Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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/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
Timepoint [1] 0 0
Week 6
Secondary outcome [1] 0 0
Number of Participants With Clinical Remission
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
Sex
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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2009
Sample size
Target
Accrual to date
Final
291
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
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Iowa
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
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
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Oklahoma
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
South Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Tennessee
Country [19] 0 0
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
Country [22] 0 0
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
Country [35] 0 0
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
Country [41] 0 0
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
State/province [46] 0 0
Miskolc
Country [47] 0 0
Hungary
State/province [47] 0 0
Pécs
Country [48] 0 0
Hungary
State/province [48] 0 0
Szekesfehervar
Country [49] 0 0
Hungary
State/province [49] 0 0
Szombathely
Country [50] 0 0
India
State/province [50] 0 0
Hyderabad Andh Prad
Country [51] 0 0
India
State/province [51] 0 0
Jaipur
Country [52] 0 0
India
State/province [52] 0 0
Lucknow
Country [53] 0 0
India
State/province [53] 0 0
Ludhiana
Country [54] 0 0
India
State/province [54] 0 0
Pune
Country [55] 0 0
Israel
State/province [55] 0 0
Afula
Country [56] 0 0
Israel
State/province [56] 0 0
Hedera
Country [57] 0 0
Israel
State/province [57] 0 0
Jerusalem
Country [58] 0 0
Israel
State/province [58] 0 0
Kfar Sava
Country [59] 0 0
Israel
State/province [59] 0 0
Tel-Aviv
Country [60] 0 0
Latvia
State/province [60] 0 0
Daugavpils
Country [61] 0 0
Latvia
State/province [61] 0 0
Riga
Country [62] 0 0
Lithuania
State/province [62] 0 0
Klaipeda
Country [63] 0 0
Lithuania
State/province [63] 0 0
Siauliai
Country [64] 0 0
Lithuania
State/province [64] 0 0
Vilnius LT
Country [65] 0 0
Netherlands
State/province [65] 0 0
Amsterdam
Country [66] 0 0
Netherlands
State/province [66] 0 0
Groningen
Country [67] 0 0
Netherlands
State/province [67] 0 0
Leiden
Country [68] 0 0
Netherlands
State/province [68] 0 0
Rotterdam
Country [69] 0 0
New Zealand
State/province [69] 0 0
Auckland
Country [70] 0 0
New Zealand
State/province [70] 0 0
Hastings
Country [71] 0 0
Poland
State/province [71] 0 0
Bialystok N/A
Country [72] 0 0
Poland
State/province [72] 0 0
Czestochowa
Country [73] 0 0
Poland
State/province [73] 0 0
Krakow N/A
Country [74] 0 0
Poland
State/province [74] 0 0
Krakow
Country [75] 0 0
Poland
State/province [75] 0 0
Lodz
Country [76] 0 0
Poland
State/province [76] 0 0
Skierniewice
Country [77] 0 0
Poland
State/province [77] 0 0
Sopot
Country [78] 0 0
Romania
State/province [78] 0 0
Bucuresti
Country [79] 0 0
Romania
State/province [79] 0 0
Timisoara
Country [80] 0 0
Russian Federation
State/province [80] 0 0
Moscow
Country [81] 0 0
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 LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00488774