AzTrials
AzTrials

Psoriatic ArthritisPhase 3FUTURE5NCT02404350

Study to Demonstrate the Efficacy (Including Inhibition of Structural Damage), Safety and Tolerability up to 2 Years of Secukinumab in Active Psoriatic Arthritis

A Phase 3 study testing Secukinumab in people with Psoriatic Arthritis, run by Novartis Pharmaceuticals at 172 sites in 28 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study was to demonstrate efficacy including effect on inhibition of progression of structural damage, safety and tolerability up to 2 years with primary focus at Week 16 (week 24 for structural damage), to support the use of secukinumab pre-filled syringe (PFS) by subcutaneous (s.c.)… 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
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
997 participants
Where
172 sitesin 28 countries
Study dates
31 Aug 2015to 24 Jan 2019
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 PsA classified by CASPAR criteria and with symptoms for at least 6 months with moderate to severe PsA who must have at BSL ≥3 tender joints out of 78 and ≥3 swollen joints out of 76 (dactylitis of a digit counts as one joint each).
  • Rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) antibodies negative at screening.
  • Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis or a documented history of plaque psoriasis.
  • Subjects with PsA should have taken NSAIDs for at least 4 weeks prior to randomization with inadequate control of symptoms or at least one dose if stopped due to intolerance to NSAIDs.-Subjects who are regularly taking NSAIDs as part of their PsA therapy are required to be on a stable dose for at least 2 weeks before study randomization and should remain on a stable dose up to Week 24.
  • Subjects taking corticosteroids must be on a stable dose of ≤10 mg/day prednisone or equivalent for at least 2 weeks before randomization and should remain on a stable dose up to Week 24.
  • Subjects taking MTX (≤ 25 mg/week) are allowed to continue their medication if the dose is stable for at least 4 weeks before randomization and should remain on a stable dose up to Week 52.
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  • Subjects on MTX must be on folic acid supplementation at randomization.
  • Subjects who are on a DMARD other than MTX must discontinue the DMARD 4 weeks prior to randomization visit except for leflunomide, which has to be discontinued for 8 weeks prior to randomization unless a cholestyramine wash-out has been performed.
  • Subjects who have been on a TNFα inhibitor must have experienced an inadequate response to previous or current treatment with a TNFα inhibitor given at an approved dose for at least 3 months or have stopped treatment due to safety/tolerability problems after at least one administration of a TNFα inhibitor.
  • Subjects who have previously been treated with TNFα inhibitors (investigational or approved) will be allowed entry into study after appropriate wash-out period prior to randomization

Who cannot join

  • Chest X-ray or chest 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 IL-17 or IL-17 receptor. - Ongoing use of prohibited psoriasis treatments / medications (e.g., topical corticosteroids, UV therapy) at randomization.
  • Any intramuscular or intravenous or intra-articular corticosteroid treatment within 4 weeks before randomization.
  • Subjects who have ever received biologic immunomodulating agents except for those targeting TNFα (investigational or approved).
  • Previous treatment with any cell-depleting therapies including but not limited to anti- CD20, investigational agents
  • Other protocol-defined exclusion criteria do apply

Trial locations and contacts

172 sites in 28 countries.

