Targeted treatment early with etanercept and methotrexate or methotrexate with treat to target (standard) care for treatment-naive early rheumatoid arthritis patients, based on baseline naive T-cell frequency.

Phase 1

• Conditions: Rheumatoid Arthritis; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2016-002344-16-GB
• Lead Sponsor: niversity of Leeds

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-29
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 106

Inclusion Criteria

1. Subject has a diagnosis of RA as defined by the new ACR/EULAR 2010 classification criteria
2. Newly diagnosed (within 12 weeks)
3. Active disease at screening (DAS28ESR =3.2)
4. Anti-citrillunated peptide protein antibody positive (ACPA)
5. Male & female subjects =18 years old.
6. DMARD-naïve
7. No use of intra-muscular/Intra-articular or oral corticosteroids 4 weeks prior to screening.
8. 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.
9. Patients must have the capacity and be willing to provide written informed consent and comply with the requirements of the protocol.
10. Subjects 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 below exclusion criteria

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. Use of any additional investigational medications or products within 4 weeks of screening.
2. Use of intramuscular, intra-articular or oral corticosteroids within 4 weeks prior to screening.
3. Pregnant/lactating women or planning pregnancy within 24 weeks of last protocol treatment
4. Planned surgery within the study period (requiring omission of study medication > 28 days).
5. The presence of other comorbidities, which the physician deems as significant to interfere with evaluation (musculoskeletal condition such as osteoarthritis & fibromyalgia).
6. Diagnosis of another inflammatory arthritis or conective tissue disease e.g. psoriatic arthritis or Ankylosing spondylitis, primary Sjogren’s syndrome, systemic sclerosis, systemic lupus erythematosus, polymyositis.
7. Patients with any ongoing or active infection or any major episode of severe infection requiring hospitalization or treatment with IV antibiotics within the preceding 4 weeks of screening and/or orally administered antibiotics in the preceding 2 weeks of screening.
8. Any contraindication to conventional DMARD’s and anti-TNF therapy
9. In receipt of a live vaccination within 4 weeks prior to screening
10.Patients with abnormal liver function at the time of screening or abnormal blood tests as shown by:
o Aminotransferase (AST)/alanine aminotransferase (ALT) >3x upper limit of normal (ULN), OR Bilirubin >51µmol/L
o Serum Creatinine >175 mmol/L, eGFR below 30ml/L/min/1.73m2
o Neutrophils <2000 x 10*6/L
o Platelets <125 x 109/L
o Haemoglobin <90 g/L for males and <85 g/L for females

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified