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Arthritis, RheumatoidPhase 3SIRROUND-HNCT02019472

A Study Comparing Sirukumab (CNTO 136) Monotherapy With Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid Arthritis

A Phase 3 study testing adalimumab 40 mg, sirukumab 100 mg and sirukumab 50 mg in people with Arthritis, Rheumatoid, run by Janssen Research & Development, LLC at 107 sites in 16 countries.

Completed

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

Official record
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Trial summary

The primary objective is to investigate the efficacy of sirukumab monotherapy compared with adalimumab monotherapy in biologic naïve subjects with active rheumatoid arthritis who are intolerant to methotrexate, who are considered inappropriate for treatment with methotrexate or who are inadequate responders to… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Arthritis, Rheumatoid
What is being tested?
adalimumab 40 mg, sirukumab 100 mg and sirukumab 50 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
559 participants
Where
107 sitesin 16 countries
Study dates
4 Apr 2014to 17 Aug 2016
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

  • Have a diagnosis of rheumatoid arthritis (RA) for at least 6 months before screening
  • Have moderately to severely active RA with at least 8 of 68 tender joints and 6 of 66 swollen joints, at screening and at baseline
  • Have previous or current treatment with methotrexate (MTX) and are considered intolerant to MTX, and/or are considered inappropriate for treatment with MTX, (including MTX-naïve subjects for whom it is inappropriate to administer MTX) and/or an inadequate responder to methotrexate
  • Must not have received MTX or any other non-biologic DMARD including but not limited to sulfasalazine, hydroxychloroquine, chloroquine, and bucillamine for at least 2 weeks prior to the first administration of the study agent
  • C-reactive protein >= 10.00 mg/L or erythrocyte sedimentation rate >=28 mm/hr at screening

Who cannot join

  • Has Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis
  • Has ever received biologic therapy for RA, including but not limited to the following: TNF-alpha inhibitors, tocilizumab, rituximab, anakinra, abatacept
  • Has ever used tofacitinib therapy or any other JAK inhibitor
  • Has received intra-articular, intramuscular, or IV corticosteroids for RA, including adrenocorticotrophic hormone during the 4 weeks prior to first study agent administration
  • Has received leflunomide within 24 months before the first study agent administration and has not undergone a drug elimination procedure, unless the M1 metabolite is measured and is undetectable

Trial locations and contacts

107 sites in 16 countries.

107 sites in 16 countries

United States42 sites

  • Study site

    Arvin, California

  • Study site

    Austin, Texas

  • Study site

    Aventura, Florida

  • Study site

    Birmingham, Alabama

  • Study site

    Carrollton, Texas

  • Study site

    Chesapeake, Virginia

  • Study site

    Clarksburg, West Virginia

  • Study site

    Corpus Christi, Texas

  • Study site

    Cypress, Texas

  • Study site

    Dayton, Ohio

  • Study site

    Duncansville, Pennsylvania

  • Study site

    Dunedin, Florida

  • Study site

    El Cajon, California

  • Study site

    Elizabethtown, Kentucky

  • Study site

    Frederick, Maryland

  • Study site

    Huntington Beach, California

  • Study site

    Jackson, Tennessee

  • Study site

    Kansas City, Kansas

  • Study site

    Las Vegas, Nevada

  • Study site

    Lubbock, Texas

  • Study site

    McKinney, Texas

  • Study site

    Mesquite, Texas

  • Study site

    Miami, Florida

  • Study site

    Nashville, Tennessee

  • Study site

    New Port Richey, Florida

  • Study site

    Newark, Delaware

  • Study site

    Paducah, Kentucky

  • Study site

    Palm Harbor, Florida

  • Study site

    Phoenix, Arizona

  • Study site

    Plantation, Florida

  • Study site

    Pleasanton, California

  • Study site

    Portland, Oregon

  • Study site

    Salisbury, North Carolina

  • Study site

    St Louis, Missouri

  • Study site

    Tampa, Florida

  • Study site

    Thousand Oaks, California

  • Study site

    Tustin, California

  • Study site

    Wexford, Pennsylvania

  • Study site

    Wheaton, Maryland

  • Study site

    Whittier, California

  • Study site

    Wilmington, North Carolina

  • Study site

    Wyomissing, Pennsylvania

Other trials in United States

Russia13 sites

  • Study site

    Arkhangelsk

  • Study site

    Kazan'

  • Study site

    Kemerovo

  • Study site

    Kursk

  • Study site

    Moscow

  • Study site

    Novosibirsk

  • Study site

    Petrozavodsk

  • Study site

    Ryazan

  • Study site

    Saint Petersburg

  • Study site

    Tomsk

  • Study site

    Tver'

