|- candidate number||3028|
|- NTR Number||NTR1210|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||30-jan-2008|
|- Secondary IDs||07/298 MEC Academic Medical Center, Amsterdam, departement of clinical immunology and rheumatology|
|- Public Title||Exploratory trial on intra-articular etanercept treatment in inflammatory arthritis |
|- Scientific Title||Exploratory trial on intra-articular etanercept treatment in inflammatory arthritis |
|- ACRONYM||Enbrel i.a.|
|- hypothesis||Intra-articular etanercept therapy reduces the clinical signs and symptoms of inflammatory arthritis and improves outcome. |
|- Healt Condition(s) or Problem(s) studied||Rheumatoid arthritis, Psoriatic arthritis, Bechterew's disease (Ankylosing spondylitis)|
|- 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||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 < 3.5 x 10e9/l
20. Thrombocytopaenia <125 x10e9/l
21. Haemoglobin <8.5 g/dl
22. AST or ALT > 2.5 times upper limit of normal
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2008|
|- planned closingdate||30-jun-2009|
|- Target number of participants||60|
|- Interventions||- one intra-articular injection with 25 mg etanercept or placebo (0.9% NaCl), follow up of 6 weeks. |
|- Primary outcome||The primary endpoint of this study is the difference in clinical symptoms of inflammatory arthritis between placebo and intervention group.
|- Secondary outcome||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|
|- Timepoints||0, week 1, week 2, week 3, week 4 and week 6|
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Drs. C.J. Aalbers|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. P.P. Tak|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Department of Clinical Immunology and Rheumatology|
(Source(s) of Monetary or Material Support)
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||24-jan-2008 - 25-feb-2012|