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Psoriatic ArthritisPhase 3FUTURE 2NCT01752634

Efficacy at 24 Weeks With Long Term Safety, Tolerability and Efficacy up to 5 Years of Secukinumab in Patients of Active Psoriatic Arthritis

A Phase 3 study testing Secukinumab (AIN457) in people with Psoriatic Arthritis, run by Novartis Pharmaceuticals at 76 sites in 11 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

This study was to provide 24 - 52 week efficacy, safety and tolerability data to support the registration of the secukinumab (AIN457) prefilled syringe (PFS) for subcutaneous self administration in subjects with active PsA despite current or previous NSAID, DMARD and/or anti-TNFα therapy. 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 (AIN457)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
397 participants
Where
76 sitesin 11 countries
Study dates
14 Apr 2013to 9 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

Inclusion Criteria:Patients eligible for inclusion in this study have to fulfill all of the following criteria:

  • 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 at screening
  • Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis or 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 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.

Exclusion Criteria:Patients fulfilling any of the following criteria are not eligible for inclusion in this study:

  • Chest X-ray or chest MRI with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician
  • Subjects taking high potency opioid analgesics (e.g. methadone, hydromorphone, morphine)
  • 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. The following wash out periods need to be observed:
  • Oral or topical retinoids 4 weeks
  • Photochemotherapy (e.g. PUVA) 4 weeks
  • Phototherapy (UVA or UVB) 2 weeks
  • Topical skin treatments (except in face, scalp and genital area during screening, only corticosteroids with mild to moderate potency) 2 weeks
  • 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 (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19)

Trial locations and contacts

76 sites in 11 countries.

