Observational Study of Golimumab Intravenous Infusion (GO-IV)
16 november 2016 uppdaterad av: Janssen Inc.
Golimumab Intravenous Infusion Registry (GO-IV)
The purpose of this study is to evaluate the incidence and management of infusion reactions with Golimumab intravenous infusion.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Faktisk)
78
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Victoria, Kanada
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Newfoundland and Labrador
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Saint-John'S, Newfoundland and Labrador, Kanada
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Ontario
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Ancaster, Ontario, Kanada
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Barrie, Ontario, Kanada
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Kitchener, Ontario, Kanada
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Mississauga, Ontario, Kanada
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Nepean, Ontario, Kanada
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Oakville, Ontario, Kanada
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St.Catharines, Ontario, Kanada
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Toronto, Ontario, Kanada
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Quebec
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Laval, Quebec, Kanada
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Montreal, Quebec, Kanada
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Saskatchewan
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Saskatoon, Saskatchewan, Kanada
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Canadian participants with rheumatoid arthritis (RA), who have been prescribed intravenous golimumab prior to, and independently of, study enrollment.
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
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Golimumab Intravenous
Participants with rheumatoid arthritis (RA) in Canada, will be observed for 24 months.
Only data available from source documentation will be collected.
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This is a non-interventional study.
Participants with rheumatoid arthritis in Canada will be observed for 24 months.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Number of Participants With Infusion Reactions
Tidsram: Up to end of study (2 years) or early withdrawal
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The count of infusion reactions will be reported.
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Up to end of study (2 years) or early withdrawal
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Number of Participants With use of Pre-infusion Medications
Tidsram: Baseline up to end of study (2 years) or early withdrawal
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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.
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Baseline up to end of study (2 years) or early withdrawal
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Number of Participants With use of Concomitant Medications at Time of Infusion
Tidsram: Baseline up to end of study (2 years) or early withdrawal
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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.
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Baseline up to end of study (2 years) or early withdrawal
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Number of Participants With Infusion Reaction Treatments
Tidsram: Baseline up to end of study (2 years) or early withdrawal
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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.
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Baseline up to end of study (2 years) or early withdrawal
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Number of Participants With Subsequent Reactions After the First Infusion Reaction
Tidsram: Baseline up to end of study (2 years) or early withdrawal
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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.
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Baseline up to end of study (2 years) or early withdrawal
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Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) Score
Tidsram: Baseline up to end of study (2 years) or early withdrawal
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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).
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Baseline up to end of study (2 years) or early withdrawal
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Percentage of Participants With Absolute Change of at Least 3 Points in RAID Score
Tidsram: 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).
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Baseline up to end of study (2 years) or early withdrawal
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Percentage of Participants With Relative Change of at Least 50 Percent (%) and a Maximum Score of 2 in RAID Score
Tidsram: 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).
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Baseline up to end of study (2 years) or early withdrawal
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 februari 2015
Primärt slutförande (Faktisk)
1 oktober 2016
Avslutad studie (Faktisk)
1 oktober 2016
Studieregistreringsdatum
Först inskickad
11 mars 2015
Först inskickad som uppfyllde QC-kriterierna
11 mars 2015
Första postat (Uppskatta)
17 mars 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
17 november 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
16 november 2016
Senast verifierad
1 november 2016
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CR105631
- CNTO148ARA4003 (Annan identifierare: Janssen Inc.)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .