A Prospective, Single-centre, Randomised Study Evaluating the Clinical, Imaging and Immunological Depth of Remission Achieved by Very Early versus Delayed Etanercept in patients with Rheumatoid Arthritis (VEDERA) - Very Early versus Delayed Etanercept in patients with RA (VEDERA)

Phase 1

• Conditions: Rheumatoid Arthritis; MedDRA version: 13.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

• Registration Number: EUCTR2010-023910-30-GB
• Lead Sponsor: niversity of Leeds

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-02-28
• Study Completion: 2019-02-25
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Male and female patients aged between 18 and 80 years. Diagnosis of rheumatoid arthritis (new 2010 ACR/EULAR RA classification criteria). Symptom onset within the preceding 12 months. Patients with active RA at baseline: clinical evidence of synovitis (or imaging evidence of synovitis in cases of uncertainty/subclinical disease) and DAS28-ESR=3.2. Presence of anti-citrullinated peptide antibody (ACPA) or if ACPA negative, presence of power Doppler in at least 1 joint on ultrasound imaging. Naïve to disease-modifying therapy. Active synovitis in hand and/or wrist joints evaluable by ultrasound and MRI. 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Previous treatment with disease-modifying anti-rheumatic drugs (for example, methotrexate, sulfasalazine or hydroxychloroquine). Intramuscular, oral or intra-articular (of non-target joint for synovial biopsy) corticosteroid within 28 days of the screening visit or intra-articular corticosteroid of the chosen target joint within 12 weeks of screening visit. Use of more than one non-steroidal anti-inflammatory (NSAID), change in NSAID or change in dose of NSAID within 28 days of the baseline visit. Contraindications to MRI (e.g. pacemaker) or unable or unwilling to attend for all imaging assessments. Unable or unwilling to attend for all synovial biopsies. Pregnancy or breastfeeding. Other contraindications to TNF inhibitor as determined by local prescribing guidelines and physician discretion. Whilst some of the below are absolute contraindications, physician discretion will be applied as in usual clinical practice: active infection, open leg ulcers, previously infected prosthetic joint (unless completely removed), septic arthritis in last year, HIV, Hepatitis B or Hepatitis C carriers, previous malignancy within 10 years (except basal cell carcinoma), severe heart failure (New York Heart Association grade 3 or more), any history of demyelinating disease, uncontrolled diabetes, pulmonary fibrosis, bronchiectasis, previous PUVA therapy (of >1000 Joules), history of TB or positive Purified Protein Derivative test (in this event, a TB gold quanteferon blood test will be performed: if negative a patient may be included, if positive a patient may be included if treated with isoniazid and pyridoxine one month before starting the study and for a further 6 months whilst on study treatments). History of other significant medical conditions, including: o Severe pulmonary disease, defined as requiring previous hospital admission or supplemental oxygen. o Active or severe cardiovascular disease: uncontrolled hypertension, myocardial infarction within 12 months of screening, angina within 6 months of screening. o Other immunodeficiency disorders. o Connective tissue diseases, e.g. Sjogren’s syndrome, systemic sclerosis, systemic lupus erythematosus, polymyositis. o Psoriasis. o Renal impairment (creatinine 175µmol/L). o Neutropenia (neutrophils < 2.0 x 109/L). o Thrombocytopenia (platelets < 125 x 109/L). o Abnormal liver function (alanine transaminase > 3 x upper limit of normal). o Anaemia (haemoglobin < 8 g/dL).

Study & Design

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