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, 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
3 other identifiers
interventional
274
11 countries
47
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2012
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 6, 2012
CompletedFirst Posted
Study publicly available on registry
July 20, 2012
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedResults Posted
Study results publicly available
December 19, 2014
CompletedMay 12, 2016
May 1, 2016
1.3 years
June 6, 2012
December 12, 2014
May 10, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (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).
Week 28
Secondary Outcomes (3)
Change From Baseline in Disease Activity Index Score 28 (DAS28; Using C-reactive Protein [CRP]) Score at Week 28
From Baseline to Week 28
Percentage of Participants With American College of Rheumatology 20 (ACR 20) Response at Week 12
Week 12
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 28
Baseline and Week 28
Study Arms (5)
Group 1
PLACEBO COMPARATORGroup 2
EXPERIMENTALGroup 3
EXPERIMENTALGroup 4
EXPERIMENTALGroup 5
EXPERIMENTALInterventions
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: 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: 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: 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: 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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (47)
Unknown Facility
Palm Harbor, Florida, United States
Unknown Facility
Rock Island, Illinois, United States
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St Louis, Missouri, United States
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Buenos Aires, Argentina
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San Juan, Argentina
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San Miguel de Tucumán, Argentina
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Plovdiv, Bulgaria
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Sofia, Bulgaria
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Osorno, Chile
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Bogotá, Colombia
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Bucaramanga, Colombia
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Cali, Colombia
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Chía, Colombia
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Medellín, Colombia
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Hlučín, Czechia
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Kladno, Czechia
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Uherské Hradiště, Czechia
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Budapest, Hungary
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Gödöllő, Hungary
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Székesfehérvár, Hungary
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Szombathely, Hungary
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Veszprém, Hungary
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Bialystok, Poland
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Elblag, Poland
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Krakow, Poland
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Poznan, Poland
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Sopot, Poland
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Sosnowiec, Poland
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Warsaw, Poland
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Kazan', Russia
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Moscow, Russia
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Novosibirsk, Russia
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Petrozavodsk, Russia
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Saint Petersburg, Russia
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Saratov, Russia
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Ufa, Russia
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Ulyanovsk, Russia
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Yaroslavl, Russia
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Singapore, Singapore
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Donetsk, Ukraine
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Ivano-Frankivsk, Ukraine
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Kharkiv, Ukraine
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Kiev, Ukraine
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Simferopol, Ukraine
Unknown Facility
Ternopil, Ukraine
Unknown Facility
Uzhhorod, Ukraine
Unknown Facility
Vinnitsa, Ukraine
Related Publications (1)
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.
PMID: 28087506DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Director Clin Development
- Organization
- Janssen Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2012
First Posted
July 20, 2012
Study Start
August 1, 2012
Primary Completion
December 1, 2013
Study Completion
May 1, 2014
Last Updated
May 12, 2016
Results First Posted
December 19, 2014
Record last verified: 2016-05