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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00488631




Registration number
NCT00488631
Ethics application status
Date submitted
18/06/2007
Date registered
20/06/2007
Date last updated
26/04/2016

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 3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects With Moderately to Severely Active Ulcerative Colitis
Secondary ID [1] 0 0
2006-003399-37
Secondary ID [2] 0 0
CR014179
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 50 mg
Other interventions - Golimumab 100 mg
Other interventions - Golimumab 200 mg

Placebo Comparator: Golimumab induction responders (GLM-I-Rsp)-Placebo Maintenance - Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response will have their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.

Experimental: GLM-I-Rsp-Golimumab 50 mg Maintenance - Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response will be re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injections every 4 weeks through Week 52.

Experimental: GLM-I-Rsp-Golimumab 100 mg Maintenance - Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response will be re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injections every 4 weeks through Week 52.

Placebo Comparator: Placebo induction responders (PBO-I-Rsp)-Placebo Maintenance - Participants in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Participants with loss of clinical response will have their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.

Experimental: PBO-I-nonRsp-Golimumab 100 mg Maintenance - Participants not in clinical response to placebo at Week 6 induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized.

Experimental: GLM-I-nonRsp-Golimumab 100 mg Maintenance - Participants not in clinical response to golimumab at Week 6 of induction study and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized.


Other interventions: Placebo
Participants receive placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631).

Other interventions: Golimumab 50 mg
Participants receive golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631).

Other interventions: Golimumab 100 mg
Participants receive golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631) initially or after dose adjustment following loss of clinical response.

Other interventions: Golimumab 200 mg
Participants receiving golimumab 100 mg initially who on loss of clinical response receive golimumab 200 mg administered every 4 weeks through Week 52.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants in Clinical Response Through Week 54
Timepoint [1] 0 0
Induction Baseline, Week 0 through Week 54
Secondary outcome [1] 0 0
Number of Participants With Clinical Remission at Both Week 30 and Week 54
Timepoint [1] 0 0
Week 30 and Week 54
Secondary outcome [2] 0 0
Number of Participants With Mucosal Healing at Both Week 30 and Week 54
Timepoint [2] 0 0
Week 30 and Week 54
Secondary outcome [3] 0 0
Number of Participants With Clinical Remission at Both Week 30 and 54 Among Participants With Clinical Remission at Week 0 of Maintenance Study
Timepoint [3] 0 0
Week 30 and Week 54
Secondary outcome [4] 0 0
Number of Participants With Clinical Remission at Week 54 and Not Receiving Concomitant Corticosteroids Among Participants on Corticosteroids at Week 0 of Maintenance Study
Timepoint [4] 0 0
Week 54

Eligibility
Key inclusion criteria
- Participants who received all study agent administrations and completed the Week 6
Mayo score evaluation in induction study C0524T16 (NCT00488774) or C0524T17
(NCT00487539)

- Participants who completed the Week 0 visit for this maintenance study C0524T18
(NCT00488631) on the same day as the Week 6 visit of the induction study C0524T16
(NCT00488774) or C0524T17 (NCT00487539)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participants who increased the dose of their concomitant (given at the same time) UC
medications since Week 0 of induction study C0524T16 (NCT00488774) or C0524T17
(NCT00487539)

- Participants who initiated a concomitant UC medication since Week 0 of an induction
study C0524T16 (NCT00488774) or C0524T17 (NCT00487539)

- Participants who had a partial or total colectomy (surgery to remove part or all of
the colon) or an ostomy (surgical construction of an artificial opening (stoma) for
external fistulization of a duct or vessel by insertion of a tube with or without a
supportive stent) since Week 0 of an induction study C0524T16 (NCT00488774) or
C0524T17 (NCT00487539)

- Participants with signs or symptoms of latent or active granulomatous infection
(including TB); a nontuberculous mycobacterial infection or opportunistic infection;
or infection with HIV (Human Immunodeficiency Virus), hepatitis B, or hepatitis C

- Participants with signs and symptoms of any malignancy or suggestive of a possible
lymphoproliferative disease (disorders characterized by proliferation of lymphoid
tissue, general or unspecified)

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 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
1/09/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2015
Sample size
Target
Accrual to date
Final
1228
Recruitment in Australia
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- Adelaide
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- Bankstown
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- Box Hill
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- Cairns
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- Fitzroy
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- Fremantle
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- Herston
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- Launceston
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- Malvern
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- Parkville
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- Prahran
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- Westmead
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- Adelaide
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- Herston
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- Launceston
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- Malvern
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- Parkville
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- Prahran
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- Westmead
Recruitment outside Australia
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Debrecen
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Gyula
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India
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India
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India
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India
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India
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India
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India
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India
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Israel
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Israel
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Israel
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Israel
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Hedera
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Israel
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Israel
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Israel
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Kiryat Bialik
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Israel
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Nazareth
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Israel
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Petah-Tikv
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Israel
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Rechovot
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Israel
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Tel Hashomer
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Israel
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Tel-Aviv
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Japan
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Bunkyo-Ku
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Japan
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Bunkyo
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Japan
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Chikushinoshi
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Japan
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Fukuoka
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Japan
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Hiroshima
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Japan
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Kagoshima
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Japan
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Kurashiki
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Japan
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Kurume
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Nagoya
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Japan
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Nishinomiya
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Okayama
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Japan
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Osaka
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Sakura
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Sapporo-Shi
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Sapporo
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Tokyo N/A
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Tokyo
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Japan
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Yokkaichi
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Riga
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Kaunas
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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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Lithuania
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Vilnius
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Netherlands
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Amsterdam
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Ede Gld
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Groningen
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Leiden
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Nieuwegein
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Rotterdam
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Auckland
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Christchurch
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Dunedin
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Hamilton
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Hastings
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Bialystok N/A
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Bydgoszcz N/A
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Czestochowa
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Elblag
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Gdansk
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Krakow N/A
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Krakow
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Kraków N/A
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Lodz
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Lublin
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Opole N/A
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Skierniewice
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Sopot
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Torun
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Warszawa N/A
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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 LLC
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 safety and efficacy of golimumab administered
subcutaneously (under the skin) injections in maintenance therapy.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00488631
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/ct2/show/NCT00488631