Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, Observational, Golimumab, SIMPONI, Intravenous Infusion
Brief summary
The purpose of this study is to evaluate the incidence and management of infusion reactions with Golimumab intravenous infusion.
Detailed description
This is a prospective, observational, non-interventional (no treatment given during course of the study) multi-center (when more than one hospital or medical school team work on a medical research study), study that will enroll participants with rheumatoid arthritis (RA) in Canada. Only data available from source documentation will be collected. The participation in this study will not impact on the standard of care of the participant or any benefits to which they are otherwise entitled. All aspects of treatment decisions and clinical management of participants will be in accordance with clinical practice and at the discretion of the health care provider. Participants' safety will be monitored throughout the study.
Interventions
BIOLOGICALGolimumab Intravenous
This is a non-interventional study. Participants with rheumatoid arthritis in Canada will be observed for 24 months.
Sponsors
Janssen Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants must have a confirmed diagnosis of rheumatoid arthritis * Participants must have provided a written consent for data collection by signing an informed consent form indicating that he/she understand the purpose and procedures for data collection and are willing to participate in the study * Participants are golimumab-naive (never have used golimumab both SC and IV formulations) * Participants are prescribed golimumab intravenous by an appropriate physician as per the Canadian Product Monograph
Exclusion criteria
* Participant who has been treated with golimumab in the past * Participant has been diagnosed with psoriatic arthritis or ankylosing spondylitis * Participant has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days before the start of the study or first data collection time point * Participant is currently enrolled in an interventional study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Infusion Reactions | Up to end of study (2 years) or early withdrawal | The count of infusion reactions will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With use of Concomitant Medications at Time of Infusion | Baseline up to end of study (2 years) or early withdrawal | Participants with type of concomitant medications used at time of infusion will be reported. The groups of concomitant medication of interest are: any immunosuppressant (IS), methotrexate and corticosteroids. |
| Number of Participants With Infusion Reaction Treatments | Baseline up to end of study (2 years) or early withdrawal | For each infusion administration with infusion reactions, type of medications was used to treat the reaction will be reported. The list of medications includes anti-histamines, steroids, and epinephrine. |
| Number of Participants With Subsequent Reactions After the First Infusion Reaction | Baseline up to end of study (2 years) or early withdrawal | For each participant who has experienced at least 1 infusion reaction after enrolment, occurrence of infusion reaction at subsequent infusions after the first infusion reaction will be assessed. |
| Number of Participants With use of Pre-infusion Medications | Baseline up to end of study (2 years) or early withdrawal | Participants with administration of Pre-infusion medications or combination of Pre-infusion medications will be reported. The list of pre-treatments includes: acetaminophen, anti-histamines, steroids (Hydrocortisone, Prednisone), acetaminophen alone, anti-histamines alone, steroids alone, steroids + anti-histamines, steroids + acetaminophen, anti-histamines + acetaminophen, steroids + anti-histamines + acetaminophen. |
| Percentage of Participants With Absolute Change of at Least 3 Points in RAID Score | Baseline up to end of study (2 years) or early withdrawal | The RAID is self-administered questionnaire which includes seven domains (pain, function, fatigue, physical and psychological wellbeing, sleep disturbance and coping). Each domain is evaluated using a single question answered by a 0 to 10 numerical rating scale. Each domain also has a specific weight assigned by a patient survey. The RAID score is a continuous variable ranging from 0 (best) to 10 (worst). |
| Percentage of Participants With Relative Change of at Least 50 Percent (%) and a Maximum Score of 2 in RAID Score | Baseline up to end of study (2 years) or early withdrawal | The RAID is self-administered questionnaire which includes seven domains (pain, function, fatigue, physical and psychological wellbeing, sleep disturbance and coping). Each domain is evaluated using a single question answered by a 0 to 10 numerical rating scale. Each domain also has a specific weight assigned by a patient survey. The RAID score is a continuous variable ranging from 0 (best) to 10 (worst). |
| Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) Score | Baseline up to end of study (2 years) or early withdrawal | The RAID is self-administered questionnaire which includes seven domains (pain, function, fatigue, physical and psychological wellbeing, sleep disturbance and coping). Each domain is evaluated using a single question answered by a 0 to 10 numerical rating scale. Each domain also has a specific weight assigned by a patient survey. The RAID score is a continuous variable ranging from 0 (best) to 10 (worst). |
Countries
Canada
Outcome results
None listed