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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01848561




Registration number
NCT01848561
Ethics application status
Date submitted
3/05/2013
Date registered
7/05/2013
Date last updated
7/01/2021

Titles & IDs
Public title
A Long-Term Registry of Humira® (Adalimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (UC)
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)
Secondary ID [1] 0 0
P11-282
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis (UC) 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evaluation of long term safety of Adalimumab in patients with moderately to severely active UC
Timepoint [1] 0 0
10 years observational period
Secondary outcome [1] 0 0
Evaluation of long term effectiveness of Adalimumab in patients with moderately to severely active UC who have had an inadequate response to conventional therapy
Timepoint [1] 0 0
10 years observational period

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
Minimum age
18 Years
Maximum age
99 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
The Canberra Hospital /ID# 157980 - Garran
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital /ID# 157986 - Camperdown
Recruitment hospital [3] 0 0
Concord Repatriation General /ID# 157983 - Concord
Recruitment hospital [4] 0 0
St. Vincents Hospital /ID# 157978 - East Lismore
Recruitment hospital [5] 0 0
Hunter New England Local Healt /ID# 157999 - New Lambton
Recruitment hospital [6] 0 0
Royal Brisbane and Women's Hospital /ID# 158086 - Herston
Recruitment hospital [7] 0 0
Mater Misericordiae /ID# 164171 - South Brisbane
Recruitment hospital [8] 0 0
Royal Adelaide Hospital /ID# 158026 - Adelaide
Recruitment hospital [9] 0 0
Flinders Centre for Innovation /ID# 157979 - Bedford Park
Recruitment hospital [10] 0 0
Austin Hospital /ID# 157998 - Heidelberg
Recruitment hospital [11] 0 0
Alfred Health /ID# 159261 - Melbourne
Recruitment hospital [12] 0 0
Box Hill Hospital /ID# 157987 - Melbourne
Recruitment hospital [13] 0 0
Royal Melbourne Hospital /ID# 157993 - Parkville
Recruitment hospital [14] 0 0
Fiona Stanley Hospital /ID# 157992 - Murdoch
Recruitment postcode(s) [1] 0 0
2605 - Garran
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2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2139 - Concord
Recruitment postcode(s) [4] 0 0
2480 - East Lismore
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2305 - New Lambton
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4029 - Herston
Recruitment postcode(s) [7] 0 0
4101 - South Brisbane
Recruitment postcode(s) [8] 0 0
5000 - Adelaide
Recruitment postcode(s) [9] 0 0
5042 - Bedford Park
Recruitment postcode(s) [10] 0 0
3084 - Heidelberg
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3004 - Melbourne
Recruitment postcode(s) [12] 0 0
3128 - Melbourne
Recruitment postcode(s) [13] 0 0
3050 - Parkville
Recruitment postcode(s) [14] 0 0
6150 - Murdoch
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Yeovil

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT01848561
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AbbVie Inc.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications