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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/NCT00195715
Registration number
NCT00195715
Ethics application status
Date submitted
13/09/2005
Date registered
20/09/2005
Date last updated
12/07/2011
Titles & IDs
Public title
Long-term Safety and Tolerability Study of Adalimumab in Subjects With Crohn's Disease
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Scientific title
A Multi Center, 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 Crohn's Disease
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Secondary ID [1]
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M04-690
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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:
Crohn's Disease
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Condition category
Condition code
Oral and Gastrointestinal
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0
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Inflammatory bowel disease
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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0
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Crohn's disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Adalimumab
Other interventions: Adalimumab
Adalimumab 40 mg by subcutaneous injection every other week or every week
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Intervention code [1]
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Other interventions
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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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Percentage of Subjects Achieving Clinical Remission
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Assessment method [1]
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Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of < 150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.
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Timepoint [1]
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Week 156
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Secondary outcome [1]
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Percentage of Subjects Achieving Clinical Remission
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Assessment method [1]
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Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of < 150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.
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Timepoint [1]
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Week 48
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Secondary outcome [2]
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Percentage of Subjects Achieving Clinical Remission
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Assessment method [2]
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Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of < 150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.
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Timepoint [2]
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Week 108
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Secondary outcome [3]
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Percentage of Subjects Achieving Clinical Remission
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Assessment method [3]
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Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of < 150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.
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Timepoint [3]
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Week 204
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Secondary outcome [4]
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Percentage of Subjects Achieving Clinical Response 100 (CR-100)
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Assessment method [4]
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A CR-100 is a decrease from baseline in CDAI score of 100 or more points. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.
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Timepoint [4]
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Week 156
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Secondary outcome [5]
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Percentage of Subjects Achieving Clinical Response 70 (CR-70)
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Assessment method [5]
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A CR-70 is a decrease from baseline in CDAI score of 70 or more points. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.
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Timepoint [5]
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Week 156
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Secondary outcome [6]
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Percentage of Subjects Achieving Steroid-free Clinical Remission
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Assessment method [6]
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Steroid-free remission was achieved if the subject stopped taking steroids before the visit and had a Crohn's Disease Activity Index (CDAI) score of <150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.
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Timepoint [6]
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Week 156
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Secondary outcome [7]
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Percentage of Subjects Achieving Steroid-free CR-100
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Assessment method [7]
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Steroid-free CR-100 was achieved if the subject stopped taking steroids before the visit and had a decrease from baseline in CDAI score of 100 or more points at that visit. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.
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Timepoint [7]
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Week 156
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Secondary outcome [8]
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Percentage of Subjects With Fistula Remission
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Assessment method [8]
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Fistula remission was defined as the absence of draining fistulas in subjects with fistula present at the preceding study's baseline visit.
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Timepoint [8]
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Week 156
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Secondary outcome [9]
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Percentage of Subjects With Infection
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Assessment method [9]
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Timepoint [9]
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Up to 262 weeks of adalimumab treatment
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Secondary outcome [10]
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Percentage of Subjects With Serious Infection
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Assessment method [10]
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Serious infections are infectious adverse events that meet at least one criterion for a serious adverse event (e.g., death, life threatening event, hospitalization) including tuberculosis (TB), bacterial sepsis, invasive fungal infections (e.g., histoplasmosis), and infections due to other opportunistic pathogens.
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Timepoint [10]
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Up to 262 weeks of adalimumab treatment
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Secondary outcome [11]
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Percentage of Subjects With Malignancy
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Assessment method [11]
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Timepoint [11]
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Up to 262 weeks of adalimumab treatment
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Secondary outcome [12]
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Percentage of Subjects With Lymphoma
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Assessment method [12]
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Timepoint [12]
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Up to 262 weeks of adalimumab treatment
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Secondary outcome [13]
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Percentage of Subjects With Nonmelanoma Skin Cancer
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Assessment method [13]
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Timepoint [13]
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Up to 262 weeks of adalimumab treatment
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Secondary outcome [14]
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Percentage of Subjects With Malignancy (Excluding Nonmelanoma Skin Cancer and Lymphoma)
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Assessment method [14]
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Timepoint [14]
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Up to 262 weeks of adalimumab treatment
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Secondary outcome [15]
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Percentage of Subjects With Malignancy (Including Lymphoma, Excluding Nonmelanoma Skin Cancer)
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Assessment method [15]
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Timepoint [15]
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Up to 262 weeks of adalimumab treatment
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Secondary outcome [16]
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Percentage of Subjects With Injection Site Reaction-related Adverse Event
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Assessment method [16]
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An injection site reaction is any adverse event corresponding to a preferred term beginning with "injection site" excluding injection site arthritis, injection site movement impairment, injection site photosensitivity, injection site joint effusion, injection site joint inflammation, injection site scab, injection site joint pain, or injection site laceration.
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Timepoint [16]
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Up to 262 weeks of adalimumab treatment
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Secondary outcome [17]
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Percentage of Subjects With Opportunistic Infection (Excluding Tuberculosis)
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Assessment method [17]
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Timepoint [17]
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Up to 262 weeks of adalimumab treatment
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Secondary outcome [18]
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Percentage of Subjects With Congestive Heart Failure
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Assessment method [18]
0
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Timepoint [18]
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Up to 262 weeks of adalimumab treatment
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Secondary outcome [19]
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Percentage of Subjects With Demyelinating Disease
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Assessment method [19]
0
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Timepoint [19]
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Up to 262 weeks of adalimumab treatment
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Secondary outcome [20]
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Percentage of Subjects With Hepatic-related Adverse Event
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Assessment method [20]
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Timepoint [20]
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Up to 262 weeks of adalimumab treatment
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Secondary outcome [21]
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Percentage of Subjects With Allergic Reaction-related Adverse Event
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Assessment method [21]
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Timepoint [21]
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Up to 262 weeks of adalimumab treatment
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Secondary outcome [22]
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Percentage of Subjects With Lupus-like Syndrome
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Assessment method [22]
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Timepoint [22]
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Up to 262 weeks of adalimumab treatment
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Secondary outcome [23]
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Percentage of Subjects With Hematologic-related Adverse Event
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Assessment method [23]
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Timepoint [23]
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Up to 262 weeks of adalimumab treatment
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Secondary outcome [24]
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Percentage of Subjects With Fatal Adverse Event
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Assessment method [24]
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Timepoint [24]
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Up to 262 weeks of adalimumab treatment
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Eligibility
Key inclusion criteria
- Subject must have successfully completed either the M02-404 (NCT00077779) or M04-691
(NCT00105300) protocol to be eligible for this study
- Diagnosis of Crohn's disease
- Willing and able to give informed consent
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Minimum age
18
Years
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Maximum age
75
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
- Diagnosis of ulcerative colitis
- Women cannot be pregnant or breastfeeding
- Previous history of listeria infection or untreated tuberculosis
- Previous history of cancer other than successfully treated skin cancer or
carcinoma-in-situ of the cervix
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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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
1/09/2004
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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
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Actual
1/12/2008
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Sample size
Target
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Accrual to date
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Final
777
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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Site Ref # / Investigator 1938 - Camperdown
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Recruitment hospital [2]
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Site Ref # / Investigator 1940 - Bedford Park
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Recruitment hospital [3]
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Site Ref # / Investigator 1935 - Box Hill
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Recruitment hospital [4]
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Site Ref # / Investigator 1937 - Parkville
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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SA 5042 - Bedford Park
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Recruitment postcode(s) [3]
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3128 - Box Hill
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Recruitment postcode(s) [4]
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3050 - Parkville
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Recruitment outside Australia
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United States of America
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Alabama
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United States of America
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California
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United States of America
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Colorado
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Connecticut
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Florida
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Georgia
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Illinois
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Indiana
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Louisiana
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Mississippi
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Missouri
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Arhus C
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Odense C
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France
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Amiens
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France
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Heerlen
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Poland
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71-252
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GT
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NL
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Madrid
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Edinburgh
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United Kingdom
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Rotherham
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Abbott
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
To evaluate the long-term maintenance of response, safety and tolerability of repeated
administration of adalimumab in subjects with Crohn's disease who participated in and
successfully completed Protocol M02-404 or Protocol M04-691.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00195715
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Anne Camez, MD
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Address
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Abbott
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00195715
Download to PDF