Extension Study up to 3 Years for Secukinumab in Psoriatic Arthritis

NCT01892436 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: CAIN457F2306E12013-001241-13
• Study Type: interventional
• Target: 460
• Locations: 18 countries
• Sites: 94

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

Keywords

Extension study, psoriatic arthritis, pre-filled syringe

Outcome Measures

Primary Outcomes (3)

• Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20

  Proportion of subjects with a positive clinical response to treatment (individual improvement) in disease activity according to ACR20 criteria if he/she has at least 20% improvement in 1. Tender 68-joint count 2. Swollen 66-joint count and 3. At least 3 of the following 5 measures: * Patient's assessment of Psoriatic Arthritis (PsA) pain * Patient's global assessment of disease activity * Physician's global assessment of disease activity * Subject self-assessed disability (Health-Assessment Questionnaire \[HAQ-DI\] score) * Acute phase reactant (hsCRP or ESR)

  weeks 116, 128, 140, 156, 180, 208, 232 and 260

• Proportion of Subjects Who Reached ACR50

  Proportion of subjects that have a positive clinical response to treatment (individual improvement) in disease activity according to ACR50 criteria if he/she has at least 50% improvement in 1. Tender 68-joint count 2. Swollen 66-joint count and 3. At least 3 of the following 5 measures: * Patient's assessment of PsA pain * Patient's global assessment of disease activity * Physician's global assessment of disease activity * Subject self-assessed disability (Health-Assessment Questionnaire \[HAQ-DI\] score) * Acute phase reactant (hsCRP or ESR)

  weeks 116, 128, 140, 156, 180, 208, 232 and 260

• Proportion of Subjects Who Reached ACR70

  Proportion of subjects that have a positive clinical response to treatment (individual improvement) in disease activity according to ACR70 criteria if he/she has at least 70% improvement in 1. Tender 68-joint count 2. Swollen 66-joint count and 3. At least 3 of the following 5 measures:- Patient's assessment of PsA pain * Patient's global assessment of disease activity * Physician's global assessment of disease activity * Subject self-assessed disability (Health-Assessment Questionnaire \[HAQ-DI\] score) * Acute phase reactant (hsCRP or ESR)

  weeks 116, 128, 140, 156, 180, 208, 232 and 260

Secondary Outcomes (5)

• Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)

  weeks 116, 128, 140, 156, 180, 208, 232 and 260

• Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI)

  weeks 116, 128, 140, 156, 180, 208, 232 and 260

• Change From Baseline in Disease Activity Score-CRP (DAS28)

  weeks 116, 128, 140, 156, 180, 208, 232 and 260

• Percentage of Subjects Achieving Low Disease Activity

  weeks 116, 128, 140, 156, 180, 208, 232 and 260

• Percentage of Subjects Achieving Disease Remission (DAS28<2.6)

  weeks 116, 128, 140, 156, 180, 208, 232 and 260

Study Arms (4)

Secukinumab 75mg

EXPERIMENTAL

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

Drug: Secukinumab

Secukinumab 150mg

EXPERIMENTAL

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

Drug: Secukinumab

Placebo - AIN457A 75mg

EXPERIMENTAL

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

Drug: Secukinumab; Drug: Placebo

Placebo - AIN457 150mg

EXPERIMENTAL

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

Drug: Secukinumab; Drug: Placebo

Interventions

Secukinumab 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).

Also known as: AIN457

Placebo - AIN457 150mg; Placebo - AIN457A 75mg; Secukinumab 150mg; Secukinumab 75mg

Placebo DRUG

Placebo

Also known as: Placebo - AIN457A

Placebo - AIN457 150mg; Placebo - AIN457A 75mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (94)

