Comparative and Pragmatic Study of Golimumab Intravenous (IV) (Simponi Aria) Versus Infliximab (Remicade) in Rheumatoid Arthritis
NCT ID: NCT02728934
Last Updated: 2020-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1279 participants
OBSERVATIONAL
2016-02-25
2020-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Golimumab Intravenous (IV)
This is an observational study. Patients who will receive golimumab IV will be observed for 3 years.
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.
Infliximab
This is an observational study. Patients who will receive infliximab will be observed for 3 years.
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.
Interventions
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Golimumab Intravenous (IV)
This is an observational study. Patients who will receive golimumab IV will be observed for 3 years.
Infliximab
This is an observational study. Patients who will receive infliximab will be observed for 3 years.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Janssen Scientific Affairs, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Scientific Affairs, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Scientific Affairs, LLC
Locations
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Birmingham, Alabama, United States
Huntsville, Alabama, United States
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
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
Denver, Colorado, United States
Lakewood, Colorado, United States
Clearwater, Florida, United States
Palm Harbor, Florida, United States
Plantation, Florida, United States
Tamarac, Florida, United States
Venice, Florida, United States
Lawrenceville, Georgia, United States
Springfield, Illinois, United States
Muncie, Indiana, United States
Bowling Green, Kentucky, United States
Baton Rouge, Louisiana, United States
Monroe, Louisiana, United States
Shreveport, Louisiana, United States
Cumberland, Maryland, United States
Hagerstown, Maryland, United States
Towson, Maryland, United States
Wheaton, Maryland, United States
Ann Arbor, Michigan, United States
Lansing, Michigan, United States
Saint Clair Shores, Michigan, United States
Eagan, Minnesota, United States
Edina, Minnesota, United States
Las Vegas, Nevada, United States
Nashua, New Hampshire, United States
Freehold, New Jersey, United States
Voorhees Township, New Jersey, United States
Brooklyn, New York, United States
Orchard Park, New York, United States
Greensboro, North Carolina, United States
Leland, North Carolina, United States
Raleigh, North Carolina, United States
Winston-Salem, North Carolina, United States
Edmond, Oklahoma, United States
Tulsa, Oklahoma, United States
Bethlehem, Pennsylvania, United States
Duncansville, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Wexford, Pennsylvania, United States
Myrtle Beach, South Carolina, United States
Nashville, Tennessee, United States
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
Arlington, Virginia, United States
Chesapeake, Virginia, United States
Newport News, Virginia, United States
Kennewick, Washington, United States
Seattle, Washington, United States
Beckley, West Virginia, United States
South Charleston, West Virginia, United States
Glendale, Wisconsin, United States
Onalaska, Wisconsin, United States
Countries
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References
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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.
Bingham 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.
Curtis 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.
Other Identifiers
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CNTO148ART4011
Identifier Type: OTHER
Identifier Source: secondary_id
CR108132
Identifier Type: -
Identifier Source: org_study_id
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