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Psoriatic ArthritisPhase 3NCT01989468

24 Week Efficacy and 3-year Safety and Efficacy of Secukinumab in Active Psoriatic Arthritis

A Phase 3 study testing Secukinumab in people with Psoriatic Arthritis, run by Novartis Pharmaceuticals at 77 sites in 13 countries.

Completed

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

Official record
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Trial summary

The purpose of this study is to provide 24 - 52 week efficacy, safety and tolerability data, and up to 3-year efficacy, safety and tolerability data in subjects with active Psoriatic Arthritis despite current or previous nonsteroidal anti-inflammatory drug (NSAID), disease-modifying antirheumatic drug (DMARD) therapy… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriatic Arthritis
What is being tested?
Secukinumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
414 participants
Where
77 sitesin 13 countries
Study dates
10 Apr 2014to 28 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

Who may be able to join

  • Diagnosis of Psoriatic Arthritis (PsA) classified by ClASsification criteria for Psoriatic ARthritis (CASPAR) criteria.
  • Rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies negative.
  • Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis.
  • Inadequate control of symptoms with NSAID.

Who cannot join

  • Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process.
  • Subjects taking high potency opioid analgesics.
  • Previous exposure to secukinumab or other biologic drug directly targeting interleukin-17 (IL-17) or IL-17 receptor.
  • Ongoing use of prohibited psoriasis treatments / medications.
  • Subjects who have ever received biologic immunomodulating agents except for those targeting TNFα.
  • Previous treatment with any cell-depleting therapies.

Trial locations and contacts

77 sites in 13 countries.

