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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03813771
• Date of registration: 12/09/2018
• Prospective Registration: Yes
• Primary sponsor: University of Leeds
• Public title: Targeted Treatment Early With Etanercept + Methotrexate vs.T2T Care for DMARD-naïve Early RA Patients Based on naïve T-cell Stratification TEEMS
• Scientific 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.
• Date of first enrolment: March 2019
• Target sample size: 106
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/show/NCT03813771
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

United Kingdom

Contacts

• Name: Paul Emery, Professor
• Affiliation: Institute of Rheumatic & Musculoskeletal Medicine, Chapel Allerton Hospital

• Name: Paul Emery, Professor

• Name: James Goulding

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Methotrexate

Drug: Benepali

Drug: Hydroxychloroquine

Drug: Sulfasalazine

Primary Outcome(s)

Clinical Remission at 24 weeks (Arms A vs B) [Time Frame: 24 weeks]

Secondary Outcome(s)

Cumulative Steroid Use [Time Frame: 24 weeks]

Clinical Remission at 12 weeks (Arms A vs B) [Time Frame: 12 weeks]

Patient Reported Outcomes at 12 and 24 weeks (Arm B vs C) [Time Frame: 12 and 24 weeks]

Patient Reported Outcomes at 12 and 24 weeks (Arm A vs B) [Time Frame: 12 and 24 weeks]

Clinical Remission at 12 and 24 weeks (Arms B vs C) [Time Frame: 12 and 24 weeks]

Immunological Remission [Time Frame: 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]

Sustained Clinical Remission [Time Frame: 12 and 24 weeks]

Secondary ID(s)

2016-002344-16

RR16/209

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Samsung Bioepis Co., Ltd.