Comparative and Pragmatic Study of Golimumab Intravenous (IV) (Simponi Aria) Versus Infliximab (Remicade) in Rheumatoid Arthritis (AWARE)

April 14, 2020 updated by: Janssen Scientific Affairs, LLC

Comparative and Pragmatic Study of Simponi Aria Versus Remicade in Rheumatoid Arthritis

The purpose of this study is to compare the proportion of patients with an infusion reaction in Rheumatoid arthritis (RA) patients treated with Golimumab Intravenous (IV) or Infliximab.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, noninterventional (no treatment medication provided by the study), observational (study in which the investigators/ physicians observe the patients and measure their outcomes), multicenter (study conducted at multiple sites) study of Golimumab IV and Infliximab in RA patients. The study allows for an anticipated 2-year enrollment period and a 3-year study duration for each patient. No interventions will be given to patients as a part of this study. This study will be conducted in the US, at rheumatology-based clinical practices and will enroll adult RA patients who meet all entry criteria. The primary endpoint of this study is the proportion of patients with an infusion reaction through week 52. Patients will be enrolled in a 1:1 ratio to initiate treatment with either Golimumab IV or Infliximab. Patients' safety will be monitored throughout the study.

Study Type

Observational

Enrollment (Actual)

1279

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

  • United States
    • Alabama
      • Birmingham, Alabama, United States
      • Huntsville, Alabama, United States
    • Arizona
      • Glendale, Arizona, United States
      • Mesa, Arizona, United States
      • Peoria, Arizona, United States
      • Phoenix, Arizona, United States
      • Prescott, Arizona, United States
      • Sun City, Arizona, United States
    • California
      • Bakersfield, California, United States
      • Campbell, California, United States
      • Covina, California, United States
      • El Cajon, California, United States
      • Hemet, California, United States
      • Los Angeles, California, United States
      • Santa Cruz, California, United States
      • Thousand Oaks, California, United States
      • Upland, California, United States
      • Van Nuys, California, United States
      • West Hills, California, United States
      • Whittier, California, United States
    • Colorado
      • Denver, Colorado, United States
      • Lakewood, Colorado, United States
    • Florida
      • Clearwater, Florida, United States
      • Palm Harbor, Florida, United States
      • Plantation, Florida, United States
      • Tamarac, Florida, United States
      • Venice, Florida, United States
    • Georgia
      • Lawrenceville, Georgia, United States
    • Illinois
      • Springfield, Illinois, United States
    • Indiana
      • Muncie, Indiana, United States
    • Kentucky
      • Bowling Green, Kentucky, United States
    • Louisiana
      • Baton Rouge, Louisiana, United States
      • Monroe, Louisiana, United States
      • Shreveport, Louisiana, United States
    • Maryland
      • Cumberland, Maryland, United States
      • Hagerstown, Maryland, United States
      • Towson, Maryland, United States
      • Wheaton, Maryland, United States
    • Michigan
      • Ann Arbor, Michigan, United States
      • Lansing, Michigan, United States
      • Saint Clair Shores, Michigan, United States
    • Minnesota
      • Eagan, Minnesota, United States
      • Edina, Minnesota, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New Hampshire
      • Nashua, New Hampshire, United States
    • New Jersey
      • Freehold, New Jersey, United States
      • Voorhees, New Jersey, United States
    • New York
      • Brooklyn, New York, United States
      • Orchard Park, New York, United States
    • North Carolina
      • Greensboro, North Carolina, United States
      • Leland, North Carolina, United States
      • Raleigh, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Oklahoma
      • Edmond, Oklahoma, United States
      • Tulsa, Oklahoma, United States
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States
      • Duncansville, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • Wexford, Pennsylvania, United States
    • South Carolina
      • Myrtle Beach, South Carolina, United States
    • Tennessee
      • Nashville, Tennessee, United States
    • Texas
      • Amarillo, Texas, United States
      • Beaumont, Texas, United States
      • College Station, Texas, United States
      • Corpus Christi, Texas, United States
      • Dallas, Texas, United States
      • Houston, Texas, United States
      • Lubbock, Texas, United States
      • Mesquite, Texas, United States
      • Nassau Bay, Texas, United States
      • Plano, Texas, United States
      • San Antonio, Texas, United States
      • San Marcos, Texas, United States
      • Sugar Land, Texas, United States
      • The Woodlands, Texas, United States
      • Waco, Texas, United States
    • Virginia
      • Arlington, Virginia, United States
      • Chesapeake, Virginia, United States
      • Newport News, Virginia, United States
    • Washington
      • Kennewick, Washington, United States
      • Seattle, Washington, United States
    • West Virginia
      • Beckley, West Virginia, United States
      • South Charleston, West Virginia, United States
    • Wisconsin
      • Glendale, Wisconsin, United States
      • Onalaska, Wisconsin, United States

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

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients in the US who enroll in the study will have a rheumatologist confirmed diagnosis of Rheumatoid arthritis (RA) and will be medically eligible for, and will have been prescribed but not yet initiated treatment with, either Golimumab IV or Infliximab.

