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Spondylitis, AnkylosingPhase 3MEASURE 3NCT02008916

16-week Efficacy and 3-year Safety, Tolerability and Efficacy of Secukinumab in Active Ankylosing Spondylitis Patients

A Phase 3 study testing Secukinumab in people with Spondylitis, Ankylosing, run by Novartis Pharmaceuticals at 57 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study was to generate 16-week efficacy data, as well as up to 3-year efficacy, safety and tolerability data in subjects with active AS despite current or previous NSAID, DMARD and/or anti-TNF therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Spondylitis, Ankylosing
What is being tested?
Secukinumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
226 participants
Where
57 sitesin 10 countries
Study dates
14 Jan 2014to 11 Dec 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Inclusion criteria: moderate to severe AS, prior radiographic evidence according to the Modified NY Criteria (1984), inadequate response to NSAIDs. -- Exclusion criteria: pregnancy or lactation, on-going infectious or malignant process on a chest X-ray or MRI, previous exposure to IL-17 or IL-17R targeting therapies, previous exposure to any biological immunomodulating agent excluding TNF antagonists, previous cell depleting therapy.

Trial locations and contacts

57 sites in 10 countries.

57 sites in 10 countries

United States14 sites

  • Novartis Investigative Site

    Albany, New York, 12206

  • Novartis Investigative Site

    Austin, Texas, 78731

  • Novartis Investigative Site

    Charleston, South Carolina, 29460

  • Novartis Investigative Site

    Duncansville, Pennsylvania, 16635

  • Novartis Investigative Site

    Jackson, Tennessee, 38305

  • Novartis Investigative Site

    Mesa, Arizona, 85202

  • Novartis Investigative Site

    Mesquite, Texas, 75150

  • Novartis Investigative Site

    Mobile, Alabama, 36604

  • Novartis Investigative Site

    Oklahoma City, Oklahoma, 73103

  • Novartis Investigative Site

    Palm Harbor, Florida, 34684

  • Novartis Investigative Site

    Passaic, New Jersey, 07055

  • Novartis Investigative Site

    Pembroke Pines, Florida, 33026

  • Novartis Investigative Site

    Peoria, Arizona, 85381

  • Novartis Investigative Site

    Upland, California, 91786

Other trials in United States

Germany14 sites

  • Novartis Investigative Site

    Bad Doberan, 18209

  • Novartis Investigative Site

    Berlin, 12203

  • Novartis Investigative Site

    Berlin, 13125

  • Novartis Investigative Site

    Cottbus, 03042

  • Novartis Investigative Site

    Erlangen, 91054

  • Novartis Investigative Site

    Erlangen, 91056

  • Novartis Investigative Site

    Göttingen, 37075

  • Novartis Investigative Site

    Hamburg, 22081

  • Novartis Investigative Site

    Hanover, 30625

  • Novartis Investigative Site

    Herne, 44649

  • Novartis Investigative Site

    Jena, 07740

  • Novartis Investigative Site

    Magdeburg, 39110

  • Novartis Investigative Site

    München, 81541

  • Novartis Investigative Site

    Zerbst, 39261

Other trials in Germany

Spain6 sites

  • Novartis Investigative Site

    A Coruña, Galicia, 15006

  • Novartis Investigative Site

    Córdoba, Andalusia, 14004

  • Novartis Investigative Site

    El Palmar, Murcia, 30120

  • Novartis Investigative Site

    Madrid, 28046

  • Novartis Investigative Site

    Sabadell, Barcelona, 08208

  • Novartis Investigative Site

    Santander, Cantabria, 39008

Other trials in Spain

Greece5 sites

  • Novartis Investigative Site

    Athens, GR, 115 27

  • Novartis Investigative Site

    Athens, 115 21

  • Novartis Investigative Site

    Athens, 115 27

  • Novartis Investigative Site

    Heraklion, 700 13

  • Novartis Investigative Site

    Thessaloniki, GR, 564 29

Other trials in Greece

Portugal4 sites

  • Novartis Investigative Site

    Almada, 2801 951

  • Novartis Investigative Site

    Lisbon, 1050-034

  • Novartis Investigative Site

    Lisbon, 1349-019

  • Novartis Investigative Site

    Lisbon, 1649-035

Other trials in Portugal

Russia4 sites

  • Novartis Investigative Site

    Kazan', 420097

  • Novartis Investigative Site

    Moscow, 115522

  • Novartis Investigative Site

    Saint Petersburg, 190068

  • Novartis Investigative Site

    Saint Petersburg, 197022

Other trials in Russia

Mexico3 sites

  • Novartis Investigative Site

    Culiacan, State of Mexico, 80000

  • Novartis Investigative Site

    Mexicali, Estado de Baja California, 21100

  • Novartis Investigative Site

    Torreón, Coahuila, 27000

Other trials in Mexico

United Kingdom3 sites

  • Novartis Investigative Site

    London, England, E11 1NR

  • Novartis Investigative Site

    Norwich, NR4 7UY

  • Novartis Investigative Site

    Torquay, TQ2 7AA

Other trials in United Kingdom

