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Arthritis, RheumatoidPhase 3NCT01606761

A Study of CNTO 136 (Sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients With Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy (SIRROUND-T)

A Phase 3 study testing Sirukumab in people with Arthritis, Rheumatoid, run by Janssen Research & Development, LLC at 201 sites in 22 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

The purpose of this study is to assess the efficacy of sirukumab as measured by the reduction of the signs and symptoms of rheumatoid arthritis (RA) in patients with active RA who are unresponsive or intolerant to treatment with anti-TNF-alpha agents. 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?
Sirukumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
878 participants
Where
201 sitesin 22 countries
Study dates
6 Aug 2012to 12 Jan 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 3 months before screening
  • Have moderately to severely active RA with at least 4 of 68 tender joints and 4 of 66 swollen joints, at screening and at baseline
  • Have had anti-tumor necrosis factor (TNF)-alpha therapy and were unresponsive by 1 of the following 2 reasons: Lack of benefit to at least 1 anti-TNF-alpha biologic therapy, as assessed by the treating physician, after at least 12 weeks of etanercept, yisaipu, adalimumab, golimumab, or certolizumab pegol therapy and/or at least a 14-week dosage regimen (ie, at least 4 doses) of infliximab; Intolerance to at least 2 anti-TNF-alpha biologic therapies, as assessed by the treating physician, to etanercept, yisaipu, adalimumab, golimumab, certolizumab pegol, or infliximab or have documented intolerance to an anti-TNF-alpha agent as described above that precludes further administration of anti-TNF-alpha agents
  • If using oral corticosteroids, must be on a stable dose equivalent to less than or equal to 10 mg/day of prednisone for at least 2 weeks prior to the first administration of study agent. If currently not using corticosteroids, must not have received oral corticosteroids for at least 2 weeks prior to the first administration of study agent
  • If using non nonsteroidal anti-inflammatory drug (NSAIDs) or other analgesics for RA, must be on a stable dose for at least 2 weeks prior to the first administration of study agent
  • If using non-biologic disease modifying antirheumatic drugs (DMARDs) such as methotrexate (MTX), sulfasalazine (SSZ), hydroxychloroquine, chloroquine, or bucillamine, must be on a stable dose for at least 4 weeks prior to the first administration of study agent and should have no serious toxic side effects attributable to the DMARD
  • C-reactive protein (CRP) 8.00 mg/L or more or erythrocyte sedimentation rate (ESR) 28 mm/hr or more at screening

Who cannot join

  • Has received infliximab, infliximab biosimilar, or golimumab intravenous (IV) within 8 weeks of the first study agent administration
  • Has received subcutaneously (SC) golimumab, adalimumab, or certolizumab pegol within 6 weeks of the first study agent administration
  • Has received etanercept or yisaipu within 4 weeks of the first study agent administration
  • Has a history of intolerance to tocilizumab that precluded further treatment with it, or inadequate response to 3 months of tocilizumab (anti-IL-6 receptor) therapy. Has used tocilizumab within 8 weeks of the first study agent administration
  • Has used B-cell-depleting therapy (eg, rituximab) within 7 months of first study agent administration or have evidence during screening of abnormally low B-cell level caused by previous B-cell depletion therapy
  • Has used anakinra within 1 week of first study agent administration
Show all 12Show fewer
  • Has used abatacept or any other biologic therapy for the treatment of RA within 8 weeks of the first study agent administration
  • Has received intra-articular (IA), intramuscular (IM), 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
  • Has a history of cyclophosphamide or cytotoxic agent use
  • Has received cyclosporine A, azathioprine, tacrolimus, mycophenolate mofetil, oral or parenteral gold, or D-penicillamine within 4 weeks of the first study agent administration
  • Has received an investigational drug (including investigational vaccines) or used an investigational medical device within 3 months or 5 half-lives, whichever is longer, before the first study agent administration

Trial locations and contacts

201 sites in 22 countries.

