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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00408629




Registration number
NCT00408629
Ethics application status
Date submitted
5/12/2006
Date registered
7/12/2006
Date last updated
3/05/2011

Titles & IDs
Public title
Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Active Ulcerative Colitis
Scientific title
A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Moderately to Severely Active Ulcerative Colitis
Secondary ID [1] 0 0
2006-002782-40
Secondary ID [2] 0 0
M06-827
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
Other interventions - placebo

Experimental: adalimumab group -

Experimental: placebo group -


Other interventions: adalimumab
Prefilled syringe, 40 mg, 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week between Weeks 4 and 50.

Other interventions: placebo
Matching Placebo for prefilled syringe, 40 mg,

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

Outcomes
Primary outcome [1] 0 0
Proportion of Participants Who Achieved Clinical Remission Per Mayo Score at Week 8 - Clinical remission per Mayo score is defined as a total Mayo score of at least 2 and no individual subscore greater than 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:
Stool Frequency Subscore (SFS), Rectal Bleeding Subscore (RBS), Endoscopy Subscore, and Physician's Global Assessment Subscore (PGA), each of which ranges from 0 (normal) to 3 (severe disease).
Timepoint [1] 0 0
Week 8
Primary outcome [2] 0 0
Proportion of Participants Who Achieved Clinical Remission Per Mayo Score at Week 52 - Clinical remission per Mayo score is defined as a total Mayo score of at least 2 and no individual subscore greater than 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:
SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease).
Timepoint [2] 0 0
Week 52
Secondary outcome [1] 0 0
Proportion of Participants Who Achieved Sustained Clinical Remission Per Mayo Score at Both Week 8 and Week 52 - Clinical remission per Mayo score is defined as a total Mayo score of at least 2 and no individual subscore greater than 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:
SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease).
Timepoint [1] 0 0
Week 8, Week 52
Secondary outcome [2] 0 0
Proportion of Participants Who Achieved Clinical Response Per Mayo Score at Week 8 - Clinical response per Mayo score is defined as a decrease in Mayo score of at least 3 points and at least 30% from Baseline, plus either a decrease in rectal bleeding subscore (RBS) of at least 1 point from Baseline or an absolute RBS of 0 or 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:
SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease).
Timepoint [2] 0 0
Week 8
Secondary outcome [3] 0 0
Proportion of Participants Who Achieved Clinical Response Per Mayo Score at Week 52 - Clinical response per Mayo score is defined as a decrease in Mayo score of at least 3 points and at least 30% from Baseline, plus either a decrease in RBS of at least 1 point from Baseline or an absolute RBS of 0 or 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:
SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease).
Timepoint [3] 0 0
Week 52
Secondary outcome [4] 0 0
Proportion of Participants Who Achieved Sustained Clinical Response Per Mayo Score at Both Week 8 and Week 52 - Clinical response per Mayo score is defined as a decrease in Mayo score of at least 3 points and at least 30% from Baseline, plus either a decrease in RBS of at least 1 point from Baseline or an absolute RBS of 0 or 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:
SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease).
Timepoint [4] 0 0
Week 8, Week 52
Secondary outcome [5] 0 0
Proportion of Participants Who Achieved Mucosal Healing at Week 8 - Mucosal healing is defined as an Endoscopy Subscore of 0 or 1 as assessed by flexible sigmoidoscopy. Possible scores range from 0-3 as follows:
0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease(spontaneous bleeding, ulceration).
Timepoint [5] 0 0
Week 8
Secondary outcome [6] 0 0
Proportion of Participants Who Achieved Mucosal Healing at Week 52 - Mucosal healing is defined as an Endoscopy Subscore of 0 or 1 as assessed by flexible sigmoidoscopy. Possible scores range from 0-3 as follows:
0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease(spontaneous bleeding, ulceration).
Timepoint [6] 0 0
Week 52
Secondary outcome [7] 0 0
