Arthritis, Rheumatoid
Conditions
Keywords
Rheumatoid Arthritis, Golimumab, 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.
Interventions
BIOLOGICALGolimumab Intravenous (IV)
This is an observational study. Patients who will receive golimumab IV will be observed for 3 years.
BIOLOGICALInfliximab
This is an observational study. Patients who will receive infliximab will be observed for 3 years.
BIOLOGICALBiosimilar 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.
Sponsors
Janssen Scientific Affairs, LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients With an Infusion Reaction Through Week 52 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in CDAI Score in Bionaïve Patients at Month 12 | 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. |
| Change from Baseline in CDAI Score in Bionaïve Patients at Month 3 | 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. |
| CDAI Score in Patients with or Without Concomitant Methotrexate use | 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. |
| Change from Baseline in CDAI Score in Patients with or Without Concomitant Methotrexate use | 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. |
| CDAI Score in Dose-escalated Patients | 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. |
| Change from Baseline in CDAI Score in Dose-escalated Patients | 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. |
| CDAI Score in Patients who Previously Administered Remicade (or Other Biologic[s]) | 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. |
| Change from Baseline in Clinical Disease Activity Index (CDAI) Score in Bionaïve Patients at Month 6 | 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. |
| Number of Patients With Serious Infusion Reaction and Discontinuation of Therapy due to Infusion Reaction | 3 years | — |
| Number of Infusions With Infusion Reactions | 3 years | — |
| Discontinuation Rates | 3 years | Participants discontinuation rates for both the Simponi Aria and Remicade groups will be reported. |
| Persistency of use of Treatment | 3 years | Persistency of use, defined as the continuous period of time a participant receives either Simponi Aria or Remicade, will be reported. |
| Number of Patients with Adverse Events (AEs) and Serious AEs | 3 years | — |
| Number of Patients With an Infusion Reaction | 3 years | — |
| Number of Patients With Severe Infusion Reaction and Discontinuation of Therapy due to Infusion Reaction | Up to week 52 | — |
| Change from Baseline in CDAI Score in Patients who Previously Administered Remicade (or Other Biologic[s]) | 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. |
Countries
United States
Outcome results
None listed