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

Arthritis, Rheumatoid Clinical Trial

— AWARE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02728934
• Other study ID #: CR108132
• Secondary ID: CNTO148ART4011
• Status: Completed
• Start date: February 25, 2016
• Est. completion date: January 31, 2020

Study information

• Verified date: April 2020
• Source: Janssen Scientific Affairs, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1279
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

Biological:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Scientific Affairs, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from Baseline in Clinical Disease Activity Index (CDAI) Score in Bionaïve Patients at 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
Secondary	Change from Baseline in CDAI Score in Bionaïve Patients at 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
Secondary	Change from Baseline in CDAI Score in Bionaïve Patients at 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
Secondary	CDAI Score in Patients with or Without Concomitant Methotrexate use	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)
Secondary	Change from Baseline in CDAI Score in Patients with or Without Concomitant Methotrexate use	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)
Secondary	CDAI Score in Dose-escalated Patients	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)
Secondary	Change from Baseline in CDAI Score in Dose-escalated Patients	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)
Secondary	CDAI Score in Patients who Previously Administered Remicade (or Other Biologic[s])	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)
Secondary	Change from Baseline in CDAI Score in Patients who Previously Administered Remicade (or Other Biologic[s])	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)
Secondary	Number of Patients With Serious Infusion Reaction and Discontinuation of Therapy due to Infusion Reaction		3 years
Secondary	Number of Infusions With Infusion Reactions		3 years
Secondary	Discontinuation Rates	Participants discontinuation rates for both the Simponi Aria and Remicade groups will be reported.	3 years
Secondary	Persistency of use of Treatment	Persistency of use, defined as the continuous period of time a participant receives either Simponi Aria or Remicade, will be reported.	3 years
Secondary	Number of Patients with Adverse Events (AEs) and Serious AEs		3 years
Secondary	Number of Patients With an Infusion Reaction		3 years
Secondary	Number of Patients With Severe Infusion Reaction and Discontinuation of Therapy due to Infusion Reaction		Up to week 52