Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar) (SURPASS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03259074
Recruitment Status : Recruiting
First Posted : August 23, 2017
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE August 21, 2017
First Posted Date  ICMJE August 23, 2017
Last Update Posted Date October 8, 2019
Actual Study Start Date  ICMJE October 24, 2017
Estimated Primary Completion Date September 2, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2019)
No radiographic progression as measured by modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) [ Time Frame: 104 weeks ]
To demonstrate the proportion of subjects on secukinumab (150 mg s.c. or 300 mg s.c.) with no radiographic progression as measured by mSASSS at Week 104 is superior to subjects on GP2017 (adalimumab biosimilar 40 mg s.c.)
Original Primary Outcome Measures  ICMJE
 (submitted: August 21, 2017)
No radiographic progression as measured by modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) [ Time Frame: 104 weeks ]
To demonstrate the proportion of subjects on secukinumab (combined 150 mg s.c. and 300 mg s.c.) with no radiographic progression as measured by mSASSS at Week 104 is superior to subjects on GP2017 (adalimumab biosimilar 40 mg s.c.)
Change History Complete list of historical versions of study NCT03259074 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2019)
  • Change from baseline in modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) [ Time Frame: 104 weeks ]
    To demonstrate the change from baseline in mSASSS in subjects on secukinumab (150 mg s.c. or 300 mg s.c.) is superior to GP2017 (adalimumab biosimilar 40 mg s.c.) at Week 104
  • No new syndesmophytes as measured by mSASSS [ Time Frame: 104 weeks ]
    The proportion of subjects with no new syndesmophytes is defined as the number of patients with a syndesmophyte at baseline who develops one by week 104, as measured by mSASSS
  • Assessment of SpondyloArthritis International Society 20 (ASAS20) [ Time Frame: 104 weeks ]
    ASAS20 response is defined as an improvement of ≥20% and ≥1 unit on a scale of 10 in at least three of the four ASAS main domains and no worsening of ≥20% and ≥1 unit in the remaining domain
  • ASAS40 [ Time Frame: 104 weeks ]
    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
  • ASAS partial remission [ Time Frame: 104 weeks ]
    ASAS partial remission is defined as a value not above 2 units in each of four main domains on a scale of 0 to 10
  • Ankylosing Spondylitis Disease Activity Score (ASDAS) inactive disease [ Time Frame: 104 weeks ]
    An ASDAS inactive disease response is a score of <1.3 on a composite index to assess disease activity in Ankylosing Spondylitis. Parameters include spinal pain, the patient's global assessment of disease activity, peripheral pain/swelling, duration of morning stiffness and C-reactive protein (CRP) in mg/L.
  • Berlin sacroiliac (SI) joint edema score [ Time Frame: 104 weeks ]
    To evaluate the Berlin SI joint edema score in subjects on secukinumab (150 mg s.c. or 300 mg s.c.) at Week 104 versus GP2017 (adalimumab biosimilar 40 mg s.c.)
  • Ankylosing Spondylitis Spine Magnetic Resonance Imaging - activity (ASspiMRI-a) Berlin modification score [ Time Frame: 104 weeks ]
    To evaluate the ASspiMRI-a Berlin modification score in subjects on secukinumab (150 mg s.c. or 300 mg s.c.) at Week 104 versus GP2017 (adalimumab biosimilar 40 mg s.c.)
Original Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2017)
  • No radiographic progression as measured by modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) [ Time Frame: 104 weeks ]
    To demonstrate the proportion of subjects on secukinumab (150 mg s.c. or 300 mg s.c.) with no radiographic progression as measured by mSASSS at Week 104 is superior to subjects on GP2017 (adalimumab biosimilar 40 mg s.c.)
  • Change from baseline in modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) [ Time Frame: 104 weeks ]
    To demonstrate the change from baseline in mSASSS in subjects on secukinumab (150 mg s.c. or 300 mg s.c.) is superior to GP2017 (adalimumab biosimilar 40 mg s.c.) at Week 104
  • No new syndesmophytes as measured by mSASSS [ Time Frame: 104 weeks ]
    The proportion of subjects with no new syndesmophytes is defined as the number of patients with a syndesmophyte at baseline who develops one by week 104, as measured by mSASSS
  • Assessment of SpondyloArthritis International Society 20 (ASAS20) [ Time Frame: 104 weeks ]
    ASAS20 response is defined as an improvement of ≥20% and ≥1 unit on a scale of 10 in at least three of the four ASAS main domains and no worsening of ≥20% and ≥1 unit in the remaining domain
  • ASAS40 [ Time Frame: 104 weeks ]
    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
