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16 Week Efficacy and 5 Year Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing Spondylitis (MEASURE2)

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ClinicalTrials.gov Identifier: NCT01649375
Recruitment Status : Completed
First Posted : July 25, 2012
Results First Posted : October 30, 2019
Last Update Posted : October 30, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE July 20, 2012
First Posted Date  ICMJE July 25, 2012
Results First Submitted Date  ICMJE July 24, 2019
Results First Posted Date  ICMJE October 30, 2019
Last Update Posted Date October 30, 2019
Actual Study Start Date  ICMJE October 18, 2012
Actual Primary Completion Date August 4, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2019)
Percentage of Participants Achieving ASAS 20 (SpondyloArthritis International Society Criteria) Response at Week 16 [ Time Frame: Baseline up to 16 weeks ]
ASAS 20 response is a validated composite assessment reflecting the percentage of treated patients who achieve within a defined timeframe an improvement of 20% and ≥1 unit on a scale of 1 to 10 in at least three of the four ASAS main domains and no worsening of ≥20% and ≥1 unit in the remaining domain. ASAS 20 is used to assess the efficacy of at least one dose of secukinumab against placebo.
Original Primary Outcome Measures  ICMJE
 (submitted: July 24, 2012)
Proportion of subjects achieving ASAS 20 response at week 16 [ Time Frame: 16 weeks ]
Primary endpoint is proportion of subjects achieving an ASAS 20 (Assessment of SpondyloArthritis International Society criteria) response at week 16 in subgroup of patients who are TNFα inhibitor naïve compared to placebo. ASAS Response Criteria is defined as an improvement of at least 20% and absolute improvement of at least 10 units on a 0-100mm scale in at least 3 of 4 assessment domains (1. subject's global assessment of disease activity 2. subject's assessment of inflammatory back pain 3. function represented by BASFI VAS 4. morning stiffness represented by the last 2 questions on BASDAI)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2019)
  • Percentage of Participants Achieving ASAS 40 (SpondyloArthritis International Society Criteria) Response [ Time Frame: Baseline up to 16 weeks ]
    ASAS 40 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined timeframe an improvement of ≥40% and ≥2 units on a scale of 0 to 10 (0 being worse and 10 being better) in at least three of the four ASAS main domains (patient global, pain, function and inflammation) and no worsening at all in the remaining domain. ASAS 40 is used to assess the efficacy of at least one dose of secukinumab against placebo.
  • Change From Baseline at Week 16 in Serum hsCRP [ Time Frame: Baseline up to 16 weeks ]
    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 post-baseline values, whereas ratios greater than 1.0 represent increased post-baseline values. Blood levels of C-reactive protein (CRP), an acute phase reactant, are indicative of inflammation and of its severity, and can be used to monitor treatment response. A high sensitvity CRP (hsCRP) test is implemented in this study to assess the efficacy of at least one dose of secukinumab versus placebo in reducing AS elicited systemic inflammation over time.
  • Percentage of Participants Achieving ASAS 5/6 (SpondyloArthritis International Society Criteria) Response at Week 16 [ Time Frame: Baseline up to 16 weeks ]
    ASAS 5/6 response is a validated composite assessment, reflecting the percentage 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 relevant to AS (pain, patient global assessment, function, inflammation, spinal mobility, C-reative protein) without deterioration in the 6th 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 at Week 16 for Total Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [ Time Frame: Baseline up to 16 weeks ]
    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 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.
  • Change From Baseline at Week 16 in Physical Function Component Summary (PCS) of the Medical Outcomes Study Questionnaire Short-form Health Survey (SF-36) [ Time Frame: Baseline up to 16 weeks ]
    Physical Function Component Summary (PCS) is only 1 component of SF-36. This scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
  • Change From Baseline at Week 16 in ASQoL [ Time Frame: Baseline up to 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.
  • Percentage of Participants Achieving ASAS Partial Remission at Week 16 [ Time Frame: Baseline up to 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 0 to 10. In this study ASAS partial remission is used to assess the efficacy of at least one dose of secukinumab versus placebo.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2012)
  • Proportion of subjects achieving ASAS 20 response at week 16 in whole study population [ Time Frame: 16 weeks ]
    Proportion of patients achieving an ASAS 20 response in the whole study population compared to placebo at week 16. The ASAS Response Criteria is defined as an improvement of at least 20% and absolute improvement of at least 10 units on a 0-100mm scale in at least 3 of 4 assessment domains (1. subject's global assessment of disease activity 2. subject's assessment of inflammatory back pain 3. function represented by BASFI VAS 4. morning stiffness represented by the last 2 questions on BASDAI)
  • Proportion of subjects achieving ASAS 40 response at week 16 [ Time Frame: 16 weeks ]
    Proportion of subjects achieving an ASAS 40 response at week 16 in subgroup of patients who are TNFα inhibitor naïve compared to placebo. ASAS Response Criteria is defined as an improvement of at least 40% and absolute improvement of at least 10 units on a 0-100mm scale in at least 3 of 4 assessment domains (1. subject's global assessment of disease activity 2. subject's assessment of inflammatory back pain 3. function represented by BASFI VAS 4. morning stiffness represented by the last 2 questions on BASDAI)
  • Proportion of subjects achieving ASAS 40 response at week 16 in whole study population [ Time Frame: 16 weeks ]
    Proportion of patients achieving an ASAS 40 response in the whole study population compared to placebo at week 16. The ASAS Response Criteria is defined as an improvement of at least 40% and absolute improvement of at least 10 units on a 0-100mm scale in at least 3 of 4 assessment domains (1. subject's global assessment of disease activity 2. subject's assessment of inflammatory back pain 3. function represented by BASFI VAS 4. morning stiffness represented by the last 2 questions on BASDAI)
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 5 Year Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing Spondylitis
Official Title  ICMJE A Randomized, Double-blind, Placebo-controlled Phase III Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate Efficacy at 16 Weeks and to Assess Long-term Efficacy, Safety and Tolerability up to 5 Years in Patients With Active Ankylosing Spondylitis
Brief Summary This study assessed the efficacy and safety of secukinumab in patients with active ankylosing spondylitis who were tolerant to or had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor
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 Anklyosing Spondylitis
Intervention  ICMJE
  • Drug: Secukinumab (75 mg)
    Secukinumab 75 mg s.c.
    Other Name: AIN457 75 mg
  • Drug: Placebo
    Placebo
  • Drug: Secukinumab (150 mg)
    Secukinumab 150 mg s.c.
    Other Name: AIN457 150 mg
Study Arms  ICMJE
  • Experimental: Secukinumab 75 mg
    Secukinumab 75 mg subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks.
    Intervention: Drug: Secukinumab (75 mg)
  • Experimental: Secukinumab 150 mg
    Secukinumab 150 mg subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks
    Intervention: Drug: Secukinumab (150 mg)
  • Placebo Comparator: Placebo
    Placebo subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks
    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: April 20, 2017)
219
Original Estimated Enrollment  ICMJE
 (submitted: July 24, 2012)
222
Actual Study Completion Date  ICMJE September 18, 2018
Actual Primary Completion Date August 4, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Chest X-ray (or MRI) 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
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 Austria,   Canada,   Czechia,   Finland,   Germany,   Italy,   Netherlands,   Russian Federation,   Singapore,   Spain,   Switzerland,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01649375
Other Study ID Numbers  ICMJE CAIN457F2310
2012-000046-35 ( EudraCT Number )
Has Data Monitoring Committee Yes
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
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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