anterior uveïtis flares in axial spondyloarthritis
Conditions
Interventions
Cimzia 200 mg solution for injection
anterior uveitis
axial spondyloarthritis
Sponsors
UCB Biopharma SPRL
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: The study population will be subjects *18 years, with a documented diagnosis of adult onset axSpA as meeting the Assessment of SpondyloArthritis International Society ([ASAS] criteria of at least 3 months* symptom duration, and with active disease defined by a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) *4, and spinal pain *4 on a 0 to 10 Numerical Rating Scale (NRS). Nonradiographic axSpA subjects must either have C Reactive Protein > upper limit of normal (ULN) and /or current evidence of sacroiliitis on Magnetic Resonance Imaging taken within 3 months prior to Baseline (no confirmation by central reading) as defined by ASAS criteria and ankylosing spondylitis subjects must have evidence of sacroiliitis on an x-ray taken within 12 months prior to Baseline meeting modified New York criteria according to the Investigator. Subjects must have a documented history of AU diagnosed by an ophthalmologist and have at least 2 AU flares in the past, of which at least 1 AU flare was in the last 12 months prior to Baseline. Additionally, subjects must be HLA-B27 positive (if known prior to Screening, no additional testing is to be performed; if unknown, testing is to be performed at Screening and checked at Baseline) and subjects must have been intolerant to or had an inadequate response to at least 2 Nonsteroidal Anti-inflammatory drugs (NSAIDs). Inadequate response to an NSAID is defined as lack of response to at least 14 days of continuous NSAID therapy at the highest tolerated dose of the administered NSAID.
Exclusion criteria
Exclusion criteria: 1. The subject has previously participated in this study or has previously received CZP treatment in or outside of another clinical study. However rescreening is possible if prophylactic treatment for latent tuberculosis infection (LTBI) was to be given but the Screening Period exceeded the 12 weeks. 2. The subject has participated in another study of an investigational medicinal product (IMP) (or a medical device) within the previous 3 months or is currently participating in another study of an IMP (or a medical device). 3. The subject has a history of chronic alcohol or drug abuse. 4. The subject has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject*s ability to participate in this study. 5. The subject has a known hypersensitivity to any components of CZP or a history of an adverse reaction to polyethylene glycol. Axial SpA-disease related exclusions 6. Subjects must not have any other inflammatory arthritis (eg, rheumatoid arthritis, systemic lupus erythematosus, sarcoidosis, or fibromyalgia). 7. Subjects must not have a secondary, noninflammatory condition that, in the Investigator*s opinion, is symptomatic enough to interfere with evaluation of the effect of study drug on the subject*s primary diagnosis of axSpA. Ophthalmic exclusion criteria 8. Any history of uveitis (eg, posterior, panuveitis) except for AU associated with axSpA. 9. Any condition or complicating factor that may interfere with the AU assessment, for example: a. History of cataract surgery within 6 months prior to Baseline b. Corneal or lens opacity c. Proliferative or severe nonproliferative diabetic retinopathy or clinically significant macular edema due to diabetic retinopathy d. Neovascular/wet age-related macular degeneration e. History of scleritis f. History of intraocular surgery, with the exception of phacoemulsification 10. Subject has Retisert® or Iluvien® (glucocorticosteroid implant) within 3 years prior to the Baseline Visit or has had complications related to the device. Subject has had Retisert or Iluvien (glucocorticosteroid implant) removed within 90 days prior to the Baseline Visit or has had complications related to removal of the device. 11. Subject has received intraocular or periocular corticosteroids within 90 days prior to the Baseline visit. 12. Subject has received Ozurdex® (dexamethasone implant) within 6 months prior to the Baseline Visit. 13. Subject on cyclophosphamide within 30 days prior to the Baseline Visit. 14. Subject has received intravitreal methotrexate within 90 days prior to the Baseline Visit. 15. Subject has received intravitreal anti-vascular endothelial growth factor therapy: a. Within 45 days of the Baseline visit for Lucentis® (ranibizumab) or Avastin® (bevacizumab) or b. Within 60 days of the Baseline visit for anti-VEGF Trap Zaltrap® (aflibercept) Prior medications exclusions 16. Subjects must not have used the following medications in the manner as detailed by the exclusion criteria in Table 6-1 (protocol page 31). Previous clinical studies and previous biological therapy exclusions 17. Subjects must not have received any nonbiological therapy for axSpA not listed in Table 1 within or outside of a clinical study in the 3 months or within 5 half lives prior to the Baseline Visit (whichever is longer). 18. Subjects mus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy variable: The primary efficacy variable will be the count of distinct episodes of AU flares during the Treatment Period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary efficacy variable: The following secondary efficacy variables will be assessed at Week 48 and Week 96: · Number of AU flares per 100 patient-years in subjects with active axSpA and a history of AU · Number of AU flares per 100 patient-years in subjects with active axSpA and at least 1 AU episode within 12 months prior Baseline · Change from Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) · Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) · Assessment of ASAS 20, 40, 5/6, and partial remission (PR) response rates · Change from Baseline in tender and swollen joint count (44 joint count); Physician*s Global Assessment of Disease Activity (PhGADA). · Change from Baseline in the respective components of the ASAS response criteria, assessed by: o Patient*s Global Assessment of Disease Activity (PtGADA) o Pain assessment (total spinal pain Numerical Rating Scale [NRS]) o Function (represented by Bath Ankylosing Spondylitis Functional Index [BASFI]) o Inflammation (the mean of the BASDAI questions 5 and 6 concerning morning stiffness and duration) The following other efficacy variables will be assessed: · Duration of AU flares · Severity of AU flares · Change from Baseline in ASDAS · Change from Baseline in BASDAI · ASAS 20, 40, 5/6, and PR response rates · Change from Baseline in tender and swollen joint count (44 joint count), PhGADA. · Change from Baseline in the respective components of the ASAS criteria, assessed by: o PtGADA o Pain assessment (total spinal pain NRS) o Function (represented by BASFI) o Inflammation (the mean of the BASDAI questions 5 and 6 concerning morning stiffness and duration) · Change from Baseline in ASDAS disease activity (clinical improvement [CI], major improvement [MI], inactive disease [ID], clinically important improvement [CII]), and BASFI) (including Weeks 48 and 96) · Change from Baseline in Fatigue (NRS) (from BASDAI) (including Weeks 4 | — |
Countries
Czechia, France, Germany, Netherlands, Poland, Spain
Outcome results
None listed