Novartis Investigative Site

Anniston, Alabama, 36207-5710, United States

Location

Novartis Investigative Site

Mesa, Arizona, 85202, United States

Location

Novartis Investigative Site

Paradise Valley, Arizona, 85253, United States

Location

Novartis Investigative Site

Upland, California, 91786, United States

Location

Novartis Investigative Site

Tamarac, Florida, 33321, United States

Location

Novartis Investigative Site

Eagan, Minnesota, 55121, United States

Location

Novartis Investigative Site

St Louis, Missouri, 63117, United States

Location

Novartis Investigative Site

Lincoln, Nebraska, 68516, United States

Location

Novartis Investigative Site

Freehold, New Jersey, 07728, United States

Location

Novartis Investigative Site

Charlotte, North Carolina, 28210, United States

Location

Novartis Investigative Site

Oklahoma City, Oklahoma, 73103, United States

Location

Novartis Investigative Site

Duncansville, Pennsylvania, 16635, United States

Location

Novartis Investigative Site

Charleston, South Carolina, 29460, United States

Location

Novartis Investigative Site

Columbia, South Carolina, 29204, United States

Location

Novartis Investigative Site

Jackson, Tennessee, 38305, United States

Location

Novartis Investigative Site

Benbrook, Texas, 76126, United States

Location

Novartis Investigative Site

Dallas, Texas, 75216, United States

Location

Novartis Investigative Site

Dallas, Texas, 75246, United States

Location

Novartis Investigative Site

Houston, Texas, 77074, United States

Location

Novartis Investigative Site

League City, Texas, 77573, United States

Location

Novartis Investigative Site

Mesquite, Texas, 75150, United States

Location

Novartis Investigative Site

Seattle, Washington, 98122, United States

Location

Novartis Investigative Site

CABA, Buenos Aires, C1181ACH, Argentina

Location

Novartis Investigative Site

Rosario, Santa Fe Province, S2000CFJ, Argentina

Location

Novartis Investigative Site

Buenos Aires, C1417EYG, Argentina

Location

Novartis Investigative Site

CABA, C1419AHN, Argentina

Location

Novartis Investigative Site

Córdoba, X5000EDC, Argentina

Location

Novartis Investigative Site

Córdoba, X5016KEH, Argentina

Location

Novartis Investigative Site

Maroochydore, Queensland, 4558, Australia

Location

Novartis Investigative Site

Malvern East, Victoria, 3145, Australia

Location

Novartis Investigative Site

Genk, 3600, Belgium

Location

Novartis Investigative Site

Ghent, 9000, Belgium

Location

Novartis Investigative Site

Leuven, 3000, Belgium

Location

Novartis Investigative Site

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Novartis Investigative Site

São Paulo, São Paulo, 04023-900, Brazil

Location

Novartis Investigative Site

São Paulo, São Paulo, 04266 010, Brazil

Location

Novartis Investigative Site

Sevlievo, Gabrovo, 5400, Bulgaria

Location

Novartis Investigative Site

Pleven, 5800, Bulgaria

Location

Novartis Investigative Site

Sofia, 1612, Bulgaria

Location

Novartis Investigative Site

St. John's, Newfoundland and Labrador, A1A 5E8, Canada

Location

Novartis Investigative Site

St. John's, Newfoundland and Labrador, A1C 5B8, Canada

Location

Novartis Investigative Site

Newmarket, Ontario, L3Y 3R7, Canada

Location

Novartis Investigative Site

Waterloo, Ontario, N2J 1C4, Canada

Location

Novartis Investigative Site

Trois-Rivières, Quebec, G8Z 1Y2, Canada

Location

Novartis Investigative Site

Bruntál, Czech Republic, 792 01, Czechia

Location

Novartis Investigative Site

Uherské Hradiště, Czech Republic, 686 01, Czechia

Location

Novartis Investigative Site

Zlín, Czech Republic, 760 01, Czechia

Location

Novartis Investigative Site

Aachen, 52064, Germany

Location

Novartis Investigative Site

Cologne, 50937, Germany

Location

Novartis Investigative Site

Erlangen, 91054, Germany