Proportion of Participants Who Achieved Sustained Mucosal Healing at Both Week 8 and Week 52 - Mucosal healing is defined as an Endoscopy Subscore of 0 or 1 as assessed by flexible sigmoidoscopy. Possible scores range from 0-3 as follows:
0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease(spontaneous bleeding, ulceration).
Timepoint [7] 0 0
Week 8, Week 52
Secondary outcome [8] 0 0
Proportion of Participants Who Discontinued Corticosteroid Use Before Week 52 and Achieved Clinical Remission Per Mayo Score at Week 52 - Clinical remission per Mayo score is defined as a total Mayo score of at least 2 and no individual subscore greater than 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:
SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease).
Timepoint [8] 0 0
Baseline to Week 52
Secondary outcome [9] 0 0
Proportion of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (a Score of 0 or 1) at Week 8 - The PGA includes the 3 other subscores (SFS, RBS, and Endoscopy), the participant's daily record of abdominal discomfort and functional assessment, and other observations such as physical findings and the participant's performance status. Possible scores range from 0-3 as follows:
0 = Normal (other subscores are 0), 1 = Mild disease (other subscores are mostly 1), 2 = Moderate disease (other subscores are 1 to 2), 3 = Severe disease (other subscores are 2 to 3).
Timepoint [9] 0 0
Week 8
Secondary outcome [10] 0 0
Proportion of Participants With Stool Frequency Subscore Indicative of Mild Disease (a Score of 0 or 1) at Week 8 - SFS ranges from 0-3 as follows:
0 = Normal number of stools for this participant, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal. The participant served as his/her own control.
Timepoint [10] 0 0
Week 8
Secondary outcome [11] 0 0
Proportion of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (a Score of 0 or 1) at Week 8 - RBS ranges from 0-3 as follows:
0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, 3 = blood alone passed
Timepoint [11] 0 0
Week 8
Secondary outcome [12] 0 0
Proportion of Participants Who Discontinued Corticosteroid Use for At Least 90 Days and Achieved Clinical Remission Per Mayo Score at Week 52 - Clinical remission per Mayo score is defined as a total Mayo score of at least 2 and no individual subscore greater than 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:
SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease).
Timepoint [12] 0 0
Baseline to Week 52
Secondary outcome [13] 0 0
Proportion of Participants Who Discontinued Corticosteroid Use and Achieved Clinical Remission Per Mayo Score (Sustained) at Both Weeks 32 and 52 - Clinical remission per Mayo score is defined as a total Mayo score of at least 2 and no individual subscore greater than 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:
SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease).
Timepoint [13] 0 0
Week 32, Week 52
Secondary outcome [14] 0 0
Proportion of Inflammatory Bowel Disease Questionnaire Responders at Week 52 - Response per the Inflammatory Bowel Disease Questionnaire (IBDQ) was defined as at least a 16-point increase from Baseline in total IBDQ score. The IBDQ is a 32-item questionnaire consisting of 4 dimensions: bowel-related symptoms, systemic function, social function, and emotional status. The responses to questions within each domain range from 1 (significant impairment) to 7 (no impairment), with total score ranging from 32 (very poor) to 224 (perfect health-related quality of life).
Timepoint [14] 0 0
Week 52
Secondary outcome [15] 0 0
Proportion of Inflammatory Bowel Disease Questionnaire Responders at Week 8 - Response per the Inflammatory Bowel Disease Questionnaire (IBDQ) was defined as at least a 16-point increase from Baseline in total IBDQ score. The IBDQ is a 32-item questionnaire consisting of 4 dimensions: bowel-related symptoms, systemic function, social function, and emotional status. The responses to questions within each domain range from 1 (significant impairment) to 7 (no impairment), with total score ranging from 32 (very poor) to 224 (perfect health-related quality of life).
Timepoint [15] 0 0
Week 8

Eligibility
Key inclusion criteria
1. Participants >=18 years of age and in good health (Investigator discretion) with a
recent stable medical history

2. Diagnosis of UC for greater than 90 days prior to Baseline

3. Diagnosis of active UC confirmed by colonoscopy with biopsy or flexible sigmoidoscopy
with biopsy during the Screening Period, with exclusion of infection

4. Active UC with a Mayo score of 6 to 12 points and endoscopy subscore of 2 to 3 points,
despite concurrent treatment with at least 1 of the following (oral corticosteroids or
immunosuppressants or both as defined below):

- Stable oral corticosteroid dose (prednisone >= 20 mg/day or equivalent) for at
least 14 days prior to Baseline or maintenance, corticosteroid dose (prednisone <
20 mg/day or equivalent) for at least 40 days prior to Baseline

and/or

- At least a 90 day course of azathioprine (AZA) or 6-mercaptopurine (6-MP) prior
to Baseline, with a dose of AZA >= 1.5 mg/kg/day or 6-MP >= 1 mg/kg/day (rounded
to the nearest available tablet formulation), or a dose that is the highest
tolerated by the participant (e.g., due to leukopenia, elevated liver enzymes,
nausea) during that time. Participant must be on a stable dose for at least 28
days prior to Baseline.

Concurrent therapy was not required for participants who were previously treated with
corticosteroids or immunosuppressants (AZA or 6-MP) during the past 5 years and in the
judgment of the Investigator have failed to respond to, or could not tolerate, their
treatment.

5. Participants may have been included if they had previously used an anti-tumor necrosis
factor (TNF) agent (except ADA) and discontinued its use due to a loss of response or
intolerance to the agent.

6. Had to be able to self-administer or had caregiver who could reliably administer
subcutaneous (SC) injections.

7. Had to be able and willing to give written informed consent and to comply with the
requirements of the study protocol.

8. Female had to be either not of childbearing potential, defined as postmenopausal for
at least 1 year or surgically sterile (bilateral tubal ligation, bilateral
oophorectomy, or hysterectomy), or of childbearing potential and practicing an
approved method of birth control throughout the study and for 150 days after the last
dose of study drug. Examples of approved methods of birth control included the
following:

- Condoms, sponge, foams, jellies, diaphragm, or intrauterine device

- Oral, parenteral, intravaginal contraceptives for 90 days prior to study drug
administration

- A vasectomized partner The results of the serum pregnancy test performed at the
Screening Visit and urine pregnancy test performed at the Baseline Visit must
have been negative.

9. Judged to be in generally good health as determined by the Investigator
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch,
Koch pouch, or ileostomy for UC, or planned bowel surgery.

2. Received previous treatment with ADA or previous participation in an ADA clinical
study.

3. Received cyclosporine, tacrolimus, or mycophenolate mofetil within 30 days of
Baseline.

4. Received intravenous (IV) corticosteroids within 14 days of Screening or during the
Screening Period.

5. Received therapeutic enema or suppository, other than required for endoscopy, within
14 days of the Screening endoscopy and during the remainder of the Screening Period.

6. Current diagnosis of fulminant colitis and/or toxic megacolon.

7. Disease limited to the rectum (ulcerative proctitis).

8. Current diagnosis of indeterminate colitis.

9. Current diagnosis and/or history of Crohns disease (CD).

10. Currently receiving total parenteral nutrition.

11. Used aminosalicylates for < 90 days before Baseline or not on a stable dose for at
least 28 days before Baseline or discontinued use within 28 days of Baseline.

12. Positive Clostridium difficile stool assay.

13. Previously used infliximab or any anti-TNF agent within 56 days of Baseline.

14. Previously used infliximab or any anti-TNF agent without clinical response at any time
("primary non-responder") unless subject experienced a treatment-limiting reaction.

15. Infections requiring treatment with IV antibiotics, antivirals, or antifungals within
30 days of Baseline or oral antibiotics, antivirals, or antifungals within 14 days of
Baseline.

16. History of malignancy other than a successfully treated non-metastatic cutaneous
squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the
cervix. If the Screening colonoscopy/flexible sigmoidoscopy showed evidence of
dysplasia or a malignancy, subject was not to be enrolled in the study.

17. History of listeria, histoplasmosis, chronic or active hepatitis B infection, human
immunodeficiency virus (HIV), immunodeficiency syndrome, central nervous system
demyelinating disease, or untreated tuberculosis (TB).

