Spondylitis, AnkylosingPhase 3MEASURE 1 extNCT01863732

Extension in AS: Sustainability of Benefits, Safety and Tolerability

A Phase 3 study testing Secukinumab in people with Spondylitis, Ankylosing, run by Novartis Pharmaceuticals at 56 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 3-year extension study aims at making available the treatment with secukinumab in prefilled syringes (PFS) to patients with ankylosing spondylitis who took part in phase III study CAIN457F2305, defined as "core study", as well as to generate additional data on the sustainability of clinical benefits, safety and… 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
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 274 participants
Where: 56 sitesin 14 countries
Study dates: 6 Nov 2013to 16 Mar 2018
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: patients having completed the "core study" CAIN457F2305, indication for treatment extension. -- Exclusion Criteria: history of hypersensitivity to secukinumab or to any drug of similar chemical classes, use of any investigational drug other than secukinumab during the "core study" CAIN457F2305.

Trial locations and contacts

56 sites in 14 countries.

Country

City, postcode or hospital

56 sites in 14 countries

Germany7 sites

Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Cologne, 50937
Novartis Investigative Site
Erlangen, 91054
Novartis Investigative Site
Hamburg, 22415
Novartis Investigative Site
Herne, 44649
Novartis Investigative Site
Magdeburg, 39110
Novartis Investigative Site
Nuremberg, 90429

Other trials in Germany

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, 620109

Other trials in Russia

United States5 sites

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

Bulgaria5 sites

Novartis Investigative Site
Burgas, 8000
Novartis Investigative Site
Plovdiv, 4000
Novartis Investigative Site
Plovdiv, 4002
Novartis Investigative Site
Sofia, 1431
Novartis Investigative Site
Sofia, 1612

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Italy5 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

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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

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Belgium4 sites

Novartis Investigative Site
Brussels, 1200
Novartis Investigative Site
Genk, 3600
Novartis Investigative Site
Ghent, 9000
Novartis Investigative Site
Leuven, 3000

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Mexico4 sites

Novartis Investigative Site
Culiacán, Sinaloa, CP 80000
Novartis Investigative Site
Guadalajara, Jalisco, 44160
Novartis Investigative Site
Mexicali, Estado de Baja California, 21100
Novartis Investigative Site
Monterrey, Nuevo León, 64460

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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

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France3 sites

Novartis Investigative Site
Bordeaux, 33076
Novartis Investigative Site
Limoges, Haute Vienne, 87000
Novartis Investigative Site
Paris, 75014

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Canada2 sites

Novartis Investigative Site
St. John's, Newfoundland and Labrador, A1C 5B8
Novartis Investigative Site
Winnipeg, Manitoba, R3A 1M3

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Netherlands2 sites

Novartis Investigative Site
Amsterdam, 1105 AZ
Novartis Investigative Site
Utrecht, 3584 CX

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Taiwan2 sites

Novartis Investigative Site
Kaohsiung City, 81346
Novartis Investigative Site
Taichung, Taiwan ROC, 40201

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Turkey (Türkiye)2 sites

Novartis Investigative Site
Gaziantep, 27310
Novartis Investigative Site
Izmir, 35340

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About this study

Official title: An Extension Study to Evaluate the Sustainability of Clinical Benefits, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing Spondylitis

Conditions: Spondylitis, Ankylosing
Being tested: Secukinumab, Placebo (Pbo)
Keywords: AIN457, ankylosing spondylitis, chronic inflammatory disease, inflammatory back pain, PFS, pre-filled syringe, 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.