  • Study site

    Vladimir

  • Study site

    Yaroslavl

Other trials in Russia

Ukraine10 sites

  • Study site

    Chernihiv

  • Study site

    Kryvyi Rih

  • Study site

    Kyiv

  • Study site

    Lviv

  • Study site

    Odesa

  • Study site

    Poltava

  • Study site

    Sumy

  • Study site

    Ternopil

  • Study site

    Vinnytsia

  • Study site

    Zaporizhzhya

Other trials in Ukraine

Poland8 sites

  • Study site

    Bydgoszcz

  • Study site

    Bytom

  • Study site

    Krakow

  • Study site

    Lublin

  • Study site

    Nadarzyn

  • Study site

    Poznan

  • Study site

    Warsaw

  • Study site

    Wroclaw

Other trials in Poland

Germany5 sites

  • Study site

    Bad Doberan

  • Study site

    Berlin

  • Study site

    Cologne

  • Study site

    Ratingen

  • Study site

    Vogelsang-Gommern

Other trials in Germany

Mexico4 sites

  • Study site

    Chihuahua City

  • Study site

    Guadalajara

  • Study site

    Jalisco

  • Study site

    Mexicali

Other trials in Mexico

South Africa4 sites

  • Study site

    Cape Town

  • Study site

    Durban

  • Study site

    Kempton Park

  • Study site

    Stellenbosch

Other trials in South Africa

Colombia3 sites

  • Study site

    Barranquilla

  • Study site

    Bogotá

  • Study site

    Bucaramanga

Other trials in Colombia

Lithuania3 sites

  • Study site

    Klaipėda

  • Study site

    Šiauliai

  • Study site

    Vilnius

Other trials in Lithuania

Romania3 sites

  • Study site

    Bucharest

  • Study site

    Constanța

  • Study site

    Ploieşti

Other trials in Romania

Serbia3 sites

  • Study site

    Belgrade

  • Study site

    Novi Sad

  • Study site

    Zemun

Other trials in Serbia

Bulgaria2 sites

  • Study site

    Rousse

  • Study site

    Sofia

Other trials in Bulgaria

Chile2 sites

  • Study site

    Port Montt

  • Study site

    Temuco

Other trials in Chile

Hungary2 sites

  • Study site

    Debrecen

  • Study site

    Gödöllő

Other trials in Hungary

Spain2 sites

  • Study site

    A Coruña

  • Study site

    Madrid

Other trials in Spain

Moldova1 site

  • Study site

    Chisinau

Other trials in Moldova

About this study

Official title: A Multicenter, Randomized, Double-blind, Parallel Group Study of Sirukumab Monotherapy Compared With HUMIRA® Monotherapy Administered Subcutaneously, in Subjects With Active Rheumatoid Arthritis

The primary objective is to investigate the efficacy of sirukumab monotherapy compared with adalimumab monotherapy in biologic naïve subjects with active rheumatoid arthritis who are intolerant to methotrexate, who are considered inappropriate for treatment with methotrexate or who are inadequate responders to methotrexate.

Read the detailed description

This is a randomized, double-blind, parallel-group, global, multicenter study of subcutaneous (SC) sirukumab monotherapy compared with adalimumab monotherapy in subjects with active rheumatoid arthritis. Approximately 510 subjects will be randomly assigned in a 1:1:1 ratio to receive treatment with adalimumab 40 mg SC every 2 weeks, sirukumab 100 mg SC every 2 weeks, or 50 mg SC every 4 weeks, with approximately 170 subjects per treatment group. At Week 16, subjects in all treatment groups who have < 20% improvement from baseline in both swollen and tender joint counts will qualify for early escape. The expected duration of the study is 68 weeks. This includes 52 weeks of treatment with study agent and 16 weeks of safety follow-up after the last study agent administration. The study will end when the last subject completes the last scheduled visit (Week 68 visit or completes the 16 week safety follow-up, whichever is later). Subject safety will be monitored through the end of the study.

Being tested
adalimumab 40 mg, sirukumab 100 mg, sirukumab 50 mg, Placebo
Keywords
Rheumatoid arthritis, CNTO 136, Sirukumab, Adalimumab, HUMIRA®
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • adalimumab 40 mgBiological

