinal cohort study with an embedded pilot randomised controlled trial that aims to assess whether MTX can be rationalised as a first-line treatment for DMARD-naïve early RA patients, according to baseline naïve CD4+ T-cell stratification.
Patients with newly diagnosed RA satisfying the inclusion criteria will be recruited from our early arthritis clinic. Eligible patients will be provided with written information on the study and will be given a minimum of 24 hours to read this information prior to being contacted by a research nurse (within one week). If interested they will be invited to a screening appointment within four weeks to confirm eligibility, obtain written consent and to collect the necessary clinical and laboratory data as per the study schedule. Following the screening visit, patients will attend a baseline assessment within four weeks.
Patients will be stratified based on their naïve CD4+ T-cell frequency (normal or abnormal based on our pre-defined cut-off values according to age and sex-matched controls). Patients with a normal T-cell frequency (Arm A) will commence MTX 15mg/week PO (+HCQ 400mg od) as per standard T2T practice. Follow-up (4, 12 and 24 weeks), dose escalation of MTX and treatment of flare will also be conducted in line with T2T care.
Patients with an abnormal T-cell frequency will be randomized 1:1 into 2 groups using randomly permuted block sizes and also followed up as per T2T care:
The first group (Arm B) will receive MTX 15mg/week PO (+HCQ 400mg od) The second group (Arm C) will receive MTX 15mg/week PO (+HCQ 400mg od) in combination with 50 mg subcutaneous Benepali® administered weekly.
Patients will be followed up for a period of 24 weeks and will undergo clinical, immunological and imaging assessments as stated in the study schedule. Following completion of the study, patients will either be followed up in our established inflammatory arthritis or biologics clinic. Patients in group C will discontinue their Benepali®.
This study will take place at the rheumatology out-patient department in Chapel Allerton Hospital, Leeds.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Benepali, Sulfasalazine, Methotrexate, Hydroxychloroquine
- Keywords
- T-cells, Treat to Target, DMARD-naive, Benepali
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BenepaliDrug
Also called Etanercept
Benepali will be adminstered subcutaneously at a dose of 50mg weekly and discontinued at the primary endpoint (24 weeks).
SulfasalazineDrug
Sulfasalazine will be added at follow up visits (T2T care) if the subject fails to achieve low disease activity,administered orally at a dose of 1g twice daily.
MethotrexateDrug
Methotrexate will be administered orally at a starting dose of 15mg weekly. It may be increased in line with T2T care (to a maximum of 25mg) over the 24 weeks.
Hydroxychloroquine will be added at follow up visits (T2T care) if the subject fails to achieve low diseaseactivity, administered at a dose of 200mg daily.
| Study group | Role | What they receive |
|---|---|---|
| Abnormal T-cells: Benepali + T2T Care | Experimental | Treatment Arm C will receive Benepali and methotrexate combination therapy and followed as per T2T care over a total duration of 24 weeks. Sulfasalazine or Hydroxychloroquine may be added to therapy at follow up visits in-line with T2T care.
Benepali will be administered subcutaneously at a dose of 50mg weekly and discontinued at the primary endpoint (24 weeks).
Methotrexate will be administered orally at a starting dose of 15mg weekly. It may be increased in line with T2T care (to a maximum of 25mg) over the 24 weeks. Receives: Drug: Benepali; Drug: Methotrexate |
| Abnormal T-cells: Methotrexate + T2T Care | Active comparator | Treatment Arm B will receive initial methotrexate monotherapy with adoption of a treat to target protocol (standard care involving monthly DAS28-ESR assessment with escalation to combination synthetic DMARD (Including sulfasalazine and/or hydroxychloroquine).