SecukinumabBiological
Also called AIN457
Group 1: secukinumab 75 mg plus placebo 150 mg or Group 2 secukinumab 150 mg plus placebo 75m dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only secukinumab 75 mg or 150 mg were dosed. Secukinumab in PFS for s.c. self-administration Q4W
Placebo (Pbo)Other
Group 1: secukinumab 75 mg plus placebo 150 mg or Group 2 secukinumab 150 mg plus placebo 75m dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only secukinumab 75 mg or 150 mg were dosed. Secukinumab in PFS for s.c. self-administration Q4W

Study groups in NCT01863732
Study group	Role	What they receive
Secukinumab (AIN457) 75mg Grp1	Experimental	Group 1: AIN457 75 mg plus placebo 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 75 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W Receives: Biological: Secukinumab; Other: Placebo (Pbo)
Secukinumab (AIN457) 75 to 150mg Grp1	Experimental	Group 1: AIN457 75 mg plus placebo 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), was up titrated to AIN457 150 mg only. Secukinumab in PFS for s.c. self-administration Q4W Receives: Biological: Secukinumab; Other: Placebo (Pbo)
Secukinumab (AIN457) 150mg Grp2	Experimental	Group 2: AIN457 150 mg plus placebo 75 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 150 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W Receives: Biological: Secukinumab; Other: Placebo (Pbo)
Pbo in Core then AIN457 75mg Grp1	Experimental	Participants were on Placebo (Pbo) in Core and then in extension randomized to Group 1: secukinumab (AIN457) 75 mg plus placebo 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 75 mg was dosed.Secukinumab in PFS for s.c. self-administration Q4W Receives: Biological: Secukinumab; Other: Placebo (Pbo)
Pbo in Core then AIN457 75 to 150mg Grp1	Experimental	Participants were on Placebo in Core and then in extension randomized to Group 1: secukinumab (AIN457) 75 mg plus placebo 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), was up titrated to AIN457 150 mg only. Secukinumab in PFS for s.c. self-administration Q4W Receives: Biological: Secukinumab; Other: Placebo (Pbo)
Pbo in Core then AIN457 150mg Grp2	Experimental	Participants were on Placebo (Pbo) in Core and then in extension randomized to Group 2: AIN457 150 mg plus placebo 75 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 150 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W Receives: Biological: Secukinumab; Other: Placebo (Pbo)

What is being measured

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

Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260
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 is used to assess quantitatively the sustainability of clinical benefits of two dosage regimens of secukinumab over the treatment period from Week 104 to Week 260 No Statistical Analysis was performed This was the total for Group 1 Participants that up-titrated are counted only at the originally randomized treatment group.
Measured: Week 104 to Week 260

Secondary outcomes (1)

Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260
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 is used to assess quantitatively the sustainability of clinical benefits of two dosage regimens of secukinumab over the treatment period from Week 104 to Week 260 No Statistical Analysis was performed This was the total for Group 1 Participants that up-titrated are counted only at the originally randomized treatment group
Measured: Week 104 to Week 260

Timeline

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

6 Nov 201316 Mar 2018

First posted29 May 2013 (estimated)
Study start6 Nov 2013
Primary completion16 Mar 2018
Study completion16 Mar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Spondylitis, AnkylosingStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 274 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01863732
Sponsor's protocol ID: CAIN457F2305E1
Other IDs: 2013-001089-40
Acronym: MEASURE 1 ext
Status last verified: Jun 2019
First submitted: 23 May 2013
Last updated: 30 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided: Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect 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

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
Tseng JC, Wei JC, Deodhar A, Martin R, Porter B, McCreddin S, Talloczy Z. Secukinumab Demonstrates Sustained Efficacy and Safety in a Taiwanese Subpopulation With Active Ankylosing Spondylitis: Four-Year Results From a Phase 3 Study, MEASURE 1. Front Immunol. 2020 Nov 26;11:561748. doi: 10.3389/fimmu.2020.561748. eCollection 2020.
PubMed 33324394
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
Baraliakos X, Braun J, Deodhar A, Poddubnyy D, Kivitz A, Tahir H, Van den Bosch F, Delicha EM, Talloczy Z, Fierlinger A. Long-term efficacy and safety of secukinumab 150 mg in ankylosing spondylitis: 5-year results from the phase III MEASURE 1 extension study. RMD Open. 2019 Sep 3;5(2):e001005. doi: 10.1136/rmdopen-2019-001005. eCollection 2019.
PubMed 31565244
Braun J, Baraliakos X, Deodhar A, Poddubnyy D, Emery P, Delicha EM, Talloczy Z, Porter B. Secukinumab shows sustained efficacy and low structural progression in ankylosing spondylitis: 4-year results from the MEASURE 1 study. Rheumatology (Oxford). 2019 May 1;58(5):859-868. doi: 10.1093/rheumatology/key375.
PubMed 30590813