201 sites in 22 countries

United States81 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Austin, Texas

  • Study site

    Aventura, Florida

  • Study site

    Beckley, West Virginia

  • Study site

    Birmingham, Alabama

  • Study site

    Boca Raton, Florida

  • Study site

    Boise, Idaho

  • Study site

    Bowling Green, Kentucky

  • Study site

    Brandon, Florida

  • Study site

    Brooklyn, New York

  • Study site

    Carrollton, Texas

  • Study site

    Cedar Rapids, Iowa

  • Study site

    Charleston, South Carolina

  • Study site

    Charlotte, North Carolina

  • Study site

    Cincinnati, Ohio

  • Study site

    Clarksburg, West Virginia

  • Study site

    Columbus, Ohio

  • Study site

    Corpus Christi, Texas

  • Study site

    Covina, California

  • Study site

    Cumberland, Maryland

  • Study site

    Cypress, Texas

  • Study site

    Dallas, Texas

  • Study site

    Dayton, Ohio

  • Study site

    Daytona Beach, Florida

  • Study site

    Eagan, Minnesota

  • Study site

    East Greenwich, Rhode Island

  • Study site

    Edmond, Oklahoma

  • Study site

    El Cajon, California

  • Study site

    Erie, Pennsylvania

  • Study site

    Flowood, Mississippi

  • Study site

    Frederick, Maryland

  • Study site

    Freehold, New Jersey

  • Study site

    Glendale, Arizona

  • Study site

    Hagerstown, Maryland

  • Study site

    Hamden, Connecticut

  • Study site

    Hemet, California

  • Study site

    Hickory, North Carolina

  • Study site

    Houston, Texas

  • Study site

    Huntington Beach, California

  • Study site

    Idaho Falls, Idaho

  • Study site

    Indianapolis, Indiana

  • Study site

    Katy, Texas

  • Study site

    Kennewick, Washington

  • Study site

    La Jolla, California

  • Study site

    La Palma, California

  • Study site

    Lake Mary, Florida

  • Study site

    Lake Success, New York

  • Study site

    Las Vegas, Nevada

  • Study site

    Lubbock, Texas

  • Study site

    Mesa, Arizona

  • Study site

    Mesquite, Texas

  • Study site

    Miami, Florida

  • Study site

    Middleburg Heights, Ohio

  • Study site

    Monroe, Louisiana

  • Study site

    Naples, Florida

  • Study site

    Omaha, Nebraska

  • Study site

    Orlando, Florida

  • Study site

    Palm Harbor, Florida

  • Study site

    Phoenix, Arizona

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Placentia, California

  • Study site

    Plainview, New York

  • Study site

    Plantation, Florida

  • Study site

    Richmond, Texas

  • Study site

    Rochester, Minnesota

  • Study site

    Santa Monica, California

  • Study site

    Sarasota, Florida

  • Study site

    Seattle, Washington

  • Study site

    Shreveport, Louisiana

  • Study site

    Springfield, Missouri

  • Study site

    St Louis, Missouri

  • Study site

    Tampa, Florida

  • Study site

    Tulsa, Oklahoma

  • Study site

    Tupelo, Mississippi

  • Study site

    Tustin, California

  • Study site

    Upland, California

  • Study site

    Victoria, Texas

  • Study site

    Victorville, California

  • Study site

    Whittier, California

  • Study site

    Wyomissing, Pennsylvania

  • Study site

    Zephyrhills, Florida

Other trials in United States

Japan39 sites

  • Study site

    Ayauta

  • Study site

    Bunkyō City

  • Study site

    Fukuoka

  • Study site

    Fukuyama

  • Study site

    Higashihiroshima

  • Study site

    Hiroshima

  • Study site

    Izumo

  • Study site

    Kagoshima

  • Study site

    Katō

  • Study site

    Kawagoe

  • Study site

    Kita-Gun

  • Study site

    Kumamoto

  • Study site

    Kurume

  • Study site

    Matsuyama

  • Study site

    Miyazaki

  • Study site

    Nagano

  • Study site

    Nagasaki

  • Study site

    Nagoya

  • Study site

    Nishimuro-Gun

  • Study site

    Nishinomiya

  • Study site

    Okayama

  • Study site

    Osaka

  • Study site

    Sapporo

  • Study site

    Sasebo

  • Study site

    Shibata

  • Study site

    Shimonoseki

  • Study site

    Shimotsuke

  • Study site

    Shinjuku-Ku

  • Study site

    Sumida-Ku

  • Study site

    Takaoka,Toyama

  • Study site

    Takasaki

  • Study site

    Tokorozawa

  • Study site

    Tokushima

  • Study site

    Tomakomai

  • Study site

    Tomishiro

  • Study site

    Tonami

  • Study site

    Tsu

  • Study site

    Ureshino

  • Study site

    Yokohama

Other trials in Japan

Germany13 sites

  • Study site

    Berlin

  • Study site

    Cologne

  • Study site

    Dresden

  • Study site

    Erfurt