therapy if not achieving low disease activity (LDA) at, or after, 8 weeks). Receives: Drug: Sulfasalazine; Drug: Methotrexate; Drug: Hydroxychloroquine |
| Normal T-cells: Methotrexate + T2T Care | Other | Treatment Arm A will receive standard T2T care as per Arm B. Receives: Drug: Sulfasalazine; Drug: Methotrexate; Drug: Hydroxychloroquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Remission at 24 weeks (Arms A vs B)
The difference in the proportions of patients in clinical remission (DAS28ESR ≤2.6) at 24 weeks of first-line methotrexate with T2T care between those with normal (Arm A) vs. abnormal (Arm B) naïve CD4+ T-cell frequencies
Measured: 24 weeks
Secondary outcomes (9)
Clinical Remission at 12 weeks (Arms A vs B)
The difference in the proportions of patients in clinical remission (DAS28ESR ≤2.6) after 12 weeks of first-line methotrexate with T2T care between those with normal (Arm A) vs. abnormal (Arm B) naïve CD4+ T-cell frequencies
Measured: 12 weeks
Clinical Remission at 12 and 24 weeks (Arms B vs C)
The difference in the proportions of patients in clinical remission (DAS28ESR ≤2.6) at 12 weeks and 24 weeks for patients with abnormal baseline naïve CD4+ T-cell frequencies receiving methotrexate with T2T care (Arm B) vs. etanercept + methotrexate (Arm C)
Measured: 12 and 24 weeks
Sustained Clinical Remission
The difference in the proportions of patients achieving sustained clinical remission (DAS28ESR ≤2.6 at both 12 and 24 weeks) (Arm A vs. Arm B and Arm B vs. Arm C)
Measured: 12 and 24 weeks
Patient Reported Outcomes at 12 and 24 weeks (Arm A vs B)
The differences in the medians of patient-reported outcome measures (EMS, VAS scales, HAQ-DI) after 12 weeks \& 24 weeks of first-line methotrexate with T2T care between those with normal (Arm A) vs. abnormal (Arm B) naïve CD4+ T-cell frequencies
Measured: 12 and 24 weeks
Patient Reported Outcomes at 12 and 24 weeks (Arm B vs C)
The differences in the medians of patient-reported outcome measures (EMS, VAS scales, HAQ-DI) after 12 weeks \& 24 weeks for patients with abnormal baseline naïve CD4+ T-cell frequencies receiving methotrexate with T2T care (Arm B) vs. etanercept + methotrexate (Arm C)
Measured: 12 and 24 weeks
Imaging Remission at 24 weeks (Arm A vs B)
The difference in the proportions of patients in imaging remission (Total power doppler synovitis score=0) after 24 weeks of first-line methotrexate with T2T care between those with normal (Arm A) or abnormal (Arm B) naïve CD4+ T-cell frequencies
Measured: 24 weeks
Imaging Remission at 24 weeks (Arm B vs C)
The difference in the proportions of patients in imaging remission (Total power doppler synovitis score = 0) at 24 weeks for patients with abnormal baseline naïve CD4+ T-cell frequencies receiving methotrexate with T2T care (Arm B) vs. etanercept + methotrexate (Arm C)
Measured: 24 weeks
Immunological Remission
The difference in the proportion of patients with normal naïve CD4+ T-cells at 24 weeks for patients with abnormal baseline naïve CD4+ T-cells receiving methotrexate with T2T care (Arm B) vs. etanercept + methotrexate (Arm C)
Measured: 24 weeks
Cumulative Steroid Use
The difference in the average (median) cumulative amount of intramuscular corticosteroid use at 24 weeks between study arms (Arm A vs. Arm B and Arm B vs. Arm C). This will include any administered at the 24 week visit.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study startMar 2019 (estimated)
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Prospective, longitudinal cohort study with an embedded pilot randomised controlled trial. Patients with normal naive T-cell status will receive standard T2T care with methotrexate. Patients with abnormal naive T-cell status will be randomised 1:1 to T2T care vs. Benepali + T2T care with methotrexate
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Bioepis Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Paul Emery, Professor, Principal investigator, Institute of Rheumatic & Musculoskeletal Medicine, Chapel Allerton Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03813771
- Sponsor's protocol ID
- RR16/209
- Other IDs
- 2016-002344-16, 2016
- Acronym
- TEEMS
- Status last verified
- Jan 2019
- First submitted
- 12 Sep 2018
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Treatment Early With Etanercept Plus Methotrexate Versus T2T Care for DMARD-naïve Early RA Patients. A Prospective, Longitudinal Cohort Study With Embedded Pilot Randomised Controlled Trial to Assess Treatment Rationalisation Based on naïve T-cell Stratification.
- ClinicalTrials.gov ID
- NCT03813771
- Acronym / sponsor ID
- TEEMS / RR16/209
- Conditions
- Rheumatoid Arthritis
- Keywords
- T-cells, Treat to Target, DMARD-naive, Benepali
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- Samsung Bioepis Co., Ltd.