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Extension Study to Evaluate the Sustainability of Clinical Benefits, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing Spondylitis
ClinicalTrials.gov ID: NCT01863732
Acronym / sponsor ID: MEASURE 1 ext / CAIN457F2305E1
Conditions: Spondylitis, Ankylosing
Keywords: AIN457, ankylosing spondylitis, chronic inflammatory disease, inflammatory back pain, PFS, pre-filled syringe, secukinumab, self-injection
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 274 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 6 Nov 2013 (actual)
Primary completion: 16 Mar 2018 (actual)
Study completion: 16 Mar 2018 (actual)
First posted: 29 May 2013 (estimated)
Results: Posted 30 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Secukinumab (AIN457) 75mg Grp1	Experimental	Biological: Secukinumab, Other: Placebo (Pbo)Group 1: AIN457 75 mg plus placebo 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 75 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W
Secukinumab (AIN457) 75 to 150mg Grp1	Experimental	Biological: Secukinumab, Other: Placebo (Pbo)Group 1: AIN457 75 mg plus placebo 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), was up titrated to AIN457 150 mg only. Secukinumab in PFS for s.c. self-administration Q4W
Secukinumab (AIN457) 150mg Grp2	Experimental	Biological: Secukinumab, Other: Placebo (Pbo)Group 2: AIN457 150 mg plus placebo 75 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 150 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W
Pbo in Core then AIN457 75mg Grp1	Experimental	Biological: Secukinumab, Other: Placebo (Pbo)Participants were on Placebo (Pbo) in Core and then in extension randomized to Group 1: secukinumab (AIN457) 75 mg plus placebo 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 75 mg was dosed.Secukinumab in PFS for s.c. self-administration Q4W
Pbo in Core then AIN457 75 to 150mg Grp1	Experimental	Biological: Secukinumab, Other: Placebo (Pbo)Participants were on Placebo in Core and then in extension randomized to Group 1: secukinumab (AIN457) 75 mg plus placebo 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), was up titrated to AIN457 150 mg only. Secukinumab in PFS for s.c. self-administration Q4W
Pbo in Core then AIN457 150mg Grp2	Experimental	Biological: Secukinumab, Other: Placebo (Pbo)Participants were on Placebo (Pbo) in Core and then in extension randomized to Group 2: AIN457 150 mg plus placebo 75 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 150 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SecukinumabAlso: AIN457Group 1: secukinumab 75 mg plus placebo 150 mg or Group 2 secukinumab 150 mg plus placebo 75m dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only secukinumab 75 mg or 150 mg were dosed. Secukinumab in PFS for s.c. self-administration Q4W	Biological	Pbo in Core then AIN457 150mg Grp2, Pbo in Core then AIN457 75 to 150mg Grp1, Pbo in Core then AIN457 75mg Grp1, Secukinumab (AIN457) 150mg Grp2, Secukinumab (AIN457) 75 to 150mg Grp1, Secukinumab (AIN457) 75mg Grp1
Placebo (Pbo)Group 1: secukinumab 75 mg plus placebo 150 mg or Group 2 secukinumab 150 mg plus placebo 75m dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only secukinumab 75 mg or 150 mg were dosed. Secukinumab in PFS for s.c. self-administration Q4W	Other	Pbo in Core then AIN457 150mg Grp2, Pbo in Core then AIN457 75 to 150mg Grp1, Pbo in Core then AIN457 75mg Grp1, Secukinumab (AIN457) 150mg Grp2, Secukinumab (AIN457) 75 to 150mg Grp1, Secukinumab (AIN457) 75mg Grp1

Primary outcome

Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260
Time frame: Week 104 to Week 260
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 is used to assess quantitatively the sustainability of clinical benefits of two dosage regimens of secukinumab over the treatment period from Week 104 to Week 260 No Statistical Analysis was performed This was the total for Group 1 Participants that up-titrated are counted only at the originally randomized treatment group.

