Patients with early inflamatory arthritis (duration of symptoms of < 12 weeks) who are at very high risk of the development of rheumatoid arthritis (seropositivity for Rheumatoid factor and anti-CCP antibody)
Conditions
Interventions
Trade Name: Enbrel
Pharmaceutical Form: Solution for injection
Trade Name: Methorexate
Pharmaceutical Form: Tablet
Trade Name: Depo-Medrone
Pharmaceutical Form: Solution for injection
Trade Name:
Sponsors
University Hospitals Birmingham NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age over 18 years 2. Synovial swelling of at least 1 joint confirmed by clinical assessment 3. Duration of symptoms attributable to inflammatory joint disease (pain, swelling or early morning stiffness of >1 hour) of =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Previous history of inflammatory arthritis. 2. Previous use of DMARDs or anti-TNF-agents. 3. Any current inflammatory condition with signs or symptoms that might confound the diagnosis (e.g. connective tissue disorders). 4. Clinical evidence of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to study entry. 5. Administration, or expected administration, of any live virus or bacterial vaccination within 3 months before the first administration of study agent, or during the trial. 6. A history of an infected joint prosthesis, or administration of antibiotics for a suspected infection of a joint prosthesis, if that prosthesis has not been removed or replaced. 7. Known infection with HIV, hepatitis B, or hepatitis C. 8. A serious infection that in the opinion of the investigator precludes receipt of a TNF blocking agent. 9. Serious and uncontrolled co-existing disease that in the opinion of the investigator preclude the use of TNF-blocking medication, methotrexate or depomedrone (including pulmonary disease on chest radiograph, congestive cardiac failure (NYHA grade 3 or 4), history of demyelinating disease such as multiple sclerosis or optic neuritis). 10. Bleeding disorder of the use of anti-coagulants 11. Any known malignancy or a history of malignancy within the previous 5 years (with the exception of a basal cell carcinoma that has been treated with no evidence of recurrence). 12. Any other contraindication to etanercept, methotrexate or parenteral depomedrone. 13. Patients will also be excluded with the following laboratory results: haemoglobin 150 micromoles/litre.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This is a a pilot study to assess whether the first 12 weeks after the onset of synovitis represents a therapeutic window in patients at high risk of the subsequent development of RA. This will be done by determining whether potent therapy during this phase (with drugs which are licenced for the treatment of established RA - etanercept, methorexate and depomedrone) will induce disease remission that can be maintained without the ongoing use of Disease Modifying Anti-Rheumatic Drugs. This approach to therapy will be comaperd with standard therapy in which patients with early synovitis are treated with parenteral depomedrone at presentation, with the option of adding methotrexate after symptoms have been present for 12 weeks.;Secondary Objective: We will assess the the following as biological predictors of the response to treatment: Serum, urine, peripheral blood mononuclear cells (PBMC), synovial fluid and, where possible, synovial tissue will be collected at clinical presentation. The response to therapy will be assessed in relation to baseline serum and synovial fluid cytokine profiles and lymphocyte, macrophage and fibroblast gene expression profiles. ;Primary end point(s): The primary endpoint is the percentage of patients in drug free clinical remission at week 48 having withdrawn therapy at week 24 (i.e. the induction of drug free remission). | — |
Countries
United Kingdom
Outcome results
None listed