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

Non-radiographic Spondyloarthritis Clinical Trial

— PREVENT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02696031
• Other study ID #: CAIN457H2315
• Status: Completed
• Phase: Phase 3
• Start date: April 29, 2016
• Est. completion date: March 11, 2021

Study information

• Verified date: April 2022
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was 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 (core phase) followed by an optional extension phase consisting of a 16-week randomized dose escalation treatment period and a continuous treatment period for up to Week 208

Description:

Patients were randomized to one of three treatment groups (1:1:1) in the core phase:

• Secukinumab 150 mg Load: secukinumab 150 mg (1 mL, 150 mg/mL) s.c. pre-filled syringe (PFS) at baseline, Weeks 1, 2, and 3, followed by administration every four weeks starting at Week 4

• Secukinumab 150 mg No Load: secukinumab 150 mg (1 mL, 150 mg/mL) s.c. PFS at baseline, placebo at Weeks 1, 2, and 3, followed by secukinumab 150 mg PFS administration every four weeks starting at Week 4

• Placebo: placebo (1 mL) s.c. PFS at baseline, Weeks 1, 2, 3, followed by administration every four weeks starting at Week 4.

All patients received secukinumab 150 mg as open-label treatment from Week 52 up to Week 100, unless they had discontinued study treatment.

At Week 104, all patients who finished the core phase according to the protocol were asked to continue in an optional, exploratory extension phase. Patients who achieved ASAS20 response at Week 104 (Core Phase Responders) were randomized to the following treatment groups (blinded) in the extension phase:

• Core Phase Responder 150 mg: secukinumab 150 mg (1 mL, 150 mg/mL) s.c. PFS and placebo (1 mL) s.c. PFS every four weeks;

• Core Phase Responder 300 mg: 2 injections with secukinumab 150 mg (1 mL, 150 mg/mL) s.c. PFS every four weeks.

Core Phase Non-Responders (not achieving ASAS20 at Week 104) were escalated to secukinumab 300 mg in an open-label manner.

• Core Phase Non-Responder 300 mg: 2 injections with secukinumab 150 mg (1 mL, 150 mg/mL) s.c. PFS every four weeks open-label.

Starting from Week 156 onward, a patient could switch to secukinumab 300 mg open-label based on the clinical judgment of disease activity by the investigator.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 555
• Est. completion date: March 11, 2021
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 Tumor Necrosis Factor (TNF) a 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

Related Conditions & MeSH terms

• Non-radiographic Spondyloarthritis
• Spondylarthritis

Intervention

Drug:
• Secukinumab
Induction: 4x 150 mg Secukinumab s.c. weekly Maintenance: 150 mg Secukinumab s.c. monthly
• Placebo
Induction: 4x placebo s.c. weekly Maintenance: placebo s.c. monthly