Belgium2 sites

  • Novartis Investigative Site

    Aalst, 9300

  • Novartis Investigative Site

    Brussels, 1070

Other trials in Belgium

Czechia2 sites

  • Novartis Investigative Site

    Prague, 128 50

  • Novartis Investigative Site

    Uherské Hradiště, Czech Republic, 686 01

Other trials in Czechia

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Phase III Study of Secukinumab to Demonstrate the Efficacy at 16 Weeks and to Assess the Long-term Safety, Tolerability and Efficacy up to 3 Years in Subjects With Active Ankylosing Spondylitis

The purpose of this study was to generate 16-week efficacy data, as well as up to 3-year efficacy, safety and tolerability data in subjects with active AS despite current or previous NSAID, DMARD and/or anti-TNF therapy.

Being tested
Secukinumab, Placebo secukinumab
Keywords
AIN457, ankylosing spondylitis, chronic inflammatory disease, inflammatory back pain, secukinumab, self-injection
Medical subject headings
Spondylitis, Ankylosing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SecukinumabDrug

    Also called AIN457

    AIN457 (Secukinumab) is a human monoclonal antibody. Secukinumab binds and reduces the activity of Interleukin 17 (IL-17).

  • Placebo secukinumabDrug

    Placebo to AIN457 (Secukinumab)

Study groups in NCT02008916
Study groupRoleWhat they receive
Secukinumab 10 mg/kg i.v. / 300 mg s.c.ExperimentalThree 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.
Receives: Drug: Secukinumab
Secukinumab 10 mg/kg i.v. / 150 mg s.c.ExperimentalThree 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.
Receives: Drug: Secukinumab
Placebo i.v. and s.c.Placebo comparatorThree i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection at weeks 8 and 12. At week 16, patients were re-randomised to one of the active treatment arms, to receive secukinumab s.c. Q4W until the end of the study.
Receives: Drug: Placebo secukinumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With 20% Improvement in the Assessment of Spondyloarthritis International Society Criteria Scale / ASAS 20 Response

    ASAS 20 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 20% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS 20 was used to assess the efficacy of at least one dose of secukinumab versus placebo.

    Measured: 16 weeks

Secondary outcomes (8)

  1. ASAS 40 Response

    ASAS 40 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 40% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS 40 was used to assess the efficacy of at least one dose of secukinumab versus placebo.

    Measured: 16 weeks

  2. Serum hsCRP

    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 sensitivity CRP (hsCRP) test was implemented in this study, to assess the efficacy of at least one dose of secukinumab versus placebo in reducing AS elicited systemic inflammation over the time.

    Measured: Baseline and 16 weeks

  3. ASAS 5/6 Response

    ASAS 5/6 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 20% improvement in score in at least 5 of a conventional set of 6 clinical domains relevant to AS and no worsening in the remaining domain. In this study, ASAS 5/6 was used to assess the efficacy of at least one dose of secukinumab versus placebo.

    Measured: 16 weeks

  4. Bath Ankylosing Spondylitis Disease Activity Index / BASDAI

    BASDAI is a validated assessment tool using 0 through 10 scales (0 indicating "no problem" and 10 indicating "worst problem"), to characterise 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 index was used to assess the efficacy of at least one dose of secukinumab versus placebo.

    Measured: Baseline and 16 weeks

  5. Number of Participants With Successful Self-administration (to Measure Usability of Pre-filled Syringe)

    Successful self-administration is defined as success in steps P8 (Removed Needle Cap from Safety Syringe), P10 (Pinched the Skin at Injection Site), P11 (Inserted the Needle into Skin), P12 (Held onto the Finger Flange), P13 (Fully Depressed Plunger until End Point), and P14 (Held Plunger Down and Syringe in Place) of the Instructions for Use, as observed by the site staff at applicable visits.

    Measured: Week 8 and Week 12

  6. Pre-filled Syringe Possible Hazard

    The number and percentage of subjects who experience any of the defined possible hazards are summarized, as defined in the Possible Hazard assessment check list and as observed by the site staff at applicable visits.

    Measured: Week 8 and Week 12

  7. Prefilled Syringe Patient Satisfaction Assessment

    The self-injection assessment questionnaire (SIAQ) measures overall patient experience with subcutaneous self-injection at applicable visits. Domain scores ranging from 0 (worst experience) to 10 (best experience) are presented: Feeling about injections, Self-confidence, Satisfaction with self-injection.

