We updated the design of this site on December 18, 2017. Learn more.
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 : Not yet recruiting
First Posted : August 23, 2017
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Ankylosing Spondylitis Biological: Secukinumab Biological: GP2017 (adalimumab biosimilar) Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 837 participants
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
Official Title: 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
Anticipated Study Start Date : November 14, 2017
Estimated Primary Completion Date : October 28, 2021
Estimated Study Completion Date : November 11, 2021


Arms and Interventions

Arm Intervention/treatment
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
Biological: Secukinumab
Eligible subjects are randomized to one of three treatment arms in a 1:1:1 ratio
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
Biological: Secukinumab
Eligible subjects are randomized to one of three treatment arms in a 1:1:1 ratio
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
Biological: GP2017 (adalimumab biosimilar)
Eligible subjects are randomized to one of three treatment arms in a 1:1:1 ratio


Outcome Measures

Primary Outcome Measures :
  1. 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.)


Secondary Outcome Measures :
  1. 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.)

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

  8. 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.)

  9. 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.)


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03259074


Contacts
Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Sponsors and Collaborators
Novartis Pharmaceuticals
More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03259074     History of Changes
Other Study ID Numbers: CAIN457K2340
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017

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

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
ankylosing spondylitis, AS, secukinumab, GP2017, adalimumab biosimilar, mSASSS, ASAS20

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Adalimumab
Antibodies, Monoclonal
Anti-Inflammatory Agents
Antirheumatic Agents
Immunologic Factors
Physiological Effects of Drugs