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

January 27, 2017 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

371

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1200
        • Novartis Investigative Site
      • Genk, Belgium, 3600
        • Novartis Investigative Site
      • Gent, Belgium, 9000
        • Novartis Investigative Site
      • Leuven, Belgium, 3000
        • Novartis Investigative Site
  • Bulgaria
      • Burgas, Bulgaria, 8000
        • Novartis Investigative Site
      • Plovdiv, Bulgaria, 4002
        • Novartis Investigative Site
      • Plovdiv, Bulgaria, 4000
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1431
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1612
        • Novartis Investigative Site
  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1M3
        • Novartis Investigative Site
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1C 5B8
        • Novartis Investigative Site
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Novartis Investigative Site
  • France
      • Bordeaux Cedex, France, 33076
        • Novartis Investigative Site
      • Limoges, France, 87001
        • Novartis Investigative Site
      • Paris, France, 75014
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany, 12203
        • Novartis Investigative Site
      • Erlangen, Germany, 91054
        • Novartis Investigative Site
      • Hamburg, Germany, 22415
        • Novartis Investigative Site
      • Hamburg, Germany, 22143
        • Novartis Investigative Site
      • Herne, Germany, 44649
        • Novartis Investigative Site
      • Jena, Germany, 07740
        • Novartis Investigative Site
      • Koeln, Germany, 50924
        • Novartis Investigative Site
      • Magdeburg, Germany, 39110
        • Novartis Investigative Site
      • Nürnberg, Germany, 90429
        • Novartis Investigative Site
      • Ratingen, Germany, 40882
        • Novartis Investigative Site
  • Italy
    • (vr)
      • Valeggio Sul Mincio, (vr), Italy, 37067
        • Novartis Investigative Site
    • BS
      • Brescia, BS, Italy, 25123
        • Novartis Investigative Site
    • CT
      • Catania, CT, Italy, 95100
        • Novartis Investigative Site
    • PA
      • Palermo, PA, Italy, 90127
        • Novartis Investigative Site
    • SI
      • Siena, SI, Italy, 53100
        • Novartis Investigative Site
    • TO
      • Torino, TO, Italy, 10126
        • Novartis Investigative Site
  • Mexico
    • Baja California
      • Mexicali, Baja California, Mexico, 21100
        • Novartis Investigative Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44160
        • Novartis Investigative Site
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64020
        • Novartis Investigative Site
    • Sinaloa
      • Culiacan, Sinaloa, Mexico, 80000
        • Novartis Investigative Site
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Novartis Investigative Site
      • Utrecht, Netherlands, 3584 CX
        • Novartis Investigative Site
  • Peru
    • Lima
      • Jesus Maria, Lima, Peru, 11
        • Novartis Investigative Site
      • La Victoria, Lima, Peru, 13
        • Novartis Investigative Site
      • Pueblo Libre, Lima, Peru, 21
        • Novartis Investigative Site
      • San Isidro, Lima, Peru, 27
        • Novartis Investigative Site
      • Surquillo, Lima, Peru, 34
        • Novartis Investigative Site
  • Russian Federation
      • Ekaterinburg, Russian Federation, 620028
        • Novartis Investigative Site
      • Ekaterinburg, Russian Federation, 620102
        • Novartis Investigative Site
      • Moscow, Russian Federation, 115522
        • Novartis Investigative Site
      • Saint-Petersburg, Russian Federation, 197341
        • Novartis Investigative Site
      • Tula, Russian Federation, 300053
        • Novartis Investigative Site
      • Yaroslavl, Russian Federation, 150003
        • Novartis Investigative Site
  • Taiwan
      • Kaohsiung, Taiwan, 81346
        • Novartis Investigative Site
    • Taiwan ROC
      • Taichung, Taiwan ROC, Taiwan, 40201
        • Novartis Investigative Site
  • Turkey
      • Balcova / Izmir, Turkey, 35340
        • Novartis Investigative Site
      • Fatih / Istanbul, Turkey, 34098
        • Novartis Investigative Site
      • Gaziantep, Turkey, 27310
        • Novartis Investigative Site
  • United Kingdom
      • Cambridge, United Kingdom, CB2 2QQ
        • Novartis Investigative Site
      • Newcastle Upon Tyne, United Kingdom, NE1 4LP
        • Novartis Investigative Site
      • Wolverhampton, United Kingdom, WV10 0QP
        • Novartis Investigative Site
    • England
      • London, England, United Kingdom, E11 1NR
        • Novartis Investigative Site
  • United States
    • Idaho
      • Boise, Idaho, United States, 83702
        • Novartis Investigative Site
    • Iowa
      • Cedar Rapids, Iowa, United States, 52401-2112
        • Novartis Investigative Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • Novartis Investigative Site
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Novartis Investigative Site
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Novartis Investigative Site
      • Kingsport, Tennessee, United States, 37660
        • Novartis Investigative Site
    • Texas
      • Austin, Texas, United States, 78731
        • Novartis Investigative Site
      • Benbrook, Texas, United States, 76126
        • Novartis Investigative Site
      • Dallas, Texas, United States, 75231
        • Novartis Investigative Site
    • Washington
      • Spokane, Washington, United States, 99204
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
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)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
16 weeks
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.
Base line and Week 16
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.
16 weeks
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.
Baseline and 16 weeks
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.
baseline, 16 weeks
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.
baseline and 16 weeks
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.
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

May 19, 2011

First Submitted That Met QC Criteria

May 20, 2011

First Posted (ESTIMATE)

May 23, 2011

Study Record Updates

Last Update Posted (ACTUAL)

March 9, 2017

Last Update Submitted That Met QC Criteria

January 27, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAIN457F2305
  • 2010-024529-18 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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