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Psoriatic ArthritisPhase 3FUTURE 1 extNCT01892436

Extension Study up to 3 Years for Secukinumab in Psoriatic Arthritis

A Phase 3 study testing Secukinumab in people with Psoriatic Arthritis, run by Novartis Pharmaceuticals at 94 sites in 18 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 designed as a 3-year extension to the phase III core study CAIN457F2306. It aimed to provide continuous treatment with secukinumab in pre-filled syringes (PFS) for subjects who completed the core study CAIN457F2306, to obtain further long term efficacy, safety and tolerability information in subjects… 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
460 participants
Where
94 sitesin 18 countries
Study dates
30 Sep 2013to 11 Jan 2018
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

  • Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed
  • Subjects must have participated in core study CAIN457F2306, and must have completed the entire treatment period
  • Subjects must be deemed by the investigator to benefit from continued secukinumab therapy

Who cannot join

  • Any subject taking other concomitant biologic immunomodulating agent(s) except secukinumab
  • Any subject who is deemed not to be benefiting from the study treatment based upon lack of improvement or worsening of their symptoms
  • Pregnant or nursing (lactating) women
  • Women of child-bearing potential, unless they are using effective methods of contraception during the entire study or longer if required by locally approved prescribing information (e.g., 20 weeks in EU)
  • Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

94 sites in 18 countries.

94 sites in 18 countries

United States22 sites

  • Novartis Investigative Site

    Anniston, Alabama, 36207-5710

  • Novartis Investigative Site

    Benbrook, Texas, 76126

  • Novartis Investigative Site

    Charleston, South Carolina, 29460

  • 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, 77074

  • Novartis Investigative Site

    Jackson, Tennessee, 38305

  • Novartis Investigative Site

    League City, Texas, 77573

  • Novartis Investigative Site

    Lincoln, Nebraska, 68516

  • Novartis Investigative Site

    Mesa, Arizona, 85202

  • Novartis Investigative Site

    Mesquite, Texas, 75150

  • Novartis Investigative Site

    Oklahoma City, Oklahoma, 73103

  • Novartis Investigative Site

    Paradise Valley, Arizona, 85253

  • Novartis Investigative Site

    Seattle, Washington, 98122

  • Novartis Investigative Site

    St Louis, Missouri, 63117

  • Novartis Investigative Site

    Tamarac, Florida, 33321

  • Novartis Investigative Site

    Upland, California, 91786

Other trials in United States

Germany11 sites

  • Novartis Investigative Site

    Aachen, 52064

  • Novartis Investigative Site

    Cologne, 50937

  • Novartis Investigative Site

    Erlangen, 91054

  • Novartis Investigative Site

    Erlangen, 91056

  • Novartis Investigative Site

    Gommern, 39245

  • Novartis Investigative Site

    Hamburg, 22415

  • Novartis Investigative Site

    Hildesheim, 31134

  • Novartis Investigative Site

    Leipzig, 04103

  • Novartis Investigative Site

    Nuremberg, 90429

  • Novartis Investigative Site

    Ratingen, 40878

  • Novartis Investigative Site

    Zerbst, 39261

Other trials in Germany

Philippines8 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, 1003

  • Novartis Investigative Site

    Manila, 1008

  • Novartis Investigative Site

    Quezon City, 1102

  • Novartis Investigative Site

    Quezon City, 1118

Other trials in Philippines

Argentina6 sites

  • Novartis Investigative Site

    Buenos Aires, C1417EYG

  • Novartis Investigative Site

    CABA, Buenos Aires, C1181ACH

  • Novartis Investigative Site

    CABA, C1419AHN

  • Novartis Investigative Site

    Córdoba, X5000EDC

  • Novartis Investigative Site

    Córdoba, X5016KEH

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000CFJ

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, 620109

Other trials in Russia

Canada5 sites

  • Novartis Investigative Site

    Newmarket, Ontario, L3Y 3R7

  • Novartis Investigative Site

    St. John's, Newfoundland and Labrador, A1A 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, G31 2ER

