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Rheumatoid ArthritisPhase 3REASSURE2NCT01770379

Secukinumab Efficacy and Safety Study in Patients With Rheumatoid Arthritis and Inadequate Response to Anti-TNFα Agents.

A Phase 3 study testing Secukinumab (AIN457) in people with Rheumatoid Arthritis, run by Novartis Pharmaceuticals at 77 sites in 16 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study will provide efficacy and safety data of the secukinumab pre-filled syringe (PFS) for subcutaneous self-administration in patients with active rheumatoid arthritis who are intolerant to or have had an inadequate response to anti-TNF-α agents. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Secukinumab (AIN457)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
242 participants
Where
77 sitesin 16 countries
Study dates
Oct 2012to May 2015
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: • Presence of Rheumatoid Arthritis classified by ACR 2010 revised criteria for at least 3 months •Disease activity defined by ≥6 tender joints out of 68 and ≥ 6 swollen joints out of 66 at baseline and with: Either Anti-CCP antibodies positive OR Rheumatoid Factor positive AND WITH Either hsCRP ≥ 10 mg/L OR ESR ≥28 mm/1st hr •Intake of at least one anti-TNF-α agent such as etanercept, adalimumab, infliximab, certolizumab or golimumab for at least 3 months before entering the study and to have experienced an inadequate response to treatment or to have been intolerant to at least one administration Exclusion Criteria:

  • Current RA functional status class IV according to the ACR 1991 revised criteria •Previous use of secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor and/or any history of hypersensitivity to secukinumab or its excipient or to drugs of similar chemical classes. Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

77 sites in 16 countries.