    Also called HUMIRA®

    SC injections

  • sirukumab 100 mgBiological

    Also called CNTO 136

    SC injections

  • sirukumab 50 mgBiological

    Also called CNTO 136

    SC injections

  • PlaceboDrug

    SC injections

Study groups in NCT02019472
Study groupRoleWhat they receive
Group 1 (adalimumab 40 mg)ExperimentalAdalimumab 40 mg SC at Weeks 0, 2, and every 2 weeks through Week 52. At Week 16, subjects who have < 20% improvement from baseline in both swollen and tender joint counts will early escape in a blinded fashion and receive adalimumab 40 mg every week through Week 52.
Receives: Biological: adalimumab 40 mg
Group 2 (sirukumab 100 mg)ExperimentalSirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks through Week 52. Subjects may meet the early escape criteria at Week 16 (< 20% improvement from baseline in both swollen and tender joint counts) but no sirukumab dose adjustments will made for these subjects. However, these subjects will receive placebo injections every 2 weeks between the sirukumab injections (ie, subjects that early escape will receive a weekly injection of alternating sirukumab and placebo, to preserve the blind).
Receives: Biological: sirukumab 100 mg; Drug: Placebo
Group 3 (sirukumab 50 mg)ExperimentalSirukumab 50 mg SC at Weeks 0, 4, and every 4 weeks through Week 52. Between sirukumab injections, placebo SC injections will be administered at Weeks 2, 6, and every 4 weeks through Week 50. At Week 16, subjects who have < 20% improvement from baseline in both swollen and tender joint counts will early escape in a blinded fashion and receive sirukumab 100 mg every 2 weeks through Week 52 and placebo injections every 2 weeks between the sirukumab injections (ie, subjects that early escape will receive a weekly injection of alternating sirukumab and placebo, to preserve the blind).
Receives: Biological: sirukumab 50 mg; Drug: Placebo

What is being measured

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

  1. Change From Baseline in Disease Activity Index Score 28 (DAS28) Erythrocyte Sedimentation Rate (ESR) at Week 24

    The Disease Activity Index Score 28 using ESR [DAS28 (ESR)] is a derived score combining tender joints (28 joints), swollen joints (28 joints), ESR, and Patient's Global Assessment of Disease Activity. The 28 joints evaluated for swelling and tenderness were shoulder, elbow, wrist, MCP1, MCP2, MCP3, MCP4, MCP5, PIP1, PIP2, PIP3, PIP4, PIP5 joints of the upper right and upper left extremities as well as the knee joints of the lower right and lower left extremities. The DAS28-ESR is expressed on a score range of "0-10", with the minimum score= 0 (best) to maximum score= 10 (worst).

    Measured: Baseline and Week 24

  2. Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 24

    The ACR 50 Response is defined as greater than or equal to (>=) 50 percent (%) improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >= 50% improvement in 3 of following 5 assessments: subject's assessment of pain using Visual Analog Scale (VAS) (0-10 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), subject's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS (the scale ranges from 0 to 10, [0=no arthritis activity to 10=extremely active arthritis]), participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI) (the scale ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).

    Measured: Week 24

Secondary outcomes (2)

  1. Percentage of Participants With Disease Activity Index Score 28 (DAS28) Using Erythrocyte Sedimentation Rate (ESR) Remission at Week 24

    The Disease Activity Index Score 28 using ESR [DAS28 (ESR)] is a derived score combining tender joints (28 joints), swollen joints (28 joints), ESR, and Patient's Global Assessment of Disease Activity. The 28 joints evaluated for swelling and tenderness were shoulder, elbow, wrist, MCP1, MCP2, MCP3, MCP4, MCP5, PIP1, PIP2, PIP3, PIP4, PIP5 joints of the upper right and upper left extremities as well as the knee joints of the lower right and lower left extremities. The DAS28-ESR is expressed on a score range of "0-10", with the minimum score= 0 (best) to maximum score= 10 (worst). The DAS28 (ESR) remission is defined as a DAS28 (ESR) value of less than 2.6 at a visit.

    Measured: Week 24

  2. Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 24

    The ACR 20 Response is defined as >= 20% improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20% improvement in 3 of following 5 assessments: subject's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), subject's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, subject's assessment of physical function measured by HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum CRP.

    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 posted24 Dec 2013 (estimated)
  2. Study start4 Apr 2014
  3. Primary completion17 Aug 2016
  4. Study completion17 Aug 2016

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
559 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02019472
Sponsor's protocol ID
CR103111
Other IDs
CNTO136ARA3005, 2013-001417-32
Acronym
SIRROUND-H
Status last verified
Sep 2017
First submitted
18 Dec 2013
Last updated
26 Oct 2017
Data monitoring committee
Yes
FDA-regulated device
No

Publications

  • Taylor PC, Schiff MH, Wang Q, Jiang Y, Zhuang Y, Kurrasch R, Daga S, Rao R, Tak PP, Hsu B. Efficacy and safety of monotherapy with sirukumab compared with adalimumab monotherapy in biologic-naive patients with active rheumatoid arthritis (SIRROUND-H): a randomised, double-blind, parallel-group, multinational, 52-week, phase 3 study. Ann Rheum Dis. 2018 May;77(5):658-666. doi: 10.1136/annrheumdis-2017-212496. Epub 2018 Feb 26.

    PubMed 29483080

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing adalimumab 40 mg, sirukumab 100 mg and sirukumab 50 mg in people with Arthritis, Rheumatoid, run by Janssen Research & Development, LLC at 107 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?

The sponsor lists 5 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 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 107 sites in United States, Russia, Ukraine, Poland, Germany 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. 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 14 Sep 2017). 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?

Change From Baseline in Disease Activity Index Score 28 (DAS28) Erythrocyte Sedimentation Rate (ESR) at Week 24 (time frame: Baseline and Week 24). The study lists 2 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 NCT02019472, 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 26 Oct 2017.

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