Back to resultsAn Efficacy And Safety Study of CNTO 6785 In Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
CNTO 6785 200 mg
CNTO 6785 200 mg
CNTO 6785 100 mg
CNTO 6785 50 mg
CNTO 6785 15 mg
Methotrexate (MTX)
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Active rheumatoid arthritis despite methotrexate therapy, CNTO 6785, Methotrexate
Eligibility Criteria
Inclusion Criteria:
- Have a diagnosis of rheumatoid arthritis (RA) (according to the revised 1987 criteria of the American Rheumatism Association) and have had RA for at least 6 months prior to the date of signing the informed consent at screening
- Have active RA defined study as persistent disease activity with both of the following criteria: at least 6 swollen and 6 tender joints using a 66/68 joint count at the time of screening and at baseline; and serum C-reactive protein (CRP) ≥ 0.8 mg/dL at screening or erythrocyte sedimentation rate (ESR) ≥ 28 mm in the first hour at screening or baseline
- Have been treated with and tolerated methotrexate (MTX) treatment at dosages from 7.5 to 25 mg/week, inclusive, for a minimum of 6 months prior to screening and must have a stable MTX dose for a minimum of 6 weeks prior to the first dosing with study agent
Exclusion Criteria:
- Has inflammatory diseases other than RA, that might confound the evaluation of the benefit of study agent therapy
- Has a diagnosis of fibromyalgia
- Has a recent history (within 12 months prior to screening) of uncontrolled, chronic disease including, but not limited to, pulmonary, psychiatric, and metabolic disturbances, cardiovascular, endocrine, neurological, hepatic, gastrointestinal, renal, hematological, or urological diseases that the investigator believes are clinically significant
- At screening, the results of laboratory tests must meet protocol-specified criteria
- Has ever received any approved or investigational biologic agent for a rheumatic indication
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Arm Label
Placebo/CNTO 6785 200 mg+Methotrexate (MTX)
CNTO 6785 200 mg+MTX
CNTO 6785 100 mg+MTX
CNTO 6785 50 mg+MTX
CNTO 6785 15 mg+MTX
Arm Description
Outcomes
Primary Outcome Measures
The proportion of participants who achieve an ACR 20 response at Week 16
American College of Rheumatology (ACR) 20 response is a >=20% improvement in rheumatoid arthritis (RA) symptoms.
Secondary Outcome Measures
Change from baseline in DAS28 (CRP) at Week 16
DAS28 (using CRP [C-reactive protein]) is a measure of tender and swollen joints and the patient's assessment of disease activity.
The proportion of participants who achieve ACR 50 response at Week 16
American College of Rheumatology (ACR) 50 response is a >=50% improvement in rheumatoid arthritis (RA) symptoms.
The proportion of participants who achieve ACR 20 response through Week 32
The proportion of participants who achieve ACR 50 response through Week 32
The proportion of participants who achieve ACR 70 response through Week 32
American College of Rheumatology (ACR) 70 response is a >=70% improvement in rheumatoid arthritis (RA) symptoms.
Change from baseline of DAS28 (CRP) through Week 32
The proportion of participants with DAS28 (CRP) response through Week 32
DAS28 (using CRP [C-reactive protein]) response is improvement from baseline, with >1.2 indicating a good or moderate response and <=0.6 indicating no response.
The proportion of participants with DAS28 (CRP) remission at Week 16
DAS28 (using CRP [C-reactive protein]) remission is defined as a value of <2.6 on the Disease Activity Index, a measure of tender and swollen joints and the patient's assessment of disease activity.
The proportion of participants with DAS28 (CRP) remission at Week 32
Change from baseline in DAS28 (ESR) at Week 16
DAS28 (using erythrocyte sedimentation rate) is a measure of tender and swollen joints and the patient's assessment of disease activity.
Change from baseline in DAS28 (ESR) at Week 32
Change from baseline in HAQ-DI score through Week 32
The Health Assessment Questionnaire-Disability Index (HAQ-DI) assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas, each scored from 0 (no difficulty) to 3 (inability to perform a task).
Change from baseline in SF-36 at Week 16
The SF-36 is a medical outcome study health measure and consists of 8 multi-item scales that are scored from 0 to 100, with higher scores indicating better health.
Change from baseline in SF-36 at Week 32
Change from baseline in CDAI at Week 16
Clinical Disease Activity Index (CDAI) score is a derived score combining tender joints (28 joints), swollen joints (28 joints), Patient's Global Assessment of Disease Activity, and Physician's Global Assessments of Disease Activity.
Change from baseline in CDAI at Week 32
Change from baseline in SDAI at Week 16
The Simplified Disease Activity Index (SDAI) score is a derived score combining tender joints (28 joints), swollen joints (28 joints), Patient's Global Assessment of Disease Activity, Physician's Global Assessments of Disease Activity, and CRP.
Change from baseline in SDAI at Week 32
The proportion of participants with SDAI-based ACR/EULAR remission at Week 16
The Simplified Disease Activity Index (SDAI)-based ACR/EULAR (European League Against Rheumatism) remission is defined as a SDAI value of <=3.3 at a visit.
The proportion of participants with SDAI-based ACR/EULAR remission at Week 32
The proportion of participants with Boolean-based ACR/EULAR remission at Week 16
Boolean-based ACR/EULAR remission is achieved if all of the following 4 criteria at that visit are met: tender joint count (68 joints) <=1; swollen joint count (66 joints) <=1; CRP <=1 mg/dL; and Patient's Global Assessment of Disease Activity on VAS <=1 on a 0 to 10 scale.
The proportion of participants with Boolean-based ACR/EULAR remission at Week 32
Full Information
NCT ID
NCT01909427
First Posted
July 10, 2013
Last Updated
February 3, 2016
Sponsor
Janssen Research & Development, LLC
1. Study Identification
Unique Protocol Identification Number
NCT01909427
Brief Title
An Efficacy And Safety Study of CNTO 6785 In Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Official Title
A Randomized, Placebo-controlled Double-blind, Multicenter, Phase 2 Dose Ranging Study To Assess The Efficacy And Safety of CNTO 6785 In Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to assess the efficacy and safety of CNTO6785 in participants with active rheumatoid arthritis (RA) despite methotrexate (MTX) therapy.
Detailed Description
This is a randomized (participants are assigned to treatment by chance), double-blind (participants and study personnel will not know which treatments are being given), placebo-controlled (a placebo appears identical to a study drug but has no active ingredients), multicenter study. The study will consist of 3 phases: a screening phase, a treatment phase, and a follow-up phase. Approximately 250 participants with active RA despite MTX therapy will be randomly assigned to receive placebo or CNTO 6785 during the double-blind treatment phase. The maximum period of active treatment will be 28 weeks. The maximum duration of study participation will be 44 weeks. Participant safety will be monitored throughout the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Active rheumatoid arthritis despite methotrexate therapy, CNTO 6785, Methotrexate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
257 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo/CNTO 6785 200 mg+Methotrexate (MTX)
Arm Type
Placebo Comparator
Arm Title
CNTO 6785 200 mg+MTX
Arm Type
Experimental
Arm Title
CNTO 6785 100 mg+MTX
Arm Type
Experimental
Arm Title
CNTO 6785 50 mg+MTX
Arm Type
Experimental
Arm Title
CNTO 6785 15 mg+MTX
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo subcutaneous injections (SC) every 4 weeks through Week 12
Intervention Type
Drug
Intervention Name(s)
CNTO 6785 200 mg
Intervention Description
CNTO 6785 200 mg SC every 4 weeks from Week 16 through Week 28
Intervention Type
Drug
Intervention Name(s)
CNTO 6785 200 mg
Intervention Description
CNTO 6785 200 mg SC every 4 weeks through Week 28
Intervention Type
Drug
Intervention Name(s)
CNTO 6785 100 mg
Intervention Description
CNTO 6785 100 mg SC every 4 weeks through Week 28
Intervention Type
Drug
Intervention Name(s)
CNTO 6785 50 mg
Intervention Description
CNTO 6785 50 mg SC every 4 weeks through Week 28
Intervention Type
Drug
Intervention Name(s)
CNTO 6785 15 mg
Intervention Description
CNTO 6785 15 mg SC every 4 weeks through Week 28
Intervention Type
Drug
Intervention Name(s)
Methotrexate (MTX)
Intervention Description
MTX at the same stable dose through Week 32, that participants were receiving prior to screening.