76 sites in 11 countries

United States21 sites

  • Novartis Investigative Site

    Asheville, North Carolina, 28801

  • Novartis Investigative Site

    Aventura, Florida, 33180

  • Novartis Investigative Site

    Charleston, South Carolina, 29460

  • Novartis Investigative Site

    Charlotte, North Carolina, 28210

  • Novartis Investigative Site

    Columbia, South Carolina, 29204

  • Novartis Investigative Site

    Duncansville, Pennsylvania, 16635

  • Novartis Investigative Site

    Freehold, New Jersey, 07728

  • Novartis Investigative Site

    Greenville, South Carolina, 29601

  • Novartis Investigative Site

    League City, Texas, 77573

  • Novartis Investigative Site

    Lincoln, Nebraska, 68516

  • Novartis Investigative Site

    Mesquite, Texas, 75150

  • Novartis Investigative Site

    Oklahoma City, Oklahoma, 73102

  • Novartis Investigative Site

    Oklahoma City, Oklahoma, 73103

  • Novartis Investigative Site

    Omaha, Nebraska, 68114

  • Novartis Investigative Site

    Palm Harbor, Florida, 34684

  • Novartis Investigative Site

    Peoria, Arizona, 85381

  • Novartis Investigative Site

    Sarasota, Florida, 34239

  • Novartis Investigative Site

    Syracuse, New York, 13210

  • Novartis Investigative Site

    Tamarac, Florida, 33321

  • Novartis Investigative Site

    Tampa, Florida, 33624

  • Novartis Investigative Site

    Zephyrhills, Florida, 33542

Other trials in United States

United Kingdom12 sites

  • Novartis Investigative Site

    Blackpool, FY3 7EN

  • Novartis Investigative Site

    Cambridge, CB2 2QQ

  • Novartis Investigative Site

    Cannock, Staffordshire, WS11 2XY

  • Novartis Investigative Site

    Dudley, West Midlands, DY1 2HQ

  • Novartis Investigative Site

    Glasgow, G51 4TF

  • Novartis Investigative Site

    Guildford, Surrey, GU2 7XX

  • Novartis Investigative Site

    Leeds, West Yorkshire, LS7 4SA

  • Novartis Investigative Site

    London, England, E11 1NR

  • Novartis Investigative Site

    London, NW3 2QG

  • Novartis Investigative Site

    London, SE1 9RT

  • Novartis Investigative Site

    Salford, Manchester, M6 8HD

  • Novartis Investigative Site

    Southampton, SO16 6YD

Other trials in United Kingdom

Germany9 sites

  • Novartis Investigative Site

    Aachen, 52064

  • Novartis Investigative Site

    Berlin, 12203

  • Novartis Investigative Site

    Erlangen, 91054

  • Novartis Investigative Site

    Erlangen, 91056

  • Novartis Investigative Site

    Germering, 82110

  • Novartis Investigative Site

    Hamburg, 22081

  • Novartis Investigative Site

    Herne, 44649

  • Novartis Investigative Site

    Würzburg, 97080

  • Novartis Investigative Site

    Zerbst, 39261

Other trials in Germany

Russia9 sites

  • Novartis Investigative Site

    Chelyabinsk, 454076

  • Novartis Investigative Site

    Kazan', 420097

  • Novartis Investigative Site

    Moscow, 115522

  • Novartis Investigative Site

    Petrozavodsk, 185019

  • Novartis Investigative Site

    Rostov-on-Don, 344022

  • Novartis Investigative Site

    Saint Petersburg, 190068

  • Novartis Investigative Site

    Sestroretsk, 197706

  • Novartis Investigative Site

    Yaroslavl, 150003

  • Novartis Investigative Site

    Yekaterinburg, 620028

Other trials in Russia

Canada6 sites

  • Novartis Investigative Site

    Pointe-Claire, Quebec, H9R 3J1

  • Novartis Investigative Site

    Québec, Quebec, G1W 4R4

  • Novartis Investigative Site

    Sainte-Foy, Quebec, G1W 4Y5

  • Novartis Investigative Site

    Trois-Rivières, Quebec, G8Z 1Y2

  • Novartis Investigative Site

    Waterloo, Ontario, N2J 1C4

  • Novartis Investigative Site

    Winnipeg, Manitoba, R3A 1M3

Other trials in Canada

Poland6 sites

  • Novartis Investigative Site

    Lodz, 90-265

  • Novartis Investigative Site

    Poznan, 60 529

  • Novartis Investigative Site

    Poznan, 60-218

  • Novartis Investigative Site

    Warsaw, 02 691

  • Novartis Investigative Site

    Warsaw, 04141

  • Novartis Investigative Site

    Wroclaw, 50-368

Other trials in Poland

Australia4 sites

  • Novartis Investigative Site

    Hobart, Tasmania, 7000

  • Novartis Investigative Site

    Kogarah, New South Wales, 2217

  • Novartis Investigative Site

    Malvern East, Victoria, 3145

  • Novartis Investigative Site

    Maroochydore, Queensland, 4558

Other trials in Australia

Czechia4 sites

  • Novartis Investigative Site

    Bruntál, Czech Republic, 792 01

  • Novartis Investigative Site

    Pardubice, Czech Republic, 53002

  • Novartis Investigative Site

    Prague, 128 50

  • Novartis Investigative Site

    Uherské Hradiště, 686 01

Other trials in Czechia

Belgium3 sites

  • Novartis Investigative Site

    Genk, 3600

  • Novartis Investigative Site

    Hasselt, 3500

  • Novartis Investigative Site

    Leuven, 3000

Other trials in Belgium

Puerto Rico1 site

  • Novartis Investigative Site

    Ponce, 00716

Other trials in Puerto Rico

Thailand1 site

  • Novartis Investigative Site

    Bangkok, 10400

Other trials in Thailand

About this study

Official title: A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Efficacy, Safety and Tolerability up to 5 Years in Patients With Active Psoriatic Arthritis

This study was to provide 24 - 52 week efficacy, safety and tolerability data to support the registration of the secukinumab (AIN457) prefilled syringe (PFS) for subcutaneous self administration in subjects with active PsA despite current or previous NSAID, DMARD and/or anti-TNFα therapy. An additional 4 years of long-term efficacy and safety data were collected during the post Week 52 period of the study.

