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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/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
Other interventions - Golimumab 50 mg injections
Other interventions - 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.

Other interventions: Golimumab 50 mg injections
SC injections

Other interventions: Golimumab 100 mg injections
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
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
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United States of America
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Alabama
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United States of America
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California
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Florida
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Idaho
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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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Pennsylvania
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United States of America
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Texas
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Argentina
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Buenos Aires
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Argentina
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Cordoba
Country [15] 0 0
Argentina
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Rosario
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Argentina
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S.M. De Tucuman
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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
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Manitoba
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Canada
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Newfoundland and Labrador
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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
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Leeds
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United Kingdom
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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
The purpose of this study is to evaluate the efficacy and safety of golimumab, alone or in
combination with methotrexate, as compared to methotrexate alone in rheumatoid arthritis
subjects who have not been previously treated with methotrexate.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00264537
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/NCT00264537