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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 )

Tracking Information
First Submitted Date  ICMJE May 19, 2011
First Posted Date  ICMJE May 23, 2011
Results First Submitted Date  ICMJE December 14, 2015
Results First Posted Date  ICMJE January 27, 2017
Last Update Posted Date March 9, 2017
Study Start Date  ICMJE October 2011
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 20, 2011)
Efficacy of each secukinumab regimen is superior to placebo in patients with active AS based on the proportion of patients achieving an ASAS 20 response in the subgroup of patients who are TNFα inhibitor naïve [ Time Frame: Week 16 ]
Efficacy of each secukinumab regimen is superior to placebo in patients with active AS based on the proportion of patients achieving an ASAS 20 (Assessment of Spondyloarthritis International Society criteria) response in the subgroup of patients who are TNFα inhibitor naïve
Change History Complete list of historical versions of study NCT01358175 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2016)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2011)
  • Efficacy of each secukinumab regimen is superior to placebo in patients with active AS based on the proportion of patients achieving an ASAS 20 response in the whole study population [ Time Frame: Week 16 ]
  • Efficacy of each secukinumab regimen is superior to placebo in patients with active AS based on the proportion of patients achieving an ASAS 40 response in patients who are TNFα inhibitor naïve [ Time Frame: Week 16 ]
  • of each secukinumab regimen is superior to placebo in patients with active AS based on the proportion of patients achieving an ASAS 40 response in the whole study population [ Time Frame: Week 16 ]
  • Spinal mobility assessed by Bath Ankylosing Spondylitis Metrology Index (BASMI) linear scores [ Time Frame: Week 2, 12, 16 and over time up to 2 years of treatment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 16 Week Efficacy and 2 Year Long Term Safety and Efficacy of Secukinumab in Patients With Active Ankylosing Spondylitis
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Ankylosing Spondylitis
Intervention  ICMJE
  • Drug: Secukinumab (75 mg)
    Secukinumab (75 mg)
  • Drug: Secukinumab (150 mg)
    Secukinumab (150 mg)
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • 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.
    Intervention: Drug: 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.
    Intervention: Drug: 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.
    Intervention: Drug: Placebo
Publications *

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: December 1, 2016)
371
Original Estimated Enrollment  ICMJE
 (submitted: May 20, 2011)
348
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Bulgaria,   Canada,   France,   Germany,   Italy,   Mexico,   Netherlands,   Peru,   Russian Federation,   Taiwan,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01358175
Other Study ID Numbers  ICMJE CAIN457F2305
2010-024529-18 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date January 2017

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