AzTrials
AzTrials

Ankylosing SpondylitisPhase 3MEASURE 1NCT01358175

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

A Phase 3 study testing Secukinumab (75 mg) and Secukinumab (150 mg) in people with Ankylosing Spondylitis, run by Novartis Pharmaceuticals at 67 sites in 14 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

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ankylosing Spondylitis
What is being tested?
Secukinumab (75 mg) and Secukinumab (150 mg)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
371 participants
Where
67 sitesin 14 countries
Study dates
Oct 2011to Dec 2014
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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

67 sites in 14 countries.

67 sites in 14 countries

United States10 sites

  • Novartis Investigative Site

    Austin, Texas, 78731

  • Novartis Investigative Site

    Benbrook, Texas, 76126

  • Novartis Investigative Site

    Boise, Idaho, 83702

  • Novartis Investigative Site

    Cedar Rapids, Iowa, 52401-2112

  • Novartis Investigative Site

    Dallas, Texas, 75231

  • Novartis Investigative Site

    Duncansville, Pennsylvania, 16635

  • Novartis Investigative Site

    Jackson, Tennessee, 38305

  • Novartis Investigative Site

    Kingsport, Tennessee, 37660

  • Novartis Investigative Site

    Portland, Oregon, 97239

  • Novartis Investigative Site

    Spokane, Washington, 99204

Other trials in United States

Germany10 sites

  • Novartis Investigative Site

    Berlin, Germany, 12203

  • Novartis Investigative Site

    Cologne, 50924

  • Novartis Investigative Site

    Erlangen, 91054

  • Novartis Investigative Site

    Hamburg, 22143

  • Novartis Investigative Site

    Hamburg, 22415

  • Novartis Investigative Site

    Herne, 44649

  • Novartis Investigative Site

    Jena, 07740

  • Novartis Investigative Site

    Magdeburg, 39110

  • Novartis Investigative Site

    Nuremberg, 90429

  • Novartis Investigative Site

    Ratingen, 40882

Other trials in Germany

Italy6 sites

  • Novartis Investigative Site

    Brescia, BS, 25123

  • Novartis Investigative Site

    Catania, CT, 95100

  • Novartis Investigative Site

    Palermo, PA, 90127

  • Novartis Investigative Site

    Siena, SI, 53100

  • Novartis Investigative Site

    Torino, TO, 10126

  • Novartis Investigative Site

    Valeggio sul Mincio, (vr), 37067

Other trials in Italy

Russia6 sites

  • Novartis Investigative Site

    Moscow, 115522

  • Novartis Investigative Site

    Saint Petersburg, 197341

  • Novartis Investigative Site

    Tula, 300053

  • Novartis Investigative Site

    Yaroslavl, 150003

  • Novartis Investigative Site

    Yekaterinburg, 620028

  • Novartis Investigative Site

    Yekaterinburg, 620102

Other trials in Russia

Bulgaria5 sites

  • Novartis Investigative Site

    Burgas, Bulgaria, 8000

  • Novartis Investigative Site

    Plovdiv, Bulgaria, 4000

  • Novartis Investigative Site

    Plovdiv, Bulgaria, 4002

  • Novartis Investigative Site

    Sofia, Bulgaria, 1431

  • Novartis Investigative Site

    Sofia, Bulgaria, 1612

Other trials in Bulgaria

Peru5 sites

  • Novartis Investigative Site

    Jesus Maria, Lima region, 11

  • Novartis Investigative Site

    La Victoria, Lima region, 13

  • Novartis Investigative Site

    Pueblo Libre, Lima region, 21

  • Novartis Investigative Site

    San Isidro, Lima region, 27

  • Novartis Investigative Site

    Surquillo, Lima region, 34

Other trials in Peru

Belgium4 sites

  • Novartis Investigative Site

    Brussels, 1200

  • Novartis Investigative Site

    Genk, 3600

  • Novartis Investigative Site

    Ghent, 9000

  • Novartis Investigative Site

    Leuven, 3000

Other trials in Belgium

Mexico4 sites

  • Novartis Investigative Site

    Culiacán, Sinaloa, 80000

  • Novartis Investigative Site

    Guadalajara, Jalisco, 44160

  • Novartis Investigative Site

    Mexicali, Estado de Baja California, 21100

  • Novartis Investigative Site

    Monterrey, Nuevo León, 64020

Other trials in Mexico

United Kingdom4 sites

  • Novartis Investigative Site

    Cambridge, CB2 2QQ

  • Novartis Investigative Site

    London, England, E11 1NR

  • Novartis Investigative Site

    Newcastle upon Tyne, NE1 4LP

  • Novartis Investigative Site

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Canada3 sites