Primary Outcome Measure Information:
Title
The proportion of participants who achieve an ACR 20 response at Week 16
Description
American College of Rheumatology (ACR) 20 response is a >=20% improvement in rheumatoid arthritis (RA) symptoms.
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Change from baseline in DAS28 (CRP) at Week 16
Description
DAS28 (using CRP [C-reactive protein]) is a measure of tender and swollen joints and the patient's assessment of disease activity.
Time Frame
Baseline to Week 16
Title
The proportion of participants who achieve ACR 50 response at Week 16
Description
American College of Rheumatology (ACR) 50 response is a >=50% improvement in rheumatoid arthritis (RA) symptoms.
Time Frame
Week 16
Title
The proportion of participants who achieve ACR 20 response through Week 32
Time Frame
Week 32
Title
The proportion of participants who achieve ACR 50 response through Week 32
Time Frame
Week 32
Title
The proportion of participants who achieve ACR 70 response through Week 32
Description
American College of Rheumatology (ACR) 70 response is a >=70% improvement in rheumatoid arthritis (RA) symptoms.
Time Frame
Week 32
Title
Change from baseline of DAS28 (CRP) through Week 32
Time Frame
Baseline to Week 32
Title
The proportion of participants with DAS28 (CRP) response through Week 32
Description
DAS28 (using CRP [C-reactive protein]) response is improvement from baseline, with >1.2 indicating a good or moderate response and <=0.6 indicating no response.
Time Frame
Week 32
Title
The proportion of participants with DAS28 (CRP) remission at Week 16
Description
DAS28 (using CRP [C-reactive protein]) remission is defined as a value of <2.6 on the Disease Activity Index, a measure of tender and swollen joints and the patient's assessment of disease activity.
Time Frame
Week 16
Title
The proportion of participants with DAS28 (CRP) remission at Week 32
Time Frame
Week 32
Title
Change from baseline in DAS28 (ESR) at Week 16
Description
DAS28 (using erythrocyte sedimentation rate) is a measure of tender and swollen joints and the patient's assessment of disease activity.
Time Frame
Baseline to Week 16
Title
Change from baseline in DAS28 (ESR) at Week 32
Time Frame
Baseline to Week 32
Title
Change from baseline in HAQ-DI score through Week 32
Description
The Health Assessment Questionnaire-Disability Index (HAQ-DI) assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas, each scored from 0 (no difficulty) to 3 (inability to perform a task).
Time Frame
Baseline to Week 32
Title
Change from baseline in SF-36 at Week 16
Description
The SF-36 is a medical outcome study health measure and consists of 8 multi-item scales that are scored from 0 to 100, with higher scores indicating better health.
Time Frame
Baseline to Week 16
Title
Change from baseline in SF-36 at Week 32
Time Frame
Baseline to Week 32
Title
Change from baseline in CDAI at Week 16
Description
Clinical Disease Activity Index (CDAI) score is a derived score combining tender joints (28 joints), swollen joints (28 joints), Patient's Global Assessment of Disease Activity, and Physician's Global Assessments of Disease Activity.
Time Frame
Baseline to Week 16
Title
Change from baseline in CDAI at Week 32
Time Frame
Baseline to Week 32
Title
Change from baseline in SDAI at Week 16
Description
The Simplified Disease Activity Index (SDAI) score is a derived score combining tender joints (28 joints), swollen joints (28 joints), Patient's Global Assessment of Disease Activity, Physician's Global Assessments of Disease Activity, and CRP.
