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

NCT ID: NCT01358175

Last Updated: 2017-03-09

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

371 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Ankylosing Spondylitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Secukinumab (75 mg)

Intervention Type DRUG

Secukinumab (75 mg)

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.

Group Type EXPERIMENTAL

Secukinumab (150 mg)

Intervention Type DRUG

Secukinumab (150 mg)

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Secukinumab (75 mg)

Secukinumab (75 mg)

Intervention Type DRUG

Secukinumab (150 mg)

Secukinumab (150 mg)

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Boise, Idaho, United States

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Cedar Rapids, Iowa, United States

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Portland, Oregon, United States

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Duncansville, Pennsylvania, United States

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Jackson, Tennessee, United States

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Kingsport, Tennessee, United States

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Austin, Texas, United States

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Benbrook, Texas, United States

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Dallas, Texas, United States

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Spokane, Washington, United States

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Brussels, , Belgium

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Genk, , Belgium

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Ghent, , Belgium

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Leuven, , Belgium

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Burgas, Bulgaria, Bulgaria

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Plovdiv, Bulgaria, Bulgaria

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Plovdiv, Bulgaria, Bulgaria

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Sofia, Bulgaria, Bulgaria

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Sofia, Bulgaria, Bulgaria

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Winnipeg, Manitoba, Canada

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St. John's, Newfoundland and Labrador, Canada

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Toronto, Ontario, Canada

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Bordeaux, , France

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Limoges, , France

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Paris, , France

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Berlin, Germany, Germany

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Cologne, , Germany

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Erlangen, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Herne, , Germany

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Jena, , Germany

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Magdeburg, , Germany

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Nuremberg, , Germany

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Ratingen, , Germany

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Valeggio sul Mincio, (vr), Italy

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Brescia, BS, Italy

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Catania, CT, Italy

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Palermo, PA, Italy

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Siena, SI, Italy

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Torino, TO, Italy

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Mexicali, Estado de Baja California, Mexico

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Guadalajara, Jalisco, Mexico

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Monterrey, Nuevo León, Mexico

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Culiacán, Sinaloa, Mexico

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Amsterdam, , Netherlands

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Utrecht, , Netherlands

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Jesus Maria, Lima region, Peru

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La Victoria, Lima region, Peru

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Pueblo Libre, Lima region, Peru

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San Isidro, Lima region, Peru

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Surquillo, Lima region, Peru

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Moscow, , Russia

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Saint Petersburg, , Russia

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Tula, , Russia

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Yaroslavl, , Russia

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Yekaterinburg, , Russia

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Yekaterinburg, , Russia

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Taichung, Taiwan ROC, Taiwan

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Kaohsiung City, , Taiwan

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Balcova / Izmir, , Turkey (Türkiye)

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Fatih / Istanbul, , Turkey (Türkiye)

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Gaziantep, , Turkey (Türkiye)

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London, England, United Kingdom

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Cambridge, , United Kingdom

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Newcastle upon Tyne, , United Kingdom

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Novartis Investigative Site

Wolverhampton, , United Kingdom

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Countries

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United States Belgium Bulgaria Canada France Germany Italy Mexico Netherlands Peru Russia Taiwan Turkey (Türkiye) United Kingdom

References

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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 Jun 9:keaf323. doi: 10.1093/rheumatology/keaf323. Online ahead of print.

Reference Type DERIVED
PMID: 40489668 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34903218 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34618347 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33722947 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33351179 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33252266 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33227175 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32352653 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31203228 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30564451 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28544533 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27965257 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27390130 (View on PubMed)

Baeten D, Sieper J, Braun J, Baraliakos X, Dougados M, Emery P, Deodhar A, Porter B, Martin R, Andersson M, Mpofu S, Richards HB; MEASURE 1 Study Group; MEASURE 2 Study Group. Secukinumab, an Interleukin-17A Inhibitor, in Ankylosing Spondylitis. N Engl J Med. 2015 Dec 24;373(26):2534-48. doi: 10.1056/NEJMoa1505066.

Reference Type DERIVED
PMID: 26699169 (View on PubMed)

Other Identifiers

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2010-024529-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CAIN457F2305

Identifier Type: -

Identifier Source: org_study_id

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