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

October 28, 2019 updated by: Novartis Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

219

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

  • Austria
      • Graz, Austria, 8036
        • Novartis Investigative Site
      • Vienna, Austria, 1100
        • Novartis Investigative Site
  • Canada
      • Quebec, Canada, G1W 4R4
        • Novartis Investigative Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1M3
        • Novartis Investigative Site
    • Quebec
      • Pointe-Claire, Quebec, Canada, H9R 3J1
        • Novartis Investigative Site
      • Sainte-Foy, Quebec, Canada, G1v 3M7
        • Novartis Investigative Site
  • Czechia
      • Uherske Hradiste, Czechia, 686 01
        • Novartis Investigative Site
    • Czech Republic
      • Bruntal, Czech Republic, Czechia, 792 01
        • Novartis Investigative Site
      • Ostrava, Czech Republic, Czechia, 772 00
        • Novartis Investigative Site
      • Praha 2, Czech Republic, Czechia, 128 50
        • Novartis Investigative Site
  • Finland
      • HUS, Finland, 00029
        • Novartis Investigative Site
      • Helsinki, Finland, FI 00100
        • Novartis Investigative Site
      • Hyvinkaa, Finland, 05800
        • Novartis Investigative Site
      • Jyvaskyla, Finland, 40620
        • Novartis Investigative Site
      • Seinajoki, Finland, 60200
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany, 12203
        • Novartis Investigative Site
      • Herne, Germany, 44649
        • Novartis Investigative Site
      • Wuerzburg, Germany, 97080
        • Novartis Investigative Site
  • Italy
    • CT
      • Catania, CT, Italy, 95100
        • Novartis Investigative Site
    • TO
      • Torino, TO, Italy, 10128
        • Novartis Investigative Site
    • VR
      • Verona, VR, Italy, 37134
        • Novartis Investigative Site
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Novartis Investigative Site
    • The Netherlands
      • Utrecht, The Netherlands, Netherlands, 3508 GA
        • Novartis Investigative Site
  • Russian Federation
      • Ekaterinburg, Russian Federation, 620028
        • Novartis Investigative Site
      • Korolev, Russian Federation, 141060
        • Novartis Investigative Site
      • Moscow, Russian Federation, 115522
        • Novartis Investigative Site
      • Petrozavodsk, Russian Federation, 185019
        • Novartis Investigative Site
      • Saint Petersburg, Russian Federation, 197022
        • Novartis Investigative Site
      • St Petersburg, Russian Federation, 190068
        • Novartis Investigative Site
      • Yaroslavl, Russian Federation, 150003
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 119074
        • Novartis Investigative Site
      • Singapore, Singapore, 169608
        • Novartis Investigative Site
  • Spain
      • Madrid, Spain, 28046
        • Novartis Investigative Site
      • Madrid, Spain, 28009
        • Novartis Investigative Site
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Novartis Investigative Site
    • Galicia
      • La Coruna, Galicia, Spain, 15006
        • Novartis Investigative Site
  • Switzerland
      • Basel, Switzerland, 4031
        • Novartis Investigative Site
      • Fribourg, Switzerland, 1708
        • Novartis Investigative Site
      • Zuerich, Switzerland, CH 8091
        • Novartis Investigative Site
  • United Kingdom
      • Norwich, United Kingdom, NR4 7UY
        • Novartis Investigative Site
      • Torquay, United Kingdom, TQ2 7AA
        • Novartis Investigative Site
    • London
      • Leytonstone, London, United Kingdom, E11 1NR
        • Novartis Investigative Site
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS7 4SA
        • Novartis Investigative Site
  • United States
    • Arizona
      • Mesa, Arizona, United States, 85202
        • Novartis Investigative Site
    • California
      • Upland, California, United States, 91786
        • Novartis Investigative Site
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Novartis Investigative Site
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • Novartis Investigative Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Novartis Investigative Site
      • Oklahoma City, Oklahoma, United States, 73102
        • Novartis Investigative Site
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Novartis Investigative Site
    • South Carolina
      • Charleston, South Carolina, United States, 29460
        • Novartis Investigative Site
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Novartis Investigative Site
    • Texas
      • Mesquite, Texas, United States, 75150
        • 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
  • 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

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 75 mg
Secukinumab 75 mg subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks.
Drug: Secukinumab (75 mg)
Secukinumab 75 mg s.c.
Other Names:
  • AIN457 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
Drug: Secukinumab (150 mg)
Secukinumab 150 mg s.c.
Other Names:
  • AIN457 150 mg
PLACEBO_COMPARATOR: Placebo
Placebo subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks
Drug: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline up to 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline up to 16 weeks
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.
Baseline up to 16 weeks
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.
Baseline up to 16 weeks
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.
Baseline up to 16 weeks
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.
Baseline up to 16 weeks
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.
Baseline up to 16 weeks
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.
Baseline up to 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 (ACTUAL)

October 18, 2012

Primary Completion (ACTUAL)

August 4, 2014

Study Completion (ACTUAL)

September 18, 2018

Study Registration Dates

First Submitted

July 20, 2012

First Submitted That Met QC Criteria

July 24, 2012

First Posted (ESTIMATE)

July 25, 2012

Study Record Updates

Last Update Posted (ACTUAL)

October 30, 2019

Last Update Submitted That Met QC Criteria

October 28, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAIN457F2310
  • 2012-000046-35 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD 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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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