Research into novel therapies for rare, immune-mediated inflammatory diseases (IMIDs) is limited due to small patient populations. Patients with Behçet's disease (BD), idiopathic inflammatory myopathy (IIM, also known as myositis) and IgG4-related disease (IgG4-RD) are treated with high-dosed glucocorticoids, methotrexate, azathioprine and mycophenolate mofetil, mostly for long periods of time with attendant risks of long-term toxicity, including infections. Therefore, there is an urgent need for new, more specific anti-inflammatory therapies such as targeted synthetic and biological disease-modifying antirheumatic drugs. Due to the role of type 1 interferon in both BD, IIM and IgG4-RD, JAK-STAT inhibition may be a promising treatment strategy in these conditions, because JAK1 is critical for the signal transduction of pro-inflammatory cytokine receptors. Previous research showed that JAK1 inhibition reduces activation of type 1 interferon-regulated proteins and key chemokines that control tissue inflammation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Filgotinib
Amsterdam UMC
Amsterdam, Netherlands
RECRUITINGZuyderland Medical Center
Heerlen, Netherlands
RECRUITINGRadboud university medical center
Nijmegen, Netherlands
RECRUITINGErasmus MC
Rotterdam, Netherlands
RECRUITINGHagaziekenhuis
The Hague, Netherlands
RECRUITINGUniversity Medical Center
Utrecht, Netherlands
RECRUITINGEQ-5D-5L
Change from baseline in EuroQoL-5D-5L
Time frame: 26 weeks
Disease activity in Behcet's patients
Change from baseline in Behcet's Disease Current Activity Form (BDCAF)
Time frame: 26 weeks
Disease activity in myositis patients
Change from baseline in Total Improvement Score (TIS) of the International Myositis Assessment Clinical Studies (IMACS) group
Time frame: 26 weeks
Disease activity in IgG4-RD patients
Change from baseline in IgG4-RD responder index
Time frame: 26 weeks
Corticosteroid toxicity
Change from baseline in Glucocorticoid Toxicity Index (GTI)
Time frame: 26 weeks
Corticosteroid dosage
Change from baseline in glucocorticoid dose
Time frame: 26 weeks
VAS score of pain
Change from baseline in pain scores on the Visual Analog Scale (0-100mm). A higher score is a worse outcome
Time frame: 26 weeks
Fatigue
Change from baseline in fatigue scores on the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F). A higher score is a worse outcome
Time frame: 26 weeks
Treatment-related adverse events
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time frame: 26 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.