77 sites in 16 countries

United States25 sites

  • Novartis Investigative Site

    Albuquerque, New Mexico, 87102

  • Novartis Investigative Site

    Amarillo, Texas, 79124

  • Novartis Investigative Site

    Benbrook, Texas, 76126

  • Novartis Investigative Site

    Cumberland, Maryland, 21502

  • Novartis Investigative Site

    Edina, Minnesota, 55435

  • Novartis Investigative Site

    Houston, Texas, 77005

  • Novartis Investigative Site

    Houston, Texas, 77034

  • Novartis Investigative Site

    Jackson, Tennessee, 38305

  • Novartis Investigative Site

    Lees Summit, Missouri, 64086

  • Novartis Investigative Site

    Mesquite, Texas, 75150

  • Novartis Investigative Site

    Miami, Florida, 33135

  • Novartis Investigative Site

    Nashville, Tennessee, 37203-1424

  • Novartis Investigative Site

    North Charleston, South Carolina, 29406

  • Novartis Investigative Site

    Oklahoma City, Oklahoma, 73103

  • Novartis Investigative Site

    Oklahoma City, Oklahoma, 73134

  • Novartis Investigative Site

    Pembroke Pines, Florida, 33026

  • Novartis Investigative Site

    Peoria, Arizona, 85381

  • Novartis Investigative Site

    Rapid City, South Dakota, 57701

  • Novartis Investigative Site

    Reno, Nevada, 89502

  • Novartis Investigative Site

    Santa Monica, California, 90404

  • Novartis Investigative Site

    St Louis, Missouri, 63128

  • Novartis Investigative Site

    Tupelo, Mississippi, 38801

  • Novartis Investigative Site

    Upland, California, 91786

  • Novartis Investigative Site

    Zanesville, Ohio, 43701

  • Novartis Investigative Site

    Zephyrhills, Florida, 33542

Other trials in United States

Japan13 sites

  • Novartis Investigative Site

    Fukuoka, Fukuoka, 813-0017

  • Novartis Investigative Site

    Hamamatsu, Shizuoka, 430-8558

  • Novartis Investigative Site

    Hiroshima, Hiroshima, 733-0032

  • Novartis Investigative Site

    Kawachi-Nagano, Osaka, 586-8521

  • Novartis Investigative Site

    Kumamoto, Kumamoto, 862-0976

  • Novartis Investigative Site

    Miyagi-gun, Miyagi, 981-0112

  • Novartis Investigative Site

    Nagano, Nagano, 380-8582

  • Novartis Investigative Site

    Sasebo, Nagasaki, 857-1165

  • Novartis Investigative Site

    Setouchi, Okayama-ken, 701-4264

  • Novartis Investigative Site

    Takasaki, Gunma, 370-0053

  • Novartis Investigative Site

    Tokorozawa, Saitama, 359-1111

  • Novartis Investigative Site

    Toyama, Toyama, 930-0138

  • Novartis Investigative Site

    Yokohama, Kanagawa, 230-0023

Other trials in Japan

Germany6 sites

  • Novartis Investigative Site

    Bad Doberan, 18209

  • Novartis Investigative Site

    Göttingen, 37075

  • Novartis Investigative Site

    Hamburg, 22081

  • Novartis Investigative Site

    Hanover, Germany, 30625

  • Novartis Investigative Site

    Magdeburg, 39110

  • Novartis Investigative Site

    Pirna, 01796

Other trials in Germany

India5 sites

  • Novartis Investigative Site

    Jaipur, Rajasthan, 302013

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, 110 060

  • Novartis Investigative Site

    Pune, Maharashtra, 411 040

  • Novartis Investigative Site

    Pune, Maharashtra, 411007

  • Novartis Investigative Site

    Secunderabad, Andhra Pradesh, 500003

Other trials in India

Italy5 sites

  • Novartis Investigative Site

    Bergamo, BG, 24128

  • Novartis Investigative Site

    Bologna, 40138

  • Novartis Investigative Site

    Catania, CT, 95100

  • Novartis Investigative Site

    Roma, RM, 00152

  • Novartis Investigative Site

    Verona, VR, 37100

Other trials in Italy

Brazil4 sites

  • Novartis Investigative Site

    Curitiba, Paraná, 80030-110

  • Novartis Investigative Site

    Juiz de Fora, Minas Gerais, 36010-570

  • Novartis Investigative Site

    Salvador, Estado de Bahia, 40050-410

  • Novartis Investigative Site

    São Paulo, São Paulo, 04266-010

Other trials in Brazil

Argentina3 sites

  • Novartis Investigative Site

    Mar del Plata, Buenos Aires, B7600FZN

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000CXH

  • Novartis Investigative Site

    San Miguel de Tucumán, Tucumán Province

Other trials in Argentina

Greece3 sites

  • Novartis Investigative Site

    Athens, GR, 115 27

  • Novartis Investigative Site

    Athens, 115 27

  • Novartis Investigative Site

    Heraklion, GR, 700 13

Other trials in Greece

Colombia2 sites

  • Novartis Investigative Site

    Bogotá, 110221

  • Novartis Investigative Site

    Cali, Colombia

Other trials in Colombia

Czechia2 sites

  • Novartis Investigative Site

    Prague, 128 50

  • Novartis Investigative Site

    Uherské Hradiště, Czech Republic, 686 01

Other trials in Czechia

Panama2 sites

  • Novartis Investigative Site

    Panama City, Provincia de Panamá, 0823-01510

  • Novartis Investigative Site

    Panama City, Provincia de Panamá

Other trials in Panama

Portugal2 sites

  • Novartis Investigative Site

    Lisbon, Portugal, 1050-034

  • Novartis Investigative Site

    Lisbon, Portugal, 1600-190

Other trials in Portugal

South Korea2 sites

  • Novartis Investigative Site

    Seoul, Korea, 03080

  • Novartis Investigative Site

    Seoul, Korea, 137-701

Other trials in South Korea

Dominican Republic1 site

  • Novartis Investigative Site

    Santo Domingo, Republica Dominicana

Other trials in Dominican Republic

Guatemala1 site

  • Novartis Investigative Site

    Guatemala City, Departamento de Guatemala, 01010

Other trials in Guatemala

South Africa1 site

  • Novartis Investigative Site

    Panorama, Western Cape, 7500

Other trials in South Africa

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, Tolerability and Usability up to 5 Years in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFα Agents

This study will provide efficacy and safety data of the secukinumab pre-filled syringe (PFS) for subcutaneous self-administration in patients with active rheumatoid arthritis who are intolerant to or have had an inadequate response to anti-TNF-α agents.

Being tested
Secukinumab (AIN457), Placebo
Keywords
Rheumatoid Arthritis, RA, IL-17 blocker, subcutaneous, self-injection, AIN457, AIN457F, secukinumab, anti-TNFα, pre-filled syringe
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • Secukinumab (AIN457)Biological

    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)

  • PlaceboBiological

Study groups in NCT01770379
Study groupRoleWhat they receive
Secukinumab 75 mgExperimentalSecukinumab 75 mg s.c.
Receives: Biological: Secukinumab (AIN457)
Secukinumab 150 mgExperimentalSecukinumab 150 mg s.c.
Receives: Biological: Secukinumab (AIN457)
PlaceboPlacebo comparatorPlacebo patients will be re-randomized 1:1 to secukinumab 75 or 150mg s.c. (non-responders at Week 16 will be re-assigned to new treatment at Week 16; responders at Week 16 will be re-assigned to new treatment at Week 24)
Receives: Biological: Placebo

What is being measured

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

  1. Percentage of Participants Achieving an American College of Rheumatology Response 20 (ACR20).

    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).

    The ACR20 response results at week 24 used non-responder imputation.

    Measured: Week 24

Secondary outcomes (3)

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

    The DAS28 is a measure of disease activity in RA 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. A negative change from baseline indicates improvement.

    Measured: Week 24

  2. 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.

    Measured: Week 24

  3. Percentage of Participants Achieving ACR50

    ACR50 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).

    The ACR50 response results at week 24 used non-responder imputation.

    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 posted17 Jan 2013 (estimated)
  2. Study startOct 2012
  3. Primary completionMay 2015
  4. Study completionMay 2015

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
242 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01770379
Sponsor's protocol ID
CAIN457F2311
Other IDs
2011-006058-94
Acronym
REASSURE2
Status last verified
Jun 2016
First submitted
16 Oct 2012
Last updated
21 Jul 2016
Data monitoring committee
Yes

Publications

  • Huang Y, Fan Y, Liu Y, Xie W, Zhang Z. Efficacy and safety of secukinumab in active rheumatoid arthritis with an inadequate response to tumor necrosis factor inhibitors: a meta-analysis of phase III randomized controlled trials. Clin Rheumatol. 2019 Oct;38(10):2765-2776. doi: 10.1007/s10067-019-04595-1. Epub 2019 May 14.

    PubMed 31087226

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Secukinumab (AIN457) in people with Rheumatoid Arthritis, run by Novartis Pharmaceuticals at 77 sites in 16 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: stopped early, as of the sponsor's last update on 21 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 sites in United States, Japan, Germany, India, Italy and 11 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 21 Jul 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?

Percentage of Participants Achieving an American College of Rheumatology Response 20 (ACR20). (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 NCT01770379, 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 21 Jul 2016.

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