172 sites in 28 countries

United States22 sites

  • Novartis Investigative Site

    Aurora, Colorado, 80045

  • Novartis Investigative Site

    Brandon, Florida, 33511

  • Novartis Investigative Site

    Brooklyn, New York, 11215

  • Novartis Investigative Site

    Coeur d'Alene, Idaho, 83814

  • Novartis Investigative Site

    Denver, Colorado, 80230

  • Novartis Investigative Site

    Duncansville, Pennsylvania, 16635

  • Novartis Investigative Site

    Jackson, Tennessee, 38305

  • Novartis Investigative Site

    Kingsport, Tennessee, 37660

  • Novartis Investigative Site

    Mesquite, Texas, 75150

  • Novartis Investigative Site

    Oklahoma City, Oklahoma, 73102

  • Novartis Investigative Site

    Oklahoma City, Oklahoma, 73103

  • Novartis Investigative Site

    Portland, Oregon, 97239

  • Novartis Investigative Site

    Rochester, New York, 14623

  • Novartis Investigative Site

    Seattle, Washington, 98101

  • Novartis Investigative Site

    Seattle, Washington, 98104

  • Novartis Investigative Site

    Seattle, Washington, 98122

  • Novartis Investigative Site

    Shreveport, Louisiana, 71101

  • Novartis Investigative Site

    Spokane, Washington, 99204

  • Novartis Investigative Site

    Tampa, Florida, 33624

  • Novartis Investigative Site

    Upland, California, 91786

  • Novartis Investigative Site

    Wexford, Pennsylvania, 15090

  • Novartis Investigative Site

    Wyomissing, Pennsylvania, 19610

Other trials in United States

United Kingdom21 sites

  • Novartis Investigative Site

    Basingstoke, Hampshire, RG24 9NA

  • Novartis Investigative Site

    Bath, BA1 1RL

  • Novartis Investigative Site

    Bradford, West Yorkshire, BD5 0NA

  • Novartis Investigative Site

    Christchurch, Dorset, BH23 2JX

  • Novartis Investigative Site

    Dundee, DD1 9SY

  • Novartis Investigative Site

    Eastbourne, BN21 2UD

  • Novartis Investigative Site

    Edinburgh, EH4 2XU

  • Novartis Investigative Site

    Glasgow, G31 2ER

  • Novartis Investigative Site

    Inverness, Invernesshire, IV2 3RE

  • Novartis Investigative Site

    Leicester, LE1 5WW

  • Novartis Investigative Site

    London, England, E11 1NR

  • Novartis Investigative Site

    London, NW1 2BU

  • Novartis Investigative Site

    London, NW3 2QG

  • Novartis Investigative Site

    London, SE1 9RT

  • Novartis Investigative Site

    Manchester, M13 9WL

  • Novartis Investigative Site

    Oxford, OX3 7LD

  • Novartis Investigative Site

    Portsmouth, PO6 3LY

  • Novartis Investigative Site

    Salford, Manchester, M6 8HD

  • Novartis Investigative Site

    Stoke-on-Trent, Staffordshire, ST6 7AG

  • Novartis Investigative Site

    Truro, Cornwall, TR1 3LJ

  • Novartis Investigative Site

    Wigan, WN6 9EP

Other trials in United Kingdom

Russia15 sites

  • Novartis Investigative Site

    Chelyabinsk, 454000

  • Novartis Investigative Site

    Chelyabinsk, 454076

  • Novartis Investigative Site

    Kazan', 420064

  • Novartis Investigative Site

    Kemerovo, 650000

  • Novartis Investigative Site

    Moscow, 129301

  • Novartis Investigative Site

    Nizhny Novgorod, 603005

  • Novartis Investigative Site

    Nizhny Novgorod, 603018

  • Novartis Investigative Site

    Orenburg, 460018

  • Novartis Investigative Site

    Rostov-on-Don, 344022

  • Novartis Investigative Site

    Saint Petersburg, 194021

  • Novartis Investigative Site

    Saint Petersburg, 197022

  • Novartis Investigative Site

    Smolensk, 214019

  • Novartis Investigative Site

    Yaroslavl, 150003

  • Novartis Investigative Site

    Yekaterinburg, 620028

  • Novartis Investigative Site

    Yekaterinburg, 620137

Other trials in Russia

Germany13 sites

  • Novartis Investigative Site

    Aachen, 52064

  • Novartis Investigative Site

    Bad Abbach, 93077

  • Novartis Investigative Site

    Berlin, 13125

  • Novartis Investigative Site

    Berlin, 13353

  • Novartis Investigative Site

    Germering, 82110

  • Novartis Investigative Site

    Gommern, 39245

  • Novartis Investigative Site

    Göttingen, 37075

  • Novartis Investigative Site

    Hamburg, 22081

  • Novartis Investigative Site

    Hamburg, 22143