77 sites in 13 countries

United Kingdom13 sites

  • Novartis Investigative Site

    Barnsley, S75 2EP

  • Novartis Investigative Site

    Cannock, Staffordshire, WS11 2XY

  • Novartis Investigative Site

    Eastbourne, BN21 2UD

  • Novartis Investigative Site

    Harrogate, HG2 7SX

  • Novartis Investigative Site

    Hull, HU3 2JZ

  • Novartis Investigative Site

    London, England, E11 1NR

  • Novartis Investigative Site

    London, NW3 2QG

  • Novartis Investigative Site

    London, SE1 9RT

  • Novartis Investigative Site

    Manchester, M23 9LT

  • Novartis Investigative Site

    Salford, Manchester, M6 8HD

  • Novartis Investigative Site

    Stoke-on-Trent, Staffordshire, ST6 7AG

  • Novartis Investigative Site

    Torquay, TQ2 7AA

  • Novartis Investigative Site

    Tyne and Wear, NE29 8NH

Other trials in United Kingdom

United States12 sites

  • Novartis Investigative Site

    Albany, New York, 12206

  • Novartis Investigative Site

    Austin, Texas, 78731

  • Novartis Investigative Site

    Aventura, Florida, 33180

  • Novartis Investigative Site

    Bowling Green, Kentucky, 42101

  • Novartis Investigative Site

    Duncansville, Pennsylvania, 16635

  • Novartis Investigative Site

    Freehold, New Jersey, 07728

  • Novartis Investigative Site

    Indianapolis, Indiana, 46256

  • Novartis Investigative Site

    Mesquite, Texas, 75150

  • Novartis Investigative Site

    Palm Harbor, Florida, 34684

  • Novartis Investigative Site

    Sarasota, Florida, 34239

  • Novartis Investigative Site

    St Louis, Missouri, 63117

  • Novartis Investigative Site

    Wenatchee, Washington, 98801

Other trials in United States

Germany12 sites

  • Novartis Investigative Site

    Aachen, 52064

  • Novartis Investigative Site

    Berlin, 10117

  • Novartis Investigative Site

    Chemnitz, 09130

  • Novartis Investigative Site

    Erlangen, 91056

  • Novartis Investigative Site

    Gommern, 39245

  • Novartis Investigative Site

    Hamburg, 20095

  • Novartis Investigative Site

    Hamburg, 22081

  • Novartis Investigative Site

    Hamburg, 22415

  • Novartis Investigative Site

    Hanover, 30625

  • Novartis Investigative Site

    Hildesheim, 31134

  • Novartis Investigative Site

    Magdeburg, 39110

  • Novartis Investigative Site

    Zerbst, 39261

Other trials in Germany

Italy7 sites

  • Novartis Investigative Site

    Bologna, BO, 40138

  • Novartis Investigative Site

    Catania, CT, 95100

  • Novartis Investigative Site

    Genova, GE, 16132

  • Novartis Investigative Site

    Reggio Emilia, RE, 42123

  • Novartis Investigative Site

    Rozzano, MI, 20089

  • Novartis Investigative Site

    Torino, TO, 10128

  • Novartis Investigative Site

    Verona, VR, 37126

Other trials in Italy

Russia7 sites

  • Novartis Investigative Site

    Chelyabinsk, 454076

  • Novartis Investigative Site

    Moscow, 115522

  • Novartis Investigative Site

    Rostov-on-Don, 344022

  • Novartis Investigative Site

    Saratov, 410053

  • Novartis Investigative Site

    Sestroretsk, 197706

  • Novartis Investigative Site

    Yaroslavl, 150003

  • Novartis Investigative Site

    Yekaterinburg, 620028

Other trials in Russia

Australia4 sites

  • Novartis Investigative Site

    Hobart, Tasmania, 7000

  • Novartis Investigative Site

    Kogarah, New South Wales, 2217

  • Novartis Investigative Site

    Malvern East, Victoria, 3145

  • Novartis Investigative Site

    Maroochydore, Queensland, 4558

Other trials in Australia

Bulgaria4 sites

  • Novartis Investigative Site

    Sofia, 1413

  • Novartis Investigative Site

    Sofia, 1431

  • Novartis Investigative Site

    Sofia, 1505

  • Novartis Investigative Site

    Veliko Tarnovo, 5000

Other trials in Bulgaria

Canada4 sites

  • Novartis Investigative Site

    Toronto, Ontario, M9W 4L6

  • Novartis Investigative Site

    Trois-Rivières, Quebec, G8Z 1Y2

  • Novartis Investigative Site

    Victoria, British Columbia, V8V 3M9

  • Novartis Investigative Site

    Winnipeg, Manitoba, R3A 1M3

Other trials in Canada

Spain4 sites

  • Novartis Investigative Site

    A Coruña, Galicia, 15006

  • Novartis Investigative Site

    Barcelona, Catalonia, 08036

  • Novartis Investigative Site

    Santander, Cantabria, 39008

  • Novartis Investigative Site

    Seville, Andalusia, 41009

Other trials in Spain

Czechia3 sites

  • Novartis Investigative Site

    Bruntál, Czech Republic, 792 01

  • Novartis Investigative Site

    Prague, Czech Republic, 128 50

  • Novartis Investigative Site

    Uherské Hradiště, Czech Republic, 686 01

Other trials in Czechia

Netherlands3 sites

  • Novartis Investigative Site

    Amsterdam, 1105 AZ

  • Novartis Investigative Site

    Heerlen, 6419 PC

  • Novartis Investigative Site

    Rotterdam, 3079 DZ

Other trials in Netherlands

Puerto Rico2 sites

  • Novartis Investigative Site

    Caguas, 00725

  • Novartis Investigative Site

    Ponce, 00716

Other trials in Puerto Rico

Switzerland2 sites

  • Novartis Investigative Site

    Fribourg, 1708

  • Novartis Investigative Site

    Sankt Gallen, CH 9007

Other trials in Switzerland

About this study

Official title: A Phase III, Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab in Autoinjectors, to Demonstrate Efficacy at 24 Weeks and to Assess the Long Term Safety, Tolerability and Efficacy up to 3 Years in Subjects With Active Psoriatic Arthritis

The purpose of this study is to provide 24 - 52 week efficacy, safety and tolerability data, and up to 3-year efficacy, safety and tolerability data in subjects with active Psoriatic Arthritis despite current or previous nonsteroidal anti-inflammatory drug (NSAID), disease-modifying antirheumatic drug (DMARD) therapy and/or previous anti-tumor necrosis factor alpha (TNFα) therapy.

