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Psoriatic ArthritisPhase 3FUTURE 1NCT01392326

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)

A Phase 3 study testing Secukinumab (75 mg) and Secukinumab (150 mg) in people with Psoriatic Arthritis, run by Novartis Pharmaceuticals at 110 sites in 19 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 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. 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 (75 mg) and Secukinumab (150 mg)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
606 participants
Where
110 sitesin 19 countries
Study dates
Sep 2011to Oct 2014
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

  • 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

Who cannot join

  • Chest X-ray with evidence of ongoing infectious or malignant process
  • Subjects who have previously been treated with more than 3 different TNFα inhibitors
  • Subjects taking high potency opioid analgesics
  • Subjects who have ever received biologic immunomodulating agents except for those targeting TNFα Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

110 sites in 19 countries.

110 sites in 19 countries

United States25 sites

  • Novartis Investigative Site

    Anniston, Alabama, 36207-5710

  • Novartis Investigative Site

    Benbrook, Texas, 76126

  • Novartis Investigative Site

    Boston, Massachusetts, 02111

  • Novartis Investigative Site

    Charlotte, North Carolina, 28210

  • Novartis Investigative Site

    Columbia, South Carolina, 29204

  • Novartis Investigative Site

    Dallas, Texas, 75216

  • Novartis Investigative Site

    Dallas, Texas, 75246

  • Novartis Investigative Site

    Duncansville, Pennsylvania, 16635

  • Novartis Investigative Site

    Eagan, Minnesota, 55121

  • Novartis Investigative Site

    Freehold, New Jersey, 07728

  • Novartis Investigative Site

    Houston, Texas, 77034

  • Novartis Investigative Site

    Houston, Texas, 77074

  • Novartis Investigative Site

    Jackson, Tennessee, 38305

  • Novartis Investigative Site

    Johnston, Rhode Island, 02919

  • Novartis Investigative Site

    Lincoln, Nebraska, 68516

  • Novartis Investigative Site

    Mesa, Arizona, 85202

  • Novartis Investigative Site

    Mesquite, Texas, 75150

  • Novartis Investigative Site

    Newnan, Georgia, 30263

  • Novartis Investigative Site

    North Charleston, South Carolina, 29406

  • Novartis Investigative Site

    Oklahoma City, Oklahoma, 73103

  • Novartis Investigative Site

    Paradise Valley, Arizona, 85253

  • Novartis Investigative Site

    Richmond Heights, Missouri, 63117

  • Novartis Investigative Site

    Seattle, Washington, 98122

  • Novartis Investigative Site

    Tamarac, Florida, 33321

  • Novartis Investigative Site

    Upland, California, 91786

Other trials in United States

Germany14 sites

  • Novartis Investigative Site

    Aachen, 52064

  • Novartis Investigative Site

    Berlin, Germany, 12203

  • Novartis Investigative Site

    Cologne, 50924

  • Novartis Investigative Site

    Erlangen, 91054

  • Novartis Investigative Site

    Erlangen, 91056

  • Novartis Investigative Site

    Gommern, 39245

  • Novartis Investigative Site

    Hamburg, 22143

  • Novartis Investigative Site

    Hamburg, 22415

  • Novartis Investigative Site

    Herne, 44649

  • Novartis Investigative Site

    Hildesheim, 31134

  • Novartis Investigative Site

    Leipzig, 04103

  • Novartis Investigative Site

    Nuremberg, 90429

  • Novartis Investigative Site

    Ratingen, 40882

  • Novartis Investigative Site

    Zerbst, 39261

Other trials in Germany

Philippines9 sites

  • Novartis Investigative Site

    Dasmariñas, Cavite, 4114

  • Novartis Investigative Site

    Las Piñas, 1740

  • Novartis Investigative Site

    Lipa City, Batangas, 4217

  • Novartis Investigative Site

    Manila, National Capital Region, 1003

  • Novartis Investigative Site

    Manila, Philippines, 1003

  • Novartis Investigative Site

    Manila, 1000

  • Novartis Investigative Site

    Manila, 1008

  • Novartis Investigative Site

    Quezon City, 1102

  • Novartis Investigative Site

    Quezon City, 1121

Other trials in Philippines

Argentina8 sites

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires, C1417EYG

  • Novartis Investigative Site

    Caba, Buenos Aires, C1181ACH

  • Novartis Investigative Site

    Caba, Buenos Aires, C1419AHN

  • Novartis Investigative Site

    Córdoba, Córdoba Province, X5000EOC

  • Novartis Investigative Site

    Córdoba, Córdoba Province, X5016KEH

  • Novartis Investigative Site

    Córdoba, Córdoba Province, X5022CPU

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000CFJ

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S200BHD

Other trials in Argentina

Russia6 sites

  • Novartis Investigative Site

    Kemerovo, 650029

  • Novartis Investigative Site

    Moscow, 115522

  • Novartis Investigative Site

    Saint Petersburg, 190068

  • Novartis Investigative Site

    Yaroslavl, 150003

  • Novartis Investigative Site

    Yekaterinburg, 620028

  • Novartis Investigative Site

    Yekaterinburg, 620102

Other trials in Russia

Canada5 sites

  • Novartis Investigative Site

    Newmarket, Ontario, L3Y 3R7

  • Novartis Investigative Site

    St. John's, Newfoundland and Labrador, A1B 5E8

  • Novartis Investigative Site

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

  • Novartis Investigative Site

    Trois-Rivières, Quebec, G8Z 1Y2

  • Novartis Investigative Site

    Waterloo, Ontario, N2J 1C4

Other trials in Canada

United Kingdom5 sites

  • Novartis Investigative Site

    Bradford, West Yorkshire, BD5 0NA

  • Novartis Investigative Site

    Cannock, Staffordshire, WS11 2XY

  • Novartis Investigative Site

    Glasgow, G12 8TA

  • Novartis Investigative Site

    London, England, E11 1NR

  • Novartis Investigative Site

    London, SE1 9RT

Other trials in United Kingdom

Bulgaria4 sites

  • Novartis Investigative Site

    Pleven, 5800

  • Novartis Investigative Site

    Sevlievo, Bulgaria, 5400

  • Novartis Investigative Site

    Sofia, Bulgaria, 1612

  • Novartis Investigative Site

    Sofia, Bulgaria, 1709

Other trials in Bulgaria

Israel4 sites

  • Novartis Investigative Site

    Ashkelon, 78278

  • Novartis Investigative Site

    Haifa, 3339419

  • Novartis Investigative Site

    Ramat Gan, 5266202

  • Novartis Investigative Site

    Tel Aviv, 6423906

Other trials in Israel

Italy4 sites

  • Novartis Investigative Site

    Catania, CT, 95100

  • Novartis Investigative Site

    Prato, PO, 59100

  • Novartis Investigative Site

    Siena, SI, 53100

  • Novartis Investigative Site

    Valeggio sul Mincio, (vr), 37067

Other trials in Italy

Romania4 sites

  • Novartis Investigative Site

    Bucharest, District 1

  • Novartis Investigative Site

    Bucharest

  • Novartis Investigative Site

    Cluj-Napoca, 400006

  • Novartis Investigative Site

    Iași, Iaşi, 700195

Other trials in Romania

Thailand4 sites

  • Novartis Investigative Site

    Bangkok, Bangkok, 10400

  • Novartis Investigative Site

    Bangkok, 10400

  • Novartis Investigative Site

    Chiang Mai, 50200

  • Novartis Investigative Site

    Khon Kaen, 40002

Other trials in Thailand

Belgium3 sites

  • Novartis Investigative Site

    Genk, 3600

  • Novartis Investigative Site

    Ghent, 9000

  • Novartis Investigative Site

    Leuven, 3000

Other trials in Belgium

Brazil3 sites

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Novartis Investigative Site

    São Paulo, São Paulo, 04023-900

  • Novartis Investigative Site

    São Paulo, São Paulo, 04266-010

Other trials in Brazil

Czechia3 sites

  • Novartis Investigative Site

    Bruntál, Czech Republic, 792 01

  • Novartis Investigative Site

    Uherské Hradiště, Czech Republic, 686 01

  • Novartis Investigative Site

    Zlín, Czech Republic, 760 01

Other trials in Czechia

Singapore3 sites

  • Novartis Investigative Site

    Singapore, Singapore, 119074

  • Novartis Investigative Site

    Singapore, Singapore, 169608

  • Novartis Investigative Site

    Singapore, Singapore, 529889

Other trials in Singapore

Australia2 sites

  • Novartis Investigative Site

    Malvern, Victoria, 3144

  • Novartis Investigative Site

    Maroochydore, Queensland, 4558

Other trials in Australia

Poland2 sites

  • Novartis Investigative Site

    Bialystok, 15-351

  • Novartis Investigative Site

    Warsaw, 02-341

Other trials in Poland

Slovakia2 sites

  • Novartis Investigative Site

    Lučenec, Slovakia, 98401

  • Novartis Investigative Site

    Piešťany, Slovak Republic, 921 12

Other trials in Slovakia

About this study

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

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.

Being tested
Secukinumab (75 mg), Secukinumab (150 mg), Placebo Comparator
Keywords
Psoriatic arthritis, PsA, ACR, CASPAR
Medical subject headings
Arthritis, Psoriatic

What participants receive

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

  • Secukinumab (75 mg)Drug

    Secukinumab (75 mg)

  • Secukinumab (150 mg)Drug

    Secukinumab (150 mg)

  • Placebo ComparatorDrug

    Placebo Comparator

Study groups in NCT01392326
Study groupRoleWhat they receive
Group 1ExperimentalSecukinumab (75mg)
Receives: Drug: Secukinumab (75 mg)
Group 2ExperimentalSecukinumab (150 mg)
Receives: Drug: Secukinumab (150 mg)
Group 3Placebo comparatorNot described
Receives: Drug: Placebo Comparator

What is being measured

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

  1. 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)

    Measured: Week 24

Secondary outcomes (9)

  1. 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

    Measured: Week 24

  2. 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

    Measured: Week 24

  3. 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: <math>DAS-CRP=0.56 \times \sqrt{TEN28} + 0.28 \times \sqrt{SW28} + 0.36 \times \ln(CRP+1) + 0.014 \times SA+0.96</math> With: TEN28: number of joints with tenderness upon touching SW28: number of swollen joints CRP: C-reactive Protein SA: subjective assessment of disease activity by the patient during the preceding 7 days on a scale betweenn 0 and 100 ("0":no activity, "100": highest activity possible)

    Measured: Week 24

  4. 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.

    Measured: Week 24

  5. 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).

    Measured: Week 24

  6. 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.

    Measured: Week 24

  7. 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.

    Measured: Week 24

  8. Percent of Patients With Dactylitis in the Subset of Subjects Who Have Dactylitis at Baseline

    Measured: Week 24

  9. Percent of Patients With Enthesitis in the Subset of Subjects Who Have Enthesitis at Baseline

    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 posted12 Jul 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionOct 2014
  4. Study completionOct 2014

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
606 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01392326
Sponsor's protocol ID
CAIN457F2306
Other IDs
2011-000276-34
Acronym
FUTURE 1
Status last verified
Jan 2016
First submitted
7 Jul 2011
Last updated
4 Feb 2016
Data monitoring committee
Yes

Publications

  • Mease PJ, Kavanaugh A, Reimold A, Tahir H, Rech J, Hall S, Geusens P, Pellet P, Delicha EM, Pricop L, Mpofu S; FUTURE 1 study group. Secukinumab Provides Sustained Improvements in the Signs and Symptoms of Psoriatic Arthritis: Final 5-year Results from the Phase 3 FUTURE 1 Study. ACR Open Rheumatol. 2020 Jan;2(1):18-25. doi: 10.1002/acr2.11097. Epub 2019 Nov 14.

    PubMed 31943974

  • 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

  • Kavanaugh A, Mease PJ, Reimold AM, Tahir H, Rech J, Hall S, Geusens P, Wang Z, Pricop L, Mpofu S; FUTURE-1 Study Group. Secukinumab for Long-Term Treatment of Psoriatic Arthritis: A Two-Year Followup From a Phase III, Randomized, Double-Blind Placebo-Controlled Study. Arthritis Care Res (Hoboken). 2017 Mar;69(3):347-355. doi: 10.1002/acr.23111.

    PubMed 27696786

  • Strand V, Mease P, Gossec L, Elkayam O, van den Bosch F, Zuazo J, Pricop L, Mpofu S; FUTURE 1 study group. Secukinumab improves patient-reported outcomes in subjects with active psoriatic arthritis: results from a randomised phase III trial (FUTURE 1). Ann Rheum Dis. 2017 Jan;76(1):203-207. doi: 10.1136/annrheumdis-2015-209055. Epub 2016 May 11.

    PubMed 27169431

  • Mease PJ, McInnes IB, Kirkham B, Kavanaugh A, Rahman P, van der Heijde D, Landewe R, Nash P, Pricop L, Yuan J, Richards HB, Mpofu S; FUTURE 1 Study Group. Secukinumab Inhibition of Interleukin-17A in Patients with Psoriatic Arthritis. N Engl J Med. 2015 Oct;373(14):1329-39. doi: 10.1056/NEJMoa1412679.

    PubMed 26422723

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Secukinumab (75 mg) and Secukinumab (150 mg) in people with Psoriatic Arthritis, run by Novartis Pharmaceuticals at 110 sites in 19 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 4 inclusion and 4 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 4 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 110 sites in United States, Germany, Philippines, Argentina, Russia and 14 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 4 Feb 2016). 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?

Percent of Patients Achieving ACR20 Response Criteria on Secukinumab 75 or 150 mg vs. Placebo (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 NCT01392326, which also lists 5 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 4 Feb 2016.

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