Location

Novartis Investigative Site

Erlangen, 91056, Germany

Location

Novartis Investigative Site

Gommern, 39245, Germany

Location

Novartis Investigative Site

Hamburg, 22415, Germany

Location

Novartis Investigative Site

Hildesheim, 31134, Germany

Location

Novartis Investigative Site

Leipzig, 04103, Germany

Location

Novartis Investigative Site

Nuremberg, 90429, Germany

Location

Novartis Investigative Site

Ratingen, 40878, Germany

Location

Novartis Investigative Site

Zerbst, 39261, Germany

Location

Novartis Investigative Site

Ashkelon, 78278, Israel

Location

Novartis Investigative Site

Haifa, 3339419, Israel

Location

Novartis Investigative Site

Ramat Gan, 5265601, Israel

Location

Novartis Investigative Site

Tel Aviv, 6423906, Israel

Location

Novartis Investigative Site

Catania, CT, 95100, Italy

Location

Novartis Investigative Site

Prato, PO, 59100, Italy

Location

Novartis Investigative Site

Siena, SI, 53100, Italy

Location

Novartis Investigative Site

Verona, VR, 37134, Italy

Location

Novartis Investigative Site

Lipa City, Batangas, 4217, Philippines

Location

Novartis Investigative Site

Dasmariñas, Cavite, 4114, Philippines

Location

Novartis Investigative Site

Manila, National Capital Region, 1003, Philippines

Location

Novartis Investigative Site

Las Piñas, 1740, Philippines

Location

Novartis Investigative Site

Manila, 1003, Philippines

Location

Novartis Investigative Site

Manila, 1008, Philippines

Location

Novartis Investigative Site

Quezon City, 1102, Philippines

Location

Novartis Investigative Site

Quezon City, 1118, Philippines

Location

Novartis Investigative Site

Bialystok, 15-351, Poland

Location

Novartis Investigative Site

Warsaw, 02-341, Poland

Location

Novartis Investigative Site

Kemerovo, 650029, Russia

Location

Novartis Investigative Site

Moscow, 115522, Russia

Location

Novartis Investigative Site

Saint Petersburg, 190068, Russia

Location

Novartis Investigative Site

Yaroslavl, 150003, Russia

Location

Novartis Investigative Site

Yekaterinburg, 620028, Russia

Location

Novartis Investigative Site

Yekaterinburg, 620109, Russia

Location

Novartis Investigative Site

Singapore, 119074, Singapore

Location

Novartis Investigative Site

Singapore, 169608, Singapore

Location

Novartis Investigative Site

Singapore, 529889, Singapore

Location

Novartis Investigative Site

Lučenec, 984 01, Slovakia

Location

Novartis Investigative Site

Khon Kaen, THA, 40002, Thailand

Location

Novartis Investigative Site

Bangkok, 10400, Thailand

Location

Novartis Investigative Site

Chiang Mai, 50200, Thailand

Location

Novartis Investigative Site

Leytonstone, London, E11 1NR, United Kingdom

Location

Novartis Investigative Site

Cannock, Staffordshire, WS11 2XY, United Kingdom

Location

Novartis Investigative Site

Bradford, West Yorkshire, BD5 0NA, United Kingdom

Location

Novartis Investigative Site

Glasgow, G31 2ER, United Kingdom

Location

Novartis Investigative Site

London, SE1 9RT, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 30167329 DERIVED

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Observed data is reported for outcome measures The non-fatal adverse events are reported under "Serious Adverse Events"

Results Point of Contact

• Title: Clinical Disclosure Office
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

+1 (862) 778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2013
• First Posted: July 4, 2013
• Study Start: September 30, 2013
• Primary Completion: January 11, 2018
• Study Completion: January 11, 2018
• Last Updated: June 12, 2019
• Results First Posted: June 12, 2019

Record last verified: 2019-05

Locations

IT (4); BE (3); DE (11); TH (3); PL (2); GB (5); BU (3); RU (6); CZ (3); AU (2); AR (6); CA (5); US (22); SL (1); SG (3); BR (3); IL (4); PH (8)