Being tested
Secukinumab, Placebo
Keywords
Psoriatic arthritis, AIN457, PsA, ACR, CASPAR, PASDAS, secukinumab, autoinjector
Medical subject headings
Arthritis, Psoriatic

What participants receive

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

  • SecukinumabBiological

    Also called Secukinumab 150 mg, Secukinumab 300 mg

    Secukinumab 150 mg provided in a 1 mL autoinjector (1 autoinjector for 150 mg dose, 2 autoinjectors for 300 mg dose)

  • PlaceboBiological

    Secukinumab placebo provided in 1 mL autoinjector

Study groups in NCT01989468
Study groupRoleWhat they receive
Secukinumab (AIN457) 150 mg s.c.Experimental1 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
Receives: Biological: Secukinumab
Secukinumab (AIN457) 300 mg s.c.Experimental2 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
Receives: Biological: Secukinumab
PlaceboPlacebo comparatorMatching Placebo at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
Receives: Biological: Placebo

What is being measured

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

  1. Proportion of Patients Achieving American College of Rheumatology 20 (ACR20) Response Criteria on Secukinumab Versus Placebo at Week 24

    A patient will be considered as improved according the ACR20 criteria if she/he has at least 20% decrease in the swollen and tender joint count, and at least 20% improvements in 3 of the following 5 criteria: physical disability on the Health Assessment Questionnaire; pain score on a visual analog scale; patient global assessment; physician global assessment; and acute phase reactant [either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)]

    Measured: Week 24

Secondary outcomes (9)

  1. Proportion of Patients Achieving American College of Rheumatology 50 (ACR50) Response Criteria on Secukinumab Versus Placebo at Week 24

    A patient will be considered as improved according the ACR50 criteria if she/he has at least 50% decreases in the swollen and tender joint count, and at least 50% improvements in 3 of the following 5 criteria: physical disability on the Health Assessment Questionnaire; pain score on a visual analog scale; patient global assessment; physician global assessment; and acute phase reactant [either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)]

    Measured: Week 24

  2. Change From Baseline in Disease Activity Score for 28 Joints (DAS28-CRP) (Utilizing hsCRP) in Subjects Treated With Secukinumab Versus Placebo at Week 24

    DAS28-CRP is a measure of disease activity based on 28-Swollen and Tender Joint Count [proximal interphalangeal joints (10 joints) metacarpophalangeal joints (10) wrists (2) elbows (2) shoulders (2) knees (2)], CRP, and the Patient's Global Assessment of disease activity. Values range from 2.0 to 10.0 where higher values mean a higher disease activity. DAS28-CRP < 2.6 is interpreted as remission.

    Measured: Week 24

  3. Proportion of Subjects Achieving a Psoriatic Area and Severity Index 75 (PASI75) Response in Subjects on Secukinumab Versus Placebo at Week 24

    PASI takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis. A PASI75 represents an improvement in the PASI score of at least 75% as compared with baseline.

    Measured: Week 24

  4. Change From Baseline in Physical Function Component of the Short-form Health Survey (SF-36-PCS) in Subjects Treated With Secukinumab Versus Placebo at Week 24

    SF-36 is a 36 item questionnaire which measures Quality of Life across eight domains, which are both physically and emotionally based. Two overall summary scores, the Physical 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: Week 24

  5. Percentage of Subjects Achieving a Psoriatic Area and Severity Index 90 (PASI90) Response in Subjects Treated With Secukinumab Versus Placebo at Week 24

    PASI takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis. A PASI90 represents an improvement in the PASI score of at least 90% as compared with baseline.

    Measured: Week 24

  6. Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI Score) in Subjects Treated With Secukinumab Versus Placebo at Week 24

    The HAQ measures physical disability and functional status. It has 4 dimensions: disability, pain, drug side effects and dollar costs. In this trial, only the disability dimension was used. The disability dimension consists of 20 multiple choice items concerning difficulty in performing 8 common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Participants choose from four response categories: 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) and 3 (unable to do). Within each of the 8 categories, only the item indicating the most severe impairment contributes to the category score. The HAQ score is calculated by summing the computed scores for each category and dividing by the number of categories answered. It ranges from 0 (without any difficulty) to 3 (unable to do). A negative change from baseline indicates improvement.

