Targeted Treatment Early With Etanercept + Methotrexate vs.T2T Care for DMARD-naïve Early RA Patients Based on naïve T-cell Stratification

• Status: Not yet recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Leeds
• Collaborator: Samsung Bioepis Co., Ltd.
• Treatments: Antirheumatic Agents; Etanercept; Hydroxychloroquine; Methotrexate; Sulfasalazine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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