  • Novartis Investigative Site

    St. John's, Newfoundland and Labrador, A1C 5B8

  • Novartis Investigative Site

    Toronto, Ontario, M5T 2S8

  • Novartis Investigative Site

    Winnipeg, Manitoba, R3A 1M3

Other trials in Canada

France3 sites

  • Novartis Investigative Site

    Bordeaux, 33076

  • Novartis Investigative Site

    Limoges, 87001

  • Novartis Investigative Site

    Paris, 75014

Other trials in France

Turkey (Türkiye)3 sites

  • Novartis Investigative Site

    Balcova / Izmir, 35340

  • Novartis Investigative Site

    Fatih / Istanbul, 34098

  • Novartis Investigative Site

    Gaziantep, 27310

Other trials in Turkey (Türkiye)

Netherlands2 sites

  • Novartis Investigative Site

    Amsterdam, 1105 AZ

  • Novartis Investigative Site

    Utrecht, 3584 CX

Other trials in Netherlands

Taiwan2 sites

  • Novartis Investigative Site

    Kaohsiung City, 81346

  • Novartis Investigative Site

    Taichung, Taiwan ROC, 40201

Other trials in Taiwan

About this study

Official title: 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.

Being tested
Secukinumab (75 mg), Secukinumab (150 mg), Placebo
Keywords
Ankylosing spondylitis, AS, ASAS, inflammatory back pain
Medical subject headings
Spondylitis, Ankylosing

What participants receive

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

  • Secukinumab (75 mg)Drug

    Secukinumab (75 mg)

  • Secukinumab (150 mg)Drug

    Secukinumab (150 mg)

  • PlaceboDrug

    Placebo

Study groups in NCT01358175
Study groupRoleWhat they receive
Secukinumab 10 mg/kg i.v. / 75 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 (75 mg)
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 (150 mg)
PlaceboPlacebo comparatorThree 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: Placebo

What is being measured

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

  1. Assessment of Responders for the SpondyloArthritis International Society / ASAS 20 Response

    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.

    Measured: 16 weeks

Secondary outcomes (7)

  1. Assessment of Responders for the SpondyloArthritis International Society ASAS 40 Response

    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.

    Measured: 16 weeks

  2. Change From Baseline in Serum hsCRP

    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.

    Measured: Base line and Week 16

  3. Assessment of Responders for the SpondyloArthritis International Society ASAS 5/6 Response

    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.

    Measured: 16 weeks

  4. Change From Baseline in 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 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.

    Measured: Baseline and 16 weeks

  5. Change From Baseline in Physical Function Component of the Short-form Health Survey / SF-36 PCS

    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.

    Measured: baseline, 16 weeks

  6. Change From Baseline in Ankylosing Spondylitis Quality of Life Questionnaire / ASQoL

    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.

    Measured: baseline and 16 weeks

  7. Assessment of Responders for 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 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.

    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 posted23 May 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionDec 2014
  4. Study completionDec 2014

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
371 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01358175
Sponsor's protocol ID
CAIN457F2305
Other IDs
2010-024529-18
Acronym
MEASURE 1
Status last verified
Jan 2017
First submitted
19 May 2011
Last updated
9 Mar 2017
Data monitoring committee
Yes

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

  • Shin E, Bhat AG, Ramanathan M. Large Language Models for Clinical Trial Protocol Assessments. Clin Pharmacol Ther. 2026 Feb;119(2):393-402. doi: 10.1002/cpt.70096. Epub 2025 Oct 21.

    PubMed 41121745

  • Jamaludin A, Windsor R, Ather S, Kadir T, Zisserman A, Braun J, Gensler LS, Ostergaard M, Poddubnyy D, Coroller T, Porter B, Ligozio G, Readie A, Machado PM. Automated detection of spinal bone marrow oedema in axial spondyloarthritis: training and validation using two large phase 3 trial datasets. Rheumatology (Oxford). 2025 Oct 1;64(10):5446-5454. doi: 10.1093/rheumatology/keaf323.