- Study start
- Mar 2019 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 23 Jan 2019 (actual)
- 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 main aim of the study is to determine the clinical utility of naive T-cell stratification for rationalising treatment with methotrexate (MTX), for DMARD-naive early RA patients. Thus, it aims to determine whether TNFi therapy (Benepali) instituted as first-line therapy in DMARD-naive early RA patients with poor T-cell prognostication confers better outcomes (clinical, structural and immunological). Hence, this would enable early targeted treatment for those with a poorer prognosis based on their immunological status.
Detailed description
The current optimal therapeutic approach in early RA is to start MTX to target inflammation and induce remission.Prediction of MTX therapy response remains a key clinical need to enable the identification of patients who would benefit from an alternative, more aggressive treatment strategy. Multiple predictors of remission with MTX have been reported over the years but none have entered routine clinical practice.
We previously reported that T-cell phenotyping at baseline could predict remission in DMARD-naïve early RA treated with MTX. Reduced naïve CD4+ T-cell frequency was the most predictive factor, using both a pilot and a replication cohort.These data confirmed the potential value of using naïve CD4+ T-cells as a biomarker of MTX induced remission in early RA.
The clinical utility of measuring T-cell subsets is therefore strongly indicated by these data and suggests that measurement of T- cell subsets can be used to rationalise the use of MTX as first-line therapy.Predicting response to MTX has important clinical value to identify patients who will do well on MTX but furthermore for directing those who will have a sub-optimal response to MTX to receive alternative therapy without any harmful delay and in line with the treat to target principle.
The current study aims to confirm/validate the clinical value of T-cell subset quantification for the prediction of MTX response in early RA, by stratified interventions based on baseline naïve CD4+ T-cell status.
This is a Single centre, phase IV, open-label, prospective, longitudinal cohort study with an embedded pilot randomised controlled trial that aims to assess whether MTX can be rationalised as a first-line treatment for DMARD-naïve early RA patients, according to baseline naïve CD4+ T-cell stratification.
Patients with newly diagnosed RA satisfying the inclusion criteria will be recruited from our early arthritis clinic. Eligible patients will be provided with written information on the study and will be given a minimum of 24 hours to read this information prior to being contacted by a research nurse (within one week). If interested they will be invited to a screening appointment within four weeks to confirm eligibility, obtain written consent and to collect the necessary clinical and laboratory data as per the study schedule. Following the screening visit, patients will attend a baseline assessment within four weeks.
Patients will be stratified based on their naïve CD4+ T-cell frequency (normal or abnormal based on our pre-defined cut-off values according to age and sex-matched controls). Patients with a normal T-cell frequency (Arm A) will commence MTX 15mg/week PO (+HCQ 400mg od) as per standard T2T practice. Follow-up (4, 12 and 24 weeks), dose escalation of MTX and treatment of flare will also be conducted in line with T2T care.
Patients with an abnormal T-cell frequency will be randomized 1:1 into 2 groups using randomly permuted block sizes and also followed up as per T2T care:
The first group (Arm B) will receive MTX 15mg/week PO (+HCQ 400mg od) The second group (Arm C) will receive MTX 15mg/week PO (+HCQ 400mg od) in combination with 50 mg subcutaneous Benepali® administered weekly.
Patients will be followed up for a period of 24 weeks and will undergo clinical, immunological and imaging assessments as stated in the study schedule. Following completion of the study, patients will either be followed up in our established inflammatory arthritis or biologics clinic. Patients in group C will discontinue their Benepali®.
