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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
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California
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Colorado
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Connecticut
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Florida
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Iowa
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Kansas
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Kentucky
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Maryland
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Michigan
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Missouri
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New Hampshire
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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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Tennessee
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Texas
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Vermont
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Virginia
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Washington
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Wisconsin
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Austria
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Innsbruck N/A
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Belgium
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Bonheiden
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Belgium
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Leuven
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Bulgaria
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Rousse
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Varna
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Canada
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Alberta
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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Canada
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Saskatchewan
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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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France
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Nice Cedex 3
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Germany
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HH
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Germany
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Berlin
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Germany
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Herne
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Germany
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Magdeburg
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Hungary
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Budapest N/A
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Hungary
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Békéscsaba
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Hungary
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Gyulai Ut 18
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Hungary
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Gyõr
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Miskolc N/A
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Miskolc
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Pécs
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Szekesfehervar
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Szombathely
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Hyderabad Andh Prad
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Lucknow
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Pune
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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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Riga
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Klaipeda
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Siauliai
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Lithuania
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Vilnius LT
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Amsterdam
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Groningen
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Leiden
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Rotterdam
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New Zealand
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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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Krakow N/A
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Krakow
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Lodz
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Skierniewice
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Sopot
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Romania
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Bucuresti
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Romania
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Timisoara
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Russian Federation
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Moscow
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Russian Federation
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St.Petersburg
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Russian Federation
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Yaroslavl
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Serbia
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Belgrade
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Serbia
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Beograd
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Slovakia
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Bratislava
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Slovakia
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Nitra
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Slovakia
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Presov
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Sweden
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Göteborg
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Ukraine
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Donetsk
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Ukraine
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Ivano
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Ukraine
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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