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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02728934
Date of registration: 31/03/2016
Prospective Registration: Yes
Primary sponsor: Janssen Scientific Affairs, LLC
Public title: Comparative and Pragmatic Study of Golimumab Intravenous (IV) (Simponi Aria) Versus Infliximab (Remicade) in Rheumatoid Arthritis AWARE
Scientific title: Comparative and Pragmatic Study of Simponi Aria Versus Remicade in Rheumatoid Arthritis
Date of first enrolment: February 25, 2016
Target sample size: 1279
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02728934
Study type:  Observational [Patient Registry]
Study design:   
Phase: 
Countries of recruitment
United States
Contacts
Name:     Janssen Scientific Affairs, LLC Clinical Trial
Address: 
Telephone:
Email:
Affiliation:  Janssen Scientific Affairs, LLC
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Arthritis, Rheumatoid
Intervention(s)
Biological: Biosimilar Infliximab
Biological: Golimumab Intravenous (IV)
Biological: Infliximab
Primary Outcome(s)
Proportion of Patients With an Infusion Reaction Through Week 52 [Time Frame: Up to week 52]
Secondary Outcome(s)
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)]
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)]
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)]
Change from Baseline in CDAI Score in Bionaïve Patients at Month 12 [Time Frame: Baseline and Month 12]
Change from Baseline in CDAI Score in Bionaïve Patients at Month 3 [Time Frame: Baseline and Month 3]
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)]
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)]
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)]
Change from Baseline in Clinical Disease Activity Index (CDAI) Score in Bionaïve Patients at Month 6 [Time Frame: Baseline and Month 6]
Discontinuation Rates [Time Frame: 3 years]
Number of Infusions With Infusion Reactions [Time Frame: 3 years]
Number of Patients with Adverse Events (AEs) and Serious AEs [Time Frame: 3 years]
Number of Patients With an Infusion Reaction [Time Frame: 3 years]
Number of Patients With Serious Infusion Reaction and Discontinuation of Therapy due to Infusion Reaction [Time Frame: 3 years]
Number of Patients With Severe Infusion Reaction and Discontinuation of Therapy due to Infusion Reaction [Time Frame: Up to week 52]
Persistency of use of Treatment [Time Frame: 3 years]
Secondary ID(s)
CNTO148ART4011
CR108132
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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