An Efficacy And Safety Study of CNTO 6785 In Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy

February 3, 2016 updated by: Janssen Research & Development, LLC

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
257

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
      • Ciudad Autonoma Buenos Aires, Argentina
      • Cordoba, Argentina
      • La Capital, Argentina
      • San Juan, Argentina
  • Colombia
      • Barranquilla, Colombia
      • Bogota, Colombia
      • Medellín, Colombia
  • Czech Republic
      • Jihlava, Czech Republic
      • Praha, Czech Republic
      • Praha 5, Czech Republic
  • Philippines
      • Cebu, Philippines
      • Iloilo City, Philippines
      • Lipa City, Philippines
      • Quezon City, Philippines
  • Poland
      • Bydgoszcz, Poland
      • Grodzisk Mazowiecki, Poland
      • Lodz, Poland
      • Lublin, Poland
      • Poznan, Poland
      • Warszawa, Poland
      • Wroclaw, Poland
  • Russian Federation
      • Barnaul, Russian Federation
      • Ekaterinburg, Russian Federation
      • Kemerovo, Russian Federation
      • Kursk, Russian Federation
      • Moscow, Russian Federation
      • Novosibirsk, Russian Federation
      • Petrozavodsk, Russian Federation
      • Saint-Petersburg, Russian Federation
      • St. Petersburg, Russian Federation
      • Yaroslavl, Russian Federation
  • Thailand
      • Bangkok, Thailand
      • Chiang Mai, Thailand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo/CNTO 6785 200 mg+Methotrexate (MTX)
Drug: Placebo
Placebo subcutaneous injections (SC) every 4 weeks through Week 12
Drug: CNTO 6785 200 mg
CNTO 6785 200 mg SC every 4 weeks from Week 16 through Week 28
Drug: CNTO 6785 200 mg
CNTO 6785 200 mg SC every 4 weeks through Week 28
Drug: Methotrexate (MTX)
MTX at the same stable dose through Week 32, that participants were receiving prior to screening.
Experimental: CNTO 6785 200 mg+MTX
Drug: CNTO 6785 200 mg
CNTO 6785 200 mg SC every 4 weeks from Week 16 through Week 28
Drug: CNTO 6785 200 mg
CNTO 6785 200 mg SC every 4 weeks through Week 28
Drug: Methotrexate (MTX)
MTX at the same stable dose through Week 32, that participants were receiving prior to screening.
Experimental: CNTO 6785 100 mg+MTX
Drug: Methotrexate (MTX)
MTX at the same stable dose through Week 32, that participants were receiving prior to screening.
Drug: CNTO 6785 100 mg
CNTO 6785 100 mg SC every 4 weeks through Week 28
Experimental: CNTO 6785 50 mg+MTX
Drug: Methotrexate (MTX)
MTX at the same stable dose through Week 32, that participants were receiving prior to screening.
Drug: CNTO 6785 50 mg
CNTO 6785 50 mg SC every 4 weeks through Week 28
Experimental: CNTO 6785 15 mg+MTX
Drug: Methotrexate (MTX)
MTX at the same stable dose through Week 32, that participants were receiving prior to screening.
Drug: CNTO 6785 15 mg
CNTO 6785 15 mg SC every 4 weeks through Week 28

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The proportion of participants who achieve an ACR 20 response at Week 16
Time Frame: Week 16
American College of Rheumatology (ACR) 20 response is a >=20% improvement in rheumatoid arthritis (RA) symptoms.
Week 16

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in DAS28 (CRP) at Week 16
Time Frame: Baseline to Week 16
DAS28 (using CRP [C-reactive protein]) is a measure of tender and swollen joints and the patient's assessment of disease activity.
Baseline to Week 16
The proportion of participants who achieve ACR 50 response at Week 16
Time Frame: Week 16
American College of Rheumatology (ACR) 50 response is a >=50% improvement in rheumatoid arthritis (RA) symptoms.
Week 16
The proportion of participants who achieve ACR 20 response through Week 32
Time Frame: Week 32
Week 32
The proportion of participants who achieve ACR 50 response through Week 32
Time Frame: Week 32
Week 32
The proportion of participants who achieve ACR 70 response through Week 32
Time Frame: Week 32
American College of Rheumatology (ACR) 70 response is a >=70% improvement in rheumatoid arthritis (RA) symptoms.
Week 32
Change from baseline of DAS28 (CRP) through Week 32
Time Frame: Baseline to Week 32
Baseline to Week 32
The proportion of participants with DAS28 (CRP) response through Week 32
Time Frame: 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.
Week 32
The proportion of participants with DAS28 (CRP) remission at Week 16
Time Frame: 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.
Week 16
The proportion of participants with DAS28 (CRP) remission at Week 32
Time Frame: Week 32
Week 32
Change from baseline in DAS28 (ESR) at Week 16
Time Frame: Baseline to Week 16
DAS28 (using erythrocyte sedimentation rate) is a measure of tender and swollen joints and the patient's assessment of disease activity.
Baseline to Week 16
Change from baseline in DAS28 (ESR) at Week 32
Time Frame: Baseline to Week 32
Baseline to Week 32
Change from baseline in HAQ-DI score through Week 32
Time Frame: Baseline to 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).
Baseline to Week 32
Change from baseline in SF-36 at Week 16
Time Frame: Baseline to 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.
Baseline to Week 16
Change from baseline in SF-36 at Week 32
Time Frame: Baseline to Week 32
Baseline to Week 32
Change from baseline in CDAI at Week 16
Time Frame: Baseline to 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.
Baseline to Week 16
Change from baseline in CDAI at Week 32
Time Frame: Baseline to Week 32
Baseline to Week 32
Change from baseline in SDAI at Week 16
Time Frame: Baseline to 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.
Baseline to Week 16
Change from baseline in SDAI at Week 32
Time Frame: Baseline to Week 32
Baseline to Week 32
The proportion of participants with SDAI-based ACR/EULAR remission at Week 16
Time Frame: 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.
Week 16
The proportion of participants with SDAI-based ACR/EULAR remission at Week 32
Time Frame: Week 32
Week 32
The proportion of participants with Boolean-based ACR/EULAR remission at Week 16
Time Frame: 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.
Week 16
The proportion of participants with Boolean-based ACR/EULAR remission at Week 32
Time Frame: Week 32
Week 32

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 26, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR100935
  • CNTO6785ARA2001 (Other Identifier: Janssen Research & Development, LLC)
  • 2012-003629-40 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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