Extension Study up to 3 Years for Secukinumab in Psoriatic Arthritis

NCT ID: NCT01892436

Last Updated: 2019-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 460 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2018-01-11

Brief Summary

This study was designed as a 3-year extension to the phase III core study CAIN457F2306. It aimed to provide continuous treatment with secukinumab in pre-filled syringes (PFS) for subjects who completed the core study CAIN457F2306, to obtain further long term efficacy, safety and tolerability information in subjects with active psoriatic arthritis receiving secukinumab every 4 weeks. At Week 104 of the study CAIN457F2306, eligible subjects completed the assessments associated with the core study visit and subsequently continued in this extension study on the same dose that they were receiving during the core study. The regular assessments of disease activity ensure that subjects who are experienced worsening of disease in any of the treatment groups could exit the study upon their own wish or based on the advice of the investigator at any time.

Conditions

Psoriatic Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Secukinumab 75mg

Subjects continued to receive secukinumab 75mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator

Group Type: EXPERIMENTAL

Secukinumab

Intervention Type: DRUG

Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17).

Secukinumab 150mg

Subjects continued to receive secukinumab 150mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 300 mg as judged appropriate by the investigator

Group Type: EXPERIMENTAL

Secukinumab

Intervention Type: DRUG

Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17).

Placebo - AIN457A 75mg

Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 0.5 mL solution solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 75mg

Group Type: EXPERIMENTAL

Secukinumab

Intervention Type: DRUG

Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17).

Placebo

Intervention Type: DRUG

Placebo

Placebo - AIN457 150mg

Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 1 mL solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 150 mg

Group Type: EXPERIMENTAL

Secukinumab

Intervention Type: DRUG

Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17).

Placebo

Intervention Type: DRUG

Placebo

Interventions

Secukinumab

Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17).

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Other Intervention Names

AIN457; Placebo - AIN457A

Eligibility Criteria

Inclusion Criteria

• Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed
• Subjects must have participated in core study CAIN457F2306, and must have completed the entire treatment period
• Subjects must be deemed by the investigator to benefit from continued secukinumab therapy

Exclusion Criteria

• Any subject taking other concomitant biologic immunomodulating agent(s) except secukinumab
• Any subject who is deemed not to be benefiting from the study treatment based upon lack of improvement or worsening of their symptoms
• Pregnant or nursing (lactating) women
• Women of child-bearing potential, unless they are using effective methods of contraception during the entire study or longer if required by locally approved prescribing information (e.g., 20 weeks in EU)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Anniston, Alabama, United States

