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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/NCT00299546




Registration number
NCT00299546
Ethics application status
Date submitted
3/03/2006
Date registered
7/03/2006
Date last updated
27/02/2014

Titles & IDs
Public title
A Study of the Safety and Efficacy of Golimumab (CNTO 148) in Subjects With Active Rheumatoid Arthritis Previously Treated With Biologic Anti-TNFa Agent(s)
Scientific title
A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Subjects With Active Rheumatoid Arthritis and Previously Treated With Biologic Anti- TNFa Agent(s)
Secondary ID [1] 0 0
C0524T11
Secondary ID [2] 0 0
CR006334
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthritis, Rheumatoid 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Other interventions - Golimumab 50 mg
Other interventions - Golimumab 100 mg

Placebo Comparator: Group 1: Placebo - Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); Golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; Golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period will be until the week-24 database lock.

Experimental: Group 2: Golimumab 50 mg - Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); Golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period will be until the week-24 database lock.

Experimental: Group 3: Golimumab 100 mg - Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period will be until the week-24 database lock.


Treatment: Drugs: Placebo
SC injections

Other interventions: Golimumab 50 mg
SC injections

Other interventions: Golimumab 100 mg
SC injections
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
American College of Rheumatology (ACR) 20 Response at Week 14.
Timepoint [1] 0 0
Week 14
Secondary outcome [1] 0 0
American College of Rheumatology (ACR) 50 Response at Week 14
Timepoint [1] 0 0
Week 14
Secondary outcome [2] 0 0
Disease Activity Index Score 28 (DAS 28) (Using C-reactive Protein) Response at Week 14
Timepoint [2] 0 0
Week 14
Secondary outcome [3] 0 0
American College of Rheumatology (ACR) 20 at Week 24
Timepoint [3] 0 0
From Baseline to Week 24
Secondary outcome [4] 0 0
Health Assessment Questionnaire (HAQ) Score at Week 24
Timepoint [4] 0 0
From Baseline to Week 24

Eligibility
Key inclusion criteria
- Patients have a diagnosis of rheumatoid arthritis (RA) (according to the revised 1987
criteria of the ACR) for at least 3 months prior to screening

- Have active RA as defined by persistent disease activity with at least 4 swollen and 4
tender joints, at the time of screening and baseline

- Must have been previously treated with at least one dose of etanercept, adalimumab, or
infliximab

- If currently using methotrexate, sulfasalazine and/or hydroxychloroquine must have
tolerated these agents for at least 12 weeks and be on a stable dose for at least 4
weeks prior to the first administration of study agent

- If using NSAIDs or other analgesics must be on a stable dose for at least 2 weeks
prior to the first administration of study agent

- If using oral corticosteroids must be on a stable dose equivalent to <= 10 mg of
prednisone/day for at least 2 weeks prior to first administration of study agent

- Are considered eligible according to specified tuberculosis (TB) screening criteria.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients cannot have other inflammatory diseases other than RA that might interfere
with the evaluation of the benefit of golimumab therapy

- No history of treatment with natalizumab, rituximab or cytotoxic agents

- No history of demyelinating diseases such as multiple sclerosis or optic neuritis or
of concurrent congestive heart failure (CHF), lymphoproliferative disease, known
malignancy or history of malignancy within the previous 5 years (with the exception of
a nonmelanoma skin cancer that has been treated with no evidence of recurrence)

- No history of, or ongoing, chronic or recurrent infectious disease

- No serious infection within 2 months prior to first administration of study agent.

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 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
1/02/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2012
Sample size
Target
Accrual to date
Final
461
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Cotton Tree
Recruitment hospital [3] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Cotton Tree
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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Arizona
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California
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Connecticut
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Florida
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Illinois
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Iowa
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Kansas
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Kentucky
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Maryland
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Massachusetts
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Minnesota
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Missouri
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New York
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North Carolina
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Ohio
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Pennsylvania
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Tennessee
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Texas
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Virginia
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Washington
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United States of America
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Wisconsin
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Austria
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Graz
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Austria
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Lainz/Wien N/A
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Austria
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Wien
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Canada
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British Columbia
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Canada
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Manitoba
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Canada
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Newfoundland and Labrador
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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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Claire
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Finland
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Helsinki
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Finland
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Hyvinkaa
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Finland
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Jyvalskyla
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Germany
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Baden-Baden
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Germany
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Berlin
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Germany
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Erlangen
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Germany
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Hamburg
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Germany
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Herne
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Germany
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Köln
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Germany
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München
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Germany
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Vogelsang-Gommern
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Germany
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Würzburg
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Netherlands
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Maastricht
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New Zealand
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Auckland
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New Zealand
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Rotorua
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New Zealand
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Timaru
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Spain
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Santander
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Spain
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Sevilla
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Spain
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Valencia
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United Kingdom
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Leeds
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United Kingdom
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London
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United Kingdom
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Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Centocor, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Schering-Plough
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the efficacy and safety of golimumab (CNTO 148) in
subjects who have active rheumatoid arthritis and have been treated previously with at least
1 dose of a biologic anti-TNFa agent (etanercept, adalimumab or infliximab).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00299546
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Centocor, Inc. Clinical Trial
Address 0 0
Centocor, Inc.
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/NCT00299546