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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02728934
Recruitment Status : Active, not recruiting
First Posted : April 5, 2016
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC

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.

Condition or disease Intervention/treatment
Arthritis, Rheumatoid Biological: Golimumab Intravenous (IV) Biological: Infliximab Biological: Biosimilar 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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 1279 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Comparative and Pragmatic Study of Simponi Aria Versus Remicade in Rheumatoid Arthritis
Actual Study Start Date : February 25, 2016
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Biological: Golimumab Intravenous (IV)
This is an observational study. Patients who will receive golimumab IV will be observed for 3 years.
Other Name: Simponi Aria

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.
Biological: Infliximab
This is an observational study. Patients who will receive infliximab will be observed for 3 years.
Other Name: Remicade

Biological: 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 Name: Inflectra




Primary Outcome Measures :
  1. Proportion of Patients With an Infusion Reaction Through Week 52 [ Time Frame: Up to 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.


Secondary Outcome Measures :
  1. Change from Baseline in Clinical Disease Activity Index (CDAI) Score in Bionaïve Patients at Month 6 [ Time Frame: Baseline and 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.

  2. Change from Baseline in CDAI Score in Bionaïve Patients at Month 12 [ Time Frame: Baseline and 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.

  3. Change from Baseline in CDAI Score in Bionaïve Patients at Month 3 [ Time Frame: Baseline and 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.

  4. 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) ]
    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.

  5. 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) ]
    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.

  6. 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) ]
    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.

  7. 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) ]
    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.

  8. 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) ]
    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.

  9. 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) ]
    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.

  10. Number of Patients With Serious Infusion Reaction and Discontinuation of Therapy due to Infusion Reaction [ Time Frame: 3 years ]
  11. Number of Infusions With Infusion Reactions [ Time Frame: 3 years ]
  12. Discontinuation Rates [ Time Frame: 3 years ]
    Participants discontinuation rates for both the Simponi Aria and Remicade groups will be reported.

  13. Persistency of use of Treatment [ Time Frame: 3 years ]
    Persistency of use, defined as the continuous period of time a participant receives either Simponi Aria or Remicade, will be reported.

  14. Number of Patients with Adverse Events (AEs) and Serious AEs [ Time Frame: 3 years ]
  15. Number of Patients With an Infusion Reaction [ Time Frame: 3 years ]
  16. Number of Patients With Severe Infusion Reaction and Discontinuation of Therapy due to Infusion Reaction [ Time Frame: Up to week 52 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02728934


Locations
Show Show 85 study locations
Sponsors and Collaborators
Janssen Scientific Affairs, LLC
Investigators
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Study Director: Janssen Scientific Affairs, LLC Clinical Trial Janssen Scientific Affairs, LLC

Additional Information:

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Responsible Party: Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT02728934    
Other Study ID Numbers: CR108132
CNTO148ART4011 ( Other Identifier: Janssen Scientific Affairs, LLC )
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Keywords provided by Janssen Scientific Affairs, LLC:
Rheumatoid Arthritis
Golimumab
Infliximab
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Infliximab
Antibodies, Monoclonal
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents
Immunologic Factors
Physiological Effects of Drugs