|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
EUCTR |
|
Last refreshed on:
|
20 July 2020 |
|
Main ID: |
EUCTR2010-023910-30-GB |
|
Date of registration:
|
28/02/2011 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
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)
|
|
Scientific title:
|
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) |
|
Date of first enrolment:
|
23/03/2011 |
|
Target sample size:
|
120 |
|
Recruitment status: |
Not Recruiting |
|
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-023910-30 |
|
Study type:
|
Interventional clinical trial of medicinal product |
|
Study design:
|
Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: yes
Other specify the comparator: Standard care(see cover letter) with treatment with the IMP if not acheiving remission at 6 months
|
|
Phase:
|
Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
|
|
|
Countries of recruitment
|
|
United Kingdom
| | | | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
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).
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
|
|
Health Condition(s) or Problem(s) studied
|
Rheumatoid Arthritis
MedDRA version: 13.1
Level: PT
Classification code 10039073
Term: Rheumatoid arthritis
System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
|
|
Intervention(s)
|
Trade Name: Enbrel 50mg pre-filled pen
Product Name: Etanercept (Enbrel)
Product Code: EU/1/99/126/020
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Etanercept
CAS Number: 185243-69-0
Current Sponsor code: RR10/9592
Other descriptive name: Enbrel
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Trade Name: Enbrel 50mg pre-filled syringe
Product Name: Etanercept (Enbrel)
Product Code: EU/1/99/126/017
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Etanercept
CAS Number: 185243-69-0
Current Sponsor code: RR10/9592
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
|
|
Primary Outcome(s)
|
|
Main Objective: The main aim of the study is compare remission (absence of symptoms and signs of arthritis) achieved with very early etanercept therapy to that achieved by current standard care (methotrexate and a treat to target regimen) with or without delayed etanercept, in patients with early, untreated rheumatoid arthritis. We will compare differences in: a. the proportion of patients achieving initial remission. b. the proportion of patients who remain in sustained remission. c. the depth of remission. For example, we will look for signs of active arthritis on ultrasound scans and using sensitive MRI techniques. We will also look to see the body's immune response (in rheumatoid arthritis part of the body's defence system does not act normally and attacks its own joint tissues). We will assess if it has returned to normal using blood and urine tests and examining joint tissue (synovial biopsy tissue).
|
|
Secondary Objective: 1. If there are differences in efficacy of very early compared to delayed etanercept therapy, what are the reasons for this? Are there differences in very early, untreated disease, compared to later disease which mean patients are more responsive to a TNF inhibitor? We will evaluate differences in the appearance of joints (on ultrasound and MRI) and the body's immune cells and chemical signalling between immune cells in blood, urine and joint tissue samples. 2. Why do some patients respond to etanercept and others do not? We will look for factors which may predict response to etanercept: in the appearance of joints (on ultrasound and MRI), the immune system (in blood, urine and joint tissue) and genetic factors (a persons DNA, the information in their body cells they inherit from their parents will be examined by a single blood test at the start of the study). 3. In patients achieving clinical remission (absence of symptoms and signs of arthritis) are there ongoing signs o
|
|
Primary end point(s): The primary outcome is the proportion of patients with early, treatment-naïve rheumatoid arthritis that achieve clinical remission at 48 weeks, following either: 1. Initial etanercept and methotrexate treatment. 2. Initial methotrexate with 'Treat to Target' regimen: escalation to combination therapy (methotrexate, sulfasalazine and hydroxychloroquine) at 12 weeks and switch to etanercept and methotrexate at/after 24 weeks if indicated by disease activity. The definition for clinical remission used in the primary endpoint will be DAS28-ESR remission (DAS28-ESR<2.6) or physician judgement of clinical remission with DAS28-ESR low disease activity (DAS28-ESR<3.2). DAS28-ESR is a composite score using: - the numbers of swollen and tender joints (out of 28 specified joints). - patient self-assessment of their current general health (using a visual analogue scale). - Erythrocyte Sedimentation Rate (marker of inflammation in blood).
|
|
Secondary ID(s)
|
|
RR10/9592
|
|
Source(s) of Monetary Support
|
|
Ethics review
|
Status: Approved
Approval date: 23/02/2011
Contact:
|
|