Rheumatoid ArthritisGO-IVNCT02390700
Observational Study of Golimumab Intravenous Infusion
An observational study of Rheumatoid Arthritis, run by Janssen Inc. at 13 sites in Canada.
Trial summary
The purpose of this study is to evaluate the incidence and management of infusion reactions with Golimumab intravenous infusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Golimumab Intravenous
- Type of treatment
- Injection or infusion
- How many people
- 78 participants
- Where
- 13 sitesCanada
- Study dates
- Feb 2015to Oct 2016
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Canadian participants with rheumatoid arthritis (RA), who have been prescribed intravenous golimumab prior to, and independently of, study enrollment.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Canada13 sites
Study site
Ancaster, Ontario
Study site
Barrie, Ontario
Study site
Kitchener, Ontario
Study site
Laval, Quebec
Study site
Mississauga, Ontario
Study site
Montreal, Quebec
Study site
Nepean, Ontario
Study site
Oakville, Ontario
Study site
Saskatoon, Saskatchewan
Study site
St. Catharines, Ontario
Study site
St. John's, Newfoundland and Labrador
Study site
Toronto, Ontario
Study site
Victoria
About this study
Official title: 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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Golimumab Intravenous
- Keywords
- Rheumatoid Arthritis, Observational, Golimumab, SIMPONI, Intravenous Infusion
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Golimumab IntravenousBiological
Also called SIMPONI
This is a non-interventional study. Participants with rheumatoid arthritis in Canada will be observed for 24 months.
| Study group | Role | What they receive |
|---|---|---|
| Golimumab Intravenous | Participants with rheumatoid arthritis (RA) in Canada, will be observed for 24 months. Only data available from source documentation will be collected. Receives: Biological: Golimumab Intravenous |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Infusion Reactions
The count of infusion reactions will be reported.
Measured: Up to end of study (2 years) or early withdrawal
Secondary outcomes (7)
Number of Participants With use of Pre-infusion Medications
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.
Measured: Baseline up to end of study (2 years) or early withdrawal
Number of Participants With use of Concomitant Medications at Time of Infusion
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.
Measured: Baseline up to end of study (2 years) or early withdrawal
Number of Participants With Infusion Reaction Treatments
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.
Measured: Baseline up to end of study (2 years) or early withdrawal
Number of Participants With Subsequent Reactions After the First Infusion Reaction
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.
Measured: Baseline up to end of study (2 years) or early withdrawal
Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) Score
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).
Measured: Baseline up to end of study (2 years) or early withdrawal
Percentage of Participants With Absolute Change of at Least 3 Points in RAID Score
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).
Measured: Baseline up to end of study (2 years) or early withdrawal
Percentage of Participants With Relative Change of at Least 50 Percent (%) and a Maximum Score of 2 in RAID Score
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).
Measured: Baseline up to end of study (2 years) or early withdrawal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionOct 2016
- Study completionOct 2016
Why it stopped: Business decision based on lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Janssen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Inc. Clinical Trial, Study director, Janssen Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02390700
- Sponsor's protocol ID
- CR105631
- Other IDs
- CNTO148ARA4003
- Acronym
- GO-IV
- Status last verified
- Nov 2016
- First submitted
- 11 Mar 2015
- Last updated
- 17 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Golimumab Intravenous Infusion Registry (GO-IV)
- ClinicalTrials.gov ID
- NCT02390700
- Acronym / sponsor ID
- GO-IV / CR105631
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, Observational, Golimumab, SIMPONI, Intravenous Infusion
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Business decision based on lack of enrollment
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Janssen Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Golimumab Intravenous | – | Biological: Golimumab IntravenousParticipants with rheumatoid arthritis (RA) in Canada, will be observed for 24 months. Only data available from source documentation will be collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Canadian participants with rheumatoid arthritis (RA), who have been prescribed intravenous golimumab prior to, and independently of, study enrollment.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Golimumab IntravenousAlso: SIMPONIThis is a non-interventional study. Participants with rheumatoid arthritis in Canada will be observed for 24 months. | Biological | Golimumab Intravenous |
Primary outcome
Number of Participants With Infusion Reactions
Time frame: Up to end of study (2 years) or early withdrawal
The count of infusion reactions will be reported.
7 secondary outcomes
Number of Participants With use of Pre-infusion Medications
Time frame: Baseline up to end of study (2 years) or early withdrawal
Number of Participants With use of Concomitant Medications at Time of Infusion
Time frame: Baseline up to end of study (2 years) or early withdrawal
Number of Participants With Infusion Reaction Treatments
Time frame: Baseline up to end of study (2 years) or early withdrawal
Number of Participants With Subsequent Reactions After the First Infusion Reaction
Time frame: Baseline up to end of study (2 years) or early withdrawal
Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) Score
Time frame: Baseline up to end of study (2 years) or early withdrawal
Percentage of Participants With Absolute Change of at Least 3 Points in RAID Score
Time frame: Baseline up to end of study (2 years) or early withdrawal
Percentage of Participants With Relative Change of at Least 50 Percent (%) and a Maximum Score of 2 in RAID Score
Time frame: Baseline up to end of study (2 years) or early withdrawal
Results and safety
The study was stopped early (reason given: Business decision based on lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Inc. Clinical Trial study director
Janssen Inc.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Janssen Inc. at 13 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Business decision based on lack of enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Infusion Reactions (time frame: Up to end of study (2 years) or early withdrawal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2016.