Dubbel-blind, gerandomiseerd onderzoek naar nilotinib bij spondyloartritis.

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;

4. The patient must have an active disease as defined by a patient global assessment of disease activity VAS of > 4 AND a physician global assessment of disease activity VAS of > 4 AND > 1 swollen and > 1 tender joints in case of peripheral disease AND/OR a BASDAI of > 4 in case of axial disease;

5. Patients should have an inadequate response to at least one NSAID at the maximal tolerated dose;

6. 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;

7. 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;

8. 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;

9. 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 can cause QT-prolongation, extra caution will be made.

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 uses concomitant medication which inhibit or induce CYP3A4, such as ketoconazole, itraconazole, voriconazole, ritonavir, clarithromycin, telithromycin,
rifampicin, phenytoin, carbamazepine, phenobarbital and St. John's Wort;

10. 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.