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)

Psoriatic Arthritis Clinical Trial

— FUTURE 1  

Official title:

A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Psoriatic Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01392326
• Other study ID #: CAIN457F2306
• Secondary ID: 2011-000276-34
• Status: Completed
• Phase: Phase 3
• First received: July 7, 2011
• Last updated: January 5, 2016
• Start date: September 2011
• Est. completion date: October 2014

Study information

• Verified date: January 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaAustralia: Department of Health and Ageing Therapeutic Goods AdministrationBelgium: Federal Agency for Medicinal Products and Health ProductsBrazil: National Health Surveillance AgencyBulgaria: Bulgarian Drug AgencyCanada: Health CanadaCzech Republic: State Institute for Drug ControlGermany: Federal Institute for Drugs and Medical DevicesIsrael: Ministry of HealthItaly: Ethics CommitteePeru: Ministry of HealthPhilippines: Department of HealthPoland: Ministry of HealthRomania: National Medicines AgencyRussia: Ministry of Health of the Russian FederationSingapore: Health Sciences AuthoritySlovakia: State Institute for Drug ControlThailand: Ethical CommitteeTurkey: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

This study will assess the efficacy and safety of secukinumab in patients with active psoriatic arthritis who are intolerant to or have had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 606
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Male or non-pregnant, non-lactating female patients at least 18 years of age

• Diagnosis of PsA classified by CASPAR criteria and with symptoms for at least 6 months with moderate to severe PsA who must have at Baseline =3 tender joints out of 78 and =3 swollen out of 76 (dactylitis of a digit counts as one joint each)

• Rheumatoid factor and anti-CCP antibodies negative

• Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of =2cm diameter or nail changes consistent with psoriasis or documented history o plaque psoriasis

Exclusion criteria:

• Chest X-ray with evidence of ongoing infectious or malignant process

• Subjects who have previously been treated with more than 3 different TNFa inhibitors

• Subjects taking high potency opioid analgesics

• Subjects who have ever received biologic immunomodulating agents except for those targeting TNFa Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

Drug:
• Secukinumab (75 mg)
Secukinumab (75 mg)
• Secukinumab (150 mg)
Secukinumab (150 mg)
• Placebo Comparator
Placebo Comparator

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Rosario	Santa Fe
Argentina	Novartis Investigative Site	Rosario	Santa Fe
Australia	Novartis Investigative Site	Malvern	Victoria
Australia	Novartis Investigative Site	Maroochydore	Queensland
Belgium	Novartis Investigative Site	Genk
Belgium	Novartis Investigative Site	Gent
Belgium	Novartis Investigative Site	Leuven
Brazil	Novartis Investigative Site	Porto Alegre	RS
Brazil	Novartis Investigative Site	Sao Paulo	SP
Brazil	Novartis Investigative Site	São Paulo	SP
Bulgaria	Novartis Investigative Site	Pleven
Bulgaria	Novartis Investigative Site	Sevlievo
Bulgaria	Novartis Investigative Site	Sofia
Bulgaria	Novartis Investigative Site	Sofia
Canada	Novartis Investigative Site	Newmarket	Ontario
Canada	Novartis Investigative Site	St. John	Newfoundland and Labrador
Canada	Novartis Investigative Site	St. John's	Newfoundland and Labrador
Canada	Novartis Investigative Site	Trois-Rivieres	Quebec
Canada	Novartis Investigative Site	Waterloo	Ontario
Czech Republic	Novartis Investigative Site	Bruntal
Czech Republic	Novartis Investigative Site	Uherske Hradiste
Czech Republic	Novartis Investigative Site	Zlin
Germany	Novartis Investigative Site	Aachen
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Erlangen
Germany	Novartis Investigative Site	Erlangen
Germany	Novartis Investigative Site	Gommern
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Herne
Germany	Novartis Investigative Site	Hildesheim
Germany	Novartis Investigative Site	Koeln
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Nürnberg
Germany	Novartis Investigative Site	Ratingen
Germany	Novartis Investigative Site	Zerbst
Israel	Novartis Investigative Site	Ashkelon
Israel	Novartis Investigative Site	Haifa
Israel	Novartis Investigative Site	Ramat Gan
Israel	Novartis Investigative Site	Tel-Aviv
Italy	Novartis Investigative Site	Catania	CT
Italy	Novartis Investigative Site	Prato	PO
Italy	Novartis Investigative Site	Siena	SI
Italy	Novartis Investigative Site	Valeggio Sul Mincio	(vr)
Philippines	Novartis Investigative Site	Dasmarinas	Cavite
Philippines	Novartis Investigative Site	Las Pinas
Philippines	Novartis Investigative Site	Lipa City	Batangas
Philippines	Novartis Investigative Site	Manila	Metro Manila
Philippines	Novartis Investigative Site	Manila
Philippines	Novartis Investigative Site	Manila
Philippines	Novartis Investigative Site	Manila
Philippines	Novartis Investigative Site	Quezon City
Philippines	Novartis Investigative Site	Quezon City
Poland	Novartis Investigative Site	Bialystok
Poland	Novartis Investigative Site	Warszawa
Romania	Novartis Investigative Site	Bucharest	District 1
Romania	Novartis Investigative Site	Bucharest
Romania	Novartis Investigative Site	Cluj Napoca
Romania	Novartis Investigative Site	Iasi
Russian Federation	Novartis Investigative Site	Ekaterinburg
Russian Federation	Novartis Investigative Site	Ekaterinburg
Russian Federation	Novartis Investigative Site	Kemerovo
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	St-Petersburg
Russian Federation	Novartis Investigative Site	Yaroslavl
Singapore	Novartis Investigative Site	Singapore
Singapore	Novartis Investigative Site	Singapore
Singapore	Novartis Investigative Site	Singapore
Slovakia	Novartis Investigative Site	Lucenec
Slovakia	Novartis Investigative Site	Piestany	Slovak Republic
Thailand	Novartis Investigative Site	Bangkok
Thailand	Novartis Investigative Site	Chiang Mai
Thailand	Novartis Investigative Site	Khon Kaen
United Kingdom	Novartis Investigative Site	Bradford	West Yorkshire
United Kingdom	Novartis Investigative Site	Cannock	Staffordshire
United Kingdom	Novartis Investigative Site	Glasgow
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	London	England
United States	Novartis Investigative Site	Anniston	Alabama
United States	Novartis Investigative Site	Benbrook	Texas
United States	Novartis Investigative Site	Boston	Massachusetts
United States	Novartis Investigative Site	Charlotte	North Carolina
United States	Novartis Investigative Site	Columbia	South Carolina
United States	Novartis Investigative Site	Dallas	Texas
United States	Novartis Investigative Site	Dallas	Texas
United States	Novartis Investigative Site	Duncansville	Pennsylvania
United States	Novartis Investigative Site	Eagan	Minnesota
United States	Novartis Investigative Site	Freehold	New Jersey
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Jackson	Tennessee
United States	Novartis Investigative Site	Johnston	Rhode Island
United States	Novartis Investigative Site	Lincoln	Nebraska
United States	Novartis Investigative Site	Mesa	Arizona
United States	Novartis Investigative Site	Mesquite	Texas
United States	Novartis Investigative Site	Newnan	Georgia
United States	Novartis Investigative Site	North Charleston	South Carolina
United States	Novartis Investigative Site	Oklahoma City	Oklahoma
United States	Novartis Investigative Site	Paradise Valley	Arizona
United States	Novartis Investigative Site	Richmond Heights	Missouri
United States	Novartis Investigative Site	Seattle	Washington
United States	Novartis Investigative Site	Tamarac	Florida
United States	Novartis Investigative Site	Upland	California

