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

Completed

Conditions studied: Arthritis, Rheumatoid

In brief

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.

Key facts

Study ID

NCT02728934

Run by

Janssen Scientific Affairs, LLC

People needed

1279

Starts

2016-02-25

Expected to finish

2020-01-31

Last updated by the study team

2020-04-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Study site — Huntsville, Alabama, United States
• Study site — Glendale, Arizona, United States
• Study site — Mesa, Arizona, United States
• Study site — Peoria, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Prescott, Arizona, United States
• Study site — Sun City, Arizona, United States
• Study site — Bakersfield, California, United States
• Study site — Campbell, California, United States
• Study site — Covina, California, United States
• Study site — El Cajon, California, United States
• Study site — Hemet, California, United States
• Study site — Los Angeles, California, United States
• Study site — Santa Cruz, California, United States
• Study site — Thousand Oaks, California, United States
• Study site — Upland, California, United States
• Study site — Van Nuys, California, United States
• Study site — West Hills, California, United States
• Study site — Whittier, California, United States
• Study site — Denver, Colorado, United States
• Study site — Lakewood, Colorado, United States
• Study site — Clearwater, Florida, United States
• Study site — Palm Harbor, Florida, United States
• Study site — Plantation, Florida, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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