Read the detailed description

At baseline (BSL), subjects whose eligibility was confirmed were randomized to one of the following four treatment groups.

  • 75 mg secukinumab
  • 150 mg secukinumab
  • 300 mg secukinumab
  • Placebo At Week 16, all subjects were classified as responders (≥ 20% improvement from BSL in both tender and swollen joint counts) or non-responders.

Subjects who were randomized to a secukinumab treatment group at baseline were targeted to remain on the same dose for the entire trial.

Subjects who were randomized to placebo at baseline were re-randomized at Week 16 as follows:

Placebo non-responders received secukinumab 150 mg s.c. or 300 mg s.c. (1:1) every 4 weeks, starting after the efficacy assessments at Week 16.

Placebo responders continued to receive placebo at Week 16 and Week 20 and received secukinumab 150 mg s.c. or 300 mg s.c. (1:1) every 4 weeks, starting after the efficacy assessments at Week 24.

This was a double-blind, double-dummy, randomized treatment trial until week 52 analysis was completed and open label afterwards.

An amendment to the study protocol (after all patients were in the trial for 2-3 years) introduced changes whereby patients previously treated with secukinumab 75 mg s.c. could change to receive 150 mg s.c. or 300 mg s.c., and patients previously treated with secukinumab 150 mg s.c. could change to receive 300 mg s.c., as deemed appropriate by the investigators.

Being tested
Secukinumab (AIN457), Placebo
Keywords
Psoriatic arthritis, PsA, ACR, CASPAR, PASDAS
Medical subject headings
Arthritis, Psoriatic, Salivary Gland Adenoma, Pleomorphic

What participants receive

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

  • Secukinumab (AIN457)Drug

    Secukinumab (AIN457)

  • PlaceboDrug

    Placebo PFS for s.c. administration.

Study groups in NCT01752634
Study groupRoleWhat they receive
Secukinumab (AIN457) 75 mg s.c.ExperimentalSecukinumab 75 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4.
Receives: Drug: Secukinumab (AIN457)
Secukinumab (AIN457) 150 mg s.c.ExperimentalSecukinumab 150 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4.
Receives: Drug: Secukinumab (AIN457)
Secukinumab (AIN457) 300 mg s.c.ExperimentalSecukinumab 300 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4
Receives: Drug: Secukinumab (AIN457)
Placebo s.c.Placebo comparatorPlacebo at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4. Non-responder (assessed at Week 16) were re-randomized to receive AIN457 150mg or AIN457 300 mg starting at Week 16. Responder (assessed at Week 16) were re-randomized to receive AIN457 150mg or AIN457 300 mg starting at Week 24.
Receives: Drug: Secukinumab (AIN457); Drug: Placebo

What is being measured

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

  1. Number of Participants Achieving American College of Rheumatology 20 (ACR20) Response Criteria

    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 in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient's assessment of RA 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), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR).

    For subjects with early escape at Week 16 or had missing values at Week 24 or discontinued prior to Week 24, their ACR20 was set to nonresponse at Week 24. This applied for all treatment regimens in order to minimize bias. The Placebo arm was analyzed as one group, irrespective of the re-randomization, as assessments made under the re-randomized active treatment were not included in this analysis.

    Measured: Week 24

Secondary outcomes (8)

  1. Number of Participants Achieving a PASI75 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis

    PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). PASI 75 response was defined as participants achieving >= 75% improvement from baseline. For subjects with early escape at Week 16 or had missing values at Week 24 or discontinued prior to Week 24, their value was set to nonresponse at Week 24. This applied for all treatment regimens in order to minimize bias.

    Measured: Week 24

  2. Number of Participants Achieving a PASI90 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis

    PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). PASI 90 response was defined as participants achieving >= 90% improvement from baseline. For subjects with early escape at Week 16 or had missing values at Week 24 or discontinued prior to Week 24, their value was set to nonresponse at Week 24. This applied for all treatment regimens in order to minimize bias.