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Bulgaria,  Canada,  Czech Republic,  Germany,  Israel,  Italy,  Philippines,  Poland,  Romania,  Russian Federation,  Singapore,  Slovakia,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of Patients Achieving ACR20 Response Criteria on Secukinumab 75 or 150 mg vs. Placebo	A patient will be considered as improved according the ACR20 criteria if she/he has at least 20 % improvement in the two following measures:Tender joint count,Swollen joint count and at least 3 of the following 5 measures: Patient's assessment of pain, Patient's global assessment disease activity,Physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score,Acute phase reactant (hsCRP or ESR)	Week 24	No
Secondary	Percent of Subjects Achieving a PASI75 Response in the Subgroup of Subjects Who Have =3% Skin Involvement With Psoriasis at Baseline	A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials with end points of psoriasis	Week 24	No
Secondary	Percent of Subjects Achieving a PASI90 Response in the Subgroup of Subjects Who Have =3% Skin Involvement With Psoriasis at Baseline	A 90% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 90) is above the current benchmark of primary endpoints for most clinical trials with endpoints of psoriasis	Week 24	No
Secondary	Change From Baseline in DAS28-CRP for Secukinumab 75 or 150 mg	DAS-CRP values range from 2.0 to 10.0 while higher values mean a higher disease activity. A DAS-CRP below the value of 2.6 is interpreted as Remission.DAS28 the DAS-CRP uses 28 different joints for its calculation: proximal interphalangeal joints (10 joints) metacarpophalangeal joints (10) wrists (2) elbows (2) shoulders (2) knees (2) With the above mentioned parameters, DAS-CRP is calculated as:	Week 24	No
Secondary	Change From Baseline in SF36-PCS for Secukinumab 75 or 150 mg	The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	Week 24	No
Secondary	Change From Baseline in HAQ-DI for Secukinumab 75 or 150 mg	HAQ-DI, assesses a patient's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in eight categories of functioning which represent a comprehensive set of functional activities - dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. The stem of each item asks over the past week "Are you able to …" perform a particular task. The patient's responses are made on a scale from zero (no disability) to three (completely disabled).	Week 24	No
Secondary	Percent of Patients Achieving ACR50 Response Criteria on Secukinumab 75 or 150 mg vs. Placebo	ACR50 = 50 % improvement in at least 3 of the 5 measures( Patient's assessment of pain, Patient's global assessment of disease activity, Physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, C-reactive protein (CRP)/Erythrocyte Sedimentation Rate (ESR) and 50 % improvement in the swollen and tender joint count.	Week 24	No
Secondary	Change From Baseline for Joint/Bone Structural Damage (Van Der Heijde Modified Total Sharp Score) for Secukinumab 75 and 150 mg (Pooled Doses)	Measured are 44 joints for erosions: scored 0 to 5 in hands; 0 to 10 in feet;40 joints for joint space narrowing; summed for total score by two experienced readers scored every film blinded to patient identity, treatment, sequence of film. Lower score equals better outcome. With score of zero being normal. Joint structural damage change from baseline at Week 24 using non-parametric ANCOVA, Linear extrapolation. Estimate (for the difference in mean), SE are from a non-parametric ANCOVA model with the change from baseline van der Heijde total modified Sharp score as the dependent variable, treatment and randomization stratum (TNFa status -naive or IR ) as factors, and weight and baseline van der Heijde total modified Sharp score as covariates.	Week 24	No
Secondary	Percent of Patients With Dactylitis in the Subset of Subjects Who Have Dactylitis at Baseline		Week 24	No
Secondary	Percent of Patients With Enthesitis in the Subset of Subjects Who Have Enthesitis at Baseline		Week 24	No