Novartis Investigative Site

Mesa, Arizona, United States

Novartis Investigative Site

Paradise Valley, Arizona, United States

Novartis Investigative Site

Upland, California, United States

Novartis Investigative Site

Tamarac, Florida, United States

Novartis Investigative Site

Eagan, Minnesota, United States

Novartis Investigative Site

St Louis, Missouri, United States

Novartis Investigative Site

Lincoln, Nebraska, United States

Novartis Investigative Site

Freehold, New Jersey, United States

Novartis Investigative Site

Charlotte, North Carolina, United States

Novartis Investigative Site

Oklahoma City, Oklahoma, United States

Novartis Investigative Site

Duncansville, Pennsylvania, United States

Novartis Investigative Site

Charleston, South Carolina, United States

Novartis Investigative Site

Columbia, South Carolina, United States

Novartis Investigative Site

Jackson, Tennessee, United States

Novartis Investigative Site

Benbrook, Texas, United States

Novartis Investigative Site

Dallas, Texas, United States

Novartis Investigative Site

Dallas, Texas, United States

Novartis Investigative Site

Houston, Texas, United States

Novartis Investigative Site

League City, Texas, United States

Novartis Investigative Site

Mesquite, Texas, United States

Novartis Investigative Site

Seattle, Washington, United States

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

Novartis Investigative Site

Buenos Aires, , Argentina

Novartis Investigative Site

CABA, , Argentina

Novartis Investigative Site

Córdoba, , Argentina

Novartis Investigative Site

Córdoba, , Argentina

Novartis Investigative Site

Maroochydore, Queensland, Australia

Novartis Investigative Site

Malvern East, Victoria, Australia

Novartis Investigative Site

Genk, , Belgium

Novartis Investigative Site

Ghent, , Belgium

Novartis Investigative Site

Leuven, , Belgium

Novartis Investigative Site

Porto Alegre, Rio Grande do Sul, Brazil

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Novartis Investigative Site

Sevlievo, Gabrovo, Bulgaria

Novartis Investigative Site

Pleven, , Bulgaria

Novartis Investigative Site

Sofia, , Bulgaria

Novartis Investigative Site

St. John's, Newfoundland and Labrador, Canada

Novartis Investigative Site

St. John's, Newfoundland and Labrador, Canada

Novartis Investigative Site

Newmarket, Ontario, Canada

Novartis Investigative Site

Waterloo, Ontario, Canada

Novartis Investigative Site

Trois-Rivières, Quebec, Canada

Novartis Investigative Site

Bruntál, Czech Republic, Czechia

Novartis Investigative Site

Uherské Hradiště, Czech Republic, Czechia

Novartis Investigative Site

Zlín, Czech Republic, Czechia

Novartis Investigative Site

Aachen, , Germany

Novartis Investigative Site

Cologne, , Germany

Novartis Investigative Site

Erlangen, , Germany

Novartis Investigative Site

Erlangen, , Germany

Novartis Investigative Site

Gommern, , Germany

Novartis Investigative Site

Hamburg, , Germany

Novartis Investigative Site

Hildesheim, , Germany

Novartis Investigative Site

Leipzig, , Germany

Novartis Investigative Site

Nuremberg, , Germany

Novartis Investigative Site

Ratingen, , Germany

Novartis Investigative Site

Zerbst, , Germany

Novartis Investigative Site

Ashkelon, , Israel

Novartis Investigative Site

Haifa, , Israel

Novartis Investigative Site

Ramat Gan, , Israel

Novartis Investigative Site

Tel Aviv, , Israel

Novartis Investigative Site

Catania, CT, Italy

Novartis Investigative Site

Prato, PO, Italy

Novartis Investigative Site

Siena, SI, Italy

Novartis Investigative Site

Verona, VR, Italy

Novartis Investigative Site

Lipa City, Batangas, Philippines

Novartis Investigative Site

Dasmariñas, Cavite, Philippines

Novartis Investigative Site

Manila, National Capital Region, Philippines

Novartis Investigative Site

Las Piñas, , Philippines

Novartis Investigative Site

Manila, , Philippines

Novartis Investigative Site

Manila, , Philippines

Novartis Investigative Site

Quezon City, , Philippines

Novartis Investigative Site

Quezon City, , Philippines

Novartis Investigative Site

Bialystok, , Poland

Novartis Investigative Site

Warsaw, , Poland

Novartis Investigative Site

Kemerovo, , Russia

Novartis Investigative Site

Moscow, , Russia

Novartis Investigative Site

Saint Petersburg, , Russia

Novartis Investigative Site

Yaroslavl, , Russia

Novartis Investigative Site

Yekaterinburg, , Russia

Novartis Investigative Site

Yekaterinburg, , Russia

Novartis Investigative Site

Singapore, , Singapore

Novartis Investigative Site

Singapore, , Singapore

Novartis Investigative Site

Singapore, , Singapore

Novartis Investigative Site

Lučenec, , Slovakia

Novartis Investigative Site

Khon Kaen, THA, Thailand

Novartis Investigative Site

Bangkok, , Thailand

Novartis Investigative Site

Chiang Mai, , Thailand

Novartis Investigative Site

Leytonstone, London, United Kingdom

Novartis Investigative Site

Cannock, Staffordshire, United Kingdom

Novartis Investigative Site

Bradford, West Yorkshire, United Kingdom

Novartis Investigative Site

Glasgow, , United Kingdom

Novartis Investigative Site

London, , United Kingdom

Countries

United States; Argentina; Australia; Belgium; Brazil; Bulgaria; Canada; Czechia; Germany; Israel; Italy; Philippines; Poland; Russia; Singapore; Slovakia; Thailand; United Kingdom

References

Mease PJ, Kavanaugh A, Reimold A, Tahir H, Rech J, Hall S, Geusens P, Pellet P, Delicha EM, Mpofu S, Pricop L. Secukinumab in the treatment of psoriatic arthritis: efficacy and safety results through 3 years from the year 1 extension of the randomised phase III FUTURE 1 trial. RMD Open. 2018 Aug 13;4(2):e000723. doi: 10.1136/rmdopen-2018-000723. eCollection 2018.

Reference Type: DERIVED

PMID: 30167329 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2013-001241-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CAIN457F2306E1

Identifier Type: -

Identifier Source: org_study_id