A study to assess the effects of Certolizumab Pegol on the Reduction of Anterior Uveitis (AU) Flares in Axial Spondyloarthritis Subjects with a documented history of A

Phase 1

• Conditions: Anterior Uveitis (AU) in subjects with Axial Spondyloarthritis (axSpA) and a history of AU.; MedDRA version: 19.1Level: SOCClassification code 10028395Term: Musculoskeletal and connective tissue disordersSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2016-000343-14-NL
• Lead Sponsor: CB Biopharma SPR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-31
• Last Update Posted: 9 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

1) Subjects must have a documented diagnosis of adult-onset axial Spondyloarthritis (axSpA) with at least 3 months’ symptom duration and meet the Assessment of SpondyloArthritis International Society (ASAS) criteria
2) Subjects must have active disease at Screening as defined by
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score >= 4
- Spinal pain >= 4 on a 0 to 10 Numerical Rating Scale (NRS; from BASDAI item 2)
- Nonradiographic (Nr)-axSpA subjects must either have C-reactive protein (CRP) > upper limit of normal (ULN) and /or current evidence of sacroiliitis on magnetic resonance imaging (MRI) (no confirmation by central reading) as defined by ASAS criteria
- Ankylosing spondylitis (AS) subjects must have evidence of sacroiliitis on x-ray meeting the modified New York (mNY) classification criteria according to the Investigator
3) Subjects must have a documented history of Anterior Uveitis (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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 86
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Other inflammatory arthritis
- 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 axial spondyloarthritis (axSpA)
- Any history of uveitis except for Anterior Uveitis (AU) associated with axSpA
- Any condition or complicating factor that may interfere with the AU assessment
- 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
- Intraocular or periocular corticosteroids within 90 days prior to the Baseline visit
- Ozurdex® (dexamethasone implant) within 6 months prior to the Baseline Visit
- Cyclophosphamide within 30 days prior to the Baseline Visit
- Intravitreal methotrexate (MTX) within 90 days prior to the Baseline Visit
- Intravitreal anti-vascular endothelial growth factor (VEGF) therapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified