MelanomaNCT02739386
Study of Autoimmune Disease Complications Following Ipilimumab Treatment Among Melanoma Patients With Underlying Autoimmune Diseases
An observational study of Melanoma, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The research questions to be addressed by this study are as follows: 1. What is the prevalence of ipilimumab use among adults with a history of autoimmune disease that received treatment with ipilimumab for advanced melanoma? 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Ipilimumab
- Type of treatment
- Injection or infusion
- How many people
- 370 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Feb 2016to 30 Mar 2017
- 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: Adults with an underlying autoimmune disease treated with ipilimumab for advanced melanoma.
Who may be able to join
- Received ipilimumab therapy between 03/01/2011 and 6/30/2014
- Aged 18 years or older at index date (initiation of ipilimumab)
- Diagnosed with melanoma before index
- Documented history of an autoimmune disease
- Have at least 6 months of continuous pharmaceutical and medical benefit enrollment prior to the index
- Have at least 3 months of continuous pharmaceutical and medical benefit enrollment following and including the index date
Who cannot join
- Diagnosed with melanoma but NO record of exposure to ipilimumab
- No exposure to nivolumab (Opdivo ®) at any time
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Hospitalization for Complications of Autoimmune Disease Following Ipilimumab Treatment Among Melanoma Patients With Underlying Autoimmune Diseases Treated in Routine Clinical Practices in the US
The research questions to be addressed by this study are as follows:
- What is the prevalence of ipilimumab use among adults with a history of autoimmune disease that received treatment with ipilimumab for advanced melanoma?
- Do melanoma patients with a history of autoimmune disease experience complications that require hospitalization related to their underlying autoimmune disease following treatment with ipilimumab?
- Conditions
- Melanoma
- Being tested
- Ipilimumab
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IpilimumabBiological
Also called Yervoy®
Intravenous monoclonal antibody injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort Population | Individuals included in a large US-based administrative medical claims database with underlying autoimmune disorder exposed to ipilimumab for the treatment of melanoma. Receives: Biological: Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ipilimumab treatment among adult melanoma patients with a prior or existing autoimmune disease/condition
Measured: Approximately 40 months
Incidence of hospitalizations related to the pre-existing autoimmune disease/condition following treatment with ipilimumab
Measured: Approximately 40 months
Secondary outcomes (2)
Incidence rate of hospitalization related to a complication of the underlying autoimmune condition before exposure to ipilimumab treatment
Measured: Approximately 40 months
Incidence rate of hospitalization related to a complication of the underlying autoimmune condition after exposure to ipilimumab treatment
Measured: Approximately 40 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study start29 Feb 2016
- Primary completion30 Mar 2017
- Study completion30 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02739386
- Sponsor's protocol ID
- CA184-486
- Status last verified
- Apr 2017
- First submitted
- 7 Apr 2016
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hospitalization for Complications of Autoimmune Disease Following Ipilimumab Treatment Among Melanoma Patients With Underlying Autoimmune Diseases Treated in Routine Clinical Practices in the US
- ClinicalTrials.gov ID
- NCT02739386
- Acronym / sponsor ID
- CA184-486
- Conditions
- Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 29 Feb 2016 (actual)
- Primary completion
- 30 Mar 2017 (actual)
- Study completion
- 30 Mar 2017 (actual)
- First posted
- 15 Apr 2016 (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 research questions to be addressed by this study are as follows:
- What is the prevalence of ipilimumab use among adults with a history of autoimmune disease that received treatment with ipilimumab for advanced melanoma?
- Do melanoma patients with a history of autoimmune disease experience complications that require hospitalization related to their underlying autoimmune disease following treatment with ipilimumab?
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort Population | – | Biological: IpilimumabIndividuals included in a large US-based administrative medical claims database with underlying autoimmune disorder exposed to ipilimumab for the treatment of melanoma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with an underlying autoimmune disease treated with ipilimumab for advanced melanoma.
Key inclusion criteria (6 listed)
- Received ipilimumab therapy between 03/01/2011 and 6/30/2014
- Aged 18 years or older at index date (initiation of ipilimumab)
- Diagnosed with melanoma before index
- Documented history of an autoimmune disease
- Have at least 6 months of continuous pharmaceutical and medical benefit enrollment prior to the index
Key exclusion criteria (2 listed)
- Diagnosed with melanoma but NO record of exposure to ipilimumab
- No exposure to nivolumab (Opdivo ®) at any time
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 |
|---|---|---|
| IpilimumabAlso: Yervoy®Intravenous monoclonal antibody injection | Biological | Cohort Population |
Primary outcome
Incidence of ipilimumab treatment among adult melanoma patients with a prior or existing autoimmune disease/condition
Time frame: Approximately 40 months
Incidence of hospitalizations related to the pre-existing autoimmune disease/condition following treatment with ipilimumab
Time frame: Approximately 40 months
2 secondary outcomes
Incidence rate of hospitalization related to a complication of the underlying autoimmune condition before exposure to ipilimumab treatment
Time frame: Approximately 40 months
Incidence rate of hospitalization related to a complication of the underlying autoimmune condition after exposure to ipilimumab treatment
Time frame: Approximately 40 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma, run by Bristol-Myers Squibb at 1 site in United States.
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 6 inclusion and 2 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: finished, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of ipilimumab treatment among adult melanoma patients with a prior or existing autoimmune disease/condition (time frame: Approximately 40 months). The study lists 2 primary outcomes in all. 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 27 Apr 2017.