Clinical trial NCT02728934: Comparative and Pragmatic Study of Golimumab Intravenous (IV) (Simponi Aria) Versus Infliximab (Remicade) in Rheumatoid Arthritis
Official title: Comparative and Pragmatic Study of Simponi Aria Versus Remicade in Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Rheumatoid
Keywords: Rheumatoid Arthritis
Golimumab
Infliximab
Lead sponsor: Janssen Scientific Affairs, LLC
Sponsor class: INDUSTRY
First posted: 2016-04-05
Enrollment: 1279
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of Patients With an Infusion Reaction Through Week 52
timeFrame: Up to week 52
Secondary outcomes:
measure: Change from Baseline in Clinical Disease Activity Index (CDAI) Score in Bionaïve Patients at Month 6
timeFrame: Baseline and Month 6
measure: Change from Baseline in CDAI Score in Bionaïve Patients at Month 12
timeFrame: Baseline and Month 12
measure: Change from Baseline in CDAI Score in Bionaïve Patients at Month 3
timeFrame: Baseline and Month 3
measure: CDAI Score in Patients with or Without Concomitant Methotrexate use
timeFrame: Months 3, 6, 12, and at 6-month intervals through the end of the study (up to Month 36)
measure: Change from Baseline in CDAI Score in Patients with or Without Concomitant Methotrexate use
timeFrame: Baseline, Months 3, 6, 12, and at 6-month intervals through the end of the study (up to Month 36)
measure: CDAI Score in Dose-escalated Patients
timeFrame: Months 6, 12, and at 6-month intervals through the end of the study (up to Month 36)
measure: Change from Baseline in CDAI Score in Dose-escalated Patients
timeFrame: Baseline, Months 6, 12, and at 6-month intervals through the end of the study (up to Month 36)
measure: CDAI Score in Patients who Previously Administered Remicade (or Other Biologic[s])
timeFrame: Months 3, 6, 12, and at 6-month intervals through the end of the study (up to Month 36)
measure: Change from Baseline in CDAI Score in Patients who Previously Administered Remicade (or Other Biologic[s])
timeFrame: Baseline, Months 3, 6, 12, and at 6-month intervals through the end of the study (up to Month 36)
measure: Number of Patients With Serious Infusion Reaction and Discontinuation of Therapy due to Infusion Reaction
timeFrame: 3 years
measure: Number of Infusions With Infusion Reactions
timeFrame: 3 years
measure: Discontinuation Rates
timeFrame: 3 years
measure: Persistency of use of Treatment
timeFrame: 3 years
measure: Number of Patients with Adverse Events (AEs) and Serious AEs
timeFrame: 3 years
measure: Number of Patients With an Infusion Reaction
timeFrame: 3 years
measure: Number of Patients With Severe Infusion Reaction and Discontinuation of Therapy due to Infusion Reaction
timeFrame: Up to week 52
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Glendale
country: United States
state: Arizona
city: Mesa
country: United States
state: Arizona
city: Peoria
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Prescott
country: United States
state: Arizona
city: Sun City
country: United States
state: Arizona
city: Bakersfield
country: United States
state: California
city: Campbell
country: United States
state: California
city: Covina
country: United States
state: California
city: El Cajon
country: United States
state: California
city: Hemet
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Santa Cruz
country: United States
state: California
city: Thousand Oaks
country: United States
state: California
city: Upland
country: United States
state: California
city: Van Nuys
country: United States
state: California
city: West Hills
country: United States
state: California
city: Whittier
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Lakewood
country: United States
state: Colorado
city: Clearwater
country: United States
state: Florida
city: Palm Harbor
country: United States
state: Florida
city: Plantation
country: United States
state: Florida
city: Tamarac
country: United States
state: Florida
city: Venice
country: United States
state: Florida
city: Lawrenceville
country: United States
state: Georgia
city: Springfield
country: United States
state: Illinois
city: Muncie
country: United States
state: Indiana
city: Bowling Green
country: United States
state: Kentucky
city: Baton Rouge
country: United States
state: Louisiana
city: Monroe
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Cumberland
country: United States
state: Maryland
city: Hagerstown
country: United States
state: Maryland
city: Towson
country: United States
state: Maryland
city: Wheaton
country: United States
state: Maryland
city: Ann Arbor
country: United States
state: Michigan
city: Lansing
country: United States
state: Michigan
city: Saint Clair Shores
country: United States
state: Michigan
city: Eagan
country: United States
state: Minnesota
city: Edina
country: United States
state: Minnesota
city: Las Vegas
country: United States
state: Nevada
city: Nashua
country: United States
state: New Hampshire
city: Freehold
country: United States
state: New Jersey
city: Voorhees
country: United States
state: New Jersey
city: Brooklyn
country: United States
state: New York
city: Orchard Park
country: United States
state: New York
city: Greensboro
country: United States
state: North Carolina
city: Leland
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Edmond
country: United States
state: Oklahoma
city: Tulsa
country: United States
state: Oklahoma
city: Bethlehem
country: United States
state: Pennsylvania
city: Duncansville
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Wexford
country: United States
state: Pennsylvania
city: Myrtle Beach
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Amarillo
country: United States
state: Texas
city: Beaumont
country: United States
state: Texas
city: College Station
country: United States
state: Texas
city: Corpus Christi
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Lubbock
country: United States
state: Texas
city: Mesquite
country: United States
state: Texas
city: Nassau Bay
country: United States
state: Texas
city: Plano
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: San Marcos
country: United States
state: Texas
city: Sugar Land
country: United States
state: Texas
city: The Woodlands
country: United States
state: Texas
city: Waco
country: United States
state: Texas
city: Arlington
country: United States
state: Virginia
city: Chesapeake
country: United States
state: Virginia
city: Newport News
country: United States
state: Virginia
city: Kennewick
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
city: Beckley
country: United States
state: West Virginia
city: South Charleston
country: United States
state: West Virginia
city: Glendale
country: United States
state: Wisconsin
city: Onalaska
country: United States
state: Wisconsin
Study officials:
affiliation: Janssen Scientific Affairs, LLC
name: Janssen Scientific Affairs, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.