    Measured: Baseline, weeks 8, 12 and 16

  8. ASAS Partial Remission

    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 was used to assess the efficacy of at least one dose of secukinumab versus placebo.

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2013 (estimated)
  2. Study start14 Jan 2014
  3. Primary completion23 Feb 2015
  4. Study completion11 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
226 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02008916
Sponsor's protocol ID
CAIN457F2314
Other IDs
2013-001090-24
Acronym
MEASURE 3
Status last verified
Dec 2018
First submitted
8 Dec 2013
Last updated
8 Jan 2019
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: 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

Publications

  • Ramiro S, Gaillez C, Kiltz U, Gensler LS, Pisal C, Braun J, Ogdie A. No major effect of age (< 40 vs. >/= 40 years) on response to secukinumab in patients with axSpA: a post hoc analysis of six phase 3 trials. Arthritis Res Ther. 2026 Apr 11;28(1):112. doi: 10.1186/s13075-026-03804-y.

    PubMed 41965705

  • Merola JF, McInnes IB, Deodhar AA, Dey AK, Adamstein NH, Quebe-Fehling E, Aassi M, Peine M, Mehta NN. Effect of Secukinumab on Traditional Cardiovascular Risk Factors and Inflammatory Biomarkers: Post Hoc Analyses of Pooled Data Across Three Indications. Rheumatol Ther. 2022 Jun;9(3):935-955. doi: 10.1007/s40744-022-00434-z. Epub 2022 Mar 19.

    PubMed 35305260

  • Dougados M, Kiltz U, Kivitz A, Pavelka K, Rohrer S, McCreddin S, Quebe-Fehling E, Porter B, Talloczy Z. Nonsteroidal anti-inflammatory drug-sparing effect of secukinumab in patients with radiographic axial spondyloarthritis: 4-year results from the MEASURE 2, 3 and 4 phase III trials. Rheumatol Int. 2022 Feb;42(2):205-213. doi: 10.1007/s00296-021-05044-6. Epub 2021 Nov 13.

    PubMed 34773130

  • van der Horst-Bruinsma I, Miceli-Richard C, Braun J, Marzo-Ortega H, Pavelka K, Kivitz AJ, Deodhar A, Bao W, Porter B, Pournara E. A Pooled Analysis Reporting the Efficacy and Safety of Secukinumab in Male and Female Patients with Ankylosing Spondylitis. Rheumatol Ther. 2021 Dec;8(4):1775-1787. doi: 10.1007/s40744-021-00380-2. Epub 2021 Oct 7.

    PubMed 34618347

  • Schett G, Baraliakos X, Van den Bosch F, Deodhar A, Ostergaard M, Gupta AD, Mpofu S, Fox T, Winseck A, Porter B, Shete A, Gensler LS. Secukinumab Efficacy on Enthesitis in Patients With Ankylosing Spondylitis: Pooled Analysis of Four Pivotal Phase III Studies. J Rheumatol. 2021 Aug;48(8):1251-1258. doi: 10.3899/jrheum.201111. Epub 2021 Mar 15.

    PubMed 33722947

  • Deodhar AA, Miceli-Richard C, Baraliakos X, Marzo-Ortega H, Gladman DD, Blanco R, Das Gupta A, Martin R, Safi J Jr, Porter B, Shete A, Rosenbaum JT. Incidence of Uveitis in Secukinumab-treated Patients With Ankylosing Spondylitis: Pooled Data Analysis From Three Phase 3 Studies. ACR Open Rheumatol. 2020 May;2(5):294-299. doi: 10.1002/acr2.11139. Epub 2020 Apr 30.

    PubMed 32352653

  • Deodhar A, Gladman DD, McInnes IB, Spindeldreher S, Martin R, Pricop L, Porter B, Safi J Jr, Shete A, Bruin G. Secukinumab Immunogenicity over 52 Weeks in Patients with Psoriatic Arthritis and Ankylosing Spondylitis. J Rheumatol. 2020 Apr;47(4):539-547. doi: 10.3899/jrheum.190116. Epub 2019 Jun 15.

    PubMed 31203228

  • Pavelka K, Kivitz A, Dokoupilova E, Blanco R, Maradiaga M, Tahir H, Pricop L, Andersson M, Readie A, Porter B. Efficacy, safety, and tolerability of secukinumab in patients with active ankylosing spondylitis: a randomized, double-blind phase 3 study, MEASURE 3. Arthritis Res Ther. 2017 Dec 22;19(1):285. doi: 10.1186/s13075-017-1490-y.

    PubMed 29273067

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Secukinumab in people with Spondylitis, Ankylosing, run by Novartis Pharmaceuticals at 57 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in United States, Germany, Spain, Greece, Portugal and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With 20% Improvement in the Assessment of Spondyloarthritis International Society Criteria Scale / ASAS 20 Response (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02008916, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2019.

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