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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00207688




Registration number
NCT00207688
Ethics application status
Date submitted
13/09/2005
Date registered
21/09/2005
Date last updated
6/07/2018

Titles & IDs
Public title
A Long Term Safety Study of Infliximab (Remicade) in in Ulcerative Colitis Patients
Scientific title
A Multicenter International Study of the Long-term Safety of Infliximab (REMICADE) in Ulcerative Colitis
Secondary ID [1] 0 0
C0168T62
Secondary ID [2] 0 0
CR004801
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
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Infliximab 5 mg/kg
Treatment: Drugs - Infliximab 10 mg/kg
Treatment: Drugs - Placebo

Infliximab 5 mg/kg - This is an observational study which includes patients from primary studies C0168T37, C0168T46, C0168T72.

Infliximab 10 mg/kg - This is an observational study which includes patients from primary studies C0168T37, C0168T46, C0168T72.

Placebo - This is an observational study which includes patients from primary studies C0168T37, C0168T46, C0168T72.


Treatment: Drugs: Infliximab 5 mg/kg
Patients who received infliximab 5 mg/kg from C0168T37, C0168T46, C0168T72 studies will be observed.

Treatment: Drugs: Infliximab 10 mg/kg
Patients who received infliximab10 mg/kg from C0168T37, C0168T46, C0168T72 studies will be observed.

Treatment: Drugs: Placebo
Patients who received placebo from C0168T37, C0168T46, C0168T72 studies will be observed.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of patients with adverse events as a measure of safety
Timepoint [1] 0 0
5 years
Secondary outcome [1] 0 0
Number of patients with malignancies by malignancy type
Timepoint [1] 0 0
5 years
Secondary outcome [2] 0 0
Number of patients with serious infections by type of infection
Timepoint [2] 0 0
5 years
Secondary outcome [3] 0 0
Number of patients with surgical procedures (including colectomy) for the treatment of ulcerative colitis
Timepoint [3] 0 0
5 years
Secondary outcome [4] 0 0
Number of patients with hospitalizations for the treatment of ulcerative colitis
Timepoint [4] 0 0
5 years

Eligibility
Key inclusion criteria
* All patients enrolled in three Phase 3 Janssen-sponsored (C0168T37, C0168T46, C0168T72) infliximab clinical studies in ulcerative colitis that require long-term safety follow-up
* Patients must have received at least 1 dose of study agent to be eligible for participation in the study
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients who refuse consent or are unwilling to respond to requests for long-term safety information within the required timeframe will be excluded. In addition, patients participating in a study extension to the primary study are not eligible for participation in the C0168T62 study during the study extension participation

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/08/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/09/2015
Sample size
Target
Accrual to date
Final
505
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Bedford
Recruitment hospital [2] 0 0
- Box Hill
Recruitment hospital [3] 0 0
- Garran
Recruitment hospital [4] 0 0
- Herston
Recruitment hospital [5] 0 0
- Kogarah
Recruitment hospital [6] 0 0
- Parkville
Recruitment hospital [7] 0 0
- Perth
Recruitment hospital [8] 0 0
- South Brisbane
Recruitment postcode(s) [1] 0 0
- Bedford
Recruitment postcode(s) [2] 0 0
- Box Hill
Recruitment postcode(s) [3] 0 0
- Garran
Recruitment postcode(s) [4] 0 0
- Herston
Recruitment postcode(s) [5] 0 0
- Kogarah
Recruitment postcode(s) [6] 0 0
- Parkville
Recruitment postcode(s) [7] 0 0
- Perth
Recruitment postcode(s) [8] 0 0
- South Brisbane
Recruitment outside Australia
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Arizona
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Federal
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Innsbruck
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Antwerpen
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Imeldalaan 9
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Pardubice
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Praha 10
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Aalborg
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Aarhus C.
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Hvidovre N/A
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Toulouse
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Germany
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Germany
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München
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Germany
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Stade
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Israel
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Jerusalem
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Israel
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Kfar Saba
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Israel
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Rehovot
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Israel
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Tel-Aviv
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Eindhoven
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Nijmegen
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Auckland
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Dundee
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Glasgow
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Harrow
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Liverpool
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London
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Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Janssen Biologics BV
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate long-term safety information of infliximab in patients who have participated in infliximab clinical studies in ulcerative colitis.
Trial website
https://clinicaltrials.gov/study/NCT00207688
Trial related presentations / publications
Sandborn WJ, Rutgeerts P, Feagan BG, Reinisch W, Olson A, Johanns J, Lu J, Horgan K, Rachmilewitz D, Hanauer SB, Lichtenstein GR, de Villiers WJ, Present D, Sands BE, Colombel JF. Colectomy rate comparison after treatment of ulcerative colitis with placebo or infliximab. Gastroenterology. 2009 Oct;137(4):1250-60; quiz 1520. doi: 10.1053/j.gastro.2009.06.061. Epub 2009 Jul 28.
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/study/NCT00207688