Rheumatoid arthritis Psoriatic arthritis Ankylosing spondylitis Reumatoide artritis Artritis psoriatica Ziekte van Bechterew
Conditions
Interventions
- one intra-articular injection with 25 mg etanercept or placebo (0.9% NaCl), follow up of 6 weeks.
Sponsors
Prof. dr. P.P. Tak, internist-reumatoloog
Afd. Klinische immunologie en reumatologie
F4-218
Meibergdreef 9
1105 AZ Amsterdam
T 020-5662171
Eligibility
Inclusion criteria
Inclusion criteria: 1. Provision of a written informed consent 2. Age range 18-85 3. Presence of active knee arthritis 4. Presence of rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis ( - Patients with RA for at least 6 months, diagnosed according to the revised 1987 ACR criteria for the classification of RA; Patients with AS for at least 6 months, diagnosed according to the ACR criteria for Spondylarthropathy; Patients with AS or PsA for at least 6 months, diagnosed according to CASPAR criteria)
Exclusion criteria
Exclusion criteria: 1. Contra-indication for TNF-blockade 2. Contra-indication for intra-articular treatment 3. Bone/ joint surgery within 8 weeks prior to inclusion, or joint surgery planned within 24 weeks of inclusion. 4. Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study and/or evidence of an uncooperative attitude. 5. Clinical judgment by the investigator that the subject should not participate in the study, such as severe co-morbidity Exclusions are in line with warning and contra-indications in the SmpC. 6. Use of DMARDs other than methotrexate (MTX) within four weeks prior to inclusion. 7. Patients or reproductive potential (males and females) must use a reliable means of contraception (e.g. contraceptive pill, IUD, physical barrier). 8. Intra-articular or parenteral corticosteroids within 3 months prior to inclusion. 9. Oral corticosteroid therapy exceeding a prednisone equivalent of 10 mg daily within 4 weeks prior to inclusion. 10. Receipt of a live vaccine within 4 weeks prior to randomization. 11. Previous treatment with etanercept (Enbrel) or any other form of systemic anti-TNFa therapy. 12. Known active bacterial, viral, fungal, mycobacterial or other infection (including tuberculosis, or atypical mycobacterial disease, but excluding fungal infections of nail beds), or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening. Patients with a positive PPD skin test should take isoniazide for at least 4 weeks before they can be included in the study. 13. History of recurrent significant infection or history of recurrent bacterial infections. 14. Primary or secondary immunodeficiency (history of, or currently active). 15. Pregnant women or nursing (breastfeeding) mothers. 16. History of cancer, including solid tumors and hematologic malignancies (except basal cell or squamous cell carcinoma of the skin that have been excised and cured). 17. Sever heart, kidney, and/or lung disease 18. Creatinine > 175 umol/l 19. Leucopaenia 2.5 times upper limit of normal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is the difference in clinical symptoms of inflammatory arthritis between placebo and intervention group. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints of this study are (measured at all time points): - Safety endpoints - Acute phase reactants: Erythrocyte Sedimentation Rate (ESR) and C-Reactive Protein (CRP) - several questionnaires | — |
Contacts
Public ContactC.J. Aalbers
Afd. Klinische immunologie en reumatologie F4-218 Meibergdreef 9
Outcome results
None listed