Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Treatment: Other - Adalimumab

Treatment: Other: Adalimumab
Adalimumab 40 mg by subcutaneous injection every other week or every week
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Subjects Achieving Clinical Remission
Timepoint [1] 0 0
Week 156
Secondary outcome [1] 0 0
Percentage of Subjects Achieving Clinical Remission
Timepoint [1] 0 0
Week 48
Secondary outcome [2] 0 0
Percentage of Subjects Achieving Clinical Remission
Timepoint [2] 0 0
Week 108
Secondary outcome [3] 0 0
Percentage of Subjects Achieving Clinical Remission
Timepoint [3] 0 0
Week 204
Secondary outcome [4] 0 0
Percentage of Subjects Achieving Clinical Response 100 (CR-100)
Timepoint [4] 0 0
Week 156
Secondary outcome [5] 0 0
Percentage of Subjects Achieving Clinical Response 70 (CR-70)
Timepoint [5] 0 0
Week 156
Secondary outcome [6] 0 0
Percentage of Subjects Achieving Steroid-free Clinical Remission
Timepoint [6] 0 0
Week 156
Secondary outcome [7] 0 0
Percentage of Subjects Achieving Steroid-free CR-100
Timepoint [7] 0 0
Week 156
Secondary outcome [8] 0 0
Percentage of Subjects With Fistula Remission
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
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
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
Sex
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
1/09/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2008
Sample size
Target
Accrual to date
Final
777
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
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Minnesota
Country [14] 0 0
United States of America
State/province [14] 0 0
Mississippi
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
New Jersey
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
North Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Ohio
Country [20] 0 0
United States of America
State/province [20] 0 0
Oregon
Country [21] 0 0
United States of America
State/province [21] 0 0
Pennsylvania
Country [22] 0 0
United States of America
State/province [22] 0 0
South Carolina
Country [23] 0 0
United States of America
State/province [23] 0 0
Tennessee
Country [24] 0 0
United States of America
State/province [24] 0 0
Texas
Country [25] 0 0
United States of America
State/province [25] 0 0
Utah
Country [26] 0 0
United States of America
State/province [26] 0 0
Virginia
Country [27] 0 0
United States of America
State/province [27] 0 0
Washington
Country [28] 0 0
United States of America
State/province [28] 0 0
Wisconsin
Country [29] 0 0
Belgium
State/province [29] 0 0
Bonheiden
Country [30] 0 0
Belgium
State/province [30] 0 0
Brussels
Country [31] 0 0
Belgium
State/province [31] 0 0
Leuven
Country [32] 0 0
Canada
State/province [32] 0 0
Alberta
Country [33] 0 0
Canada
State/province [33] 0 0
British Columbia
Country [34] 0 0
Canada
State/province [34] 0 0
Manitoba
Country [35] 0 0
Canada
State/province [35] 0 0
Nova Scotia
Country [36] 0 0
Canada
State/province [36] 0 0
Ontario
Country [37] 0 0
Canada
State/province [37] 0 0
Quebec
Country [38] 0 0
Denmark
State/province [38] 0 0
Arhus C
Country [39] 0 0
Denmark
State/province [39] 0 0
Odense C
Country [40] 0 0
France
State/province [40] 0 0
Amiens
Country [41] 0 0
France
State/province [41] 0 0
Lillie Cedex
Country [42] 0 0
France
State/province [42] 0 0
Paris
Country [43] 0 0
Germany
State/province [43] 0 0
Kiel
Country [44] 0 0
Germany
State/province [44] 0 0
Regensburg
Country [45] 0 0
Germany
State/province [45] 0 0
Stuttgart
Country [46] 0 0
Hungary
State/province [46] 0 0
Budapest
Country [47] 0 0
Hungary
State/province [47] 0 0
Szekszard
Country [48] 0 0
Italy
State/province [48] 0 0
Bologna
Country [49] 0 0
Italy
State/province [49] 0 0
Rome
Country [50] 0 0
Italy
State/province [50] 0 0
Turin
Country [51] 0 0
Netherlands
State/province [51] 0 0
Amsterdam
Country [52] 0 0
Netherlands
State/province [52] 0 0
Heerlen
Country [53] 0 0
Poland
State/province [53] 0 0
71-252
Country [54] 0 0
Poland
State/province [54] 0 0
Warsaw
Country [55] 0 0
South Africa
State/province [55] 0 0
GT
Country [56] 0 0
South Africa
State/province [56] 0 0
NL
Country [57] 0 0
South Africa
State/province [57] 0 0
WC
Country [58] 0 0
Spain
State/province [58] 0 0
Madrid
Country [59] 0 0
Spain
State/province [59] 0 0
Puerto de Sagunto
Country [60] 0 0
Sweden
State/province [60] 0 0
Gothenburg
Country [61] 0 0
Sweden
State/province [61] 0 0
Stockholm
Country [62] 0 0
United Kingdom
State/province [62] 0 0
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/study/NCT00195715
Trial related presentations / publications
Ryan C, Sobell JM, Leonardi CL, Lynde CW, Karunaratne M, Valdecantos WC, Hendrickson BA. Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis. Am J Clin Dermatol. 2018 Jun;19(3):437-447. doi: 10.1007/s40257-017-0341-6.
Schreiber S, Reinisch W, Colombel JF, Sandborn WJ, Hommes DW, Robinson AM, Huang B, Lomax KG, Pollack PF. Subgroup analysis of the placebo-controlled CHARM trial: increased remission rates through 3 years for adalimumab-treated patients with early Crohn's disease. J Crohns Colitis. 2013 Apr;7(3):213-21. doi: 10.1016/j.crohns.2012.05.015. Epub 2012 Jun 16.
Colombel JF, Schwartz DA, Sandborn WJ, Kamm MA, D'Haens G, Rutgeerts P, Enns R, Panaccione R, Schreiber S, Li J, Kent JD, Lomax KG, Pollack PF. Adalimumab for the treatment of fistulas in patients with Crohn's disease. Gut. 2009 Jul;58(7):940-8. doi: 10.1136/gut.2008.159251. Epub 2009 Feb 6.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00195715