  • Novartis Investigative Site

    Herne, 44649

  • Novartis Investigative Site

    Leipzig, 04103

  • Novartis Investigative Site

    Lübeck, 23538

  • Novartis Investigative Site

    Nienburg, 31582

Other trials in Germany

Spain13 sites

  • Novartis Investigative Site

    Alicante, Valencia, 03010

  • Novartis Investigative Site

    Barakaldo, Vizcaya, 48903

  • Novartis Investigative Site

    Barcelona, Catalonia, 08003

  • Novartis Investigative Site

    Barcelona, Catalonia, 08036

  • Novartis Investigative Site

    Barcelona, 08041

  • Novartis Investigative Site

    Bilbao, Basque Country, 48013

  • Novartis Investigative Site

    Córdoba, Andalusia, 14004

  • Novartis Investigative Site

    Madrid, 28046

  • Novartis Investigative Site

    Sabadell, Barcelona, 08208

  • Novartis Investigative Site

    Sant Joan Despí, Barcelona, 08970

  • Novartis Investigative Site

    Santiago de Compostela, Galicia, 15706

  • Novartis Investigative Site

    Valencia, Valencia, 46026

  • Novartis Investigative Site

    Vigo, Pontevedra, 36200

Other trials in Spain

Czechia7 sites

  • Novartis Investigative Site

    Bruntál, Czech Republic, 792 01

  • Novartis Investigative Site

    Ostrava, Czech Republic, 70200

  • Novartis Investigative Site

    Prague, Czech Republic, 128 50

  • Novartis Investigative Site

    Prague, Czech Republic, 140 00

  • Novartis Investigative Site

    Prague, Czech Republic, 140 59

  • Novartis Investigative Site

    Prague, Czech Republic, 148 00

  • Novartis Investigative Site

    Uherské Hradiště, 686 01

Other trials in Czechia

Canada6 sites

  • Novartis Investigative Site

    Sainte-Foy, Quebec, G1V 3M7

  • Novartis Investigative Site

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

  • Novartis Investigative Site

    Trois-Rivières, Quebec, G8Z 1Y2

  • Novartis Investigative Site

    Vancouver, British Columbia, V5Z 4E8

  • Novartis Investigative Site

    Victoria, British Columbia, V8V 3M9

  • Novartis Investigative Site

    Winnipeg, Manitoba, R3A 1M1

Other trials in Canada

Hungary6 sites

  • Novartis Investigative Site

    Budapest, 1036

  • Novartis Investigative Site

    Budapest, 1062

  • Novartis Investigative Site

    Eger, 3300

  • Novartis Investigative Site

    Kistarcsa, 2143

  • Novartis Investigative Site

    Székesfehérvár, H-8000

  • Novartis Investigative Site

    Veszprém, 8200

Other trials in Hungary

India6 sites

  • Novartis Investigative Site

    Ahmedabad, Gujarat, 380015

  • Novartis Investigative Site

    Mumbai, Maharashtra, 400 053

  • Novartis Investigative Site

    Nashik, Maharashtra, 422 101

  • Novartis Investigative Site

    New Delhi, 110029

  • Novartis Investigative Site

    Pune, Maharashtra, 411007

  • Novartis Investigative Site

    Secunderabad, Andhra Pradesh, 500003

Other trials in India

Israel6 sites

  • Novartis Investigative Site

    Ashkelon, 78278

  • Novartis Investigative Site

    Haifa, 343621

  • Novartis Investigative Site

    Kfar Saba, 4428164

  • Novartis Investigative Site

    Petah Tikva, 49100

  • Novartis Investigative Site

    Ramat Gan, 5265601

  • Novartis Investigative Site

    Tel Aviv, 6423906

Other trials in Israel

Lithuania6 sites

  • Novartis Investigative Site

    Kaunas, LT, LT-45130

  • Novartis Investigative Site

    Kaunas, LT, LT-50128

  • Novartis Investigative Site

    Klaipėda, LT-92288

  • Novartis Investigative Site

    Šiauliai, LT-76231

  • Novartis Investigative Site

    Vilnius, 09310

  • Novartis Investigative Site

    Vilnius, LT-07195

Other trials in Lithuania

Greece5 sites

  • Novartis Investigative Site

    Athens, GR, 115 27

  • Novartis Investigative Site

    Athens, 115 27

  • Novartis Investigative Site

    Athens, 12462

  • Novartis Investigative Site

    Pátrai, 265 00

  • Novartis Investigative Site

    Thessaloniki, GR, 564 29

Other trials in Greece

Italy5 sites

  • Novartis Investigative Site

    Brescia, BS, 25123

  • Novartis Investigative Site

    Palermo, PA, 90127

  • Novartis Investigative Site

    Pavia, PV, 27100

  • Novartis Investigative Site

    Potenza, PZ, 85100

