MedDataX Logo

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

NCT ID: NCT01989468

Last Updated: 2019-04-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

414 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-10

Study Completion Date

2018-03-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy at 24 Weeks and Long Term Safety, Tolerability and Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Psoriatic Arthritis (PsA)

NCT01392326

Psoriatic Arthritis
COMPLETED PHASE3

Study of Efficacy and Safety of Secukinumab 2 mL Auto-injector (300 mg) in Subjects With Moderate to Severe Plaque Psoriasis

NCT03589885

Plaque Psoriasis
COMPLETED PHASE3

Study to Evaluate the Safety and Efficacy of Secukinumab 300 mg and 150 mg in Adult Patients With Active Psoriatic Arthritis (PsA) After 16 Weeks of Treatment Compared to Placebo

NCT02798211

Psoriatic Arthritis
COMPLETED PHASE4

Efficacy of Secukinumab Compared to Adalimumab in Patients With Psoriatic Arthritis

NCT02745080

Psoriatic Arthritis
COMPLETED PHASE3

First Study of Secukinumab in Pre-filled Syringes in Subjects With Chronic Plaque-type Psoriasis: Response at 12 Weeks

NCT01555125

Moderate to Severe Plaque-type Psoriasis
COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Psoriatic Arthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Secukinumab (AIN457) 150 mg s.c.

1 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.

Group Type EXPERIMENTAL

Secukinumab

Intervention Type BIOLOGICAL

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

Secukinumab (AIN457) 300 mg s.c.

2 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.

Group Type EXPERIMENTAL

Secukinumab

Intervention Type BIOLOGICAL

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

Placebo

Matching Placebo at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Secukinumab placebo provided in 1 mL autoinjector

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Secukinumab

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

Intervention Type BIOLOGICAL

Placebo

Secukinumab placebo provided in 1 mL autoinjector

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Secukinumab 150 mg Secukinumab 300 mg

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novartis Investigative Site

Aventura, Florida, United States

Site Status

Novartis Investigative Site

Palm Harbor, Florida, United States

Site Status

Novartis Investigative Site

Sarasota, Florida, United States

Site Status

Novartis Investigative Site

Indianapolis, Indiana, United States

Site Status

Novartis Investigative Site

Bowling Green, Kentucky, United States

Site Status

Novartis Investigative Site

St Louis, Missouri, United States

Site Status

Novartis Investigative Site

Freehold, New Jersey, United States

Site Status

Novartis Investigative Site

Albany, New York, United States

Site Status

Novartis Investigative Site

Duncansville, Pennsylvania, United States

Site Status

Novartis Investigative Site

Austin, Texas, United States

Site Status

Novartis Investigative Site

Mesquite, Texas, United States

Site Status

Novartis Investigative Site

Wenatchee, Washington, United States

Site Status

Novartis Investigative Site

Kogarah, New South Wales, Australia

Site Status

Novartis Investigative Site

Maroochydore, Queensland, Australia

Site Status

Novartis Investigative Site

Hobart, Tasmania, Australia

Site Status

Novartis Investigative Site

Malvern East, Victoria, Australia

Site Status

Novartis Investigative Site

Sofia, , Bulgaria

Site Status

Novartis Investigative Site

Sofia, , Bulgaria

Site Status

Novartis Investigative Site

Sofia, , Bulgaria

Site Status

Novartis Investigative Site

Veliko Tarnovo, , Bulgaria

Site Status

Novartis Investigative Site

Victoria, British Columbia, Canada

Site Status

Novartis Investigative Site

Winnipeg, Manitoba, Canada

Site Status

Novartis Investigative Site

Toronto, Ontario, Canada

Site Status

Novartis Investigative Site

Trois-Rivières, Quebec, Canada

Site Status

Novartis Investigative Site

Bruntál, Czech Republic, Czechia

Site Status

Novartis Investigative Site

Prague, Czech Republic, Czechia

Site Status

Novartis Investigative Site

Uherské Hradiště, Czech Republic, Czechia

Site Status

Novartis Investigative Site

Aachen, , Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Chemnitz, , Germany