    PubMed 40489668

  • Braun J, Buehring B, Baraliakos X, Gensler LS, Porter B, Quebe-Fehling E, Haemmerle S. Effects of secukinumab on bone mineral density and bone turnover biomarkers in patients with ankylosing spondylitis: 2-year data from a phase 3 study, MEASURE 1. BMC Musculoskelet Disord. 2021 Dec 13;22(1):1037. doi: 10.1186/s12891-021-04930-1.

    PubMed 34903218

  • 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

  • Baraliakos X, Van den Bosch F, Machado PM, Gensler LS, Marzo-Ortega H, Sherif B, Quebe-Fehling E, Porter B, Gaillez C, Deodhar A. Achievement of Remission Endpoints with Secukinumab Over 3 Years in Active Ankylosing Spondylitis: Pooled Analysis of Two Phase 3 Studies. Rheumatol Ther. 2021 Mar;8(1):273-288. doi: 10.1007/s40744-020-00269-6. Epub 2020 Dec 22.

    PubMed 33351179

  • Himmler S, Branner JC, Ostwald DA. The societal impact of a biologic treatment of ankylosing spondylitis: a case study based on secukinumab. J Comp Eff Res. 2021 Feb;10(2):143-155. doi: 10.2217/cer-2020-0077. Epub 2020 Nov 30.

    PubMed 33252266

  • Kvien TK, Conaghan PG, Gossec L, Strand V, Ostergaard M, Poddubnyy D, Williams N, Porter B, Shete A, Gilloteau I, Deodhar A. Secukinumab and Sustained Reduction in Fatigue in Patients With Ankylosing Spondylitis: Long-Term Results of Two Phase III Randomized Controlled Trials. Arthritis Care Res (Hoboken). 2022 May;74(5):759-767. doi: 10.1002/acr.24517. Epub 2022 Mar 10.

    PubMed 33227175

  • 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

  • Braun J, Deodhar A, Landewe R, Baraliakos X, Miceli-Richard C, Sieper J, Quebe-Fehling E, Martin R, Porter B, Gandhi KK, van der Heijde D; MEASURE 1 and MEASURE 2 study groups. Impact of baseline C-reactive protein levels on the response to secukinumab in ankylosing spondylitis: 3-year pooled data from two phase III studies. RMD Open. 2018 Nov 21;4(2):e000749. doi: 10.1136/rmdopen-2018-000749. eCollection 2018.

    PubMed 30564451

  • Wei JC, Baeten D, Sieper J, Deodhar A, Bhosekar V, Martin R, Porter B. Efficacy and safety of secukinumab in Asian patients with active ankylosing spondylitis: 52-week pooled results from two phase 3 studies. Int J Rheum Dis. 2017 May;20(5):589-596. doi: 10.1111/1756-185X.13094. Epub 2017 May 25.

    PubMed 28544533

  • Braun J, Baraliakos X, Deodhar A, Baeten D, Sieper J, Emery P, Readie A, Martin R, Mpofu S, Richards HB; MEASURE 1 study group. Effect of secukinumab on clinical and radiographic outcomes in ankylosing spondylitis: 2-year results from the randomised phase III MEASURE 1 study. Ann Rheum Dis. 2017 Jun;76(6):1070-1077. doi: 10.1136/annrheumdis-2016-209730. Epub 2016 Dec 13.

    PubMed 27965257

  • Deodhar AA, Dougados M, Baeten DL, Cheng-Chung Wei J, Geusens P, Readie A, Richards HB, Martin R, Porter B. Effect of Secukinumab on Patient-Reported Outcomes in Patients With Active Ankylosing Spondylitis: A Phase III Randomized Trial (MEASURE 1). Arthritis Rheumatol. 2016 Dec;68(12):2901-2910. doi: 10.1002/art.39805.

    PubMed 27390130

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Secukinumab (75 mg) and Secukinumab (150 mg) in people with Ankylosing Spondylitis, run by Novartis Pharmaceuticals at 67 sites in 14 countries.

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

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. 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 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 sites in United States, Germany, Italy, Russia, Bulgaria and 9 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 27 Jan 2017). 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?

Assessment of Responders for the SpondyloArthritis International Society / 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 NCT01358175, which also lists 16 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 9 Mar 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in