    Measured: Week 24

  3. Change From Baseline in DAS28-CRP

    The DAS28 is a measure of disease activity based on Swollen and Tender Joint Counts, ESR or CRP and the Patient Global Assessment. A DAS28 score > 5.1 implies active disease, ≤ 3.2 low disease activity, and < 2.6 remission. The score can range from 0 - 9.4. The data collected after the patient switched to secukinumab were treated as missing for placebo patients and were analyzed using a mixed-effects repeated measures model. For secukinumab patients, the actual values were used in the analysis.

    The Placebo arm was analyzed as one group, irrespective of the re-randomization, as assessments made under the re-randomized active treatment were not included in this analysis.

    Measured: Baseline, Week 24

  4. Change From Baseline in SF36-Physical Component Score

    The SF-36 is an instrument to measure health-related quality of life among healthy patients and patients with acute and chronic conditions.

    Score range is from 0 (no problems) to 100 (unable to perform the activity). SF-36 is a 36 item questionnaire which measures Quality of Life across eight domains, which are both physically and emotionally based. Two overall summary scores, the Physical Component Summary (PCS) and Mental Component Summary (MCS) can be computed. In this study, SF-36 PCS was used.

    The Placebo arm was analyzed as one group, irrespective of the re-randomization, as assessments made under the re-randomized active treatment were not included in this analysis.

    Measured: Baseline, Week 24

  5. Change From Baseline in Stanford Health Assessment Questionnaire Disability Index (HAQ-DI)

    The HAQ-DI assesses a subject'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 8 categories of functioning including 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'. Each item is scored on a 4 point scale from 0 - 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) and unable to do (3). The disability index score is calculated as the mean of the available category scores, ranging from 0 to 3. A negative change from baseline indicates improvement. The Placebo arm was analyzed as one group, irrespective of the re-randomization, as assessments made under the re-randomized active treatment were not included in this analysis.

    Measured: Baseline, Week 24

  6. Number of Participants Achieving American College of Rheumatology 50 (ACR50) Response Criteria

    ACR20 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 50% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient's assessment of RA 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), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). For subjects with early escape at Week 16 or had missing values at Week 24 or discontinued prior to Week 24, their ACR20 was set to nonresponse at Week 24. This applied for all treatment regimens in order to minimize bias. The Placebo arm was analyzed as one group, irrespective of the re-randomization, as assessments made under the re-randomized active treatment were not included in this analysis.

    Measured: Week 24

  7. Number of Participants With Dactylitis in the Subset of Subjects Who Had Dactylitis at Baseline

    Resolution of dactylitis was evaluated in the subset of patients who had disease activity at baseline. In this analysis, a lower percentage is desirable and resolution is defined as complete absence of the symptom. For subjects with early escape at Week 16 or had missing values at Week 24 or discontinued prior to Week 24, their assessment was set to nonresponse at Week 24 (presence of dactylitis). This applied for all treatment regimens in order to minimize bias. The Placebo arm was analyzed as one group, irrespective of the re-randomization, as assessments made under the re-randomized active treatment were not included in this analysis.

    Measured: Week 24

  8. Number of Participants With Enthesitis in the Subset of Subjects Who Had Enthesitis at Baseline

    Resolution of enthesitis was evaluated in the subset of patients who had disease activity at baseline. In this analysis, a lower percentage is desirable and resolution is defined as complete absence of the symptom. For subjects with early escape at Week 16 or had missing values at Week 24 or discontinued prior to Week 24, their assessment was set to nonresponse at Week 24 (presence of enthesitis). This applied for all treatment regimens in order to minimize bias. The Placebo arm was analyzed as one group, irrespective of the re-randomization, as assessments made under the re-randomized active treatment were not included in this analysis.

