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

NCT03020992 | Completed Phase 4 Results

• 2 other identifiers: AS00072016-000343-14
• Study Type: interventional
• Target: 89
• Locations: 5 countries
• Sites: 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)

Keywords

Axial Spondyloarthritis; axSpA; Anterior Uveitis; Certolizumab Pegol; Cimzia

Outcome Measures

Primary Outcomes (1)

• Number of Distinct Episodes of Anterior Uveitis (AU) Flares During the Treatment Period

  A flare was defined as being a new episode of Anterior Uveitis (AU) that, based on the judgment of an ophthalmologist, required specific treatment. A flare was considered a new episode if a gap of at least 3 months occurred between 2 flares.

  During the pre-study period and during the Treatment Period up to 96 weeks

Secondary Outcomes (31)

• Number of Anterior Uveitis (AU) Flares Per 100 Patient-years in Participants With Active Axial SpondyloArthritis (axSpA) and a History of AU at Week 48

  During the pre-study period and during the Treatment Period up to 48 weeks

• Number of Anterior Uveitis (AU) Flares Per 100 Patient-years in Participants With Active Axial SpondyloArthritis (axSpA) and a History of AU at Week 96

  During the pre-study period and during the Treatment Period up to 96 weeks

• Number of Anterior Uveitis (AU) Flares Per 100 Patient-years in Participants With Active Axial SpondyloArthritis (axSpA) and at Least 1 AU Episode Within 12 Months Prior Baseline at Week 48

  During the pre-study period and during the Treatment Period up to 48 weeks

• Number of Anterior Uveitis (AU) Flares Per 100 Patient-years in Participants With Active Axial SpondyloArthritis (axSpA) and at Least 1 AU Episode Within 12 Months Prior Baseline at Week 96

  During the pre-study period and during the Treatment Period up to 96 weeks

• Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 48

  From Baseline to Week 48

Study Arms (1)

Certolizumab Pegol

EXPERIMENTAL

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

Drug: Certolizumab Pegol

Interventions

Certolizumab Pegol DRUG

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

Also known as: Cimzia, CZP, CDP870

Certolizumab Pegol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Biopharma SRL: lead

Study Sites (23)

As0007 101

Brno, Czechia

Location

As0007 103

Brno, Czechia

Location

As0007 107

Brno, Czechia

Location

As0007 108

Ostrava, Czechia

Location

As0007 109

Pardubice, Czechia

Location

As0007 102

Prague, Czechia

Location

As0007 105

Prague, Czechia

Location

As0007 301

Freiburg im Breisgau, Germany

Location

As0007 302

München, Germany

Location

As0007 303

Münster, Germany

Location

As0007 401

Amsterdam, Netherlands

Location

As0007 506

Bialystok, Poland

Location

As0007 510

Lublin, Poland

Location

As0007 509

Poznan, Poland

Location

As0007 511

Poznan, Poland

Location

As0007 502

Torun, Poland

Location

As0007 501

Warsaw, Poland

Location

As0007 505

Warsaw, Poland

Location

As0007 504

Wroclaw, Poland

Location

As0007 507

Wroclaw, Poland

Location

As0007 508

Wroclaw, Poland

Location

As0007 604

Barcelona, Spain

Location

As0007 601

Córdoba, Spain

Location

Related Publications (1)

• 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.

  PMID: 33854572 DERIVED

Related Links

• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Axial Spondyloarthritis; Uveitis, Anterior

Interventions

Certolizumab Pegol

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Panuveitis; Uveitis; Uveal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Polyethylene Glycols; Polymers; Macromolecular Substances; Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: UCB
• Organization: Cares

UCBCares@ucb.com

+1844 599

Study Officials

• UCB Cares

  001 844 599 2273 (UCB)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2017
• First Posted: January 13, 2017
• Study Start: December 21, 2016
• Primary Completion: December 4, 2019
• Study Completion: January 23, 2020
• Last Updated: February 9, 2021
• Results First Posted: December 31, 2020

Record last verified: 2021-01

Locations

DE (3); NL (1); PL (10); ES (2); CZ (7)