spondyloarthritis
Conditions
Interventions
1. Nilotinib (Tasigna ®) or matching placebo capsules (50% chance)
2. Athroscopy when arthritis.
Patients will receive 400 mg Nilotinib twice a day. After three months, all patients will receive this dose (open label phase).
Sponsors
AMC
Eligibility
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; 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.
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Patient global assessment of disease activity VAS at week 12; 2. Physician global assessment of disease activity VAS at week 12; 3. Safety and tolerability over 24 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient global assessment of disease activity VAS at week 24; 2. Physician global assessment of disease activity VAS at week 24; 3. ASAS20 response at week 12 and 24; 4. ASDAS response at week 12 and 24. | — |
Contacts
Public ContactD.L. Baeten
AMC afd Kir Meibergdreef 9
Outcome results
None listed