A Study to Evaluate Long-Term Safety and Effectiveness of HUMIRA (Adalimumab) in Pediatric Patients with Moderately to Severely Active Crohn's Disease
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-004413
NCT ID: NCT02130362
Sponsor Protocol Number: P11-292
About this study
The purpose of this study is to evaluate the long-term safety and effectiveness of adalimumab in pediatric patients with moderately to severely active crohn's disease
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- For the HUMIRA treatment group
- Children between the ages of 6 and 17 years inclusive at the time of enrollment
- Diagnosed with moderately to severely active Crohn's Disease
- Has been prescribed Humira therapy according to the local approved Humira product label
- For the immunosuppressant therapy treatment group
- Children between the ages of 6 and 17 years inclusive at the time of enrollment
- Diagnosed with moderately to severely active Crohn's Disease
- Has been prescribed azathioprine, 6-mercaptopurine or methotrexate
- Parent or guardian or patient (if 18 years of age or older at enrollment and rolling over from an AbbVie-sponsored investigational Pediatric Crohn's Disease investigation trial) has voluntarily signed and dated an Authorization for Use/Disclosure of Data informed consent form after the nature of the registry has been explained and there has been the opportunity to ask questions
Exclusion Criteria
- Cannot be treated in accordance with the local Humira product label
- Is currently being treated with any investigational agents or is receiving any investigational procedures
- Should not be enrolled into the immunosuppressant therapy treatment group if they require ongoing treatment with approved biologic agents including HUMIRA
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Michael Stephens, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available