Active axial and peripheral spondyloarthritis
Conditions
Interventions
Trade Name: Tasigna
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: NILOTINIB
CAS Number: 641571-10-0
Current Sponsor code: EU/1/07/422/001-004
Other descriptive name: Tasigna
Concentration un
Sponsors
Academic Medical Center, Division of Clinical Immunology and Rheumatology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients should be able and willing to give written informed consent and comply with the requirements of the study protocol. 2. Patients should be between 18 and 65 years of age. 3. Patients must have a diagnosis of spondyloarthritis according to the ESSG criteria. The patient must have an active disease as defined by a patient global assessment of disease activity VAS of equal or more than 4 AND a physician global assessment of disease activity VAS of equal or more than 4 AND at least 1 swollen and 1 tender joints in case of peripheral disease AND/OR a BASDAI of equal or more than 4 in case of axial disease 4. Patients should have an inadequate response to at least one NSAID at the maximal tolerated dose. 5. The use of concomitant NSAIDs and corticosteroids is allowed. The dose of corticosteroids should not exceed a prednisone equivalent = 10 mg/day and must be stable for at least 4 weeks prior to baseline. The dose of concomitant NSAIDs and corticosteroids should be kept stable during the whole study period. 6. The use of concomitant DMARDs (methotrexate, sulphasalazine, or leflunomide) is allowed. If using DMARDs, patients must have received a minimum of 3 months of therapy and be on a stable dose for at least 4 weeks prior to baseline. The DMARDs should be kept stable during the study period. 7. Patients of reproductive potential (males and females) must use reliable methods of contraception (e.g. contraceptive pill, IUD, physical barrier) during the whole study until 150 days post-study. 8. Patients are considered to be in generally good health based upon the result of a medical history, physical examination, laboratory profile, chest ?X-ray and ECG. In case of use of co-medication which engage CYP3A4 or which can cause QT-prolongation, extra caution will be made. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patient has a significant comorbidity, including a cardiac, renal, hepatic, neurological, metabolic or any other disease, including ECG alterations, hypokalemia, and hypomagnesemia, that may affect his/her participation in this study. 2. Patient has a recent history of (or persistent) infection requiring hospitalization or antibiotic treatment within 4 weeks of baseline. 3. Patient has active tuberculosis. A PPD test and chest X-ray at screening should be negative (in case of latent tuberculosis, a patient may enter the study if prophylaxis with isoniazide is begun prior to administration of nilotinib). If a patient has an adequately treated active tuberculosis in the past he/she may enter the trial. 4. Patient has previously failed anti-TNF therapy or any other biological agent. 5. Patient has received an intra-articular injection with corticosteroids within 4 weeks prior to baseline. 6. Patient has an active articular disease other than spondyloarthritis that could interfere with the assessment of spondyloarthritis. 7. Patient has an active or recent malignancy (other than basal cell carcinoma of the skin). 8. If female, patient should not be pregnant or breast-feeding. A urine pregnancy-test will be performed at screening and has to be negative. 9. Patient is, in the opinion of the investigator, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the clinical efficacy and safety of tyrosine kinase inhibition by nilotinib in spondyloarthritis;Secondary Objective: To assess the effect of nilotinib on: - synovial immunopathology (macrophage subsets, mast cell infiltration, fibroblast phenotype and function, and inflammatory mediator production) - soluble biomarkers of structural damage;Primary end point(s): - Patient global assessment of disease activity VAS at week 12 - Physician global assessment of disease activity VAS at week 12 - Safety and tolerability over 24 weeks | — |
Countries
Netherlands
Outcome results
None listed