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 AU

NCT ID: NCT03020992

Last Updated: 2021-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-21
• Study Completion Date: 2020-01-23

Brief Summary

The purpose of the study is to demonstrate the effect of Certolizumab Pegol (CZP) treatment on the reduction of Anterior Uveitis (AU) flares in subjects with active axial Spondyloarthritis (axSpA) and a documented history of AU.

Conditions

Axial Spondyloarthritis (axSpA); Anterior Uveitis (AU)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Certolizumab Pegol

Subjects will receive a loading dose of Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) administered at Baseline, Week 2, and Week 4 followed by CZP 200 mg sc every two Weeks

Group Type: EXPERIMENTAL

Certolizumab Pegol

Intervention Type: DRUG

• pharmaceutical form: solution for infusion in prefilled syringe
• concentration: 200 mg/mL
• route of administration: subcutaneous

Interventions

Certolizumab Pegol

• pharmaceutical form: solution for infusion in prefilled syringe
• concentration: 200 mg/mL
• route of administration: subcutaneous

Intervention Type: DRUG

Other Intervention Names

Cimzia; CZP; CDP870

Eligibility Criteria

Inclusion Criteria

• 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
• 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
• 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Biopharma SRL

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Cares

Role: STUDY_DIRECTOR

001 844 599 2273 (UCB)

Locations

As0007 101

Brno, , Czechia

As0007 103

Brno, , Czechia

As0007 107

Brno, , Czechia

As0007 108

Ostrava, , Czechia

As0007 109

Pardubice, , Czechia

As0007 102

Prague, , Czechia

As0007 105

Prague, , Czechia

As0007 301

Freiburg im Breisgau, , Germany

As0007 302

München, , Germany

As0007 303

Münster, , Germany

As0007 401

Amsterdam, , Netherlands

As0007 506

Bialystok, , Poland

As0007 510

Lublin, , Poland

As0007 509

Poznan, , Poland

As0007 511

Poznan, , Poland

As0007 502

Torun, , Poland

As0007 501

Warsaw, , Poland

As0007 505

Warsaw, , Poland

As0007 504

Wroclaw, , Poland

As0007 507

Wroclaw, , Poland

As0007 508

Wroclaw, , Poland

As0007 604

Barcelona, , Spain

As0007 601

Córdoba, , Spain

Countries

Czechia; Germany; Netherlands; Poland; Spain

References

van der Horst-Bruinsma IE, van Bentum RE, Verbraak FD, Deodhar A, Rath T, Hoepken B, Irvin-Sellers O, Thomas K, Bauer L, Rudwaleit M. Reduction of anterior uveitis flares in patients with axial spondyloarthritis on certolizumab pegol treatment: final 2-year results from the multicenter phase IV C-VIEW study. Ther Adv Musculoskelet Dis. 2021 Mar 29;13:1759720X211003803. doi: 10.1177/1759720X211003803. eCollection 2021.

Reference Type: DERIVED

PMID: 33854572 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

2016-000343-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AS0007

Identifier Type: -

Identifier Source: org_study_id