1 secondary outcome

Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260
Time frame: Week 104 to Week 260

Results and safety

Results posted to the registry on 30 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Secukinumab (AIN457) 75mg Group 1	100	87
Secukinumab (AIN457) 150mg Group 2	87	75
Pbo in Core Then AIN457 75mg Group 1	46	35
Pbo in Core Then AIN457 150mg Group 2	41	33

Primary outcome: Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260

Time frame: Week 104 to Week 260. Number. Unit: % of responders

Measure	Secukinumab (AIN457) 75mg Group 1 n = 100	Secukinumab (AIN457) 150mg Group 2 n = 87	Pbo in Core Then AIN457 75mg Group 1 n = 46	Pbo in Core Then AIN457 150mg Group 2 n = 41
Week 104	71.4	80.0	78.6	73.0
Week 116	76.0	82.1	76.1	70.7
Week 128	70.1	77.1	84.8	75.0
Week 140	77.1	75.0	75.6	72.5
Week 156	75.5	80.2	76.1	67.5
Week 168	74.7	78.3	83.3	78.4
Week 180	81.7	80.0	81.0	78.4
Week 192	72.3	84.8	81.0	73.0

Population analysed: Extension Full Analysis Set (FAS): all participants enrolled in the extension study. No Statistical Analysis was performed

1 secondary outcome is reported in the full results.

Adverse events

Time frame: CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Any Secukinumab (AIN457) 75 mg	36 of 179 (20.1%)	126 of 179 (70.4%)	2 of 179
Any Secukinumab (AIN457) 150 mg	33 of 263 (12.5%)	157 of 263 (59.7%)	1 of 263
Placebo	5 of 122 (4.1%)	45 of 122 (36.9%)	1 of 122

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33351179Baraliakos 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.
Derived from this study: PubMed 33324394Tseng JC, Wei JC, Deodhar A, Martin R, Porter B, McCreddin S, Talloczy Z. Secukinumab Demonstrates Sustained Efficacy and Safety in a Taiwanese Subpopulation With Active Ankylosing Spondylitis: Four-Year Results From a Phase 3 Study, MEASURE 1. Front Immunol. 2020 Nov 26;11:561748. doi: 10.3389/fimmu.2020.561748. eCollection 2020.
Derived from this study: PubMed 33227175Kvien 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.
Derived from this study: PubMed 31565244Baraliakos X, Braun J, Deodhar A, Poddubnyy D, Kivitz A, Tahir H, Van den Bosch F, Delicha EM, Talloczy Z, Fierlinger A. Long-term efficacy and safety of secukinumab 150 mg in ankylosing spondylitis: 5-year results from the phase III MEASURE 1 extension study. RMD Open. 2019 Sep 3;5(2):e001005. doi: 10.1136/rmdopen-2019-001005. eCollection 2019.
Derived from this study: PubMed 30590813Braun J, Baraliakos X, Deodhar A, Poddubnyy D, Emery P, Delicha EM, Talloczy Z, Porter B. Secukinumab shows sustained efficacy and low structural progression in ankylosing spondylitis: 4-year results from the MEASURE 1 study. Rheumatology (Oxford). 2019 May 1;58(5):859-868. doi: 10.1093/rheumatology/key375.
Introduction to clinical research conducted by Novartis and to the results of completed studies. For the sake of transparency, objective scientific information is made publicly available in a standardised format.Link provided by the sponsor.
Individual participant dataSharing planned: Undecided. Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect 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

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

56 sites in 14 countries: see every site and its status.

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 56 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?

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 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in Germany, Russia, United States, Bulgaria, Italy 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. 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 30 Jul 2019). 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 Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 (time frame: Week 104 to Week 260). 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 NCT01863732, which also lists 5 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 30 Jul 2019.