  • ASAS partial remission [ Time Frame: 104 weeks ]
    ASAS partial remission is defined as a value not above 2 units in each of four main domains on a scale of 0 to 10
  • Ankylosing Spondylitis Disease Activity Score (ASDAS) inactive disease [ Time Frame: 104 weeks ]
    An ASDAS inactive disease response is a score of <1.3 on a composite index to assess disease activity in Ankylosing Spondylitis. Parameters include spinal pain, the patient's global assessment of disease activity, peripheral pain/swelling, duration of morning stiffness and C-reactive protein (CRP) in mg/L.
  • Berlin sacroiliac (SI) joint edema score [ Time Frame: 104 weeks ]
    To evaluate the Berlin SI joint edema score in subjects on secukinumab (150 mg s.c. and 300 mg s.c.) at Week 104 versus GP2017 (adalimumab biosimilar 40 mg s.c.)
  • Ankylosing Spondylitis Spine Magnetic Resonance Imaging - activity (ASspiMRI-a) Berlin modification score [ Time Frame: 104 weeks ]
    To evaluate the ASspiMRI-a Berlin modification score in subjects on secukinumab (150 mg s.c. and 300 mg s.c.) at Week 104 versus GP2017 (adalimumab biosimilar 40 mg s.c.)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar)
Official Title  ICMJE A Randomized, Partially-blinded Study of Secukinumab to Demonstrate Reduction of Radiographic Progression Versus GP2017 (Adalimumab Biosimilar) at 104 Weeks and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Ankylosing Spondylitis
Brief Summary The purpose of this study is to demonstrate the impact of secukinumab on progression of structural damage in the spine, as measured by the mSASSS in patients with AS.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
The Participant, Care Provider, Investigator and Sponsor are blinded to Secukinumab dose
Primary Purpose: Treatment
Condition  ICMJE Ankylosing Spondylitis
Intervention  ICMJE
  • Biological: Secukinumab
    Eligible subjects are randomized to one of three treatment arms in a 1:1:1 ratio
  • Biological: GP2017 (adalimumab biosimilar)
    Eligible subjects are randomized to one of three treatment arms in a 1:1:1 ratio
Study Arms  ICMJE
  • Experimental: Secukinumab 150 mg s.c.
    Secukinumab 150 mg will be administered at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 100
    Intervention: Biological: Secukinumab
  • Experimental: Secukinumab 300 mg s.c.
    Secukinumab 300 mg will be administered at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 100
    Intervention: Biological: Secukinumab
  • Experimental: GP2017 (adalimumab biosimilar) 40mg s.c.
    GP2017 (adalimumab biosimilar) 40 mg will be administered at Baseline followed by dosing every 2 weeks until Week 102
    Intervention: Biological: GP2017 (adalimumab biosimilar)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 21, 2017)
837
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 23, 2021
Estimated Primary Completion Date September 2, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or non-pregnant, non-nursing female patients at least 18 years of age
  • Diagnosis of moderate to severe Ankylosing Spondylitis with radiologic evidence (centrally read X-ray) fulfilling the Modified New York criteria for AS despite previous or current NSAID/ nonbiologic DMARD therapy
  • Active AS assessed by total BASDAI ≥ 4 on a scale of 0-10
  • Spinal pain as measured by BASDAI question #2 ≥ 4 (0-10)
  • Total back pain as measured by visual analog scale (VAS) ≥ 40 mm (0-100 mm)
  • hsCRP ≥ 5 mg/L OR presence of at least 1 syndesmophyte on centrally read spinal X-ray

Exclusion Criteria:

  • Patients with total ankylosis of the spine
  • Pregnant or nursing (lactating) women
  • Evidence of ongoing infectious or malignant process
  • Previous exposure to any biologic immunomodulating agent, including those targeting IL-17, IL-17 receptor or TNFα
  • Subjects taking high potency opioid analgesics
  • Previous treatment with any cell-depleting therapies including but not limited to anti-CD20, investigational agents

Other protocol-defined inclusion/exclusion criteria may apply

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111
Listed Location Countries  ICMJE Chile,   Russian Federation,   Argentina,   Australia,   Belgium,   Canada,   Colombia,   Czechia,   Denmark,   Finland,   France,   Germany,   Greece,   Israel,   Japan,   Korea, Republic of,   Mexico,   Monaco,   Netherlands,   Peru,   Philippines,   Poland,   Portugal,   Romania,   Slovakia,   Spain,   Taiwan,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03259074
Other Study ID Numbers  ICMJE CAIN457K2340
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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

Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Novartis
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP