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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00487539




Registration number
NCT00487539
Ethics application status
Date submitted
14/06/2007
Date registered
18/06/2007
Date last updated
17/02/2014

Titles & IDs
Public title
An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis
Scientific title
A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects With Moderately to Severely Active Ulcerative Colitis
Secondary ID [1] 0 0
C0524T17
Secondary ID [2] 0 0
CR014176
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colitis, Ulcerative 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 - Placebo
Other interventions - Golimumab 100 mg
Other interventions - Golimumab 200 mg
Other interventions - Golimumab 400 mg
Other interventions - Golimumab 50 mg

Placebo Comparator: Placebo - Placebo subcutaneous injection (given under the skin by way of a needle) matching to golimumab administered at Week 0 and Week 2.

Experimental: Golimumab 100 mg -> 50 mg - Golimumab 100 milligram (mg) subcutaneous injection administered at Week 0 and dose is decreased to 50 mg at Week 2.

Experimental: Golimumab 200 mg -> 100 mg - Golimumab 200 mg subcutaneous injection administered at Week 0 and dose is decreased to 100 mg at Week 2.

Experimental: Golimumab 400 mg -> 200 mg - Golimumab 400 mg subcutaneous injection administered at Week 0 and dose is decreased to 200 mg at Week 2.


Other interventions: Placebo
Placebo subcutaneous injection (given under the skin by way of a needle) matching to golimumab administered at Week 0 and Week 2.

Other interventions: Golimumab 100 mg
Golimumab 100 mg subcutaneous injection administered at Week 0 for Golimumab 100 mg -> 50 mg arm group and at Week 2 for Golimumab 200 mg -> 100 mg arm group.

Other interventions: Golimumab 200 mg
Golimumab 200 mg subcutaneous injection administered at Week 0 for Golimumab 200 mg -> 100 mg arm group and at Week 2 for Golimumab 400 mg -> 200 mg arm group.

Other interventions: Golimumab 400 mg
Golimumab 400 mg subcutaneous injection administered at Week 0 for Golimumab 400 mg -> 200 mg arm group.

Other interventions: Golimumab 50 mg
Golimumab 50 mg subcutaneous injection administered at Week 2 for Golimumab 100 mg -> 50 mg arm group.

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

Outcomes
Primary outcome [1] 0 0
Number of Participants With Clinical Response at Week 6 - Clinical response is defined as decrease from baseline in Mayo score by greater than or equal to 30 percent and greater than or equal to 3, with either a decrease from baseline in rectal bleeding sub-score of greater than or equal to 1 or a rectal bleeding sub-score of 0 or 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12.
Timepoint [1] 0 0
Baseline, Week 6
Secondary outcome [1] 0 0
Number of Participants With Clinical Remission at Week 6 - Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12.
Timepoint [1] 0 0
Week 6
Secondary outcome [2] 0 0
Number of Participants With Mucosal Healing at Week 6 - Mucosal healing is determined from the endoscopy sub-score of the Mayo score. Mucosal healing is defined as an endoscopy sub-score of 0 or 1. Higher score indicates higher severity of disease. Endoscopy sub-score ranges from 0 (normal or inactive disease) to 3 (severe disease; spontaneous bleeding and ulceration).
Timepoint [2] 0 0
Week 6
Secondary outcome [3] 0 0
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 6 - The IBDQ is used to measure disease specific quality of life on a 32 Likert-scaled items questionnaire. The IBDQ scale contains 4 component subscales: bowel symptoms, systemic symptoms, emotional function and social function with scores ranging from 10 to 70, 5 to 35, 12 to 84 and 5 to 35 respectively and the total score ranges from 32 to 224. Higher scores indicate better health related quality of life.
Timepoint [3] 0 0
Baseline to Week 6

Eligibility
Key inclusion criteria
- Participants diagnosed with moderately to severely active ulcerative colitis (UC)
defined by a Mayo score of 6 to 12 inclusive at Baseline (Week 0), including an
endoscopic (examination of an internal part of the body with a lighted tube; looking
at a part of the body with a lighted tube) subscore of greater than or equal to 2

- Participants must have biopsy results (collected at the screening endoscopy (procedure
or obtained within the last year) consistent with the diagnosis of UC

- Participants either currently receiving treatment with, or have a history of failure
to respond to, or tolerate, at least 1 of the following therapies: oral
5-aminosalicylate, oral corticosteroids, 6-mercaptopurine and azathioprine

- Participants with current dependency or with a history of corticosteroid dependency
(i.e., an inability to successfully taper corticosteroids without a return of the
symptoms of UC)

- Not have a diagnosis of active tuberculosis

- Participants with negative stool test for enteric (by way of the intestines) pathogens
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participants with prior exposure to biologic anti-tumor necrosis factor (TNF) agents

- Participants with severe extensive UC that is likely to require a colectomy (surgery
to remove part or all of the colon) within 12 weeks of study entry

- Participants having UC limited to the rectum only or to less than 20 centimeter of the
colon

- Presence of a stoma (an artificial permanent opening especially in the abdominal wall
made in surgical procedures) or presence of a fistula

- Participants with a history of extensive colonic resection

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2/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)
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- Bankstown
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- Box Hill
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- Fitzroy
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- Herston
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- Launceston
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- Parkville
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- Prahran
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- Westmead
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- Bankstown
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- Box Hill
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- Fitzroy
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- Herston
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- Launceston
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- Parkville
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- Prahran
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- Westmead
Recruitment outside Australia
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Warszawa
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Romania
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Yaroslavl
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Serbia
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Belgrade
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Serbia
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Serbia
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Pretoria Gauteng
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Sweden
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Stockholm
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Kyiv
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Simferopol
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Vynnytsya
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Zhaporozhia 69104

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Merck Sharp & Dohme Corp.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the effects (good and bad) of golimumab (CNTO 148)
therapy in participants with ulcerative colitis (UC).
Trial website
https://clinicaltrials.gov/show/NCT00487539
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
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