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Coffs Harbour	New South Wales
Australia	Novartis Investigative Site	Hobart	Tasmania
Australia	Novartis Investigative Site	Malvern East	Victoria
Australia	Novartis Investigative Site	Maroochydore	Queensland
Australia	Novartis Investigative Site	Woolloongabba
Austria	Novartis Investigative Site	Graz
Austria	Novartis Investigative Site	Vienna
Belgium	Novartis Investigative Site	Bruxelles
Belgium	Novartis Investigative Site	Genk
Belgium	Novartis Investigative Site	Gent
Bulgaria	Novartis Investigative Site	Pleven
Bulgaria	Novartis Investigative Site	Sofia
Bulgaria	Novartis Investigative Site	Sofia
Czechia	Novartis Investigative Site	Brno	CZ
Czechia	Novartis Investigative Site	Brno-Zidonice	CZE
Czechia	Novartis Investigative Site	Praha 11	Czech Republic
Czechia	Novartis Investigative Site	Praha 2	Czech Republic
Czechia	Novartis Investigative Site	Praha 5	Czech Republic
Czechia	Novartis Investigative Site	Uherske Hradiste
France	Novartis Investigative Site	Bordeaux Cedex
France	Novartis Investigative Site	Boulogne Billancourt
France	Novartis Investigative Site	Chambray les Tours
France	Novartis Investigative Site	Limoges cedex	Haute Vienne
France	Novartis Investigative Site	Monaco
France	Novartis Investigative Site	Paris Cedex 14
France	Novartis Investigative Site	Poitiers
France	Novartis Investigative Site	Rouen Cedex
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Cottbus
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Erlangen
Germany	Novartis Investigative Site	Freiburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hannover	Niedersachsen
Germany	Novartis Investigative Site	Herne
Germany	Novartis Investigative Site	Magdeburg
Germany	Novartis Investigative Site	Potsdam
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Debrecen
Hungary	Novartis Investigative Site	Eger
Hungary	Novartis Investigative Site	Szeged
Hungary	Novartis Investigative Site	Szekesfehervar
Hungary	Novartis Investigative Site	Veszprem
Israel	Novartis Investigative Site	Haifa
Israel	Novartis Investigative Site	Kfar Saba
Israel	Novartis Investigative Site	Ramat Gan
Israel	Novartis Investigative Site	Tel Aviv
Italy	Novartis Investigative Site	Bologna
Italy	Novartis Investigative Site	Novara
Italy	Novartis Investigative Site	Padova
Italy	Novartis Investigative Site	Pisa
Italy	Novartis Investigative Site	Verona	VR
Japan	Novartis Investigative Site	Bunkyo ku	Tokyo
Japan	Novartis Investigative Site	Chuo ku	Tokyo
Japan	Novartis Investigative Site	Kawachinagano	Osaka
Japan	Novartis Investigative Site	Kita-gun	Kagawa
Japan	Novartis Investigative Site	Meguro	Tokyo
Japan	Novartis Investigative Site	Shinjuku ku	Tokyo
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Mexico	Novartis Investigative Site	Culiacan	MEX
Mexico	Novartis Investigative Site	Guadalajara	Jalisco
Mexico	Novartis Investigative Site	Metepec	Estado De Mexico
Mexico	Novartis Investigative Site	Torreon	Coahuila
Netherlands	Novartis Investigative Site	Amsterdam
Netherlands	Novartis Investigative Site	Groningen
Netherlands	Novartis Investigative Site	Maastricht
Norway	Novartis Investigative Site	Kongsvinger
Norway	Novartis Investigative Site	Moss
Poland	Novartis Investigative Site	Krakow
Poland	Novartis Investigative Site	Poznan
Poland	Novartis Investigative Site	Poznan
