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16 Week Efficacy and 2 Year Long Term Safety and Efficacy of Secukinumab in Patients With Active Ankylosing Spondylitis (MEASURE 1)

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ClinicalTrials.gov Identifier: NCT01358175
Recruitment Status : Completed
First Posted : May 23, 2011
Results First Posted : January 27, 2017
Last Update Posted : March 9, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
This study will assess the efficacy and safety of secukinumab in patients with active ankylosing spondylitis who are intolerant to or have had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor therapy.

Condition or disease Intervention/treatment Phase
Ankylosing Spondylitis Drug: Secukinumab (75 mg) Drug: Secukinumab (150 mg) Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 371 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Secukinumab to Demonstrate the 16 Week Efficacy and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Ankylosing Spondylitis
Study Start Date : October 2011
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Secukinumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Secukinumab 10 mg/kg i.v. / 75 mg s.c.
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
 Drug: Secukinumab (75 mg)
Secukinumab (75 mg)
Experimental: Secukinumab 10 mg/kg i.v. / 150 mg s.c.
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
 Drug: Secukinumab (150 mg)
Secukinumab (150 mg)
Placebo Comparator: Placebo
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
 Drug: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Assessment of Responders for the SpondyloArthritis International Society / ASAS 20 Response [ Time Frame: 16 weeks ]
    ASAS 20 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined timeframe at least 20% improvement in score in at least 3 of a conventional set of 4 clinical domains relevent to AS and no worsening in the fourth domain. ASAS 20 is used to assess the efficacy of at least one dose of secukinumab against placebo.


Secondary Outcome Measures :
  1. Assessment of Responders for the SpondyloArthritis International Society ASAS 40 Response [ Time Frame: 16 weeks ]
    ASAS 40 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined timeframe at least 40% improvement in score in at least 3 of a conventional set of 4 clinical domains relevent to AS and no worsening in the fourth domain. ASAS 40 is used to assess the efficacy of at least one dose of secukinumab against placebo.

  2. Change From Baseline in Serum hsCRP [ Time Frame: Base line and Week 16 ]
    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 postbaseline values, whereas ratios greater than 1.0 represent increased post-baseline values.

  3. Assessment of Responders for the SpondyloArthritis International Society ASAS 5/6 Response [ Time Frame: 16 weeks ]
    ASAS 5/6 response is a validated composite assessment, reflecting the proportion 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 relevent to AS and no worsening in the remaining domain. In this study, ASAS 5/6 is used to assess the efficacy of at least one dose of secukinumab against placebo.

  4. Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index / BASDAI [ Time Frame: Baseline and 16 weeks ]
    BASDAI is a validated assessment tool using 0 through 10 scales (0 indicating "no problem" and 10 indicating " worst problem"), to characterize six clinical domains 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. To give each symptom equal weighting, the mean (average) of the two scores relating to morning stiffness is taken. The resulting 0 to 50 score is divided by 5 to give a final 0 - 10 BASDAI score. Scores of 4 or greater suggest suboptimal control of disease, and patients with scores of 4 or greater are usually good candidates for either a change in their medical therapy or for enrollment in clinical trials evaluating new drug therapies directed at Ankylosing Spondylitis.

  5. Change From Baseline in Physical Function Component of the Short-form Health Survey / SF-36 PCS [ Time Frame: baseline, 16 weeks ]
    SF-36 is a 36 item questionnaire which measures Quality of Life across eight domains, which are both phyically and emotionally based. Two overall summary scores, the Phyical Component Summary (PCS) and Mental Component Summary (MCS) can be computed. In this study, SF-36 PCS is used to assess improvement from baseline of at least one dose of secukinumab versus placebo.The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.

  6. Change From Baseline in Ankylosing Spondylitis Quality of Life Questionnaire / ASQoL [ Time Frame: baseline and 16 weeks ]
    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.

  7. Assessment of Responders for ASAS Partial Remission [ Time Frame: 16 weeks ]
    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 of 10. In this study ASAS partial remission is used to assess the efficacy of at least one dose of secukinumab versus placebo.ASAS partial remission was defined as a VAS score of less than 2 units in each of the 4 domains of ASAS 20: participant global assessment, pain (total back pain), function and inflammation. The percentages of participants who achieved ASAS partial remission were calculated.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Male or non-pregnant, non-lactating female patients at least 18 years of age
  • 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 are regularly taking NSAIDs as part of their AS therapy are required to be on a stable dose
  • Patients who have been on an anti-TNFα agent (not more than one) must have experienced an inadequate response

Exclusion criteria:

  • Chest X-ray 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
  • Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
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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): NCT01358175


Locations
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Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01358175    
Other Study ID Numbers: CAIN457F2305
2010-024529-18 ( EudraCT Number )
First Posted: May 23, 2011    Key Record Dates
Results First Posted: January 27, 2017
Last Update Posted: March 9, 2017
Last Verified: January 2017
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Ankylosing spondylitis
AS
ASAS
inflammatory back pain
Additional relevant MeSH terms:
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Spondylitis
Spondylarthritis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infections
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
 Arthritis
Joint Diseases
Axial Spondyloarthritis
Spondylarthropathies
Ankylosis
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs