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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00264537




Registration number
NCT00264537
Ethics application status
Date submitted
11/12/2005
Date registered
13/12/2005
Date last updated
5/09/2014

Titles & IDs
Public title
A Study of the Safety and Efficacy of Golimumab in Subjects With Rheumatoid Arthritis That Are Methotrexate-naive
Scientific title
A Multicenter, Randomized, Double-blind, Placebo-controlledTrial of Golimumab, a Fully Human Anti-TNFa MonoclonalAntibody, Administered Subcutaneously, in Methotrexate-naive Subjects With Active Rheumatoid Arthritis
Secondary ID [1] 0 0
GO-BEFORE
Secondary ID [2] 0 0
CR006331
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 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 injections
Treatment: Drugs - Placebo capsules
Treatment: Drugs - Methotrexate capsules
Treatment: Other - Golimumab 50 mg injections
Treatment: Other - Golimumab 100 mg injections

Experimental: Group 1: Placebo + Methotrexate - Placebo subcutaneous injections (SC) every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 50 mg SC injections every 4 weeks from Week 28 up to 5 years; Golimumab - Dr's discretion after unblinding (in participants receiving methotrexate plus placebo), 50 mg SC injections every 4 weeks up to 5 years; 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-52 database lock.

Experimental: Group 2: Golimumab 100 mg + Placebo - Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; placebo capsules weekly from Week 0 for up to 5 years (unless early escape at Week 28); Methotrexate - if early escape, 10 to 20 mg weekly from Week 28 up to 5 years; Methotrexate - Dr's discretion after unblinding (in participants receiving golimumab plus placebo) 10 to 20 mg weekly for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period will be until the week-52 database lock.

Experimental: Group 3: Golimumab 50 mg + Methotrexate - Golimumab 50 mg SC injections every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 28 for 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-52 database lock.

Experimental: Group 4: Golimumab 100 mg + Methotrexate - Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period will be until the week-52 database lock.


Treatment: Drugs: Placebo injections
SC injections

Treatment: Drugs: Placebo capsules
Placebo capsules will be filled with microcrystalline cellulose (Avicel PH 102).

Treatment: Drugs: Methotrexate capsules
Methotrexate capsules will be filled with microcrystalline cellulose (Avicel PH 102) and a 2.5 mg methotrexate tablet.

Treatment: Other: Golimumab 50 mg injections
SC injections

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

Outcomes
Primary outcome [1] 0 0
Number of Participants Who Achieved American College of Rheumatology (ACR) 50 Response at Week 24
Timepoint [1] 0 0
Week 24
Primary outcome [2] 0 0
Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 52
Timepoint [2] 0 0
Baseline and Week 52
Secondary outcome [1] 0 0
Number of Participants Who Achieved American College of Rheumatology (ACR) 20 Response at Week 24
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Number of Patients With Abnormal Baseline C-reactive Protein (CRP) Who Achieved American College of Rheumatology (ACR) 50 Response at Week 24
Timepoint [2] 0 0
Week 24
Secondary outcome [3] 0 0
Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 52 in Patients With Abnormal C-reactive Protein (CRP Greater Than 1.0 mg/dL) at Baseline
Timepoint [3] 0 0
Baseline and Week 52

Eligibility
Key inclusion criteria
* Have a diagnosis of rheumatoid arthritis (RA) (according to the revised 1987 criteria of the ACR) for at least 3 months prior to first administration of study agent
* Are methotrexate (MTX)-naïve (ie, have not received more than 3 weekly doses of MTX for RA at any time)
* 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, and at least 2 of the following 4 criteria: a) C-reactive protein (CRP) >=1.5 mg/dL at screening or erythrocyte sedimentation rate (ESR) by Westergren method of >= 28 mm in the first hour at screening or baseline, b)Morning stiffness of >= 30 minutes at screening and baseline, c)Bone erosion by x-ray and/or MRI prior to first administration of study agent, d)Anti-cyclic citrullinated peptide (anti-CCP) antibody-positive or rheumatoid factor (RF) positive at screening
* 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Can not have inflammatory diseases other than RA that might confound the evaluation of the benefit of golimumab therapy
* No treatment with disease-modifying anti-rheumatic drugs (DMARDs)/systemic immunosuppressives during the 4 weeks prior to the first administration of study agent
* No prior treatment with biologic anti-TNF drugs (infliximab, etanercept, adalimumab)
* 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
1/12/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2012
Sample size
Target
Accrual to date
Final
637
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Maroochydore
Recruitment hospital [2] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
- Maroochydore
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
California
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United States of America
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Florida
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United States of America
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Idaho
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United States of America
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Illinois
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Kansas
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Minnesota
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Missouri
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Nebraska
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North Carolina
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United States of America
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Pennsylvania
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United States of America
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Texas
Country [13] 0 0
Argentina
State/province [13] 0 0
Buenos Aires
Country [14] 0 0
Argentina
State/province [14] 0 0
Cordoba
Country [15] 0 0
Argentina
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Rosario
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Argentina
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S.M. De Tucuman
Country [17] 0 0
Argentina
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San Miguel De Tucuman
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Austria
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Wien
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Belgium
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Brussels
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Belgium
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Liege
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Canada
State/province [21] 0 0
Manitoba
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Canada
State/province [22] 0 0
Newfoundland and Labrador
Country [23] 0 0
Chile
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Rancagua
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Chile
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Santiago
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Hungary
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Budapest
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Hungary
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Gyula
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Hungary
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Szombathely
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India
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Bangalore
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India
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Lucknow Gpo
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India
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Secunderabad
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Korea, Republic of
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Daejeon
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seoul
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Korea, Republic of
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Suwon
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Malaysia
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Precinct 7
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Malaysia
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Saemban
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Malaysia
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Selayang N/A
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New Zealand
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Auckland
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New Zealand
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Timaru
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Philippines
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Cebu
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Philippines
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Manila
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Philippines
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Quezon
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Poland
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Bialystok
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Elblag
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Poland
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Kalisz
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Poland
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Szczecin
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Poland
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Warsaw
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Russian Federation
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Moscow
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Russian Federation
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Saratov
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Russian Federation
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Yaroslavl
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Singapore
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Singapore
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Spain
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Madrid
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Spain
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Santander
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Spain
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Sevilla N/A
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Spain
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Sevilla
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Spain
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Valencia
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Taipei
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Taiwan
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Tiachung
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Thailand
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Bangkok
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Thailand
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Chiang Mai
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Ukraine
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Dnipropetrovsk
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Ukraine
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Donetsk
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Ukraine
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Kharkiv
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Ukraine
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Kiev
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United Kingdom
State/province [67] 0 0
Leeds
Country [68] 0 0
United Kingdom
State/province [68] 0 0
London

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
Trial website
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

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/NCT00264537