Description

Inclusion Criteria:

  • Patient must be a male or female 18 years of age or older as the study is intended to assess Golimumab intravenous (IV) and Infliximab in adult RA patients
  • Patient must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study
  • Patient has a confirmed diagnosis of Rheumatoid arthritis (RA) and is medically eligible for treatment with Golimumab IV or Infliximab in accordance with standard of care (example, screening for tuberculosis [TB], vaccinations, etc.)
  • At the time of enrollment the patient will be initiating treatment with Golimumab IV or Infliximab. The patient may or may not have previously received treatment with a biologic. Patients with previous exposure to subcutaneously administered Simponi may enroll in the study
  • Patient must be willing to complete Patient reported outcomes (PRO) forms during the study and agree to return completed forms to the site if receiving an infusion of Golimumab IV or Infliximab at a location remote from the study site

Exclusion Criteria:

  • Patient is less than 18 years of age
  • Patient is pregnant or planning a pregnancy
  • Patient is currently enrolled in an interventional study
  • Patient has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 28 days, as appropriate, before the planned first dose of Golimumab IV or Infliximab
  • Patient previously received Golimumab IV if planning to receive Golimumab IV in this study or the patient previously received Infliximab if planning to receive Infliximab or BI in this study. Patient previously receive BI if planning to receive BI or Remicade in this study
  • Patient has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient (example, compromise the patient's well-being) or that could prevent, limit, or confound the protocol-specified assessments

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Golimumab Intravenous (IV)
Patients in the US who enroll in the study will have a rheumatologist confirmed diagnosis of Rheumatoid arthritis (RA) and will be medically eligible for, and will have been prescribed but not yet initiated treatment with Golimumab IV.
Biological: Golimumab Intravenous (IV)
This is an observational study. Patients who will receive golimumab IV will be observed for 3 years.
Other Names:
  • Simponi Aria
Infliximab
Patients in the US who enroll in the study will have a rheumatologist confirmed diagnosis of Rheumatoid arthritis (RA) and will be medically eligible for, and will have been prescribed but not yet initiated treatment with Infliximab.
Biological: Infliximab
This is an observational study. Patients who will receive infliximab will be observed for 3 years.
Other Names:
  • Remicade
Biological: Biosimilar Infliximab
This is an observational study. New patients who will receive biosimilar infliximab will be observed for 3 years (maximum). Biosimilar Infliximab patients will be included in Exploratory analyses only and will not be included in Primary or Secondary outcome measures analyses.
Other Names:
  • Inflectra

