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Arthritis, RheumatoidPhase 2NCT01645280

A Study of the Effectiveness and Safety of Ustekinumab (STELARA) and CNTO 1959 Administered Under the Skin of Patients With Active Rheumatoid Arthritis, Despite Existing Methotrexate Therapy

A Phase 2 study testing Ustekinumab + MTX (Group 2), Ustekinumab + MTX (Group 3) and CNTO 1959 + MTX (Group 4) in people with Arthritis, Rheumatoid, run by Janssen Research & Development, LLC at 47 sites in 11 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 purpose of this study is to evaluate the efficacy of ustekinumab and CNTO 1959 in reducing the signs and symptoms of disease in patients with active rheumatoid arthritis (RA) despite concomitant methotrexate (MTX) therapy and to evaluate the safety of ustekinumab and CNTO 1959 in this population. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Arthritis, Rheumatoid
What is being tested?
Ustekinumab + MTX (Group 2), Ustekinumab + MTX (Group 3) and CNTO 1959 + MTX (Group 4)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
274 participants
Where
47 sitesin 11 countries
Study dates
Aug 2012to May 2014
Phase
Phase 2
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have had RA for at least 6 months prior to screening
  • Have a diagnosis of RA according to the revised 1987 criteria of the American Rheumatism Association - Be positive for either anti-cyclic citrullinated peptide antibody or rheumatoid factor in serum at screening
  • Have been treated with and tolerated MTX for at least 6 months prior to screening, and have a MTX dose of >= 10 mg and <= 25 mg per week and stable for at least 12 weeks prior to first administration of study agent
  • Have active RA, defined as persistent disease activity with both of the following criteria: at least 6 swollen and 6 tender joints at the time of screening and baseline; serum C-reactive protein (CRP) >= 0.80 mg/dL at screening. The investigator may consider the patient eligible if the CRP value is at least 0.80 mg/dL in a single repeat testing during the screening period
  • If using oral corticosteroids, must be on a stable dose of <= 10 mg/day of prednisone or an equipotent dose of another oral corticosteroid for at least 2 weeks prior to the first administration of study agent. If not using corticosteroids at Week 0, the patient must not have received oral corticosteroids for at least 2 weeks prior to the first administration of study agent
  • If using nonsteroidal anti-inflammatory drugs (NSAIDs) or other analgesics regularly for RA, the patient must have been on a stable dose for at least 2 weeks prior to the first administration of study agent. If not using NSAIDs or other analgesics for RA at Week 0, the patient must have not received NSAIDs or other analgesics for RA for at least 2 weeks prior to the first administration of study agent

Who cannot join

  • Has other inflammatory diseases, including but not limited to psoriatic arthritis, ankylosing spondylitis (AS), systemic lupus erythematosus, or Lyme disease, that might confound the evaluation of the benefit of study agent therapy
  • Has current signs or symptoms of liver insufficiency or cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances that are severe, progressive, or uncontrolled
  • Has any known malignancy or history of malignancy (with the exception of basal cell carcinoma, squamous cell carcinoma in situ of the skin, or cervical carcinoma in situ that has been treated with no evidence of recurrence, or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years prior to the first administration of study agent)
  • Has a history of lymphoproliferative disease, including lymphoma, or signs suggestive of possible lymphoproliferative disease such as lymphadenopathy of unusual size or location, or clinically significant splenomegaly
  • Has known allergies, hypersensitivity, or intolerance to ustekinumab or CNTO 1959 or its inactive ingredients
  • Has ever received any approved or investigational biologic agent

Trial locations and contacts

47 sites in 11 countries.

47 sites in 11 countries

Russia9 sites

  • Study site

    Kazan'

  • Study site

    Moscow

  • Study site

    Novosibirsk

  • Study site

    Petrozavodsk

  • Study site

    Saint Petersburg

  • Study site

    Saratov

  • Study site

    Ufa

  • Study site

    Ulyanovsk

  • Study site

    Yaroslavl

Other trials in Russia

Ukraine8 sites

  • Study site

    Donetsk

  • Study site

    Ivano-Frankivsk

  • Study site

    Kharkiv

  • Study site

    Kiev

  • Study site

    Simferopol

  • Study site

    Ternopil

  • Study site

    Uzhhorod

  • Study site

    Vinnitsa

Other trials in Ukraine

Poland7 sites

  • Study site

    Bialystok

  • Study site

    Elblag

  • Study site

    Krakow

  • Study site

    Poznan

  • Study site

    Sopot

  • Study site

    Sosnowiec

  • Study site

    Warsaw

Other trials in Poland

Colombia5 sites

  • Study site

    Bogotá

  • Study site

    Bucaramanga

  • Study site

    Cali

  • Study site

    Chía

  • Study site

    Medellín

Other trials in Colombia

Hungary5 sites

  • Study site

    Budapest

  • Study site

    Gödöllő

  • Study site

    Székesfehérvár

  • Study site

    Szombathely

  • Study site

    Veszprém

Other trials in Hungary

United States3 sites

  • Study site

    Palm Harbor, Florida

  • Study site

    Rock Island, Illinois

  • Study site

    St Louis, Missouri

Other trials in United States

Argentina3 sites

  • Study site

    Buenos Aires

  • Study site

    San Juan

  • Study site

    San Miguel de Tucumán

Other trials in Argentina

Czechia3 sites

  • Study site

    Hlučín

  • Study site

    Kladno

  • Study site

    Uherské Hradiště

Other trials in Czechia

Bulgaria2 sites

  • Study site

    Plovdiv

  • Study site

    Sofia

Other trials in Bulgaria

Chile1 site

  • Study site

    Osorno

Other trials in Chile

Singapore1 site

  • Study site

    Singapore

Other trials in Singapore

About this study

Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Study Evaluating the Efficacy and Safety of Ustekinumab (STELARA®) and CNTO 1959 Administered Subcutaneously in Subjects With Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy

The purpose of this study is to evaluate the efficacy of ustekinumab and CNTO 1959 in reducing the signs and symptoms of disease in patients with active rheumatoid arthritis (RA) despite concomitant methotrexate (MTX) therapy and to evaluate the safety of ustekinumab and CNTO 1959 in this population.

