16 Week Efficacy and 5 Year Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing Spondylitis

Novartis Pharmaceuticals219 enrolled

Overview

This study assessed the efficacy and safety of secukinumab in patients with active ankylosing spondylitis who were tolerant to or had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

219

Conditions

Anklyosing Spondylitis

Interventions

Secukinumab (75 mg)DRUG

Secukinumab 75 mg s.c.

PlaceboDRUG

Placebo

Secukinumab (150 mg)DRUG

Secukinumab 150 mg s.c.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or non-pregnant, non-lactating female patients * Diagnosis of moderate to severe AS with prior documented radiologic evidence (x-ray) fulfilling the Modified New York criteria for AS (1984) * Patients should have been on NSAIDs with an inadequate response * Patients who were regularly taking NSAIDs as part of their AS therapy are required to be on a stable dose * Patients who had been on an anti-TNFα agent (not more than one) must have experienced an inadequate response Exclusion Criteria: * Chest X-ray (or MRI) with evidence of ongoing infectious or malignant process * Patients with total ankylosis of the spine * Patients previously treated with any biological immunomodulating agents except for those targeting TNFα * Previous treatment with any cell-depleting therapies

Locations (53)

Outcomes

Primary Outcomes

Percentage of Participants Achieving ASAS 20 (SpondyloArthritis International Society Criteria) Response at Week 16

ASAS 20 response is a validated composite assessment reflecting the percentage of treated patients who achieve within a defined timeframe an improvement of 20% and ≥1 unit on a scale of 1 to 10 in at least three of the four ASAS main domains and no worsening of ≥20% and ≥1 unit in the remaining domain. ASAS 20 is used to assess the efficacy of at least one dose of secukinumab against placebo.

Time frame: Baseline up to 16 weeks

Secondary Outcomes

Percentage of Participants Achieving ASAS 40 (SpondyloArthritis International Society Criteria) Response

ASAS 40 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined timeframe an improvement of ≥40% and ≥2 units on a scale of 0 to 10 (0 being worse and 10 being better) in at least three of the four ASAS main domains (patient global, pain, function and inflammation) and no worsening at all in the remaining domain. ASAS 40 is used to assess the efficacy of at least one dose of secukinumab against placebo.

Time frame: Baseline up to 16 weeks

Change From Baseline at Week 16 in Serum hsCRP

The change from baseline in hsCRP is expressed as a ratio of post-baseline to baseline values. With the ratio normalized to 1.0 at baseline, ratios less than 1.0 represent decreased post-baseline values, whereas ratios greater than 1.0 represent increased post-baseline values. Blood levels of C-reactive protein (CRP), an acute phase reactant, are indicative of inflammation and of its severity, and can be used to monitor treatment response. A high sensitvity CRP (hsCRP) test is implemented in this study to assess the efficacy of at least one dose of secukinumab versus placebo in reducing AS elicited systemic inflammation over time.

Time frame: Baseline up to 16 weeks

Percentage of Participants Achieving ASAS 5/6 (SpondyloArthritis International Society Criteria) Response at Week 16

Data from ClinicalTrials.gov

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Novartis Investigative Site

Mesa, Arizona, United States

Novartis Investigative Site

Upland, California, United States

Novartis Investigative Site

Edina, Minnesota, United States

Novartis Investigative Site

Tupelo, Mississippi, United States

Novartis Investigative Site

Oklahoma City, Oklahoma, United States

Novartis Investigative Site

Oklahoma City, Oklahoma, United States

Novartis Investigative Site

Duncansville, Pennsylvania, United States

Novartis Investigative Site

Charleston, South Carolina, United States

Novartis Investigative Site

Knoxville, Tennessee, United States

Novartis Investigative Site

Mesquite, Texas, United States

...and 43 more locations

ASAS 5/6 response is a validated composite assessment, reflecting the percentage of treated patients who achieve within a defined timeframe at least 20% improvement in score in at least 5 of a conventional set of 6 clinical domains relevant to AS (pain, patient global assessment, function, inflammation, spinal mobility, C-reative protein) without deterioration in the 6th domain. In this study, ASAS 5/6 is used to assess the efficacy of at least one dose of secukinumab against placebo.

Time frame: Baseline up to 16 weeks

Change From Baseline at Week 16 for Total Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

BASDAI is a validated assessment tool using 1 through 10 scales (1 indicating "no problem" and 10 indicating " worst problem"), to characterize six clinical domains (fatigue, spinal pain, joint pain/selling, localized tenderness, morning stiffness duration, morning stiffness severity) pertaining to five major symptoms of AS perceived by the patients. Computed composite scores of 4 or greater indicate suboptimal disease control. In this study, the BASDAI is used to assess the efficacy of at least one dose of secukinumab verus placebo.

Time frame: Baseline up to 16 weeks

Change From Baseline at Week 16 in Physical Function Component Summary (PCS) of the Medical Outcomes Study Questionnaire Short-form Health Survey (SF-36)

Physical Function Component Summary (PCS) is only 1 component of SF-36. This scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

Time frame: Baseline up to 16 weeks

Change From Baseline at Week 16 in ASQoL

ASQoL is an 18 item questionnaire that assesses disease-specific quality of life (QoL), consisting of statements that are relevant to the physical and mental conditions for a participant with AS: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each statement is answered by the participant as a 'Yes' (scored as 1) or 'No' (scored as 0). All item scores are summed to give a total score. Total score can range from 0 (good QoL) to 18 (poor QoL). In this study, ASQoL is used to assess improvement from baseline of at least one dose of secukinumab versus placebo.

Time frame: Baseline up to 16 weeks

Percentage of Participants Achieving ASAS Partial Remission at Week 16

ASAS partial remission is a composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame a value not above 2 units in each of the 4 ASAS domains on a scale 0 to 10. In this study ASAS partial remission is used to assess the efficacy of at least one dose of secukinumab versus placebo.

Time frame: Baseline up to 16 weeks