  • Novartis Investigative Site

    Udine, UD, 33100

Other trials in Italy

Latvia5 sites

  • Novartis Investigative Site

    Liepāja, LV 3401

  • Novartis Investigative Site

    Riga, LV, LV-1005

  • Novartis Investigative Site

    Riga, LV 1002

  • Novartis Investigative Site

    Riga, LV-1038

  • Novartis Investigative Site

    Valmiera, LV-4201

Other trials in Latvia

Mexico5 sites

  • Novartis Investigative Site

    Mérida, Yucatán, 97070

  • Novartis Investigative Site

    Metepec, State of Mexico, 52140

  • Novartis Investigative Site

    Mexicali, Estado de Baja California, 21100

  • Novartis Investigative Site

    Mexico City, Mexico City, 11850

  • Novartis Investigative Site

    San Luis Potosí City, 78200

Other trials in Mexico

Thailand5 sites

  • Novartis Investigative Site

    Bangkok, 10400

  • Novartis Investigative Site

    Bangkoknoi, Bangkok, 10700

  • Novartis Investigative Site

    Chiang Mai, 50200

  • Novartis Investigative Site

    Khon Kaen, THA, 40002

  • Novartis Investigative Site

    Songkhla, Hat Yai, 90110

Other trials in Thailand

Austria4 sites

  • Novartis Investigative Site

    Graz, 8036

  • Novartis Investigative Site

    Vienna, 1100

  • Novartis Investigative Site

    Vienna, A-1060

  • Novartis Investigative Site

    Vienna, A-1160

Other trials in Austria

Netherlands4 sites

  • Novartis Investigative Site

    Maastricht, 6229 HX

  • Novartis Investigative Site

    Rotterdam, 3079 DZ

  • Novartis Investigative Site

    Schiedam, 3118 JH

  • Novartis Investigative Site

    Utrecht, 3508 GA

Other trials in Netherlands

Argentina3 sites

  • Novartis Investigative Site

    CABA, Buenos Aires, C1221ADC

  • Novartis Investigative Site

    San Miguel de Tucumán, Tucumán Province

  • Novartis Investigative Site

    San Miguel de Tucumán, 4000

Other trials in Argentina

Philippines3 sites

  • Novartis Investigative Site

    Manila, National Capital Region, 1000

  • Novartis Investigative Site

    Manila, 1008

  • Novartis Investigative Site

    Quezon City, 1102

Other trials in Philippines

Vietnam3 sites

  • Novartis Investigative Site

    Hanoi, 100000

  • Novartis Investigative Site

    Ho Chi Minh City, VNM, 700000

  • Novartis Investigative Site

    Ho Chi Minh City, 7000

Other trials in Vietnam

Chile2 sites

  • Novartis Investigative Site

    Santiago, 8207257

  • Novartis Investigative Site

    Vitacura, Santiago Metropolitan, 7640881

Other trials in Chile

Guatemala2 sites

  • Novartis Investigative Site

    Guatemala City, 01010

  • Novartis Investigative Site

    Guatemala City, 01011

Other trials in Guatemala

Denmark1 site

  • Novartis Investigative Site

    Odense, 5000 C

Other trials in Denmark

Estonia1 site

  • Novartis Investigative Site

    Tartu, 50406

Other trials in Estonia

Finland1 site

  • Novartis Investigative Site

    Hyvinkää, 05800

Other trials in Finland

Ireland1 site

  • Novartis Investigative Site

    Dublin

Other trials in Ireland

Sweden1 site

  • Novartis Investigative Site

    Stockholm, SE-17176

Other trials in Sweden

About this study

Official title: A Phase III, Randomized, Double-blind, Placebo Controlled Multi-center Study of Subcutaneous Secukinumab (150 mg and 300 mg) in Prefilled Syringe to Demonstrate Efficacy (Including Inhibition of Structural Damage), Safety, and Tolerability up to 2 Years in Subjects With Active Psoriatic Arthritis (FUTURE 5)

The purpose of this study was to demonstrate efficacy including effect on inhibition of progression of structural damage, safety and tolerability up to 2 years with primary focus at Week 16 (week 24 for structural damage), to support the use of secukinumab pre-filled syringe (PFS) by subcutaneous (s.c.) self-administration with or without loading regimen in subjects with active Psoriatic Arthritis (PsA) despite current or previous NSAID, DMARD therapy and/or previous anti-TNFα therapy. Long term efficacy up to 2 years was based on signs and symptoms of joint/bone structure preservation (X-ray) and improvement in physical function measured by Health Assessment Questionnaire - Disability Index (HAQ-DI©), as well as skin and nail improvement for psoriasis signs.