Poland	Novartis Investigative Site	Warszawa
Poland	Novartis Investigative Site	Warszawa
Poland	Novartis Investigative Site	Wroclaw
Portugal	Novartis Investigative Site	Almada
Portugal	Novartis Investigative Site	Braga
Portugal	Novartis Investigative Site	Lisboa
Portugal	Novartis Investigative Site	Lisboa
Portugal	Novartis Investigative Site	Ponte de Lima
Russian Federation	Novartis Investigative Site	Barnaul
Russian Federation	Novartis Investigative Site	Ekaterinburg
Russian Federation	Novartis Investigative Site	Kemerovo
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Saint Petersburg
Russian Federation	Novartis Investigative Site	Saratov
Russian Federation	Novartis Investigative Site	Smolensk
Spain	Novartis Investigative Site	Bilbao	Pais Vasco
Spain	Novartis Investigative Site	Cordoba	Andalucia
Spain	Novartis Investigative Site	Elda	Alicante
Spain	Novartis Investigative Site	Hospitalet de Llobregat	Barcelona
Spain	Novartis Investigative Site	La Coruna	Galicia
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Malaga	Andalucia
Spain	Novartis Investigative Site	Sabadell	Barcelona
Spain	Novartis Investigative Site	Santander	Cantabria
Spain	Novartis Investigative Site	Santiago de Compostela	Galicia
Spain	Novartis Investigative Site	Sevilla	Andalucia
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Spain	Novartis Investigative Site	Vigo	Pontevedra
Sweden	Novartis Investigative Site	Goteborg
Sweden	Novartis Investigative Site	Lund
Sweden	Novartis Investigative Site	Uppsala
Switzerland	Novartis Investigative Site	Basel
Switzerland	Novartis Investigative Site	Fribourg
Turkey	Novartis Investigative Site	Ankara
United Kingdom	Novartis Investigative Site	Bath
United Kingdom	Novartis Investigative Site	Doncaster
United Kingdom	Novartis Investigative Site	Leytonstone	London
United Kingdom	Novartis Investigative Site	Middlesbrough
United Kingdom	Novartis Investigative Site	Northampton
United Kingdom	Novartis Investigative Site	Stoke on Trent	Staffordshire
United Kingdom	Novartis Investigative Site	Westcliff-on-Sea	Essex
United Kingdom	Novartis Investigative Site	Wolverhampton
United Kingdom	Novartis Investigative Site	Worthing	West Sussex
United States	Novartis Investigative Site	Albany	New York
United States	Novartis Investigative Site	Beverly Hills	California
United States	Novartis Investigative Site	Birmingham	Alabama
United States	Novartis Investigative Site	Bowling Green	Kentucky
United States	Novartis Investigative Site	Charleston	South Carolina
United States	Novartis Investigative Site	Charlotte	North Carolina
United States	Novartis Investigative Site	Denver	Colorado
United States	Novartis Investigative Site	Duncansville	Pennsylvania
United States	Novartis Investigative Site	Fullerton	California
United States	Novartis Investigative Site	Gainesville	Florida
United States	Novartis Investigative Site	Great Falls	Montana
United States	Novartis Investigative Site	Idaho Falls	Idaho
United States	Novartis Investigative Site	Lansing	Michigan
United States	Novartis Investigative Site	Leander	Texas
United States	Novartis Investigative Site	Mesquite	Texas
United States	Novartis Investigative Site	Oklahoma City	Oklahoma
United States	Novartis Investigative Site	Portland	Oregon
United States	Novartis Investigative Site	Potsdam	New York