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Patients With an Infusion Reaction Through Week 52
Time Frame: Up to week 52
An infusion reaction is any adverse event that occurs during an infusion or within 1 hour of completion of infusion of either Golimumab IV or Infliximab. The number of patients with infusion reactions will be reported.
Up to week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Clinical Disease Activity Index (CDAI) Score in Bionaïve Patients at Month 6
Time Frame: Baseline and Month 6
The CDAI is a validated measure of disease activity consisting of the sum of 4 clinical variables: tender joint and swollen joint count based on a 28-joint assessment, patient global assessment, and the physician global assessment of disease activity based on a visual analog scale (VAS) ranging from 0 to 10. The CDAI has a range from 0 to 76, with higher scores indicating more severe disease. The change from baseline at Month 6 in CDAI in bionaive patients will be reported.
Baseline and Month 6
Change from Baseline in CDAI Score in Bionaïve Patients at Month 12
Time Frame: Baseline and Month 12
The CDAI is a validated measure of disease activity consisting of the sum of 4 clinical variables: tender joint and swollen joint count based on a 28-joint assessment, patient global assessment, and the physician global assessment of disease activity based on a visual analog scale (VAS) ranging from 0 to 10. The CDAI has a range from 0 to 76, with higher scores indicating more severe disease. The change from baseline at Month 12 in CDAI in bionaïve patients will be reported.
Baseline and Month 12
Change from Baseline in CDAI Score in Bionaïve Patients at Month 3
Time Frame: Baseline and Month 3
The CDAI is a validated measure of disease activity consisting of the sum of 4 clinical variables: tender joint and swollen joint count based on a 28-joint assessment, patient global assessment, and the physician global assessment of disease activity based on a visual analog scale (VAS) ranging from 0 to 10. The CDAI has a range from 0 to 76, with higher scores indicating more severe disease. The change from baseline at Month 3 in CDAI in bionaïve patients will be reported.
Baseline and Month 3
CDAI Score in Patients with or Without Concomitant Methotrexate use
Time Frame: Months 3, 6, 12, and at 6-month intervals through the end of the study (up to Month 36)
The CDAI is a validated measure of disease activity consisting of the sum of 4 clinical variables: tender joint and swollen joint count based on a 28-joint assessment, patient global assessment, and the physician global assessment of disease activity based on a visual analog scale (VAS) ranging from 0 to 10. The CDAI has a range from 0 to 76, with higher scores indicating more severe disease. CDAI score in patients with or without concomitant methotrexate use, will be reported.
Months 3, 6, 12, and at 6-month intervals through the end of the study (up to Month 36)
Change from Baseline in CDAI Score in Patients with or Without Concomitant Methotrexate use
Time Frame: Baseline, Months 3, 6, 12, and at 6-month intervals through the end of the study (up to Month 36)
The CDAI is a validated measure of disease activity consisting of the sum of 4 clinical variables: tender joint and swollen joint count based on a 28-joint assessment, patient global assessment, and the physician global assessment of disease activity based on a visual analog scale (VAS) ranging from 0 to 10. The CDAI has a range from 0 to 76, with higher scores indicating more severe disease. Change from baseline in CDAI score in patients with or without concomitant methotrexate use, will be reported.
Baseline, Months 3, 6, 12, and at 6-month intervals through the end of the study (up to Month 36)
CDAI Score in Dose-escalated Patients
Time Frame: Months 6, 12, and at 6-month intervals through the end of the study (up to Month 36)
The CDAI is a validated measure of disease activity consisting of the sum of 4 clinical variables: tender joint and swollen joint count based on a 28-joint assessment, patient global assessment, and the physician global assessment of disease activity based on a visual analog scale (VAS) ranging from 0 to 10. The CDAI has a range from 0 to 76, with higher scores indicating more severe disease. CDAI score in patients in whom dose of Remicade was escalated (increased prescribe dose or reduced dose interval, or a combination of both), will be reported.
Months 6, 12, and at 6-month intervals through the end of the study (up to Month 36)
Change from Baseline in CDAI Score in Dose-escalated Patients
Time Frame: Baseline, Months 6, 12, and at 6-month intervals through the end of the study (up to Month 36)
The CDAI is a validated measure of disease activity consisting of the sum of 4 clinical variables: tender joint and swollen joint count based on a 28-joint assessment, patient global assessment, and the physician global assessment of disease activity based on a visual analog scale (VAS) ranging from 0 to 10. The CDAI has a range from 0 to 76, with higher scores indicating more severe disease. Change from baseline in CDAI score in patients in whom dose of Remicade was escalated (increased prescribe dose or reduced dose interval, or a combination of both), will be reported.
Baseline, Months 6, 12, and at 6-month intervals through the end of the study (up to Month 36)
CDAI Score in Patients who Previously Administered Remicade (or Other Biologic[s])
Time Frame: Months 3, 6, 12, and at 6-month intervals through the end of the study (up to Month 36)
The CDAI is a validated measure of disease activity consisting of the sum of 4 clinical variables: tender joint and swollen joint count based on a 28-joint assessment, patient global assessment, and the physician global assessment of disease activity based on a visual analog scale (VAS) ranging from 0 to 10. The CDAI has a range from 0 to 76, with higher scores indicating more severe disease. CDAI score in patients who previously administered Remicade (or other biologic[s]), will be reported.
Months 3, 6, 12, and at 6-month intervals through the end of the study (up to Month 36)
Change from Baseline in CDAI Score in Patients who Previously Administered Remicade (or Other Biologic[s])
Time Frame: Baseline, Months 3, 6, 12, and at 6-month intervals through the end of the study (up to Month 36)
The CDAI is a validated measure of disease activity consisting of the sum of 4 clinical variables: tender joint and swollen joint count based on a 28-joint assessment, patient global assessment, and the physician global assessment of disease activity based on a visual analog scale (VAS) ranging from 0 to 10. The CDAI has a range from 0 to 76, with higher scores indicating more severe disease. Change from baseline in CDAI score in patients who previously administered Remicade (or other biologic[s]), will be reported.
Baseline, Months 3, 6, 12, and at 6-month intervals through the end of the study (up to Month 36)
Number of Patients With Serious Infusion Reaction and Discontinuation of Therapy due to Infusion Reaction
Time Frame: 3 years
3 years
Number of Infusions With Infusion Reactions
Time Frame: 3 years
3 years
Discontinuation Rates
Time Frame: 3 years
Participants discontinuation rates for both the Simponi Aria and Remicade groups will be reported.
3 years
Persistency of use of Treatment
Time Frame: 3 years
Persistency of use, defined as the continuous period of time a participant receives either Simponi Aria or Remicade, will be reported.
3 years
Number of Patients with Adverse Events (AEs) and Serious AEs
Time Frame: 3 years
3 years
Number of Patients With an Infusion Reaction
Time Frame: 3 years
3 years
Number of Patients With Severe Infusion Reaction and Discontinuation of Therapy due to Infusion Reaction
Time Frame: Up to week 52
Up to week 52

Collaborators and Investigators

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

Sponsor

Janssen Scientific Affairs, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

February 25, 2016

Primary Completion (ACTUAL)

January 31, 2020

Study Completion (ACTUAL)

January 31, 2020

Study Registration Dates

First Submitted

March 31, 2016

First Submitted That Met QC Criteria

March 31, 2016

First Posted (ESTIMATE)

April 5, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 15, 2020

Last Update Submitted That Met QC Criteria

April 14, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR108132
  • CNTO148ART4011 (OTHER: Janssen Scientific Affairs, LLC)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

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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