Read the detailed description

This multicenter study uses a randomized, double-blind, placebo-controlled, parallel-group design. A screening period (SCR) running up to 10 weeks before randomization will be used to assess subject eligibility followed by 104 weeks of treatment.

At BSL approximately 990 subjects whose eligibility is confirmed will be randomized to one of four treatment groups in 2:2:2:3 ratio:

  • Group 1 - secukinumab 150 mg s.c. without loading regimen
  • Group 2 - secukinumab 150 mg s.c. with loading dose regimen
  • Group 3 - secukinumab 300 mg s.c. with loading dose regimen
  • Group 4 - Placebo s.c. NOTE: Group 4 is split into 2 treatment arms, detailed description below. At randomization, subjects will be stratified on the basis of previous anti-TNF therapy as TNFα inhibitor naïve (TNF-naïve) or TNFα inhibitor inadequate responders (TNF-IR).

At each study treatment visit, one (for secukinumab 150 mg) or two (for secukinumab 300 mg) s.c. injections in the form of PFS will be administered, since secukinumab is available in 1.0 mL (150 mg) PFSs. Placebo to secukinumab is also available in 1.0 mL to match the active drug.

At Week 16, subjects who have been randomized to secukinumab groups at BSL (Groups 1-3) will be classified as either responders (≥20% improvement from BSL in both tender joint count (TJC) and swollen joint counts (SJC)) or non-responders (<20% improvement from BSL TJC or SJC), however they will continue on the same treatment irrespective of their response status.

At Week 16, subjects who have been randomized to placebo at BSL (Group 4) will be classified as either responders (≥20% improvement from BSL in both TJC and SJC) or non-responders (<20% improvement from BSL TJC or SJC):

  • Subjects who are non-responders will receive either secukinumab 150 mg or 300 mg s.c. every 4 weeks starting at Week 16 (as dictated by treatment sequence assigned to these subjects at BSL).
  • Subjects who are responders will continue to receive placebo every 4 weeks. Starting Week 24, these subjects will receive either secukinumab 150 mg s.c. or 300 mg s.c. every 4 weeks starting at Week 24 (as dictated by treatment sequence assigned to these subjects at BSL).

At Week 24, the assessments to address the primary objective will be performed. As described above, subjects who are still receiving placebo s.c. injection will receive either secukinumab 150 mg s.c. or 300 mg s.c. every 4 weeks starting at Week 24 (as dictated by treatment sequence assigned to these subjects at BSL).

At week 52, based on Investigator's decision, the subjects on a 150 mg dose whose signs and symptoms do not show satisfactory response have the possibility to be allocated to secukinumab 300 mg s.c.

After the Week 52 database lock and analyses have been completed, site personnel and subjects will be unblinded to the original randomized treatment (sequence) assignment at randomization. In addition, treatment will be given open-label in order to eliminate the placebo injection. The subject will continue to receive the same active dose of secukinumab as open-label treatment administered until Week 100.

Being tested
Secukinumab
Keywords
Psoriatic Arthritis, Arthritis, Psoriatic, Psoriatic Arthropathy, Spondylitis
Medical subject headings
Arthritis, Psoriatic, Arthritis, Spondylitis

