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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02159053
Other study ID # CAIN457F2320
Secondary ID 2013-005575-41
Status Completed
Phase Phase 3
First received
Last updated
Start date May 18, 2015
Est. completion date January 2, 2018

Study information

Verified date November 2018
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to provide 16-week efficacy, safety and tolerability data versus placebo to support the use of secukinumab 150 mg by subcutaneous (s.c.) self-administration with or without a loading regimen and maintenance dosing using pre-filled syringe (PFS) and to assess efficacy, safety and tolerability up to 2 years in subjects with active AS despite current or previous NSAID, non-biologic DMARD, or biologic anti-TNFα therapy.


Recruitment information / eligibility

Status Completed
Enrollment 350
Est. completion date January 2, 2018
Est. primary completion date February 23, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: moderate to severe AS, prior radiographic evidence according to the Modified NY Criteria (1984), inadequate response to NSAIDs.

Exclusion criteria: pregnancy or lactation, on-going infectious or malignant process on a chest X-ray or MRI, previous exposure to IL-17 or IL-17R targeting therapies, previous exposure to any biological immunomodulating agent excluding TNF antagonists, previous cell depleting therapy.

Other protocol-defined inclusion/exclusion criteria do apply.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Secukinumab
Eligible subjects are randomized to each of the three treatment arms in a 1:1:1 ratio
Secukinumab
Eligible subjects are randomized to each of the three treatment arms in 1:1:1 ratio
Placebo
Eligible subjects are randomized to each of the three treatment arms in a 1:1:1 ratio