Site Status

Novartis Investigative Site

Erlangen, , Germany

Site Status

Novartis Investigative Site

Gommern, , Germany

Site Status

Novartis Investigative Site

Hamburg, , Germany

Site Status

Novartis Investigative Site

Hamburg, , Germany

Site Status

Novartis Investigative Site

Hamburg, , Germany

Site Status

Novartis Investigative Site

Hanover, , Germany

Site Status

Novartis Investigative Site

Hildesheim, , Germany

Site Status

Novartis Investigative Site

Magdeburg, , Germany

Site Status

Novartis Investigative Site

Zerbst, , Germany

Site Status

Novartis Investigative Site

Bologna, BO, Italy

Site Status

Novartis Investigative Site

Catania, CT, Italy

Site Status

Novartis Investigative Site

Genova, GE, Italy

Site Status

Novartis Investigative Site

Rozzano, MI, Italy

Site Status

Novartis Investigative Site

Reggio Emilia, RE, Italy

Site Status

Novartis Investigative Site

Torino, TO, Italy

Site Status

Novartis Investigative Site

Verona, VR, Italy

Site Status

Novartis Investigative Site

Amsterdam, , Netherlands

Site Status

Novartis Investigative Site

Heerlen, , Netherlands

Site Status

Novartis Investigative Site

Rotterdam, , Netherlands

Site Status

Novartis Investigative Site

Caguas, , Puerto Rico

Site Status

Novartis Investigative Site

Ponce, , Puerto Rico

Site Status

Novartis Investigative Site

Chelyabinsk, , Russia

Site Status

Novartis Investigative Site

Moscow, , Russia

Site Status

Novartis Investigative Site

Rostov-on-Don, , Russia

Site Status

Novartis Investigative Site

Saratov, , Russia

Site Status

Novartis Investigative Site

Sestroretsk, , Russia

Site Status

Novartis Investigative Site

Yaroslavl, , Russia

Site Status

Novartis Investigative Site

Yekaterinburg, , Russia

Site Status

Novartis Investigative Site

Seville, Andalusia, Spain

Site Status

Novartis Investigative Site

Santander, Cantabria, Spain

Site Status

Novartis Investigative Site

Barcelona, Catalonia, Spain

Site Status

Novartis Investigative Site

A Coruña, Galicia, Spain

Site Status

Novartis Investigative Site

Fribourg, , Switzerland

Site Status

Novartis Investigative Site

Sankt Gallen, , Switzerland

Site Status

Novartis Investigative Site

London, England, United Kingdom

Site Status

Novartis Investigative Site

Salford, Manchester, United Kingdom

Site Status

Novartis Investigative Site

Cannock, Staffordshire, United Kingdom

Site Status

Novartis Investigative Site

Stoke-on-Trent, Staffordshire, United Kingdom

Site Status

Novartis Investigative Site

Barnsley, , United Kingdom

Site Status

Novartis Investigative Site

Eastbourne, , United Kingdom

Site Status

Novartis Investigative Site

Harrogate, , United Kingdom

Site Status

Novartis Investigative Site

Hull, , United Kingdom

Site Status

Novartis Investigative Site

London, , United Kingdom

Site Status

Novartis Investigative Site

London, , United Kingdom

Site Status

Novartis Investigative Site

Manchester, , United Kingdom

Site Status

Novartis Investigative Site

Torquay, , United Kingdom

Site Status

Novartis Investigative Site

Tyne and Wear, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Australia Bulgaria Canada Czechia Germany Italy Netherlands Puerto Rico Russia Spain Switzerland United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 38446397 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34795065 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31801620 (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)

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.