Time Frame
Baseline to Week 16
Title
Change from baseline in SDAI at Week 32
Time Frame
Baseline to Week 32
Title
The proportion of participants with SDAI-based ACR/EULAR remission at Week 16
Description
The Simplified Disease Activity Index (SDAI)-based ACR/EULAR (European League Against Rheumatism) remission is defined as a SDAI value of <=3.3 at a visit.
Time Frame
Week 16
Title
The proportion of participants with SDAI-based ACR/EULAR remission at Week 32
Time Frame
Week 32
Title
The proportion of participants with Boolean-based ACR/EULAR remission at Week 16
Description
Boolean-based ACR/EULAR remission is achieved if all of the following 4 criteria at that visit are met: tender joint count (68 joints) <=1; swollen joint count (66 joints) <=1; CRP <=1 mg/dL; and Patient's Global Assessment of Disease Activity on VAS <=1 on a 0 to 10 scale.
Time Frame
Week 16
Title
The proportion of participants with Boolean-based ACR/EULAR remission at Week 32
Time Frame
Week 32
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have a diagnosis of rheumatoid arthritis (RA) (according to the revised 1987 criteria of the American Rheumatism Association) and have had RA for at least 6 months prior to the date of signing the informed consent at screening
Have active RA defined study as persistent disease activity with both of the following criteria: at least 6 swollen and 6 tender joints using a 66/68 joint count at the time of screening and at baseline; and serum C-reactive protein (CRP) ≥ 0.8 mg/dL at screening or erythrocyte sedimentation rate (ESR) ≥ 28 mm in the first hour at screening or baseline
Have been treated with and tolerated methotrexate (MTX) treatment at dosages from 7.5 to 25 mg/week, inclusive, for a minimum of 6 months prior to screening and must have a stable MTX dose for a minimum of 6 weeks prior to the first dosing with study agent
Exclusion Criteria:
Has inflammatory diseases other than RA, that might confound the evaluation of the benefit of study agent therapy
Has a diagnosis of fibromyalgia
Has a recent history (within 12 months prior to screening) of uncontrolled, chronic disease including, but not limited to, pulmonary, psychiatric, and metabolic disturbances, cardiovascular, endocrine, neurological, hepatic, gastrointestinal, renal, hematological, or urological diseases that the investigator believes are clinically significant
At screening, the results of laboratory tests must meet protocol-specified criteria
Has ever received any approved or investigational biologic agent for a rheumatic indication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
City
Buenos Aires
Country
Argentina
City
Ciudad Autonoma Buenos Aires
Country
Argentina
City
Cordoba
Country
Argentina
City
La Capital
Country
Argentina
City
San Juan
Country
Argentina
City
Barranquilla
Country
Colombia
City
Bogota
Country
Colombia
City
Medellín
Country
Colombia
City
Jihlava
Country
Czech Republic
City
Praha 5
Country
Czech Republic
City
Praha
Country
Czech Republic
City
Cebu
Country
Philippines
City
Iloilo City
Country
Philippines
City
Lipa City
Country
Philippines
City
Quezon City
Country
Philippines
City
Bydgoszcz
Country
Poland
City
Grodzisk Mazowiecki
Country
Poland
City
Lodz
Country
Poland
City
Lublin
Country
Poland
City
Poznan
Country
Poland
City
Warszawa
Country
Poland
City
Wroclaw
Country
Poland
City
Barnaul
Country
Russian Federation
City
Ekaterinburg
Country
Russian Federation
City
Kemerovo
Country
Russian Federation
City
Kursk
Country
Russian Federation
City
Moscow
Country
Russian Federation
City
Novosibirsk
Country
Russian Federation
City
Petrozavodsk
Country
Russian Federation
City
Saint-Petersburg
Country
Russian Federation
City
St. Petersburg
Country
Russian Federation
City
Yaroslavl
Country
Russian Federation
City
Bangkok
Country
Thailand
City
Chiang Mai
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
An Efficacy And Safety Study of CNTO 6785 In Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy
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