Locations

Country Name City State
Australia Novartis Investigative Site Hobart Tasmania
Australia Novartis Investigative Site Kogarah New South Wales
Australia Novartis Investigative Site Malvern East Victoria
Australia Novartis Investigative Site Maroochydore Queensland
Austria Novartis Investigative Site Graz
Austria Novartis Investigative Site Vienna
Austria Novartis Investigative Site Vienna
Bulgaria Novartis Investigative Site Pleven
Bulgaria Novartis Investigative Site Plovdiv
Bulgaria Novartis Investigative Site Sofia
Bulgaria Novartis Investigative Site Sofia
Bulgaria Novartis Investigative Site Targovishte
Canada Novartis Investigative Site Pointe-Claire Quebec
Canada Novartis Investigative Site Trois Rivieres Quebec
Canada Novartis Investigative Site Winnipeg Manitoba
Czechia Novartis Investigative Site Ostrava Czech Republic
Czechia Novartis Investigative Site Praha 11 Czech Republic
Czechia Novartis Investigative Site Praha 2 Czech Republic
Czechia Novartis Investigative Site Uherske Hradiste Czech Republic
Denmark Novartis Investigative Site Frederiksberg
Denmark Novartis Investigative Site Odense
Finland Novartis Investigative Site Hyvinkaa
Finland Novartis Investigative Site Jyvaskyla
Germany Novartis Investigative Site Bad Doberan
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Chemnitz
Germany Novartis Investigative Site Erlangen
Germany Novartis Investigative Site Germering
Germany Novartis Investigative Site Göttingen Lower Saxony
Germany Novartis Investigative Site Hamburg
Germany Novartis Investigative Site Herne
Germany Novartis Investigative Site Leipzig
Germany Novartis Investigative Site Magdeburg
Germany Novartis Investigative Site Muenchen
Germany Novartis Investigative Site Wurzburg
Greece Novartis Investigative Site Athens
Greece Novartis Investigative Site Athens
Greece Novartis Investigative Site Patras
Italy Novartis Investigative Site Genova GE
Italy Novartis Investigative Site Milano MI
Italy Novartis Investigative Site Milano MI
Italy Novartis Investigative Site Torino TO
Italy Novartis Investigative Site Verona VR
Netherlands Novartis Investigative Site Amsterdam
Netherlands Novartis Investigative Site Heerlen
Netherlands Novartis Investigative Site Leiden
Netherlands Novartis Investigative Site Rotterdam
Norway Novartis Investigative Site Kongsvinger
Poland Novartis Investigative Site Bialystok
Poland Novartis Investigative Site Elblag
Poland Novartis Investigative Site Poznan
Poland Novartis Investigative Site Poznan
Poland Novartis Investigative Site Poznan
Poland Novartis Investigative Site Warszawa
Russian Federation Novartis Investigative Site Barnaul
Russian Federation Novartis Investigative Site Barnaul
Russian Federation Novartis Investigative Site Kemerovo
Russian Federation Novartis Investigative Site S.-Petersburg
Russian Federation Novartis Investigative Site Saint Petersburg
Russian Federation Novartis Investigative Site St-Petersburg
Slovakia Novartis Investigative Site Partizanske
Slovakia Novartis Investigative Site Piestany SVK
Slovakia Novartis Investigative Site Sabinov
Slovakia Novartis Investigative Site Stara Lubovna
Slovakia Novartis Investigative Site Topolcany
Spain Novartis Investigative Site Baracaldo Vizcaya
Spain Novartis Investigative Site Cordoba Andalucia
Spain Novartis Investigative Site Hospitalet de Llobregat Barcelona
Spain Novartis Investigative Site La Coruna Galicia
Spain Novartis Investigative Site Madrid
Spain Novartis Investigative Site Santander Cantabria
Spain Novartis Investigative Site Santiago de Compostela Galicia
Switzerland Novartis Investigative Site Fribourg
Switzerland Novartis Investigative Site St Gallen
United Kingdom Novartis Investigative Site Doncaster
United Kingdom Novartis Investigative Site Leytonstone London
United Kingdom Novartis Investigative Site Wolverhampton
United States Novartis Investigative Site Anniston Alabama
United States Novartis Investigative Site Aventura Florida
United States Novartis Investigative Site Columbia South Carolina
United States Novartis Investigative Site Duncansville Pennsylvania
United States Novartis Investigative Site Lincoln Nebraska
United States Novartis Investigative Site Mesquite Texas
United States Novartis Investigative Site Oklahoma City Oklahoma
United States Novartis Investigative Site Peoria Illinois
United States Novartis Investigative Site Seattle Washington
United States Novartis Investigative Site Shreveport Louisiana
United States Novartis Investigative Site Upland California
United States Novartis Investigative Site Voorhees New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Bulgaria,  Canada,  Czechia,  Denmark,  Finland,  Germany,  Greece,  Italy,  Netherlands,  Norway,  Poland,  Russian Federation,  Slovakia,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants Responded for Assessment of Spondyloarthritis International Society 20 Criteria (ASAS20) at 16 Weeks ASAS 20 response is a validated composite assessment, defined as an improvement of at least 20 percent (%) and 1 unit on a scale of 10 in three main domains and no worsening of at least 20% and 1 unit on a scale of 10 in the fourth domain within a defined time frame. Four main ASAS domains include: 1. Patient's global assessment of disease activity measured on a 100 mm VAS ranging from not severe to very severe 2. Patient's assessment of back pain, measured on a 100 mm VAS ranging from no pain to unbearable pain 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions regarding ability to perform specific tasks as measured by a 0-10 VAS scale 4. Inflammation represented by average of duration and severity of morning stiffness for last 2 questions on BASDAI scale (0 - no problem, 10 - worst problem) 16 Weeks
Secondary Percentage of Participants Responded for ASAS 40 Response at 16 Weeks ASAS 20 response is a validated composite assessment, defined as an improvement of at least 40% and 2 unit on a scale of 10 in three main domains and no worsening at all in the remaining domain within a defined time frame. Four main ASAS domains include:
Patient's global assessment of disease activity measured on a 100 mm VAS ranging from not severe to very severe
