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A randomized, double blind, placebo-controlled trial to evaluate the clinical efficacy and the structure modifying properties of etanercept 50/25 mg sc weekly in patients with erosive OA of the interphalangeal finger joints.


- candidate number2941
- NTR NumberNTR1192
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-dec-2007
- Secondary IDsp07.213 
- Public TitleA randomized, double blind, placebo-controlled trial to evaluate the clinical efficacy and the structure modifying properties of etanercept 50/25 mg sc weekly in patients with erosive OA of the interphalangeal finger joints.
- Scientific TitleA randomized, double blind, placebo-controlled trial to evaluate the clinical efficacy and the structure modifying properties of etanercept 50/25 mg sc weekly in patients with erosive OA of the interphalangeal finger joints.
- ACRONYMEHOA
- hypothesisEtanercept is able to improve clinical and functional abnormalities and to halt or reverse radiographic changes in inflammatory erosive hand osteoarthritis by virtue of blocking a major pro-inflammatory cytokine, tumor necrosis factor (TNF).
- Healt Condition(s) or Problem(s) studiedOsteoarthritis, Erosive inflammatory hand
- Inclusion criteria1. Males and females > 18 years of age;
2. Subjects with inflammatory erosive hand OA;
3. At least 4 OA nodes of the IPJs;
4. At least 1 inflamed IP;
5. At least 1 IP with positive power Doppler signal at ultrasound;
6. At least 1 IPJ has the typical appearance on radiograph of a ‘J’or ‘E’ phase joint;
7. OA pain at rest > 30 mm on the VAS;
8. Flare of OA pain with activity at baseline (after NSAID washout) as defined by: >50mm on the VAS;
9. Worsening by > 20 mm on the VAS compared to screening;
10. Use of NSAIDs for finger joint pain at least 5 days per week with a stable dose for at least 4 weeks;
11. Inadequate response to at least 1 NSAIDS other than the current NSAID;
12. Able and willing to self-administer sc injections or have available a suitable person to administer sc injections;
13. Able and willing to give written informed consent and to comply with the requirements of the study protocol.
- Exclusion criteria1. Prior treatment with any investigational agent within 30 days, or five half lives of the product, whichever is longer;
2. Patients suffering from chronic inflammatory rheumatic disease;
3. All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 30 days after the last dose of test article;
4. Stable dosage for at least 3 months with chondroitin sulfate, glucosamine, biphosphonate, corticosteroids, tetracyclines and estrogens is allowed;
5. Prior use of any immunomodulating drug with possible effects on pro-inflammatory cytokine metabolism within 90 days a.o. corticosteroids, methotrexate, sulfasalazine, leflunomide, d-penicillamin, anti-malarials, cytotoxic drugs, TNF blocking agents;
6. If the patient is of child-bearing age, he/she must use effective means of contraception during the study;
7. Patient who has a known blood coagulation disorder;
8. History of cancer or lymphoproliferative disease other than a successfully and completely treated squamous cell or basal cell carcinoma of the skin or cervical dysplasia, with no recurrence within the last two years;
9. Comorbidities: uncontrolled diabetes, unstable ischemic heart disease, congestive heart failure (NYHA III, IV), active inflammatory bowel disease, recent stroke, chronic leg ulcer and any other condition which, in the opinion of the investigator, would put the subject at risk by participation in the protocol;
10. Positive serology for hepatitis B or C indicating active infection;
11. History of positive HIV status;
12. Persistent or recurrent infections or severe infections requiring hospitalization or treatment with iv antibiotics within 30 days, or oral antibiotics within 14 days prior to enrollment;
13. Female subjects who are breast-feeding;
14. History of clinically significant drug or alcohol abuse in the last year;
15. Previous diagnosis or signs of central nervous system demyelinating diseases (e.g., optic neuritis, visual disturbance, gait disorder/ataxia, facial paresis, apraxia);
16. Medical history of systemic lupus erythematosus or other connective tissue disease, RA, reactive arthritis, psoriasis;
17. Evolutive tuberculosis or other severe infections like sepsis and opportunistic infections;
18. Patients with latent TB or having other risk factors for activation of latent TB, who have not initiated a TB prophylaxis prior to the first etanercept treatment;
19. Current or prior history of blood dyscrasias. Abnormal safety baseline blood test;
20. Pre-existing or recent onset CNS demyelinating disease;
21. Uncontrolled conditions, e.g., diabetes mellitus, hypertension, severe pulmonary disease requiring hospitalization or supplemental oxygen;
22. Latex sensitivity;
23. Reasonable expectation that the subject will not be able to satisfactorily complete the study. History of or current psychiatric illness, alcohol or drug abuse that would interfere with the subject’s ability to comply with protocol requirements or give informed consent;
24. Employment by the investigator or reporting directly or indirectly to the investigator.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2008
- planned closingdate1-mrt-2010
- Target number of participants90
- InterventionsEtanercept 50 or 25 mg once weekly subcutaneously.
- Primary outcomeJoint pain over 24 weeks.
- Secondary outcome1. Joint pain over 12 weeks;
2. Joint pain over 52 weeks;
3. Effect on OA specific and generic physical function and joint stiffness over 12, 24 and 52 weeks;
4. Effect on patient global assessment over 24 and 52 weeks;
5. Tolerability and safety of etanercept over 24 and 52 weeks;
6. Effect on clinical, laboratory, and imaging assessments over 24 and 52 weeks.
- TimepointsScreening, baseline, 4,8,12,24,36,52,54 weeks.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. Margreet Kloppenburg
- CONTACT for SCIENTIFIC QUERIESDr. Margreet Kloppenburg
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Wyeth
- PublicationsN/A
- Brief summaryOsteoarthritis (OA) of the hands is one of the most prevalent musculoskeletal diseases. There exists a subgroup of patients in whom erosions in interphalangeal joints (IPJs) are particularly prominent radiological. Erosive IPJs OA characteristically show flares of pain and swelling and eventually loss of function depending on the number of joints affected. Whether or not these patients also constitute a clinical entity among patients with finger joint OA is still a matter of debate. From some recent epidemiological studies one may conclude that the incidence of erosive OA of the IPJs is around 5-10%. Since the occurrence of erosions suggests a progressive nature, there is significant interest in determining the rate of progression and likewise in means to prevent such progression. Currently, there exists no unequivocally disease-modifying remedy for this disease with the exception of symptomatic therapy.

Although the pathogenesis of OA in general and hand OA in particular is still unresolved, there appear to be several pathways governing the evolution of the disease. On the one hand, chondrocyte abnormalities are postulated. In fact, in OA cartilage chondrocyte numbers are reduced and consequently overall biosynthetic activity and it is unclear whether this is due to mechanical or other factors. Likewise, excessive bone formation is observed, with the expression of osteophytes being one example, and abnormalities in osteoblast activity, including deranged signaling pathways, may be operative in this respect. However, OA is also characterized by inflammatory components, which are exemplified by findings of pro-inflammatory cytokines in synovial fluids, and cellular infiltrates in synovial membranes, but also by a mild increase in C-reactive protein.


The present study, a placebo-controlled, double-blind, randomized trial in inflammatory erosive hand OA, has been designed to attempt to improve clinical and functional abnormalities and to halt or reverse radiographic changes by virtue of blocking a major pro-inflammatory cytokine, tumor necrosis factor (TNF).
- Main changes (audit trail)
- RECORD11-dec-2007 - 28-apr-2008


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