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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
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
Secondary ID [1] 0 0
M04-690
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Adalimumab

Other interventions: Adalimumab
Adalimumab 40 mg by subcutaneous injection every other week or every week

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Subjects Achieving Clinical Remission - 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.
Timepoint [1] 0 0
Week 156
Secondary outcome [1] 0 0
Percentage of Subjects Achieving Clinical Remission - 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.
Timepoint [1] 0 0
Week 48
Secondary outcome [2] 0 0
Percentage of Subjects Achieving Clinical Remission - 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.
Timepoint [2] 0 0
Week 108
Secondary outcome [3] 0 0
Percentage of Subjects Achieving Clinical Remission - 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.
Timepoint [3] 0 0
Week 204
Secondary outcome [4] 0 0
Percentage of Subjects Achieving Clinical Response 100 (CR-100) - 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.
Timepoint [4] 0 0
Week 156
Secondary outcome [5] 0 0
Percentage of Subjects Achieving Clinical Response 70 (CR-70) - 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.
Timepoint [5] 0 0
Week 156
Secondary outcome [6] 0 0
Percentage of Subjects Achieving Steroid-free Clinical Remission - 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.
Timepoint [6] 0 0
Week 156
Secondary outcome [7] 0 0
Percentage of Subjects Achieving Steroid-free CR-100 - 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.
Timepoint [7] 0 0
Week 156
Secondary outcome [8] 0 0
Percentage of Subjects With Fistula Remission - Fistula remission was defined as the absence of draining fistulas in subjects with fistula present at the preceding study's baseline visit.
Timepoint [8] 0 0
Week 156
Secondary outcome [9] 0 0
Percentage of Subjects With Infection
Timepoint [9] 0 0
Up to 262 weeks of adalimumab treatment
Secondary outcome [10] 0 0
Percentage of Subjects With Serious Infection - 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.
Timepoint [10] 0 0
Up to 262 weeks of adalimumab treatment
Secondary outcome [11] 0 0
Percentage of Subjects With Malignancy
Timepoint [11] 0 0
Up to 262 weeks of adalimumab treatment
Secondary outcome [12] 0 0
Percentage of Subjects With Lymphoma
Timepoint [12] 0 0
Up to 262 weeks of adalimumab treatment
Secondary outcome [13] 0 0
Percentage of Subjects With Nonmelanoma Skin Cancer
Timepoint [13] 0 0
Up to 262 weeks of adalimumab treatment
Secondary outcome [14] 0 0
Percentage of Subjects With Malignancy (Excluding Nonmelanoma Skin Cancer and Lymphoma)
Timepoint [14] 0 0
Up to 262 weeks of adalimumab treatment
Secondary outcome [15] 0 0
Percentage of Subjects With Malignancy (Including Lymphoma, Excluding Nonmelanoma Skin Cancer)
Timepoint [15] 0 0
Up to 262 weeks of adalimumab treatment
Secondary outcome [16] 0 0
Percentage of Subjects With Injection Site Reaction-related Adverse Event - 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.
Timepoint [16] 0 0
Up to 262 weeks of adalimumab treatment
Secondary outcome [17] 0 0
Percentage of Subjects With Opportunistic Infection (Excluding Tuberculosis)
Timepoint [17] 0 0
Up to 262 weeks of adalimumab treatment
Secondary outcome [18] 0 0
Percentage of Subjects With Congestive Heart Failure
Timepoint [18] 0 0
Up to 262 weeks of adalimumab treatment
Secondary outcome [19] 0 0
Percentage of Subjects With Demyelinating Disease
Timepoint [19] 0 0
Up to 262 weeks of adalimumab treatment
Secondary outcome [20] 0 0
Percentage of Subjects With Hepatic-related Adverse Event
Timepoint [20] 0 0
Up to 262 weeks of adalimumab treatment
Secondary outcome [21] 0 0
Percentage of Subjects With Allergic Reaction-related Adverse Event
Timepoint [21] 0 0
Up to 262 weeks of adalimumab treatment
Secondary outcome [22] 0 0
Percentage of Subjects With Lupus-like Syndrome
Timepoint [22] 0 0
Up to 262 weeks of adalimumab treatment
Secondary outcome [23] 0 0
Percentage of Subjects With Hematologic-related Adverse Event
Timepoint [23] 0 0
Up to 262 weeks of adalimumab treatment
Secondary outcome [24] 0 0
Percentage of Subjects With Fatal Adverse Event
Timepoint [24] 0 0
Up to 262 weeks of adalimumab treatment

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
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)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Site Ref # / Investigator 1938 - Camperdown
Recruitment hospital [2] 0 0
Site Ref # / Investigator 1940 - Bedford Park
Recruitment hospital [3] 0 0
Site Ref # / Investigator 1935 - Box Hill
Recruitment hospital [4] 0 0
Site Ref # / Investigator 1937 - Parkville
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
SA 5042 - Bedford Park
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment postcode(s) [4] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
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United States of America
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Louisiana
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United States of America
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Maryland
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Massachusetts
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Minnesota
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Mississippi
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Missouri
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New Jersey
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State/province [17] 0 0
New York
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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State/province [28] 0 0
Wisconsin
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Belgium
State/province [29] 0 0
Bonheiden
Country [30] 0 0
Belgium
State/province [30] 0 0
Brussels
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Belgium
State/province [31] 0 0
Leuven
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Canada
State/province [32] 0 0
Alberta
Country [33] 0 0
Canada
State/province [33] 0 0
British Columbia
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Canada
State/province [34] 0 0
Manitoba
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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Denmark
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Arhus C
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Denmark
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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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Lillie Cedex
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France
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Paris
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Germany
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Kiel
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Germany
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Regensburg
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Germany
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Stuttgart
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Hungary
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Budapest
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Hungary
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Szekszard
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Italy
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Bologna
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Italy
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Rome
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Italy
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Turin
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Netherlands
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Amsterdam
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Netherlands
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Heerlen
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Poland
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71-252
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Poland
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Warsaw
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South Africa
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GT
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South Africa
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NL
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South Africa
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WC
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Spain
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Madrid
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Spain
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Puerto de Sagunto
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Sweden
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Gothenburg
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Sweden
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Stockholm
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United Kingdom
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Edinburgh
Country [63] 0 0
United Kingdom
State/province [63] 0 0
Rotherham

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

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00195715
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Anne Camez, MD
Address 0 0
Abbott
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