Comparative and Pragmatic Study of Golimumab Intravenous (IV) (Simponi Aria) Versus Infliximab (Remicade) in Rheumatoid Arthritis
AWARE
2 other identifiers
observational
1,279
1 country
85
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2016
Longer than P75 for all trials
85 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
Study Start
First participant enrolled
February 25, 2016
CompletedFirst Submitted
Initial submission to the registry
March 31, 2016
CompletedFirst Posted
Study publicly available on registry
April 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2020
CompletedApril 15, 2020
April 1, 2020
3.9 years
March 31, 2016
April 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Patients With an Infusion Reaction Through 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 Outcomes (16)
Change from Baseline in Clinical Disease Activity Index (CDAI) Score in Bionaïve Patients at Month 6
Baseline and Month 6
Change from Baseline in CDAI Score in Bionaïve Patients at Month 12
Baseline and Month 12
Change from Baseline in CDAI Score in Bionaïve Patients at Month 3
Baseline and Month 3
CDAI Score in Patients with or Without Concomitant Methotrexate use
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
Baseline, Months 3, 6, 12, and at 6-month intervals through the end of the study (up to Month 36)
- +11 more secondary outcomes
Study Arms (2)
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.
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.
Interventions
This is an observational study. Patients who will receive golimumab IV will be observed for 3 years.
This is an observational study. Patients who will receive infliximab will be observed for 3 years.
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (85)
Unknown Facility
Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Glendale, Arizona, United States
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Mesa, Arizona, United States
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Peoria, Arizona, United States
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Phoenix, Arizona, United States
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Prescott, Arizona, United States
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Sun City, Arizona, United States
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Bakersfield, California, United States
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Campbell, California, United States
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Covina, California, United States
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El Cajon, California, United States
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Hemet, California, United States
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Los Angeles, California, United States
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Santa Cruz, California, United States
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Thousand Oaks, California, United States
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Upland, California, United States
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Van Nuys, California, United States
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West Hills, California, United States
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Whittier, California, United States
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Denver, Colorado, United States
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Lakewood, Colorado, United States
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Clearwater, Florida, United States
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Palm Harbor, Florida, United States
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Plantation, Florida, United States
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Tamarac, Florida, United States
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Venice, Florida, United States
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Lawrenceville, Georgia, United States
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Springfield, Illinois, United States
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Muncie, Indiana, United States
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Bowling Green, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Monroe, Louisiana, United States
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Shreveport, Louisiana, United States
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Cumberland, Maryland, United States
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Hagerstown, Maryland, United States
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Towson, Maryland, United States
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Wheaton, Maryland, United States
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Ann Arbor, Michigan, United States
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Lansing, Michigan, United States
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Saint Clair Shores, Michigan, United States
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Eagan, Minnesota, United States
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Edina, Minnesota, United States
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Las Vegas, Nevada, United States
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Nashua, New Hampshire, United States
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Freehold, New Jersey, United States
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Voorhees Township, New Jersey, United States
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Brooklyn, New York, United States
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Orchard Park, New York, United States
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Greensboro, North Carolina, United States
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Leland, North Carolina, United States
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Raleigh, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Edmond, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Bethlehem, Pennsylvania, United States
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Duncansville, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Wexford, Pennsylvania, United States
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Myrtle Beach, South Carolina, United States
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Nashville, Tennessee, United States
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Amarillo, Texas, United States
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Beaumont, Texas, United States
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College Station, Texas, United States
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Corpus Christi, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Lubbock, Texas, United States
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Mesquite, Texas, United States
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Nassau Bay, Texas, United States
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Plano, Texas, United States
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San Antonio, Texas, United States
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San Marcos, Texas, United States
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Sugar Land, Texas, United States
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The Woodlands, Texas, United States
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Waco, Texas, United States
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Arlington, Virginia, United States
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Chesapeake, Virginia, United States
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Newport News, Virginia, United States
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Kennewick, Washington, United States
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Seattle, Washington, United States
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Beckley, West Virginia, United States
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South Charleston, West Virginia, United States
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Glendale, Wisconsin, United States
Unknown Facility
Onalaska, Wisconsin, United States
Related Publications (3)
Broadwell A, Schechtman J, Conaway D, Kivitz A, Shiff NJ, Black S, Xu S, Langholff W, Schwartzman S, Curtis JR. Effectiveness and safety of intravenous golimumab with and without concomitant methotrexate in patients with rheumatoid arthritis in the prospective, noninterventional AWARE study. BMC Rheumatol. 2023 Mar 27;7(1):5. doi: 10.1186/s41927-023-00329-8.
PMID: 36973741DERIVEDBingham CO 3rd, Black S, Shiff NJ, Xu S, Langholff W, Curtis JR. Response to Treatment with Intravenous Golimumab or Infliximab in Rheumatoid Arthritis Patients: PROMIS Results from the Real-World Observational Phase 4 AWARE Study. Rheumatol Ther. 2023 Jun;10(3):659-678. doi: 10.1007/s40744-023-00533-5. Epub 2023 Feb 23.
PMID: 36820983DERIVEDCurtis JR, Chakravarty SD, Black S, Kafka S, Xu S, Langholff W, Parenti D, Greenspan A, Schwartzman S. Incidence of Infusion Reactions and Clinical Effectiveness of Intravenous Golimumab Versus Infliximab in Patients with Rheumatoid Arthritis: The Real-World AWARE Study. Rheumatol Ther. 2021 Dec;8(4):1551-1563. doi: 10.1007/s40744-021-00354-4. Epub 2021 Aug 20.
PMID: 34417735DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Scientific Affairs, LLC Clinical Trial
Janssen Scientific Affairs, LLC
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2016
First Posted
April 5, 2016
Study Start
February 25, 2016
Primary Completion
January 31, 2020
Study Completion
January 31, 2020
Last Updated
April 15, 2020
Record last verified: 2020-04