    Measured: Week 24

Timeline

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

  1. First posted19 Dec 2012 (estimated)
  2. Study start14 Apr 2013
  3. Primary completion12 May 2014
  4. Study completion9 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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
397 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01752634
Sponsor's protocol ID
CAIN457F2312
Other IDs
2012-004439-22
Acronym
FUTURE 2
Status last verified
Apr 2020
First submitted
23 Oct 2012
Last updated
13 May 2020
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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

  • McInnes IB, Mease PJ, Kivitz AJ, Nash P, Rahman P, Rech J, Conaghan PG, Kirkham B, Navarra S, Belsare AD, Delicha EM, Pricop L. Long-term efficacy and safety of secukinumab in patients with psoriatic arthritis: 5-year (end-of-study) results from the phase 3 FUTURE 2 study. Lancet Rheumatol. 2020 Apr;2(4):e227-e235. doi: 10.1016/S2665-9913(20)30036-9.

    PubMed 38268157

  • 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

  • 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.

    PubMed 31801620

  • 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.

    PubMed 31203228

  • Coates LC, Gladman DD, Nash P, FitzGerald O, Kavanaugh A, Kvien TK, Gossec L, Strand V, Rasouliyan L, Pricop L, Ding K, Jugl SM, Gaillez C; FUTURE 2 study group. Secukinumab provides sustained PASDAS-defined remission in psoriatic arthritis and improves health-related quality of life in patients achieving remission: 2-year results from the phase III FUTURE 2 study. Arthritis Res Ther. 2018 Dec 7;20(1):272. doi: 10.1186/s13075-018-1773-y.

    PubMed 30526678

  • McInnes IB, Mease PJ, Schett G, Kirkham B, Strand V, Williams N, Fox T, Pricop L, Jugl SM, Gandhi KK; FUTURE 2 Study Group. Secukinumab provides rapid and sustained pain relief in psoriatic arthritis over 2 years: results from the FUTURE 2 study. Arthritis Res Ther. 2018 Jun 7;20(1):113. doi: 10.1186/s13075-018-1610-3.

    PubMed 29880010

  • Coates LC, Mease PJ, Gossec L, Kirkham B, Sherif B, Gaillez C, Mpofu S, Jugl SM, Karyekar C, Gandhi KK. Minimal Disease Activity Among Active Psoriatic Arthritis Patients Treated With Secukinumab: 2-Year Results From a Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase III Study. Arthritis Care Res (Hoboken). 2018 Oct;70(10):1529-1535. doi: 10.1002/acr.23537. Epub 2018 Sep 1.

    PubMed 29409133

  • McInnes IB, Mease PJ, Ritchlin CT, Rahman P, Gottlieb AB, Kirkham B, Kajekar R, Delicha EM, Pricop L, Mpofu S. Secukinumab sustains improvement in signs and symptoms of psoriatic arthritis: 2 year results from the phase 3 FUTURE 2 study. Rheumatology (Oxford). 2017 Nov 1;56(11):1993-2003. doi: 10.1093/rheumatology/kex301.

    PubMed 28968735

  • McInnes IB, Mease PJ, Kirkham B, Kavanaugh A, Ritchlin CT, Rahman P, van der Heijde D, Landewe R, Conaghan PG, Gottlieb AB, Richards H, Pricop L, Ligozio G, Patekar M, Mpofu S; FUTURE 2 Study Group. Secukinumab, a human anti-interleukin-17A monoclonal antibody, in patients with psoriatic arthritis (FUTURE 2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2015 Sep 19;386(9999):1137-46. doi: 10.1016/S0140-6736(15)61134-5. Epub 2015 Jun 28.

    PubMed 26135703

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Secukinumab (AIN457) in people with Psoriatic Arthritis, run by Novartis Pharmaceuticals at 76 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in United States, United Kingdom, Germany, Russia, Canada and 6 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 13 May 2020). 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?

Number of Participants Achieving American College of Rheumatology 20 (ACR20) Response Criteria (time frame: Week 24). 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 NCT01752634, which also lists 10 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 13 May 2020; AzTrials last refreshed its copy on 1 Nov 2026.

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