Clinical trial · Observational
Study of Autoimmune Disease Complications Following Ipilimumab Treatment Among Melanoma Patients With Underlying Autoimmune Diseases
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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. 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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ipilimumab | Biological | Ipilimumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Cohort Population
- description
- Individuals included in a large US-based administrative medical claims database with underlying autoimmune disorder exposed to ipilimumab for the treatment of melanoma.
- interventionNames
- Biological: Ipilimumab
Primary outcomes (2)
- measure
- Incidence of ipilimumab treatment among adult melanoma patients with a prior or existing autoimmune disease/condition
- timeFrame
- Approximately 40 months
- measure
- Incidence of hospitalizations related to the pre-existing autoimmune disease/condition following treatment with ipilimumab
- timeFrame
- Approximately 40 months
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Diagnosed with melanoma but NO record of exposure to ipilimumab * No exposure to nivolumab (Opdivo ®) at any time
References
Publications (0)
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