What participants receive

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

  • SecukinumabBiological

    Also called AIN457

    Anti IL-17a monoclonal antibody

Study groups in NCT02404350
Study groupRoleWhat they receive
Secukinumab 150 mg load (Group 1)ExperimentalSecukinumab 150 mg sc injection every week for 4 weeks followed by Secukinumab 150 mg every 4 weeks until week 100 Beginning at Week 52, for subjects whose signs and symptoms were not fully controlled, and who the investigator believed may improve further with an increase in dose, may have had the secukinumab dose increased to 300mg s.c. every 4 weeks until week 100
Receives: Biological: Secukinumab
Secukinumab 150 mg no load (Group 2)ExperimentalSecukinumab 150 mg sc injection every 4 weeks until week 100 Beginning at Week 52, for subjects whose signs and symptoms were not fully controlled, and who the investigator believed may improve further with an increase in dose, may have had the secukinumab dose increased to 300mg s.c. every 4 weeks.
Receives: Biological: Secukinumab
Secukinumab 300 mg load (Group 3)ExperimentalSecukinumab 300 mg sc injection every week for 4 weeks followed by Secukinumab 300 mg every 4 weeks until week 100
Receives: Biological: Secukinumab
Placebo arm 1 (Group 4)Placebo comparatorPlacebo to Secukinumab sc injection every week for 4 weeks followed by placebo to Secukinumab every 4 weeks until week 16. Non-responders will be switched to Secukinumab either 150 or 300 mg sc injection every four weeks until week 100. Responders at week 16 continued receiving placebo until week 24, then were switched to secukinumab 150 or 300 mg sc injection every 4 weeks until week 100. PLEASE NOTE: Placebo arms 1 and 2 belong to the same placebo group (group 4) Beginning at Week 52, for subjects whose signs and symptoms were not fully controlled, and who the investigator believed may improve further with an increase in dose, may have had the secukinumab dose increased to 300mg s.c. every 4 weeks.
Receives: Biological: Secukinumab
Placebo arm 2 (Group 4)Placebo comparatorPlacebo to Secukinumab sc injection every week for 4 weeks followed by placebo to Secukinumab every 4 weeks until week 16. Non-responders were switched to Secukinumab either 150 or 300 mg sc injection every four weeks until week 100. Responders at week 16 continued receiving placebo until week 24, then were switched to secukinumab 150 or 300 mg sc injection every 4 weeks until week 100. PLEASE NOTE: Placebo arms 1 and 2 belong to the same placebo group (group 4) Beginning at Week 52, for subjects whose signs and symptoms were not fully controlled, and who the investigator believed may improve further with an increase in dose, may have had the secukinumab dose increased to 300mg s.c. every 4 weeks.
Receives: Biological: Secukinumab

What is being measured

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

  1. Percentage of Participants With Active Psoriatic Arthritis (PsA) Achieving an American College of Rheumatology Response 20 (ACR20) at Week 16

    ACR20 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20% improvement based on tender 78-joint count, swollen 76-joint count and at least 20% improvement in 3 of the following 5 measures: participant's assessment of PsA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, participant's self-assessed disability (Health Assessment Questionnaire Disability Index (HAQ-DI) score), and acute phase reactant evaluated as (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR)).

    Measured: Week 16

Secondary outcomes (8)

  1. Change From Baseline to Week 24 With Secukinumab Compared With Placebo for Joint/Bone Structural Damage (Using Van Der Heijde Modified Total Sharp Score (mTSS))

    PsA modified vdH-mTSS scoring method was used to assess bone erosion \& joint space narrowing (JSN) in hands \& feet; that included the 2nd through 5th distal interphalangeal (DIP) joints of each hand. Maximum score for erosions was 5 in joints of the hands and 10 in joints of the feet with 0=no erosions, 1=discrete erosion, 2=large erosion not passing the mid-line, and 3=large erosion passing the mid-line. JSN is: 0=normal, 1=asymmetrical or minimal narrowing up to a maximum of 25%, 2 = definite narrowing with loss of up to 50% of the normal space, 3 = definite narrowing with loss of 50-99% of the normal space, and 4 = absence of a joint space. Maximum erosion score is 320 (200 for the hands and 120 for the feet), and the max total JSN score is 208 (160 for the hands and 48 for the feet). Total radiographic score (hands \& feet combined) ranges from 0 to 528, where higher scores indicate more articular damage

    Measured: Baseline, Week 24

  2. Count and Percentage of Patients Achieving Psoriatic Area and Severity Index 75 (PASI75) Response

    The efficacy of secukinumab 150 mg (with or without loading regimen), or 300 mg (with loading regimen) at Week 16 compared with placebo based on the proportion of patients achieving Psoriatic Area and Severity Index 75 (PASI75) response.

    Measured: Week 16

  3. Count and Percentage of Patients Achieving Psoriatic Area and Severity Index 90 (PASI90) Response

    The efficacy of secukinumab 150 mg (with or without loading regimen), or 300 mg (with loading regimen) at Week 16 compared with placebo based on the proportion of patients achieving Psoriatic Area and Severity Index 90 (PASI90) response.

    Measured: 16 weeks

  4. Count and Percentage of Patients Achieving an ACR50 Response

    ACR 50 Response is a measure based on American College of Rheumatology criteria of at least a 50% improvement in the number of tender and swollen joints, and a 50% improvement in at least 3 of the following: the patient's global assessment of disease status; the patient's assessment of pain; the patient's assessment of function measured using the Stanford Health Assessment Questionnaire the physician's global assessment of disease status; serum C-reactive protein levels.

    Measured: 16 weeks

  5. Change From Baseline in HAQ-DI© Score

    The change (within treatment) on secukinumab 150 mg (with or without loading regimen), or 300 mg (with loading regimen), at Week 16 compared with placebo for the disease activity assessed by the changes in The Health Assessment Questionnaire disability index (HAQ-DI) relative to baseline.

    Measured: 16 weeks

  6. Change From Baseline in Disease Activity Score for 28 Joints (DAS28-CRP) (Utilizing High Sensitivity C-Reactive Protein (hsCRP))

    The improvement on secukinumab 150 mg (with or without loading regimen), or 300 mg (with loading regimen) at Week 16 compared with placebo for the disease activity assessed by the changes in Disease Activity Score for 28 joints (DAS28-CRP) (utilizing High sensitivity C-Reactive Protein (hsCRP)) relative to baseline.

    Scores range from 0 (no difficulty) to 3 (unable to do)

    Measured: 16 weeks

  7. Count and Percentage of Patients With Enthesitis in the Subset of Patients Who Had Enthesitis at Baseline

    The efficacy of secukinumab pooled regimen (150 mg with or without loading regimen, and 300 mg with loading regimen) at Week 16 compared with placebo based on the proportion of patients with enthesitis in the subset of patients who had enthesitis at baseline

    Measured: 16 weeks

  8. Count and Percentage of Participants With Dactylitis in the Subset of Patients Who Have Dactylitis at Baseline

    The efficacy of secukinumab pooled regimen (150 mg with or without loading regimen, and 300 mg with loading regimen) at Week 16 compared with placebo based on the proportion of patients with dactylitis in the subset of patients who have dactylitis at baseline

    Measured: 16 weeks

Timeline

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

  1. First posted31 Mar 2015 (estimated)
  2. Study start31 Aug 2015
  3. Primary completion16 Aug 2017
  4. Study completion24 Jan 2019

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
997 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02404350
Sponsor's protocol ID
CAIN457F2342
Other IDs
2015-000050-38, 02404350, 2015
Acronym
FUTURE5
Status last verified
Apr 2020
First submitted
16 Mar 2015
Last updated
20 Apr 2020
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
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 P, van der Heijde D, Landewe R, Mpofu S, Rahman P, Tahir H, Singhal A, Boettcher E, Navarra S, Meiser K, Readie A, Pricop L, Abrams K. Secukinumab improves active psoriatic arthritis symptoms and inhibits radiographic progression: primary results from the randomised, double-blind, phase III FUTURE 5 study. Ann Rheum Dis. 2018 Jun;77(6):890-897. doi: 10.1136/annrheumdis-2017-212687. Epub 2018 Mar 17.

    PubMed 29550766

  • Mease PJ, Coates LC, Gaillez C, Shew A, Bao W, Ritchlin CT. Relationship of radiographic progression status to low disease activity in patients with PsA receiving secukinumab treatment for 2 years. Rheumatology (Oxford). 2026 Jan 8;65(1):keaf488. doi: 10.1093/rheumatology/keaf488.

    PubMed 40973471

  • 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

  • Mease PJ, Landewe R, Rahman P, Tahir H, Singhal A, Boettcher E, Navarra S, Readie A, Mpofu S, Delicha EM, Pricop L, van der Heijde D. Secukinumab provides sustained improvement in signs and symptoms and low radiographic progression in patients with psoriatic arthritis: 2-year (end-of-study) results from the FUTURE 5 study. RMD Open. 2021 Jul;7(2):e001600. doi: 10.1136/rmdopen-2021-001600.

    PubMed 34330846

  • van der Heijde D, Mease PJ, Landewe RBM, Rahman P, Tahir H, Singhal A, Boettcher E, Navarra S, Zhu X, Ligozio G, Readie A, Mpofu S, Pricop L. Secukinumab provides sustained low rates of radiographic progression in psoriatic arthritis: 52-week results from a phase 3 study, FUTURE 5. Rheumatology (Oxford). 2020 Jun 1;59(6):1325-1334. doi: 10.1093/rheumatology/kez420.

    PubMed 31586420

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 172 sites in 28 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 10 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 20 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 172 sites in United States, United Kingdom, Russia, Germany, Spain and 23 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 28 Jun 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?

Percentage of Participants With Active Psoriatic Arthritis (PsA) Achieving an American College of Rheumatology Response 20 (ACR20) at Week 16 (time frame: Week 16). 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 NCT02404350, which also lists 6 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 20 Apr 2020.

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