Musculoskeletal Diseases: Rheumatoid arthritis (RA) Musculoskeletal Diseases Rheumatoid arthritis (RA)
Conditions
Interventions
We propose a pilot study to assess whether the first 12 weeks after the onset of symptoms represents a therapeutic window in patients at high risk of the subsequent development of RA by determining wh
Sponsors
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with very early synovitis of less than 12 week duration will be identified via the rapid access early arthritis clinics run at the participating centres. Patients fulfilling clinical inclusion criteria and not meeting exclusion criteria will have measurements of their serum levels of rheumatoid factor and anti-CCP antibody and will be given an information sheet on the study. They will be asked to attend for follow up review after 2-7 days. Those patients who are seropositive for both rheumatoid factor and anti-CCP antibody will be invited to participate in the trial. Inclusion criteria: 1. Age over 18 years 2. Synovial swelling of at least 1 joint confirmed by clinical assessment 3. Seropositivity for RF and anti-CCP Ab 4. Women of childbearing potential or men capable of fathering children must be using adequate birth control measures (eg abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, surgical sterilization) during the study 5. Female subjects of childbearing potential must test negative for pregnancy 6. Patients should be able to give informed consent to study entry
Exclusion criteria
Exclusion criteria: 1. Duration of symptoms attributable to inflammatory joint disease (pain, swelling or early morning stiffness of >1 hour) of >12 weeks 2. Previous history of inflammatory arthritis 3. Previous use of DMARDs or anti-TNF-agents 4. Any current inflammatory condition with signs or symptoms that might confound the diagnosis (e.g. connective tissue disorders) 6. A history or other evidence of latent or active granulomatous infection, including TB, histoplasmosis or coccidioidomycosis, prior to study entry 7. 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 8. 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 9. Known infection with HIV, hepatitis B, or hepatitis C 10. A serious infection that in the opinion of the investigator precludes receipt of a TNF blocking agent 11. 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, heart failure, history of demyelinating disease such as multiple sclerosis or optic neuritis) 12. Bleeding disorder or the use of anti-coagulants 13. 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) 14. Any contraindication to etanercept, methotrexate or parenteral depomedrone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The primary endpoint will be 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. 2. Clinical remission will be defined as a DAS28 score of <2.6 (EULAR definition of remission) plus no clinical evidence of joint swelling. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The percentage of patients in clinical remission (DAS28 score of <2.6 plus no clinical evidence of joint swelling) at week 24 (when all drugs will be withdrawn if remission has been achieved). 2. The percentage of patients in clinical remission defined according to ARA criteria at week 24 (when all drugs will be withdrawn if remission has been achieved). 3. The percentage of patients in radiological remission at week 24 (no MRI or ultrasound evidence of synovitis in hands and wrists). 4. Clinical disease activity measures, including ACR responder rates (20%, 50%, and 70%), Disease Activity Score in 28 joints (DAS28), functional assessments (HAQ) and health status (EuroQuol-5D) at week 24. 5. The percentage of patients in drug free clinical remission defined according to ARA criteria at week 48 having withdrawn therapy at week 24. 6. The percentage of patients in drug free radiological remission (no MRI or ultrasound evidence of synovitis) at week 48 having withdrawn therapy at week 24. 7. Clinical disease activity measures, including ACR responder rates (20%, 50%, and 70%), Disease Activity Score in 28 joints (DAS28), functional assessments (HAQ) and health status (EuroQuol-5D) at week 48. 8. The rate of progression of radiological change on conventional radiographs scored according to the van der Heijde modification of the total Sharp score from baseline to week 48 and 96. 9. In addition we will assess biological predictors of response to therapy. | — |
Countries
United Kingdom
Outcome results
None listed