    Measured: Week 24

  7. Proportion of Patients With Dactylitis at Week 24 in the Subset of Patients Who Had Dactylitis at Baseline

    The presence of dactylitis was assessed by dactylitis count (number of fingers and toes with dactylitis, with a range of 0-20). If dactylitis is present with any finger or toe, the patient is counted as a patient with dactylitis.

    Measured: Week 24

  8. Proportion of Patients With Enthesitis at Week 24 in the Subset of Patients Who Had Enthesitis at Baseline

    The presence of Enthesitis was assessed using a validated enthesitis index that uses 6 sites for evaluation of enthesitis: lateral epicondyle humerus L + R, proximal achilles L + R and medial condyle femur. If enthesitis is present at any of the 6 sites, the subject is counted as a subject with enthesitis.

    Measured: Week 24

  9. Number of Participants With Treatment Emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by Primary System Organ Class (SOC)

    Analysis of frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC).

    Measured: From first dose of study treatment to last study visit, up to 3 years

Timeline

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

  1. First posted21 Nov 2013 (estimated)
  2. Study start10 Apr 2014
  3. Primary completion27 May 2015
  4. Study completion28 Mar 2018

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
414 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01989468
Sponsor's protocol ID
CAIN457F2318
Other IDs
2013-004002-25
Status last verified
Apr 2019
First submitted
7 Nov 2013
Last updated
16 Apr 2019
Data monitoring committee
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

  • Mease PJ, Warren RB, Nash P, Grouin JM, Lyris N, Willems D, Taieb V, Eells J, McInnes IB. Comparative Effectiveness of Bimekizumab and Secukinumab in Patients with Psoriatic Arthritis at 52 Weeks Using a Matching-Adjusted Indirect Comparison. Rheumatol Ther. 2024 Jun;11(3):817-828. doi: 10.1007/s40744-024-00652-7. Epub 2024 Mar 6.

    PubMed 38446397

  • Pournara E, Kormaksson M, Nash P, Ritchlin CT, Kirkham BW, Ligozio G, Pricop L, Ogdie A, Coates LC, Schett G, McInnes IB. Clinically relevant patient clusters identified by machine learning from the clinical development programme of secukinumab in psoriatic arthritis. RMD Open. 2021 Nov;7(3):e001845. doi: 10.1136/rmdopen-2021-001845.

    PubMed 34795065

  • Coates LC, Wallman JK, McGonagle D, Schett GA, McInnes IB, Mease PJ, Rasouliyan L, Quebe-Fehling E, Asquith DL, Fasth AER, Pricop L, Gaillez C. Secukinumab efficacy on resolution of enthesitis in psoriatic arthritis: pooled analysis of two phase 3 studies. Arthritis Res Ther. 2019 Dec 4;21(1):266. doi: 10.1186/s13075-019-2055-z.

    PubMed 31801620

  • 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

  • Nash P, Mease PJ, McInnes IB, Rahman P, Ritchlin CT, Blanco R, Dokoupilova E, Andersson M, Kajekar R, Mpofu S, Pricop L; FUTURE 3 study group. Efficacy and safety of secukinumab administration by autoinjector in patients with psoriatic arthritis: results from a randomized, placebo-controlled trial (FUTURE 3). Arthritis Res Ther. 2018 Mar 15;20(1):47. doi: 10.1186/s13075-018-1551-x.

    PubMed 29544534

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Secukinumab in people with Psoriatic Arthritis, run by Novartis Pharmaceuticals at 77 sites in 13 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 4 inclusion and 6 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 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 sites in United Kingdom, United States, Germany, Italy, Russia and 8 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 16 Apr 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?

Proportion of Patients Achieving American College of Rheumatology 20 (ACR20) Response Criteria on Secukinumab Versus Placebo at Week 24 (time frame: Week 24). 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 NCT01989468, 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 16 Apr 2019.

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