Patient's assessment of back pain, measured on a 100 mm VAS ranging from no pain to unbearable pain
Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions regarding ability to perform specific tasks as measured by a 0-10 VAS scale
Inflammation represented by average of duration and severity of morning stiffness for last 2 questions on BASDAI scale (0 - no problem, 10 - worst problem).
16 Weeks
Secondary Change From Baseline in Serum High Sensitivity C-reactive Protein (hsCRP) at 16 Weeks Blood levels of C-reactive protein (CRP) is an acute phase reactant, which are indicative of inflammation and of its severity, and can be used to monitor treatment response. A hsCRP test is implemented to assess the efficacy of secukinumab (with or without load) versus placebo in reducing ankylosing spondylitis elicited systemic inflammation over the time. Baseline, 16 Weeks
Secondary Percentage of Participants Responded for ASAS 5/6 Response at 16 Weeks ASAS 5/6 response is a validated composite assessment, defined as an improvement of at least 20% in score in at least 5 of 6 clinical domains relevant to ankylosing spondylitis and no worsening in the remaining domain. ASAS domains includes:
Patient's global assessment of disease activity measured on a 100 mm VAS ranging from not severe to very severe
Patient's assessment of back pain, measured on a 100 mm VAS ranging from no pain to unbearable pain
Function represented by BASFI average of 10 questions regarding ability to perform specific tasks as measured by a 0-10 VAS scale
Inflammation represented by average of duration and severity of morning stiffness for last 2 questions on BASDAI scale (0 - no problem, 10 - worst problem)
Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment
C-reactive protein (CRP, acute phase reactant).
16 Weeks
Secondary Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at 16 Weeks BASDAI is a validated assessment tool using 0 through 10 scales (0 indicating "no problem" and 10 indicating "worst problem" on continuous VAS), to answer 6 questions (clinical domains) pertaining to 5 major symptoms of ankylosing spondylitis. Computed composite scores of 4 or greater indicate suboptimal disease control. BASDAI questions includes:
Fatigue
Spinal pain
Joint pain / swelling
Areas of localized tenderness (called enthesitis, or inflammation of tendons and ligaments)
Morning stiffness duration
Morning stiffness severity. Each symptom has equal weighting, the mean of two scores related to morning stiffness was taken (questions 5 and 6). The resulting 0 to 10 score was added to the scores from questions 1-4. The resulting 0 to 50 score was divided by 5 to give a final 0-10 BASDAI score. BASDAI was a quick and simple index taking between 30 seconds and 2 minutes for completion.
Baseline, 16 Weeks
Secondary Change From Baseline in Physical Function Component Summary (PCS) of the Medical Outcomes Study Questionnaire Short-form Health Survey (SF-36) SF-36 is a 36 item questionnaire which measures Quality of Life across eight subscales that were scored individually: physical functioning, role- physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores are weighted sums of the questions in each section. Scores range from 0-100. Lower scores = more disability, higher scores = less disability. The overall summary scores, SF-36 physical Component Summary (PCS) was used to assess improvement from baseline in the Health-Related Quality Of Life of subjects. The change in SF-36 scores were evaluated using MMRM. Baseline, 16 Weeks
Secondary Change From Baseline in Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) at 16 Weeks ASQoL is a self-administered 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 subject with ankylosing spondylitis: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each statement is answered as a 'Yes' (scored as 1) or 'No' (scored as 0). All item scores are summed to give a total score. Total score ranges from 0 (good QoL) to 18 (poor QoL). The change in ASQoL scores was evaluated using a mixed effect repeated measures model (MMRM). Baseline, 16 Weeks
Secondary Number of Participants With Adverse Events (AEs), Deaths, Serious Adverse Events (SAEs) and Related Discontinuations at 104 Weeks AEs were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards. 104 Weeks
Secondary Percentage of Participants Responded for ASAS 20 at Week 4 ASAS 20 response is a validated composite assessment, defined as an improvement of at least 20% and 1 unit on a scale of 10 in three main domains and no worsening of at least 20% and 1 unit on a scale of 10 in the fourth domain within a defined time frame. Four main ASAS domains include:
Patient's global assessment of disease activity measured on a 100 mm VAS ranging from not severe to very severe
Patient's assessment of back pain, measured on a 100 mm VAS ranging from no pain to unbearable pain
Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions regarding ability to perform specific tasks as measured by a 0-10 VAS scale
Inflammation represented by average of duration and severity of morning stiffness for last 2 questions on BASDAI scale (0 - no problem, 10 - worst problem).
Week 4
Secondary Percentage of Participants Responded for ASAS 40 Response at Week 4 ASAS 20 response is a validated composite assessment, defined as an improvement of at least 40% and 2 unit on a scale of 10 in three main domains and no worsening at all in the remaining domain within a defined time frame. Four main ASAS domains include:
Patient's global assessment of disease activity measured on a 100 mm VAS ranging from not severe to very severe
Patient's assessment of back pain, measured on a 100 mm VAS ranging from no pain to unbearable pain
Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions regarding ability to perform specific tasks as measured by a 0-10 VAS scale
Inflammation represented by average of duration and severity of morning stiffness for last 2 questions on BASDAI scale (0 - no problem, 10 - worst problem).
Week 4
See also
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