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Bulgaria,  Czechia,  France,  Germany,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Norway,  Poland,  Portugal,  Russian Federation,  Spain,  Sweden,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number and Percentage of TNF Naive Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 40 Response at Week 16	Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant).; 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. A higher score on the VAS signifies higher severity.	Week 16
Primary	The Number and Percentage of TNF Naive Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 52	Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant).; 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. A higher score on the VAS signifies higher severity.	Week 52
Secondary	The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response	Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant).; 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. A higher score on the VAS signifies higher severity.	Week 16 and week 52
Secondary	The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 20 Response	Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant).; 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. A higher score on the VAS signifies higher severity.	Week 16
Secondary	The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 5/6 Response	Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant).; The ASAS 5/6 improvement criteria is an improvement of =20% in at least five of all six domains. A higher score on the VAS signifies higher severity.	Week 16
Secondary	The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society Partial Remission (ASAS PR)	Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant).; 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. A higher score on the VAS signifies higher severity.	Week 16
Secondary	Change in Bath Ankylosing Spondylitis Functional Index (BASFI)	The Bath Ankylosing Spondylitis Functional Index (BASFI) is a set of 10 questions designed to determine the degree of functional limitation in those subjects with AS. The ten questions were chosen with a major input from subjects with AS. The first 8 questions consider activities related to functional anatomy. The final 2 questions assess the subjects' ability to cope with everyday life. A 100 mm visual analog scale (VAS) is used to answer the questions. The mean of the ten questions gives the BASFI score - a value between 0 and 10. (0 being no problem and 10 being the worst problem, captured as a continuous visual analog scale (VAS)). A higher score on the VAS signifies higher severity.	Baseline and Week 16
Secondary	The Number and Percentage of Patients to Achieve a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response	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. The BASDAI 50 is defined as an improvement of at least 50% in the BASDAI compared to baseline. A higher score on the VAS signifies higher severity.	Week 16 and 52
Secondary	Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	The Bath Ankylosing Spondylitis Disease Activity Index (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 Ankylosing Spondylitis (AS). The computed final BASDAI score is a value between 0 and 10 with a higher score indicating worse disease. A higher score on the VAS signifies higher severity.	Baseline and Week 16
Secondary	Change in Ankylosing Spondylitis Quality of Life (ASQoL) Scores at Week 16	The Ankylosing Spondylitis Quality of Life scores (ASQoL) is a self-administered questionnaire designed to assess health-related quality of life in adult patients with Ankylosing Spondylitis. The ASQoL contains 18 items with a dichotomous yes/no response option. A single point is assigned for each "yes" response and no points for each "no" response resulting in overall scores that range from 0 (least severity) to 18 (highest severity). As such, lower score indicate better quality of life. Items include an assessment of mobility/energy, self-care and mood/emotion. The recall period is "at the moment," and the measure requires approximately 6 minutes to complete.	Baseline and Week 16
Secondary	Change in Ankylosing Spondylitis Quality of Life (ASQoL) Scores at Week 52	The Ankylosing Spondylitis Quality of Life scores (ASQoL) is a self-administered questionnaire designed to assess health-related quality of life in adult patients with Ankylosing Spondylitis. The ASQoL contains 18 items with a dichotomous yes/no response option. A single point is assigned for each "yes" response and no points for each "no" response resulting in overall scores that range from 0 (least severity) to 18 (highest severity). As such, lower score indicate better quality of life. Items include an assessment of mobility/energy, self-care and mood/emotion. The recall period is "at the moment," and the measure requires approximately 6 minutes to complete.; Summary statistics are presented for participants (n) without intercurrent events.	Baseline and Week 52
Secondary	The Number and Percentage of Patients Who Achieved an Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Inactive Disease	Ankylosing Spondylitis Disease Activity Score (ASDAS) - C-reactive protein (CRP) inactive disease criteria are defined as a value below 1.3. Higher score indicates worse symptoms. The formula is: ASDAS-CRP = 0.121 x total back pain + 0.110 x patient global + 0.073 x peripheral pain/swelling + 0.058 x duration of morning stiffness + 0.579 x ln(hsCRP +1)	Week 52
Secondary	Change in High Sensitivity C-reactive Protein	High sensitivity C-reactive protein is measured as a marker of inflammation from blood samples during the study.	Baseline and Week 16
Secondary	Change in Short Form-36 Physical Component Summary (SF-36 PCS)	The Short Form-36 Physical Component Summary (SF-36 PCS) is an instrument to measure health-related quality of life among healthy patients and patients with acute and chronic conditions.; It consists of eight subscales (domains) that can be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role- Emotional, and Mental Health. Two overall summary scores, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) also can be computed. The eight domains are based on a scale from 0-100 while PCS and MCS are norm-based scores with a mean of 50 and a standard deviation of 10.; Higher scores indicate a higher level of functioning. A positive change from baseline score indicates an improvement.	Baseline and Week 16
Secondary	Change in Sacroiliac Joint Edema - Week 16	Magnetic Resonance Images (MRI) of the Sacroiliac Joint (SIJ) were assessed for the presence and severity of SIJ bone marrow edema according to the Berlin Active Inflammatory Lesions Scoring with a maximum score of 24.	Baseline and Week 16
Secondary	Change in Sacroiliac Joint Edema - Week 52	Magnetic Resonance Images (MRI) of the Sacroiliac Joint (SIJ) were assessed for the presence and severity of SIJ bone marrow edema according to the Berlin Active Inflammatory Lesions Scoring with a maximum score of 24.	Baseline and Week 52