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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00488774




Registration number
NCT00488774
Ethics application status
Date submitted
18/06/2007
Date registered
20/06/2007
Date last updated
14/06/2013

Titles & IDs
Public title
An Efficacy and Safety Study of Golimumab in Participants With 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 Intravenously, in Subjects With Moderately to Severely Active Ulcerative Colitis
Secondary ID [1] 0 0
C0524T16
Secondary ID [2] 0 0
CR014188
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
Treatment: Drugs - Golimumab 1 mg per kg
Treatment: Drugs - Golimumab 2 mg per kg
Treatment: Drugs - Golimumab 4 mg per kg

Placebo Comparator: Placebo - Matching placebo for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0

Experimental: Golimumab 1 milligram (mg) per kilogram (kg) - Golimumab 1 mg per kg intravenous (IV) infusion administered at Week 0.

Experimental: Golimumab 2 mg per kg - Golimumab 2 mg per kg intravenous (IV) infusion administered at Week 0.

Experimental: Golimumab 4 mg per kg - Golimumab 4 mg per kg, intravenous (IV) infusion administered at Week 0.


Other interventions: Placebo
Matching placebo for golimumab, intravenous infusion administered at Week 0

Treatment: Drugs: Golimumab 1 mg per kg
Golimumab 1 mg per kg intravenous (IV) infusion administered at Week 0

Treatment: Drugs: Golimumab 2 mg per kg
Golimumab 2 mg per kg intravenous (IV) infusion administered at Week 0

Treatment: Drugs: Golimumab 4 mg per kg
Golimumab 4 mg per kg intravenous (IV) infusion at Week 0

Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Clinical Response - 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 a 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 [1] 0 0
Number of Participants With Clinical Remission - 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 a 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

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 (5-ASAs), oral corticosteroids, 6-mercaptopurine (6-MP) and
azathioprine (AZA)

- 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 TB
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participants with previous 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 (cm)
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 administering the treatment/s
The people assessing the outcomes
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
Terminated
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)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Brisbane
Recruitment hospital [3] 0 0
- Malvern
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- Malvern
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
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United States of America
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Florida
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United States of America
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Iowa
Country [6] 0 0
United States of America
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Kansas
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United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
New Hampshire
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United States of America
State/province [12] 0 0
New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Oklahoma
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United States of America
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Pennsylvania
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United States of America
State/province [17] 0 0
South Carolina
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United States of America
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Tennessee
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United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Vermont
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
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United States of America
State/province [22] 0 0
Washington
Country [23] 0 0
United States of America
State/province [23] 0 0
Wisconsin
Country [24] 0 0
Austria
State/province [24] 0 0
Innsbruck N/A
Country [25] 0 0
Belgium
State/province [25] 0 0
Bonheiden
Country [26] 0 0
Belgium
State/province [26] 0 0
Leuven
Country [27] 0 0
Bulgaria
State/province [27] 0 0
Rousse
Country [28] 0 0
Bulgaria
State/province [28] 0 0
Varna
Country [29] 0 0
Canada
State/province [29] 0 0
Alberta
Country [30] 0 0
Canada
State/province [30] 0 0
British Columbia
Country [31] 0 0
Canada
State/province [31] 0 0
Ontario
Country [32] 0 0
Canada
State/province [32] 0 0
Quebec
Country [33] 0 0
Canada
State/province [33] 0 0
Saskatchewan
Country [34] 0 0
France
State/province [34] 0 0
Clichy
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France
State/province [35] 0 0
Lille Cedex
Country [36] 0 0
France
State/province [36] 0 0
Nice Cedex 3
Country [37] 0 0
Germany
State/province [37] 0 0
HH
Country [38] 0 0
Germany
State/province [38] 0 0
Berlin
Country [39] 0 0
Germany
State/province [39] 0 0
Herne
Country [40] 0 0
Germany
State/province [40] 0 0
Magdeburg
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Hungary
State/province [41] 0 0
Budapest N/A
Country [42] 0 0
Hungary
State/province [42] 0 0
Békéscsaba
Country [43] 0 0
Hungary
State/province [43] 0 0
Gyulai Ut 18
Country [44] 0 0
Hungary
State/province [44] 0 0
Gyõr
Country [45] 0 0
Hungary
State/province [45] 0 0
Miskolc N/A
Country [46] 0 0
Hungary
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Miskolc
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Hungary
State/province [47] 0 0
Pécs
Country [48] 0 0
Hungary
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Szekesfehervar
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Hungary
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Szombathely
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India
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Hyderabad Andh Prad
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India
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Jaipur
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India
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Lucknow
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India
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Ludhiana
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India
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Pune
Country [55] 0 0
Israel
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Afula
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Israel
State/province [56] 0 0
Hedera
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Israel
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Jerusalem
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Israel
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Kfar Sava
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Israel
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Tel-Aviv
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Latvia
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Daugavpils
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Latvia
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Riga
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Lithuania
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Klaipeda
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Lithuania
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Siauliai
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Lithuania
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Vilnius LT
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Netherlands
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Amsterdam
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Netherlands
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Groningen
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Netherlands
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Leiden
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Netherlands
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Rotterdam
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New Zealand
State/province [69] 0 0
Auckland
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New Zealand
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Hastings
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Poland
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Bialystok N/A
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Poland
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Czestochowa
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Poland
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Krakow N/A
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Poland
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Krakow
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Poland
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Lodz
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Poland
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Skierniewice
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Poland
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Sopot
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Romania
State/province [78] 0 0
Bucuresti
Country [79] 0 0
Romania
State/province [79] 0 0
Timisoara
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Russian Federation
State/province [80] 0 0
Moscow
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Russian Federation
State/province [81] 0 0
St.Petersburg
Country [82] 0 0
Russian Federation
State/province [82] 0 0
Yaroslavl
Country [83] 0 0
Serbia
State/province [83] 0 0
Belgrade
Country [84] 0 0
Serbia
State/province [84] 0 0
Beograd
Country [85] 0 0
Slovakia
State/province [85] 0 0
Bratislava
Country [86] 0 0
Slovakia
State/province [86] 0 0
Nitra
Country [87] 0 0
Slovakia
State/province [87] 0 0
Presov
Country [88] 0 0
Sweden
State/province [88] 0 0
Göteborg
Country [89] 0 0
Ukraine
State/province [89] 0 0
Donetsk
Country [90] 0 0
Ukraine
State/province [90] 0 0
Ivano
Country [91] 0 0
Ukraine
State/province [91] 0 0
Kiev
Country [92] 0 0
Ukraine
State/province [92] 0 0
Vynnytsya

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 active ulcerative colitis (UC) (sores in the colon).
Trial website
https://clinicaltrials.gov/show/NCT00488774
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
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00488774