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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01848561
Registration number
NCT01848561
Ethics application status
Date submitted
3/05/2013
Date registered
7/05/2013
Date last updated
18/06/2024
Titles & IDs
Public title
A Long-Term Registry of Humira® (Adalimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (UC)
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Scientific title
A Long-Term Non-Interventional Postmarketing Study to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (UC)
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Secondary ID [1]
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0
P11-282
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis (UC)
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0
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Condition category
Condition code
Oral and Gastrointestinal
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0
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
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0
0
0
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
0
0
0
0
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Inflammatory bowel disease
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Immunomodulatory Therapy - Patients who are being prescribed and treated with Immunomodulatory Therapy
Adalimumab (Humira) Treatment - Patients who are prescribed and treated with Adalimumab
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Evaluation of long term safety of Adalimumab in patients with moderately to severely active UC
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Assessment method [1]
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0
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Timepoint [1]
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10 years observational period
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Secondary outcome [1]
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Evaluation of long term effectiveness of Adalimumab in patients with moderately to severely active UC who have had an inadequate response to conventional therapy
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Assessment method [1]
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0
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Timepoint [1]
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10 years observational period
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Eligibility
Key inclusion criteria
* For enrollment into the HUMIRA treatment group; adult patients with moderately to severely active UC who has been prescribed HUMIRA therapy according to routine clinical practice and meets one of the following:
1. Is currently taking HUMIRA therapy and has received at least 8 weeks of therapy; OR
2. Is entering after participation in an Abbott or AbbVie sponsored UC study and; has received continuous HUMIRA therapy since initiation of therapy
* For enrollment into the IMM treatment group; adult patients with moderately to severely active UC who has been prescribed IMM therapy, is currently taking IMM therapy, and has received at least 12 consecutive weeks of IMM therapy
* Patients capable of and willing to grant authorization for use/disclosure of data being collected and provided to AbbVie prior to any registry-related data being collected, and to comply with the requirements of the Registry protocol
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Minimum age
18
Years
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Maximum age
99
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Patients on IMM therapy without a concurrent biologic if they cannot continue to be treated with IMM therapy or
* Patients who are being treated with any investigational agents and/or approved biologics other than Humira.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
29/04/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
24/06/2030
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Actual
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Sample size
Target
8250
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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The Canberra Hospital /ID# 157980 - Garran
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Recruitment hospital [2]
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Royal Prince Alfred Hospital /ID# 157986 - Camperdown
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Concord Repatriation General /ID# 157983 - Concord
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St Vincent's Hospital /ID# 157978 - East Lismore
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Hunter New England Local Health District /ID# 157999 - New Lambton
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Royal Brisbane and Women's Hospital /ID# 158086 - Herston
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Mater Misericordiae Limited /ID# 164171 - South Brisbane
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Royal Adelaide Hospital /ID# 158026 - Adelaide
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Flinders Medical Centre /ID# 157979 - Bedford, Park
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Box Hill Hospital /ID# 157987 - Box Hill
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Austin Health /ID# 157998 - Heidelberg
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The Alfred Hospital /ID# 159261 - Melbourne
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The Royal Melbourne Hospital /ID# 157993 - Parkville
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Fiona Stanley Hospital /ID# 157992 - Murdoch
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2605 - Garran
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2050 - Camperdown
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2139 - Concord
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2480 - East Lismore
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2305 - New Lambton
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4029 - Herston
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4101 - South Brisbane
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5000 - Adelaide
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5042 - Bedford, Park
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3128 - Box Hill
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3084 - Heidelberg
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3004 - Melbourne
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3050 - Parkville
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6150 - Murdoch
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AbbVie
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Ethics approval
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Summary
Brief summary
This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in patients with moderately to severely active UC who are treated as recommended in the product label.
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Trial website
https://clinicaltrials.gov/study/NCT01848561
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Contacts
Principal investigator
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0
ABBVIE INC.
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AbbVie
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
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Results not provided in
https://clinicaltrials.gov/study/NCT01848561
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