Read the detailed description

This is a randomized (patients assigned to treatment by chance), double-blind (study personnel and patients will not know what treatment is being assigned to patients), multicenter, placebo-controlled (a placebo is a treatment identical in appearance to the study agent, but containing no active ingredient), dose-ranging study. Approximately 250 patients will be randomly assigned to 1 of 5 treatment groups. The maximum length of study participation is 54 weeks, including a 6-week screening period. The end of the study will be the last follow-up visit of the last patient. Study visits and evaluations will occur, and patient safety will be monitored throughout the study.

Being tested
Placebo + methotrexate (MTX) (Group 1), Ustekinumab + MTX (Group 2), Ustekinumab + MTX (Group 3), CNTO 1959 + MTX (Group 4), CNTO 1959 + MTX (Group 5)
Keywords
Active rheumatoid arthritis, Ustekinumab, STELARA, CNTO 1959
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • Placebo + methotrexate (MTX) (Group 1)Drug

    Placebo: form = solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 8 weeks (Weeks 12, 20, and 28) + MTX (pre-study dose)

  • Ustekinumab + MTX (Group 2)Drug

    Ustekinumab: type = exact number, unit = mg, number = 90, form = solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 8 weeks (Weeks 12, 20, and 28) + MTX (pre-study dose)

  • Ustekinumab + MTX (Group 3)Drug

    Ustekinumab: type = exact number, unit = mg, number = 90, form = solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 12 weeks (Weeks 16 and 28) + MTX (pre-study dose)

  • CNTO 1959 + MTX (Group 4)Drug

    CNTO 1959: type = exact number, unit = mg, number = 200, form = powder for solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 8 weeks (Weeks 12, 20, and 28) + MTX (pre-study dose)

  • CNTO 1959 + MTX (Group 5)Drug

    CNTO 1959: type = exact number, unit = mg, number = 50, form = powder for solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 8 weeks (Weeks 12, 20, and 28)+ MTX (pre-study dose)

Study groups in NCT01645280
Study groupRoleWhat they receive
Group 1Placebo comparatorNot described
Receives: Drug: Placebo + methotrexate (MTX) (Group 1)
Group 2ExperimentalNot described
Receives: Drug: Ustekinumab + MTX (Group 2)
Group 3ExperimentalNot described
Receives: Drug: Ustekinumab + MTX (Group 3)
Group 4ExperimentalNot described
Receives: Drug: CNTO 1959 + MTX (Group 4)
Group 5ExperimentalNot described
Receives: Drug: CNTO 1959 + MTX (Group 5)

What is being measured

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

  1. Percentage of Participants With American College of Rheumatology 20 (ACR 20) Response at Week 28

    The ACR 20 responders are participants with at least 20 percent (%) improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) patient's assessment of arthritis pain-visual analog scale, 2) patient's global assessment of disease activity-visual analog scale, 3) physician's global assessment of disease activity-visual analog scale, 4) patient's assessment of physical function as measured by health assessment questionnaire-disability index (HAQ-Di), 5) C-reactive protein (CRP).

    Measured: Week 28

Secondary outcomes (3)

  1. Change From Baseline in Disease Activity Index Score 28 (DAS28; Using C-reactive Protein [CRP]) Score at Week 28

    The DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, CRP (mG/L) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.

    Measured: From Baseline to Week 28

  2. Percentage of Participants With American College of Rheumatology 20 (ACR 20) Response at Week 12

    The ACR 20 responders are participants with at least 20 percent (%) improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 2) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 3) Physician's Global Assessment of Disease Activity-Visual Analog Scale, 4) Patient's Assessment of Physical Function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI), 5) C-reactive Protein (CRP).

    Measured: Week 12

  3. Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 28

    The Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. 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 28

Timeline

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

  1. First posted20 Jul 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionDec 2013
  4. Study completionMay 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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
274 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01645280
Sponsor's protocol ID
CR100736
Other IDs
CNTO1275ARA2001, 2011-001122-18
Status last verified
May 2016
First submitted
6 Jun 2012
Last updated
12 May 2016
Data monitoring committee
Yes

Publications

  • Smolen JS, Agarwal SK, Ilivanova E, Xu XL, Miao Y, Zhuang Y, Nnane I, Radziszewski W, Greenspan A, Beutler A, Baker D. A randomised phase II study evaluating the efficacy and safety of subcutaneously administered ustekinumab and guselkumab in patients with active rheumatoid arthritis despite treatment with methotrexate. Ann Rheum Dis. 2017 May;76(5):831-839. doi: 10.1136/annrheumdis-2016-209831. Epub 2017 Jan 13.

    PubMed 28087506

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ustekinumab + MTX (Group 2), Ustekinumab + MTX (Group 3) and CNTO 1959 + MTX (Group 4) in people with Arthritis, Rheumatoid, run by Janssen Research & Development, LLC at 47 sites in 11 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 6 inclusion and 6 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 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in Russia, Ukraine, Poland, Colombia, Hungary and 6 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 19 Dec 2014). 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 With American College of Rheumatology 20 (ACR 20) Response at Week 28 (time frame: Week 28). 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 NCT01645280, 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 May 2016.

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