  • Novartis Investigative Site

    Leytonstone, London, E11 1NR

  • Novartis Investigative Site

    London, SE1 9RT

Other trials in United Kingdom

Israel4 sites

  • Novartis Investigative Site

    Ashkelon, 78278

  • Novartis Investigative Site

    Haifa, 3339419

  • Novartis Investigative Site

    Ramat Gan, 5265601

  • 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

    Verona, VR, 37134

Other trials in Italy

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

Bulgaria3 sites

  • Novartis Investigative Site

    Pleven, 5800

  • Novartis Investigative Site

    Sevlievo, Gabrovo, 5400

  • Novartis Investigative Site

    Sofia, 1612

Other trials in Bulgaria

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, 119074

  • Novartis Investigative Site

    Singapore, 169608

  • Novartis Investigative Site

    Singapore, 529889

Other trials in Singapore

Thailand3 sites

  • Novartis Investigative Site

    Bangkok, 10400

  • Novartis Investigative Site

    Chiang Mai, 50200

  • Novartis Investigative Site

    Khon Kaen, THA, 40002

Other trials in Thailand

Australia2 sites

  • Novartis Investigative Site

    Malvern East, Victoria, 3145

  • 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

Slovakia1 site

  • Novartis Investigative Site

    Lučenec, 984 01

Other trials in Slovakia

About this study

Official title: A Three-year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Psoriatic Arthritis

This study was designed as a 3-year extension to the phase III core study CAIN457F2306. It aimed to provide continuous treatment with secukinumab in pre-filled syringes (PFS) for subjects who completed the core study CAIN457F2306, to obtain further long term efficacy, safety and tolerability information in subjects with active psoriatic arthritis receiving secukinumab every 4 weeks. At Week 104 of the study CAIN457F2306, eligible subjects completed the assessments associated with the core study visit and subsequently continued in this extension study on the same dose that they were receiving during the core study. The regular assessments of disease activity ensure that subjects who are experienced worsening of disease in any of the treatment groups could exit the study upon their own wish or based on the advice of the investigator at any time.

Being tested
Secukinumab, Placebo
Keywords
Extension study, psoriatic arthritis, pre-filled syringe
Medical subject headings
Arthritis, Psoriatic

What participants receive

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

  • SecukinumabDrug

    Also called AIN457

    Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17).

  • PlaceboDrug

    Also called Placebo - AIN457A

    Placebo

Study groups in NCT01892436
Study groupRoleWhat they receive
Secukinumab 75mgExperimentalSubjects continued to receive secukinumab 75mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator
Receives: Drug: Secukinumab
Secukinumab 150mgExperimentalSubjects continued to receive secukinumab 150mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 300 mg as judged appropriate by the investigator
Receives: Drug: Secukinumab
Placebo - AIN457A 75mgExperimentalPlacebo (for maintaining the blind till Week 152): Placebo to secukinumab 0.5 mL solution solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 75mg
Receives: Drug: Secukinumab; Drug: Placebo
Placebo - AIN457 150mgExperimentalPlacebo (for maintaining the blind till Week 152): Placebo to secukinumab 1 mL solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 150 mg
Receives: Drug: Secukinumab; Drug: Placebo

What is being measured

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

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

    Proportion of subjects with a positive clinical response to treatment (individual improvement) in disease activity according to ACR20 criteria if he/she has at least 20% improvement in 1. Tender 68-joint count 2. Swollen 66-joint count and 3. At least 3 of the following 5 measures:

    • Patient's assessment of Psoriatic Arthritis (PsA) pain
    • Patient's global assessment of disease activity
    • Physician's global assessment of disease activity
    • Subject self-assessed disability (Health-Assessment Questionnaire [HAQ-DI] score)
    • Acute phase reactant (hsCRP or ESR)

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

  2. Proportion of Subjects Who Reached ACR50

    Proportion of subjects that have a positive clinical response to treatment (individual improvement) in disease activity according to ACR50 criteria if he/she has at least 50% improvement in 1. Tender 68-joint count 2. Swollen 66-joint count and 3. At least 3 of the following 5 measures:

    • Patient's assessment of PsA pain
    • Patient's global assessment of disease activity
    • Physician's global assessment of disease activity
    • Subject self-assessed disability (Health-Assessment Questionnaire [HAQ-DI] score)
    • Acute phase reactant (hsCRP or ESR)

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

  3. Proportion of Subjects Who Reached ACR70

    Proportion of subjects that have a positive clinical response to treatment (individual improvement) in disease activity according to ACR70 criteria if he/she has at least 70% improvement in 1. Tender 68-joint count 2. Swollen 66-joint count and 3. At least 3 of the following 5 measures:- Patient's assessment of PsA pain

    • Patient's global assessment of disease activity
    • Physician's global assessment of disease activity
    • Subject self-assessed disability (Health-Assessment Questionnaire [HAQ-DI] score)
    • Acute phase reactant (hsCRP or ESR)

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

Secondary outcomes (5)

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

    Changes from baseline in score of the disability assessment component of the HAQ (Health Assessment Questionnaire - Disability Index). 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.

    Health Assessment Questionnaire - Disability Index (HAQ-DI) ranges from 0 (no disability) to 3 (very severe disability)

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

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

    Percentage of subjects with improvements from baseline in HAQ-DI meeting or exceeding minimal clinically important difference (MCID=0.3). 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.

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

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

    Changes in DAS28 (utilizing hsCRP) from baseline up to Month 60. The DAS28 is a measure of disease activity in PsA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission. This measure represents change in scores - not the actual scores.

    DAS28 is a combined measure of disease activity based on the following formula:

    DAS28-CRP = 0.56*TJC28^0.5 + 0.28*SJC28^0.5 + 0.36*ln(CRP+1) + 0.014*PGA + 0.96 The greater the score is, the more the disease activity exists. Remission is defined as DAS28-CRP < 2.6 Low disease activity is defined as DAS28-CRP < 3.2 The minimum value can be 0.96 (not applicable in our study due to the inclusion/exclusion criteria regarding tender, swollen joints). There is no maximum expected value for this score

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

  4. Percentage of Subjects Achieving Low Disease Activity

    Percentage of subjects achieving low disease activity (DAS28 ≤ 3.2). The DAS28 is a measure of disease activity in PsA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission

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

  5. Percentage of Subjects Achieving Disease Remission (DAS28<2.6)

    Percentage of subjects achieving disease remission (DAS28<2.6). The DAS28 is a measure of disease activity in PsA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission

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

Timeline

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

  1. First posted4 Jul 2013 (estimated)
  2. Study start30 Sep 2013
  3. Primary completion11 Jan 2018
  4. Study completion11 Jan 2018

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
Double blind
Who is masked
Participant, Investigator
Enrolment
460 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01892436
Sponsor's protocol ID
CAIN457F2306E1
Other IDs
2013-001241-13
Acronym
FUTURE 1 ext
Status last verified
May 2019
First submitted
1 Jul 2013
Last updated
12 Jun 2019
Data monitoring committee
Yes
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 PJ, Kavanaugh A, Reimold A, Tahir H, Rech J, Hall S, Geusens P, Pellet P, Delicha EM, Mpofu S, Pricop L. Secukinumab in the treatment of psoriatic arthritis: efficacy and safety results through 3 years from the year 1 extension of the randomised phase III FUTURE 1 trial. RMD Open. 2018 Aug 13;4(2):e000723. doi: 10.1136/rmdopen-2018-000723. eCollection 2018.

    PubMed 30167329

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 94 sites in 18 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 3 inclusion and 5 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 12 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 94 sites in United States, Germany, Philippines, Argentina, Russia and 13 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. 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 12 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?

Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20 (time frame: weeks 116, 128, 140, 156, 180, 208, 232 and 260). The study lists 3 primary outcomes in all. 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 NCT01892436, which also lists 1 linked publication.

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 12 Jun 2019.

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