To evaluate the efficacy and safety of nilotinib in spondyloarthritis
ID
Source
Brief title
Condition
- Autoimmune disorders
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- 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
Secondary outcome
- Patient global assessment of disease activity VAS at week 24
- Physician global assessment of disease activity VAS at week 24
- ASAS20 response at week 12 and week 24
- ASDAS response at week 12 and week 24
- Change in BASDAI at week 12 and week 24
- ESR and CRP at week 12 and 24
- Change in SJC and TJC at week 12 and week 24
- Soluble biomarkers at week 12 and week 24
- Synovial tissue response at week 12 and week 24
Background summary
Spondyloarthritis (SpA) is the second most frequent form of chronic
inflammatory arthritis with a prevalence of 0.5%. It affects mainly young
adults and leads to major functional handicap due to inflammation of axial and
peripheral joints as well as progressive ankylosis and structural damage.
However standard therapy is not always successful. It has been shown in basic
research and also a small clinical trial in humans that tyrosine kinase
inhibitor might have a beneficial effect in patient with spondyloarthritis.
Study objective
To evaluate the efficacy and safety of nilotinib in spondyloarthritis
Study design
proof-of-concept randomized, placebo controlled, clinical trial
Intervention
- study medication (capsules 2 dd 2 capsules)
- mini-arthroscopie 3 times if arthritis of knee or ankle
- Chest X-ray, PPD-skin test, ECG at screening
- venapunctures
- urine sample
- general internal and rheumatological physical exam
- questionaires
Study burden and risks
12 study visitis, the risk of adverse events of the study medication and the
risk of complication related to the mini-arthroscopy if applicable
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
- Active peripheral or axial spondyloarthritis according to ESSG criteria
- Age between 18-65 years
Exclusion criteria
- Significant comorbidity
- Failure on anti-TNF-therapy
- Unstable dose of DMARDs or corticosteroids
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-023185-42-NL |
| CCMO | NL34748.018.10 |