Reference Type DERIVED
PMID: 29544534 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2013-004002-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CAIN457F2318

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Study to Demonstrate the Efficacy, Safety and Tolerability of Intravenous Secukinumab up to 52 Weeks in Subjects With Active Psoriatic Arthritis
NCT04209205 COMPLETED PHASE3
Extension Study up to 3 Years for Secukinumab in Psoriatic Arthritis
NCT01892436 COMPLETED PHASE3
Efficacy of Secukinumab Compared to Ustekinumab in Adults With Active Psoriatic Arthritis and Failure of TNFα-Inhibitor Treatment
NCT04632927 COMPLETED PHASE3
Study of Secukinumab With 2 mL Pre-filled Syringes
NCT02748863 COMPLETED PHASE3
Judging the Efficacy of Secukinumab in Patients With Psoriasis Using AutoiNjector: a Clinical Trial Evaluating Treatment Results (JUNCTURE)
NCT01636687 COMPLETED PHASE3
Efficacy and Safety of Subcutaneous Secukinumab for Moderate to Severe Chronic Plaque-type Psoriasis for up to 1 Year
NCT01365455 COMPLETED PHASE3
Study to Evaluate the Effect of Secukinumab Compared to Placebo on Aortic Vascular Inflammation in Subjects With Moderate to Severe Plaque Psoriasis
NCT02690701 COMPLETED PHASE4
Multiple-dose Regimen Study to Assess Effect of 12 Months of Secukinumab Treatment on Skin Response and Biomarkers in Psoriasis Patients
NCT01537432 COMPLETED PHASE2
Efficacy and Safety of Intravenous and Subcutaneous Secukinumab in Moderate to Severe Chronic Plaque-type Psoriasis
NCT01412944 COMPLETED PHASE3
Efficacy and Safety Study of Subcutaneous Secukinumab in Treatment of Subjects With Moderate to Severe Chronic Plaque-type Psoriasis as Compared to Etanercept and Placebo.
NCT01900782 WITHDRAWN PHASE3
Extension Study of Secukinumab Prefilled Syringes in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Completing Preceding Psoriasis Phase III Studies With Secukinumab
NCT01544595 COMPLETED PHASE3
Evaluation of Cardiovascular Risk Markers in Psoriasis Patients Treated With Secukinumab
NCT02559622 COMPLETED PHASE3
Efficacy of Secukinumab Compared to Ustekinumab in Patients With Plaque-type Psoriasis
NCT02074982 COMPLETED PHASE3
Study of Efficacy and Safety of Secukinumab in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis
NCT03066609 COMPLETED PHASE3
Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe, Chronic Plaque-Type Psoriasis
NCT01358578 COMPLETED PHASE3
A Study to Evaluate the Efficacy and Safety of PF-06700841 in Subjects With Active Psoriatic Arthritis
NCT03963401 COMPLETED PHASE2
Study to Explore the Effect of Secukinumab, Compared to Placebo, on Fat Tissue and Skin in Plaque Psoriasis Patients
NCT03055494 COMPLETED PHASE4
Efficacy and Safety of Subcutaneous Secukinumab (AIN457) for Moderate to Severe Chronic Plaque-type Psoriasis Assessing Different Doses and Dose Regimens
NCT01406938 COMPLETED PHASE3
Study of Efficacy and Safety of Secukinumab in Chinese Subjects With Active PsA Compared to Placebo.
NCT04711902 COMPLETED PHASE3
Study to Evaluate Psoriasis Severity and Its Psychosocial Impact Using the Simplified Psoriasis Index (SPI), as Well as Long-term Safety, Tolerability and Efficacy of Secukinumab Administered Subcutaneously in Patients With Moderate to Severe Psoriasis
NCT02595970 COMPLETED PHASE3
Plaque Psoriasis Efficacy and Safety With Secukinumab
NCT02409667 COMPLETED PHASE3
Efficacy and Safety of Subcutaneous Abatacept in Adults With Active Psoriatic Arthritis
NCT01860976 COMPLETED PHASE3
A 24-week, Multicenter, proSpective stUdy to Evaluate the PASI 90 Clinical Response Rate and the Safety PRofile of sEcukinuMab 300 mg in Cw6-negativE and Cw6-positive Patients With Moderate to Severe Chronic Plaque-type Psoriasis (SUPREME)
NCT02394561 COMPLETED PHASE3
Palmoplantar Pustular Psoriasis Efficacy and Safety With Secukinumab
NCT02008890 COMPLETED PHASE3
An Efficacy Study of Secukinumab in Plaque Psoriasis Patients With Subclinical Psoriatic Arthritis as Measured by Musculoskeletal Ultrasound
NCT04488185 WITHDRAWN PHASE4