chronic joint inflammation Inflammatory arthritis
Conditions
Interventions
One intra-articular injection of 25 mg etanercept (Enbrel®) or matching placebo
(NaCl 0.9%).
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1.Provision of a written informed consent 2.Age range 18-85 3.Presence of active knee, ankle, wrist, elbow or MCP arthritis 4.Presence of rheumatoid arthritis, ankylosing spondylitis or psoriatic arthritis -Patients with RA for at least 3 months, diagnosed according to the revised 1987 ACR criteria for the classification of RA -Patients with AS or PsA for at least 3 months, diagnosed according to the modified New York criteria and CASPAR criteria respectively
Exclusion criteria
Exclusion criteria: - Contra-indication for TNF-blockade or intra-articular treatment - Bone or joint surgery 8 weeks prior to inclusion - Arthroscopy within 2 weeks prior to inclusion, or arthroscopy planned during the time of the study - Intra-articular or parenteral corticosteroids within 3 months prior to inclusion. - Oral corticosteroid therapy exceeding a prednisone equivalent of 10 mg daily within 4 weeks prior to inclusion. - Use of DMARDs other than methotrexate (MTX) within 4 weeks prior to inclusion. - Receipt of a live vaccine within 4 weeks prior to randomization. - Treatment with Etanercept (Enbrel) or any other form of systemic anti-TNFa therapy within 3 months prior to inclusion - 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. - History of recurrent significant infection or history of recurrent bacterial infections. - Primary or secondary immunodeficiency (history of, or currently active). - Pregnant women or nursing (breastfeeding) mothers. - History of cancer in the past 10 years, including solid tumors and hematologic malignancies (except basal cell or squamous cell carcinoma of the skin that have been excised and cured) or a history of cancer more than 10 years ago without curative treatment - Sever heart, kidney, and/or lung disease
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. Success of treatment will be defined by the composite change index (CCI) at multiple time points (week 0-6). Separate variables of the composite change index include: - 100 mm visual analogue scale: VAS subject*s assessment of pain - Evaluation of functional disability of the treated joint, joint swelling and joint tenderness (semi quantitative score, 0-3) by physician - Patient*s and physician*s global assessment of the effect of therapy (semi quantitative score, 0-3) | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints of this study are: - Safety endpoints - Acute phase reactants: Erythrocyte Sedimentation Rate (ESR) and C-Reactive Protein (CRP) - Immunogenicity parameters: serum etanercept levels, antibodies to etanercept - 100 mm visual analogue scale: VAS subject*s assessment of disease activity and VAS physician's global assessment of patient's current disease activity - Joint assessments: DAS28, DAS68, Ritchie Articular Index - Questionnaires: HAQ, SF-36, BASDAI | — |
Countries
Netherlands
Outcome results
None listed