Status:
UNKNOWN
Targeted Treatment Early With Etanercept + Methotrexate vs.T2T Care for DMARD-naïve Early RA Patients Based on naïve T-cell Stratification
Lead Sponsor:
University of Leeds
Collaborating Sponsors:
Samsung Bioepis Co., Ltd.
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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. Thus, it aims to d...
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 identifica...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2023
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT03813771
Start Date
March 1 2019
End Date
February 1 2023
Last Update
January 23 2019
Active Locations (1)
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1
Institute of Rheumatic & Musculoskeletal Medicine, Chapel Allerton Hospital
Leeds, West Yorkshire, United Kingdom, LS7 4SA