This study will take place at the rheumatology out-patient department in Chapel Allerton Hospital, Leeds.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Prospective, longitudinal cohort study with an embedded pilot randomised controlled trial. Patients with normal naive T-cell status will receive standard T2T care with methotrexate. Patients with abnormal naive T-cell status will be randomised 1:1 to T2T care vs. Benepali + T2T care with methotrexate
| Arm | Type | Receives |
|---|---|---|
| Abnormal T-cells: Benepali + T2T Care | Experimental | Drug: Benepali, Drug: MethotrexateTreatment Arm C will receive Benepali and methotrexate combination therapy and followed as per T2T care over a total duration of 24 weeks. Sulfasalazine or Hydroxychloroquine may be added to therapy at follow up visits in-line with T2T care. Benepali will be administered subcutaneously at a dose of 50mg weekly and discontinued at the primary endpoint (24 weeks). Methotrexate will be administered orally at a starting dose of 15mg weekly. It may be increased in line with T2T care (to a maximum of 25mg) over the 24 weeks. |
| Abnormal T-cells: Methotrexate + T2T Care | Active comparator | Drug: Sulfasalazine, Drug: Methotrexate, Drug: HydroxychloroquineTreatment Arm B will receive initial methotrexate monotherapy with adoption of a treat to target protocol (standard care involving monthly DAS28-ESR assessment with escalation to combination synthetic DMARD (Including sulfasalazine and/or hydroxychloroquine). therapy if not achieving low disease activity (LDA) at, or after, 8 weeks). |
| Normal T-cells: Methotrexate + T2T Care | Other | Drug: Sulfasalazine, Drug: Methotrexate, Drug: HydroxychloroquineTreatment Arm A will receive standard T2T care as per Arm B. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject has a diagnosis of RA as defined by the new ACR/EULAR 2010 classification criteria
- Newly diagnosed (within 12 weeks)
- Active disease at screening (DAS28ESR ≥3.2 or clinical evidence of synovitis)
- Anti-citrillunated protein antibody (ACPA) positive
- Male \& female subjects ≥18 years old
Key exclusion criteria (17 listed)
- Use of any additional investigational medications or products within 28 days of screening (including prior to screening)
- Use of intra-muscular/intra-articular or oral corticosteroids within 28 days prior to screening
- Use (including use as required) of more than one NSAID, change in NSAID or change in dose of NSAID within 28 days of the baseline visit.
- Live vaccine within <28 days prior to screening
- Pregnant/lactating women or planning pregnancy within 24 weeks of last protocol treatment
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 |
|---|---|---|
| BenepaliAlso: EtanerceptBenepali will be adminstered subcutaneously at a dose of 50mg weekly and discontinued at the primary endpoint (24 weeks). | Drug | Abnormal T-cells: Benepali + T2T Care |
| SulfasalazineSulfasalazine will be added at follow up visits (T2T care) if the subject fails to achieve low disease activity,administered orally at a dose of 1g twice daily. | Drug | Abnormal T-cells: Methotrexate + T2T Care, Normal T-cells: Methotrexate + T2T Care |
| MethotrexateMethotrexate will be administered orally at a starting dose of 15mg weekly. It may be increased in line with T2T care (to a maximum of 25mg) over the 24 weeks. | Drug | Abnormal T-cells: Benepali + T2T Care, Abnormal T-cells: Methotrexate + T2T Care, Normal T-cells: Methotrexate + T2T Care |
| HydroxychloroquineHydroxychloroquine will be added at follow up visits (T2T care) if the subject fails to achieve low diseaseactivity, administered at a dose of 200mg daily. | Drug | Abnormal T-cells: Methotrexate + T2T Care, Normal T-cells: Methotrexate + T2T Care |
Primary outcome
Clinical Remission at 24 weeks (Arms A vs B)
Time frame: 24 weeks
The difference in the proportions of patients in clinical remission (DAS28ESR ≤2.6) at 24 weeks of first-line methotrexate with T2T care between those with normal (Arm A) vs. abnormal (Arm B) naïve CD4+ T-cell frequencies
9 secondary outcomes
Clinical Remission at 12 weeks (Arms A vs B)
Time frame: 12 weeks
Clinical Remission at 12 and 24 weeks (Arms B vs C)
Time frame: 12 and 24 weeks
Sustained Clinical Remission
Time frame: 12 and 24 weeks
Patient Reported Outcomes at 12 and 24 weeks (Arm A vs B)
Time frame: 12 and 24 weeks
Patient Reported Outcomes at 12 and 24 weeks (Arm B vs C)
Time frame: 12 and 24 weeks
Imaging Remission at 24 weeks (Arm A vs B)
Time frame: 24 weeks
Imaging Remission at 24 weeks (Arm B vs C)
Time frame: 24 weeks
Immunological Remission
Time frame: 24 weeks
Cumulative Steroid Use
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- Individual participant dataSharing planned: Undecided
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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.
Paul Emery, Professor principal investigator
Institute of Rheumatic & Musculoskeletal Medicine, Chapel Allerton Hospital
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 Benepali, Sulfasalazine and Methotrexate in people with Rheumatoid Arthritis, run by University of Leeds 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 17 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: status not confirmed, as of the sponsor's last update on 23 Jan 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James Goulding (0113 392 4495, j.t.r.goulding@leeds.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Remission at 24 weeks (Arms A vs B) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2019.