18. Female subject who was pregnant or breast-feeding or considering becoming pregnant
during the study (there should be at least 150 days between the last dose of study
drug and either conception or initiation of breast-feeding in women of childbearing
potential).

19. Poorly controlled medical condition(s), such as uncontrolled diabetes, unstable
ischemic heart disease, moderate to severe congestive heart failure (CHF), recent
cerebrovascular accident, and any other condition, which in the opinion of the
investigator, put the subject at risk by participation in the protocol.

20. Received any investigational agent within 30 days or 5 half lives prior to Baseline
(whichever was longer).

21. History of clinically significant drug or alcohol abuse during the past year.

22. Known hypersensitivity to the excipients of ADA as stated in the label.

23. Any prior exposure to Tysabri® (natalizumab), or Orencia® (abatacept) or any other
biological therapy [other than Kineret® (anakinra) and anti-TNF agents].

24. Currently taking both budesonide and prednisone (or equivalent) simultaneously.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
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)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Site Ref # / Investigator 13722 - Garran
Recruitment hospital [2] 0 0
Site Ref # / Investigator 16141 - Bankstown
Recruitment hospital [3] 0 0
Site Ref # / Investigator 13723 - Herston
Recruitment hospital [4] 0 0
Site Ref # / Investigator 10706 - Bedford Park
Recruitment hospital [5] 0 0
Site Ref # / Investigator 14882 - Box Hill
Recruitment hospital [6] 0 0
Site Ref # / Investigator 9002 - Malvern
Recruitment hospital [7] 0 0
Site Ref # / Investigator 10704 - Fremantle
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
NSW 2200 - Bankstown
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
SA 5042 - Bedford Park
Recruitment postcode(s) [5] 0 0
3128 - Box Hill
Recruitment postcode(s) [6] 0 0
3144 - Malvern
Recruitment postcode(s) [7] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
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Florida
Country [5] 0 0
United States of America
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Georgia
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Illinois
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Kansas
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Maryland
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Michigan
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Minnesota
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Missouri
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New York
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North Carolina
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Ohio
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Oklahoma
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Pennsylvania
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South Carolina
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Utah
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Washington
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Wisconsin
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Argentina
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Buenos Aires
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Vienna
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Bonheiden
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Belgium
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Brussels
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Belgium
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Ghent
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Belgium
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Leuven
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Canada
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Ontario
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Quebec
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Czech Republic
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Ceske Budejovice
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Czech Republic
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Hradec Kravlove 12
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Czech Republic
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Olomouc
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Prague 4
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Prague 5
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Denmark
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Hvidovre
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Denmark
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Odense C
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France
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Clichy
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France
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Lille Cedex
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Pessac Cedex
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Toulouse
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Hamburg
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Magdeburg
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Germany
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Minden
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Germany
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Muenster
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Germany
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Munich
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Germany
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Regensburg
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Gyula
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Hungary
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Miskoic
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Hungary
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Miskolc
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Israel
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Kfar Saba
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Israel
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Petah Tikva
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Israel
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Tel Aviv
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New Zealand
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Auckland
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New Zealand
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Christchurch
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New Zealand
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Hamilton
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Norway
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Gjovik
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Norway
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Oslo
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Norway
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Tromso
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Norway
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Trondheim
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Poland
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Lodz
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Warsaw
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Wroclaw
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Portugal
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Faro
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Portugal
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Lisbon
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Spain
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Barcelona
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Spain
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Madrid
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Switzerland
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Basel
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Switzerland
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Bern
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Switzerland
State/province [72] 0 0
Zurich

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

Ethics approval
Ethics application status

Summary
Brief summary
This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed
to evaluate the efficacy and safety of the human anti-tumor necrosis factor (TNF) monoclonal
antibody adalimumab (ADA) in patients with moderately to severely active ulcerative colitis
(UC).
Trial website
https://clinicaltrials.gov/show/NCT00408629
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Roopal B Thakkar, M.D.
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