Study of Efficacy and Safety of Secukinumab in Patients With Non-radiographic Axial Spondyloarthritis (PREVENT)

• ClinicalTrials.gov Identifier: NCT02696031
• Recruitment Status: Active, not recruiting
• First Posted: March 2, 2016
• Last Update Posted: October 10, 2019
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

Study Description

Brief Summary:

To demonstrate the clinical efficacy, safety and tolerability of secukinumab compared to placebo in patients with nr-axSpA at Week 16 as well as Week 52 and long term efficacy and safety up to Week 104 followed by an optional 16-week randomized dose escalation treatment period and a continuous treatment period for up to Week 208

Condition or disease	Intervention/treatment	Phase
Non-radiographic Spondyloarthritis	Drug: Secukinumab; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 555 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind, Placebo-controlled Multicenter Study of Secukinumab 150 mg in Patients With Active nr- axSpA to Evaluate the Safety,Tolerability and Efficacy up to 2 Yrs, Followed by an Opt Phase of Either 150 mg or 300 mg Randomized Dose Escalation for up to Another 2 Yrs
• Actual Study Start Date: April 29, 2016
• Estimated Primary Completion Date: December 16, 2020
• Estimated Study Completion Date: December 16, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Secukinumab; Secukinumab 150 mg s.c.	Drug: Secukinumab; Induction: 4x 150 mg Secukinumab s.c. weekly Maintenance: 150 mg Secukinumab s.c. monthly; Drug: Secukinumab; 150 mg Secukinumab s.c. monthly; Drug: Secukinumab; Dose escalation to 300mg at Year 2
Placebo Comparator: Placebo; Placebo s.c.	Drug: Placebo; Induction: 4x placebo s.c. weekly Maintenance: placebo s.c. monthly
Experimental: Experimental; Secukinumab 150 mg s.c. no load	Drug: Secukinumab; 150 mg Secukinumab s.c. monthly

Outcome Measures

Primary Outcome Measures :

1. The proportion of TNF naive participants who achieved an ASAS 40 response (Assessment of SpondyloArthritis International Society criteria) [ Time Frame: Week 16 ]
   ASAS40 (Assessment of SpondyloArthritis International Society criteria) response is defined as an improvement of ≥40% and ≥2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain
2. The proportion of TNF naive participants who achieved an ASAS 40 response (Assessment of SpondyloArthritis International Society criteria) [ Time Frame: Week 52 ]
   ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain

Secondary Outcome Measures :

1. The proportion of participants who achieved an ASAS 5/6 [ Time Frame: Week 16 ]
   The ASAS 5/6 improvement criteria is an improvement of ≥20% in at least five of all six domains
2. Change in BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) over time [ Time Frame: Week 16 ]
   The BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) consists of a 0 through 10 scale (0 being no problem and 10 being the worst problem, captured as a continuous VAS), which is used to answer 6 questions pertaining to the 5 major symptoms of AS
3. Change in SF-36 (Short Form-36 Physical Component Summary) physical Component Summary over time [ Time Frame: Week 16 ]
   The SF-36 (Short Form-36 Physical Component Summary) is an instrument to measure health-related quality of life among healthy patients and patients with acute and chronic conditions
4. The proportion of patients to achieve a BASDAI 50 response [ Time Frame: Week 16 and 52 ]
   The BASDAI 50 is defined as an improvement of at least 50% in the BASDAI compared to baseline.
5. Change in Sacroiliac Joint Edema [ Time Frame: Week 16 and 52 ]
   MRI assessment of the Sacroiliac Joint
6. Change in high sensitivity C-reactive protein over time [ Time Frame: Week 16 ]
   high sensitivity C-reactive protein is measured as a marker of inflammation from blood samples during the study
7. The proportion of participants who achieved an ASAS 20 response [ Time Frame: Week 16 and 52 ]
   ASAS 20 response is defined as an improvement of ≥40% and ≥2 unit on a scale of 10 in at least three of the four main domains and no worsening at all in the remaining domain
8. Change in BASFI (Bath Ankylosing Spondylitis Functional Index) over time [ Time Frame: Week 16 ]
   The BASFI (Bath Ankylosing Spondylitis Functional Index) is a set of 10 questions designed to determine the degree of functional limitation in those patients with AS.
9. The proportion of patients who achieved an ASAS partial remission [ Time Frame: Week 16 ]
   The ASAS partial remission criteria are defined as a value not above 2 units in each of the four main domains on a scale of 10
10. The proportion of participants who achieved an ASAS 20 response [ Time Frame: Week 16 ]
    ASAS 20 response is defined as an improvement of ≥20% and ≥1 unit on a scale of 10 in at least three of the four main domains and no worsening of ≥20% and ≥1 unit on a scale of 10 in the remaining domain
11. Change in ASQoL (Ankylosing Spondylitis Quality of Life scores) over time [ Time Frame: Week 16 and 52 ]
    The ASQoL (Ankylosing Spondylitis Quality of Life scores) is an instrument to measure health-related quality of life among patients with Ankylosig spondylosrthritis
12. The proportion of patients who achieved an Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) inactive disease [ Time Frame: Week 52 ]
    The Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) inactive disease criteria are defined as a value below 1.3 of a composite

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Male or non-pregnant, non-nursing female patients at least 18 years of age
• Diagnosis of axial spondyloarthritis according to Ankylosing SpondyloArthritis International Society (ASAS) axial spondyloarthritis criteria
• objective signs of inflammation (magnetic resonance imaging (MRI) or abnormal C-reactive protein)
• active axial spondyloarthritis as assessed by total Bath Ankylosing Spondylitis Disease Activity Index >=4 cm
• Spinal pain as measured by Bath Ankylosing Spondylitis Disease Activity Index question #2 ≥ 4 cm (0-10 cm) at baseline
• Total back pain as measured by Visual Analogue scale ≥ 40 mm (0-100 mm) at baseline
• Patients should have been on at least 2 different non-steroidal anti-inflammatory drugs with an inadequate response
• Patients who have been on a TNFα inhibitor (not more than one) must have experienced an inadequate response

Exclusion Criteria:

• Patients with radiographic evidence for sacroiliitis, grade ≥ 2 bilaterally or grade ≥ 3 unilaterally
• Inability or unwillingness to undergo MRI
• Chest X-ray or MRI with evidence of ongoing infectious or malignant process
• Patients taking high potency opioid analgesics
• Previous exposure to secukinumab or any other biologic drug directly targeting interleukin-17 (IL-17) or IL-17 receptor
• Pregnant or nursing (lactating) women

Contacts and Locations

  Show 179 Study Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

More Information

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT02696031 History of Changes
• Other Study ID Numbers: CAIN457H2315
• First Posted: March 2, 2016
• Last Update Posted: October 10, 2019
• Last Verified: October 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):

non-radiographic spondyloarthritis; axial spondyloarthritis; Ankylosing Spondylitis

Additional relevant MeSH terms:

Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Antibodies, Monoclonal; Immunologic Factors; Physiological Effects of Drugs