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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00573794




Registration number
NCT00573794
Ethics application status
Date submitted
12/12/2007
Date registered
14/12/2007
Date last updated
7/07/2021

Titles & IDs
Public title
Long-term Open-label Safety and Efficacy Study of Adalimumab in Subjects With Ulcerative Colitis
Scientific title
A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis
Secondary ID [1] 0 0
2007-004157-28
Secondary ID [2] 0 0
M10-223
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 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
Interventional
Description of intervention(s) / exposure
Other interventions - adalimumab

Experimental: Adalimumab 40 mg EOW/EW - Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.


Other interventions: adalimumab
adalimumab prefilled syringes administered as subcutaneous injection EW or EOW
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Partial Mayo Score: Change From Baseline Over Time
Timepoint [1] 0 0
Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
Primary outcome [2] 0 0
Mayo Score: Change From Baseline Over Time
Timepoint [2] 0 0
Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
Secondary outcome [1] 0 0
Percentage of Participants With Remission Per Partial Mayo Score Over Time
Timepoint [1] 0 0
Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
Secondary outcome [2] 0 0
Mayo Endoscopy Subscore: Change From Baseline Over Time
Timepoint [2] 0 0
Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
Secondary outcome [3] 0 0
Mayo Rectal Bleeding Subscore: Change From Baseline Over Time
Timepoint [3] 0 0
Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
Secondary outcome [4] 0 0
Mayo Physician's Global Assessment of Disease Severity Subscore: Change From Baseline Over Time
Timepoint [4] 0 0
Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
Secondary outcome [5] 0 0
Mayo Stool Frequency Subscore: Change From Baseline Over Time
Timepoint [5] 0 0
Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
Secondary outcome [6] 0 0
Inflammatory Bowel Disease Questionnaire (IBDQ): Change From Baseline Over Time
Timepoint [6] 0 0
Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
Secondary outcome [7] 0 0
36-Item Short Form Health Survey Version 2 (SF-36) Mental Component Score: Change From Baseline Over Time
Timepoint [7] 0 0
Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
Secondary outcome [8] 0 0
36-Item Short Form Health Survey Version 2 (SF-36) Physical Component Score: Change From Baseline Over Time
Timepoint [8] 0 0
Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
Secondary outcome [9] 0 0
Work Productivity and Activity Impairment: General Health Version 2.0 (WPAI:GH) Work Time Missed Because of Ulcerative Colitis: Change From Baseline Over Time
Timepoint [9] 0 0
Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
Secondary outcome [10] 0 0
WPAI:GH Impairment While Working: Change From Baseline Over Time
Timepoint [10] 0 0
Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
Secondary outcome [11] 0 0
WPAI:GH Overall Work Impairment: Change From Baseline Over Time
Timepoint [11] 0 0
Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
Secondary outcome [12] 0 0
WPAI:GH Activity Impairment: Change From Baseline Over Time
Timepoint [12] 0 0
Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
Secondary outcome [13] 0 0
Colectomy Rate
Timepoint [13] 0 0
5 years
Secondary outcome [14] 0 0
Health Care Resource Utilization (HCRU): Cumulative Number of Unscheduled Utilizations
Timepoint [14] 0 0
5 years
Secondary outcome [15] 0 0
Number of Participants With Adverse Events
Timepoint [15] 0 0
From first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks)
Secondary outcome [16] 0 0
Hematology: Mean Change From Baseline to Final Values in Hemoglobin
Timepoint [16] 0 0
Baseline (Week 0), final value (up to 5 years)
Secondary outcome [17] 0 0
Hematology: Mean Change From Baseline to Final Values in Hematocrit
Timepoint [17] 0 0
Baseline (Week 0), final value (up to 5 years)
Secondary outcome [18] 0 0
Hematology: Mean Change From Baseline to Final Values in Red Blood Cell Count, Platelet Count, White Blood Cell Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils
Timepoint [18] 0 0
Baseline (Week 0), final value (up to 5 years)
Secondary outcome [19] 0 0
Clinical Chemistry: Mean Change From Baseline to Final Values in Alanine Aminotransferase, Aspartate Aminotransferase, and Alkaline Phosphatase
Timepoint [19] 0 0
Baseline (Week 0), final value (up to 5 years)
Secondary outcome [20] 0 0
Clinical Chemistry: Mean Change From Baseline to Final Values in Total Bilirubin, Creatinine, and Uric Acid
Timepoint [20] 0 0
Baseline (Week 0), final value (up to 5 years)
Secondary outcome [21] 0 0
Clinical Chemistry: Mean Change From Baseline to Final Values in Blood Urea Nitrogen, Inorganic Phosphate, Calcium, Sodium, Potassium, Glucose, Cholesterol, and Triglycerides
Timepoint [21] 0 0
Baseline (Week 0), final value (up to 5 years)
Secondary outcome [22] 0 0
Clinical Chemistry: Mean Change From Baseline to Final Values in Albumin and Total Protein
Timepoint [22] 0 0
Baseline (Week 0), final value (up to 5 years)
Secondary outcome [23] 0 0
Clinical Chemistry: Mean Change From Baseline to Final Values in High-sensitivity C-reactive Protein
Timepoint [23] 0 0
Baseline (Week 0), final value (up to 5 years)

Eligibility
Key inclusion criteria
- Subject must have successfully enrolled and completed either study M06-826
(NCT00385736) or study M06-827 (NCT00408629)

- Subject is judged to be in generally good health as determined by the principal
investigator
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subject has not responded to weekly adalimumab therapy in M06-826 (NCT00385736) or
M06-827 (NCT00408629)

- Subject considered by the investigator, for any reason, to be an unsuitable candidate

- Female subject who is pregnant or breast-feeding or considering becoming pregnant

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/11/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2016
Sample size
Target
Accrual to date
Final
592
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie (prior sponsor, Abbott)
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To assess the long-term safety and maintenance of response of adalimumab in subjects with
ulcerative colitis who participated in and successfully completed M06-826 (NCT00385736) or
M06-827 (NCT00408629).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00573794
Trial related presentations / publications
Colombel JF, Sandborn WJ, Ghosh S, Wolf DC, Panaccione R, Feagan B, Reinisch W, Robinson AM, Lazar A, Kron M, Huang B, Skup M, Thakkar RB. Four-year maintenance treatment with adalimumab in patients with moderately to severely active ulcerative colitis: Data from ULTRA 1, 2, and 3. Am J Gastroenterol. 2014 Nov;109(11):1771-80. doi: 10.1038/ajg.2014.242. Epub 2014 Aug 26.
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

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