  • Study site

    Frankfurt am Main

  • Study site

    Gÿttingen N/A

  • Study site

    Hamburg

  • Study site

    Herne

  • Study site

    Kiel Kronshagen

  • Study site

    Schwerin

  • Study site

    Vogelsang-Gommern

  • Study site

    Würzburg

  • Study site

    Zerbst

Other trials in Germany

Russia9 sites

  • Study site

    Barnaul

  • Study site

    Moscow

  • Study site

    Novosibirsk

  • Study site

    Omsk

  • Study site

    Orenburg

  • Study site

    Ryazan

  • Study site

    Saint Petersburg

  • Study site

    Saratov

  • Study site

    Ulyanovsk

Other trials in Russia

South Korea9 sites

  • Study site

    Busan

  • Study site

    Daegu

  • Study site

    Daejeon

  • Study site

    Gwangju

  • Study site

    Incheon

  • Study site

    Jeonju

  • Study site

    Seongnam-si

  • Study site

    Seoul

  • Study site

    Suwon

Other trials in South Korea

Canada7 sites

  • Study site

    Burlington

  • Study site

    Kitchener, Ontario

  • Study site

    St. John's, Newfoundland and Labrador

  • Study site

    St. John's

  • Study site

    Toronto

  • Study site

    Victoria, British Columbia

  • Study site

    Winnipeg, Manitoba

Other trials in Canada

Spain7 sites

  • Study site

    A Coruña

  • Study site

    Bilbao

  • Study site

    Madrid

  • Study site

    Mérida

  • Study site

    San Cristóbal de La Laguna

  • Study site

    Santander

  • Study site

    Santiago de Compostela

Other trials in Spain

Poland6 sites

  • Study site

    Bydgoszcz

  • Study site

    Elblag

  • Study site

    Lublin

  • Study site

    Poznan

  • Study site

    Ustroń

  • Study site

    Warsaw

Other trials in Poland

United Kingdom5 sites

  • Study site

    Barnsley

  • Study site

    London

  • Study site

    Middlesbrough

  • Study site

    Sheffield

  • Study site

    Wigan

Other trials in United Kingdom

Argentina3 sites

  • Study site

    Buenos Aires

  • Study site

    Rosario

  • Study site

    San Miguel de Tucumán

Other trials in Argentina

Mexico3 sites

  • Study site

    Guadalajara

  • Study site

    Mérida

  • Study site

    San Luis Potosí City

Other trials in Mexico

New Zealand3 sites

  • Study site

    Christchurch

  • Study site

    Hamilton

  • Study site

    Wellington

Other trials in New Zealand

Taiwan3 sites

  • Study site

    Kaohsiung City

  • Study site

    Taichung

  • Study site

    Taipei

Other trials in Taiwan

Australia2 sites

  • Study site

    Campbelltown

  • Study site

    Victoria Park

Other trials in Australia

France2 sites

  • Study site

    Paris

  • Study site

    Toulouse

Other trials in France

Lithuania2 sites

  • Study site

    Kaunas

  • Study site

    Klaipėda

Other trials in Lithuania

Portugal2 sites

  • Study site

    Coimbra

  • Study site

    Lisbon

Other trials in Portugal

Austria1 site

  • Study site

    Vienna

Other trials in Austria

Belgium1 site

  • Study site

    Liège

Other trials in Belgium

Croatia1 site

  • Study site

    Zagreb

Other trials in Croatia

Netherlands1 site

  • Study site

    Sneek

Other trials in Netherlands

Puerto Rico1 site

  • Study site

    San Juan

Other trials in Puerto Rico

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (Sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects With Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy

The purpose of this study is to assess the efficacy of sirukumab as measured by the reduction of the signs and symptoms of rheumatoid arthritis (RA) in patients with active RA who are unresponsive or intolerant to treatment with anti-TNF-alpha agents.

Read the detailed description

Patients will be randomly assigned to treatment groups, and they and study personnel will not know the identity of the treatments given. Some patients will receive a placebo, which resembles a medication, but does not contain an active substance. This helps to determine if the study agent is effective. Patients will receive placebo or sirukumab by injection under the skin. The expected duration of the study is 68 weeks, which includes 52 weeks of treatment. Participants who complete participation in the study will be eligible for inclusion into the long term extension study if enrollment at a participating site is available to them. If they do not participate in the long-term study, they will continue into the safety follow-up for approximately 16 weeks. The placebo-controlled portion of the study is through Week 24, when placebo patients will cross over to one of two sirukumab dose regimens. Patient safety will be monitored throughout the study.

Being tested
Placebo, Sirukumab
Keywords
Arthritis, Rheumatoid, Active rheumatoid arthritis despite anti-TNF-alpha therapy, Sirukumab, Human Anti-IL-6 monoclonal antibody
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • PlaceboDrug

    Form=solution for injection, route=subcutaneous use; every 2 weeks from Week 0 through Week 22.

  • PlaceboDrug

    Form=solution for injection, route=subcutaneous use; Weeks 2, 6, and every 4 weeks through Week 52.

  • SirukumabDrug

    Type=exact, unit=mg, number=50 or 100, form=solution for injection, route=subcutaneous use; every 2 weeks for 100 mg and every 4 weeks for 50 mg, Week 23 through Week 52.

  • SirukumabDrug

    Type=exact, unit=mg, number=100, form=solution for injection, route=subcutaneous use; Weeks 0, 2, and every 2 weeks through Week 52.

  • SirukumabDrug

    Type=exact, unit=mg, number=50, form=solution for injection, route=subcutaneous use; Weeks 0, 4, and every 4 weeks through Week 52.

Study groups in NCT01606761
Study groupRoleWhat they receive
Group 1ExperimentalPatients will receive placebo every 2 weeks from Week 0 through Week 22, followed by a subcutaneous (SC) sirukumab dose regimen every 2 weeks through Week 52.
Receives: Drug: Placebo; Drug: Sirukumab
Group 2ExperimentalPatients will receive sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks through Week 52.
Receives: Drug: Sirukumab
Group 3ExperimentalPatients will receive sirukumab 50 mg SC at Weeks 0, 4, and every 4 weeks through Week 52. Between sirukumab injections, placebo SC administrations will be made at Weeks 2, 6, and every 4 weeks through Week 52.
Receives: Drug: Placebo; Drug: Sirukumab

What is being measured

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

  1. Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response at Week 16

    The ACR 20 Response is defined as greater than or equal to (>=) 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10 scale, 0 =no pain and 10 =worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, [0 =no pain to 10 =worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (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 C-Reactive Protein (CRP).

    Measured: Week 16

Secondary outcomes (3)

  1. Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 24

    The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.

    Measured: Baseline and Week 24

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

    The ACR 50 Response is defined as >= 50 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=50 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS ( 0-10 scale, 0 =no pain and 10 =worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, [0 =no pain to 10 =worst possible pain]), physician's global assessment of disease activity using VAS, participant'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 C-Reactive Protein (CRP).

    Measured: Week 24

  3. Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission at Week 24

    The Disease Activity Index Score 28 (DAS28) based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. DAS28 (CRP) remission is defined as a DAS28 (CRP) value of less than (<) 2.6 at any study visit.

    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 posted28 May 2012 (estimated)
  2. Study start6 Aug 2012
  3. Primary completion17 Mar 2015
  4. Study completion12 Jan 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
Double blind
Who is masked
Participant, Investigator
Enrolment
878 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01606761
Sponsor's protocol ID
CR100864
Other IDs
CNTO136ARA3003, 2010-022243-38, U1111-1135-6365
Status last verified
Feb 2018
First submitted
24 May 2012
Last updated
23 Mar 2018
Data monitoring committee
Yes
FDA-regulated drug
Yes

Publications

  • Aletaha D, Bingham CO 3rd, Tanaka Y, Agarwal P, Kurrasch R, Tak PP, Popik S. Efficacy and safety of sirukumab in patients with active rheumatoid arthritis refractory to anti-TNF therapy (SIRROUND-T): a randomised, double-blind, placebo-controlled, parallel-group, multinational, phase 3 study. Lancet. 2017 Mar 25;389(10075):1206-1217. doi: 10.1016/S0140-6736(17)30401-4. Epub 2017 Feb 16.

    PubMed 28215362

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sirukumab in people with Arthritis, Rheumatoid, run by Janssen Research & Development, LLC at 201 sites in 22 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 7 inclusion and 12 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 23 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 201 sites in United States, Japan, Germany, Russia, South Korea and 17 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 5 Feb 2018). 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 American College of Rheumatology (ACR) 20 Response at Week 16 (time frame: Week 16). 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 NCT01606761, 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 23 Mar 2018.

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