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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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 - Clinical response is defined as decrease from induction baseline in Mayo score by greater than or equal to (>=) 30 percent and >= 3, with either decrease from induction baseline in rectal bleeding subscore of >= 1 or rectal bleeding subscore of 0 or 1. Participants who lost clinical response prior to Week 54 were considered not to meet endpoint. Mayo score is sum of 4 subscores (ie, stool frequency, rectal bleeding, endoscopic findings, physician's global assessment); each rated on scale from 0 to 3, with higher scores indicating more severe disease. Total Mayo score value ranges from 0 to 12.
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 - 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 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. The number of participants in clinical remission at both the weeks that is Week 30 as well as Week 54 will be reported.
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 - Mucosal healing is determined from the endoscopy sub-score of the Mayo score. Mucosal healing is defined as an endoscopy sub-score of 0 or 1. Higher score indicates higher severity of disease. Endoscopy sub-score ranges from 0 (normal or inactive disease) to 3 (severe disease; spontaneous bleeding and ulceration). The number of participants with mucosal healing at both the weeks that is Week 30 as well as Week 54 will be reported.
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 - 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 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. The number of participants in clinical remission at both the weeks that is Week 30 as well as Week 54 will be reported.
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 - 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 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 [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
Gender
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
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
- Bankstown
Recruitment hospital [3] 0 0
- Box Hill
Recruitment hospital [4] 0 0
- Brisbane
Recruitment hospital [5] 0 0
- Cairns
Recruitment hospital [6] 0 0
- Fitzroy
Recruitment hospital [7] 0 0
- Fremantle
Recruitment hospital [8] 0 0
- Herston
Recruitment hospital [9] 0 0
- Launceston
Recruitment hospital [10] 0 0
- Malvern
Recruitment hospital [11] 0 0
- Parkville
Recruitment hospital [12] 0 0
- Prahran
Recruitment hospital [13] 0 0
- Westmead
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Bankstown
Recruitment postcode(s) [3] 0 0
- Box Hill
Recruitment postcode(s) [4] 0 0
- Brisbane
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- Cairns
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- Fitzroy
Recruitment postcode(s) [7] 0 0
- Fremantle
Recruitment postcode(s) [8] 0 0
- Herston
Recruitment postcode(s) [9] 0 0
- Launceston
Recruitment postcode(s) [10] 0 0
- Malvern
Recruitment postcode(s) [11] 0 0
- Parkville
Recruitment postcode(s) [12] 0 0
- Prahran
Recruitment postcode(s) [13] 0 0
- Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
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Alabama
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United States of America
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Arkansas
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California
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United States of America
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Colorado
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Connecticut
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Delaware
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Florida
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Georgia
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Illinois
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Iowa
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Kansas
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Kentucky
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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Missouri
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Nevada
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New Hampshire
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New Jersey
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New York
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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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Utah
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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
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Austria
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Wien N/A
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Belgium
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Bonheiden
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Gent
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Pleven
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Rousse
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Quebec
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Saskatchewan
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Toronto
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Windsor
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Czech Republic
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Hradec Kralove
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Czech Republic
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Litomerice
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Ostrava
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Czech Republic
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Èeské Budìjovice 1
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Denmark
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Aalborg
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Aarhus C.
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Denmark
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Hvidovre
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Denmark
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Odense C
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France
State/province [67] 0 0
Amiens Cedex 1 80
Country [68] 0 0
France
State/province [68] 0 0
Bordeaux 33
Country [69] 0 0
France
State/province [69] 0 0
Clichy
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France
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Lille Cedex
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France
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Marseille Cedex 13
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France
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Nice Cedex 3
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France
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Paris
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France
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Rouen
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Germany
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Aachen
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Germany
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Berlin Be
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Germany
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Berlin
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Germany
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Bochum
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Germany
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Frankfurt
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Germany
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Hamburg
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Germany
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Hannover
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Germany
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Heidelberg
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Germany
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Herne
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Germany
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Jena
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Germany
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Kiel
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Germany
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Magdeburg
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Germany
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Minden
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Germany
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Muenchen
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Germany
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München
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Germany
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Münster
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Germany
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Neustadt
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Germany
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Stade
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Hungary
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Balatonfured
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Hungary
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Budapest N/A
Country [95] 0 0
Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Dunaujvaros
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Hungary
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Gyulai Ut 18
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Hungary
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Gyula
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Hungary
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Gyõr
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Miskolc
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Pécs
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Szeged
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Szombathely
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Veszprém
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India
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Bangalore
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India
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Chennai
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India
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Hyderabad Andh Prad
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India
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Hyderabad
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India
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Jaipur
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India
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Karnad
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India
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Lucknow Gpo
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India
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Ludhiana
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India
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New Delhi
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India
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Pune
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India
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Vishakapatanam
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Israel
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Afula
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Israel
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Beer Sheva
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Israel
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Beer Yaakov
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Israel
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Haifa
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Israel
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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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Kiryat Bialik
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Israel
State/province [131] 0 0
Nazareth
Country [132] 0 0
Israel
State/province [132] 0 0
Petah-Tikv
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Israel
State/province [133] 0 0
Rechovot
Country [134] 0 0
Israel
State/province [134] 0 0
Tel Hashomer
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Israel
State/province [135] 0 0
Tel-Aviv
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Japan
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Bunkyo-Ku
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Japan
State/province [137] 0 0
Bunkyo
Country [138] 0 0
Japan
State/province [138] 0 0
Chikushinoshi
Country [139] 0 0
Japan
State/province [139] 0 0
Fukuoka
Country [140] 0 0
Japan
State/province [140] 0 0
Hiroshima
Country [141] 0 0
Japan
State/province [141] 0 0
Kagoshima
Country [142] 0 0
Japan
State/province [142] 0 0
Kurashiki
Country [143] 0 0
Japan
State/province [143] 0 0
Kurume
Country [144] 0 0
Japan
State/province [144] 0 0
Nagoya
Country [145] 0 0
Japan
State/province [145] 0 0
Nishinomiya
Country [146] 0 0
Japan
State/province [146] 0 0
Okayama
Country [147] 0 0
Japan
State/province [147] 0 0
Osaka
Country [148] 0 0
Japan
State/province [148] 0 0
Sakura
Country [149] 0 0
Japan
State/province [149] 0 0
Sapporo-Shi
Country [150] 0 0
Japan
State/province [150] 0 0
Sapporo
Country [151] 0 0
Japan
State/province [151] 0 0
Tokyo N/A
Country [152] 0 0
Japan
State/province [152] 0 0
Tokyo
Country [153] 0 0
Japan
State/province [153] 0 0
Yokkaichi
Country [154] 0 0
Latvia
State/province [154] 0 0
Balvi
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Latvia
State/province [155] 0 0
Daugavpils
Country [156] 0 0
Latvia
State/province [156] 0 0
Riga
Country [157] 0 0
Lithuania
State/province [157] 0 0
Kaunas
Country [158] 0 0
Lithuania
State/province [158] 0 0
Klaipeda
Country [159] 0 0
Lithuania
State/province [159] 0 0
Siauliai
Country [160] 0 0
Lithuania
State/province [160] 0 0
Vilnius Lt
Country [161] 0 0
Lithuania
State/province [161] 0 0
Vilnius
Country [162] 0 0
Netherlands
State/province [162] 0 0
Amsterdam
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Netherlands
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Ede Gld
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Netherlands
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Groningen
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Netherlands
State/province [165] 0 0
Leiden
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Netherlands
State/province [166] 0 0
Nieuwegein
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Netherlands
State/province [167] 0 0
Rotterdam
Country [168] 0 0
New Zealand
State/province [168] 0 0
Auckland
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New Zealand
State/province [169] 0 0
Christchurch
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New Zealand
State/province [170] 0 0
Dunedin
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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 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 safety and efficacy of golimumab administered
subcutaneously (under the skin) injections in maintenance therapy.
Trial website
https://clinicaltrials.gov/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
Other publications