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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/NCT00973479




Registration number
NCT00973479
Ethics application status
Date submitted
4/09/2009
Date registered
9/09/2009
Date last updated
25/12/2013

Titles & IDs
Public title
An Effectiveness and Safety Study of Intravenous Golimumab in Patients With Active Rheumatoid Arthritis Despite Treatment With Methotrexate Therapy
Scientific title
A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFalpha Monoclonal Antibody, Administered Intravenously, in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Secondary ID [1] 0 0
CNTO148ART3001
Secondary ID [2] 0 0
CR015784
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 - Golimumab
Other interventions - Placebo
Treatment: Drugs - methotrexate (MTX)

Experimental: Group I: Placebo + Methotrexate (MTX) - Participants will receive placebo at Weeks 0, 4, 12, and 16. Participants will cross over to golimumab at Week 24, and receive administrations at Weeks 24, 28, and every 8 weeks thereafter. They will be maintained on their stable dose of commercial methotrexate throughout the study. Participants will be eligible for early escape (receive golimumab) at Week 16 if they demonstrate a less than 10 percent improvement in both tender and swollen joint count. These participants will receive golimumab at Weeks 16, 20, and every 8 weeks thereafter.

Placebo Comparator: Group II: Golimumab + Methotrexate (MTX) - Participants will receive golimumab at Weeks 0, 4, and every 8 weeks thereafter. They will be maintained on their stable dose of commercial methotrexate throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.


Treatment: Drugs: Golimumab
Participants will receive 2 mg/kg of golimumab intravenously over 30 ± 10 minutes. Group 1: at Weeks 0, 4, and every 8 weeks thereafter (up to Week 100). Group II: Weeks 24, 28, and every 8 weeks thereafter (up to Week 100); Early escape: at Week 16, 20 and every 8 weeks thereafter (up to Week 100).

Other interventions: Placebo
Participants will receive placebo intravenous infusion over 30 ± 10 minutes as: Group I: at Week 16 and 24; Group II: at Weeks 0, 4, 12, 16, and 20; and for early escape: at Week 24.

Treatment: Drugs: methotrexate (MTX)
Participants will be maintained on their stable dose of commercial MTX (between 15 to 25 mg/week) throughout the study.
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
Proportion of Participants With an American College of Rheumatology (ACR) 20 Response at Week 14
Timepoint [1] 0 0
Week 14
Secondary outcome [1] 0 0
Proportion of Participants With Moderate or Good Response in Disease Activity Index Score 28 (DAS28) Using C-reactive Protein (CRP) at Week 14
Timepoint [1] 0 0
Week 14
Secondary outcome [2] 0 0
Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 14
Timepoint [2] 0 0
Week 14
Secondary outcome [3] 0 0
Proportion of Participants Who Achieved American College of Rheumatology (ACR) 50 Response at Week 24
Timepoint [3] 0 0
Week 24
Secondary outcome [4] 0 0
Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 24.
Timepoint [4] 0 0
Week 24

Eligibility
Key inclusion criteria
- Diagnosis of rheumatoid arthritis (RA) for at least 3 months prior to screening

- Have been treated with and tolerated methotrexate (MTX) at a dose of at least 15
mg/week for at least 3 months prior to screening, and have been on a stable MTX dose
of 15 mg/week to 25 mg/week for at least 4 weeks prior to screening

- Have an active RA, as defined by disease activity with at least 6 swollen and 6 tender
joints, at the time of screening and at baseline

- C-Reactive Protein greater than or equal to 1.0 mg/dL at screening

- No history of latent or active tuberculosis prior to screening
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Other inflammatory diseases, including but not limited to psoriatic arthritis,
ankylosing spondylitis, systemic lupus erythematosus, or lyme disease

- Treated with disease modifying agents (other than methotrexate)/systemic
immunosuppressives (eg, D-penicillamine, hydroxychloroquine, chloroquine, oral or
parenteral gold, sulfasalazine, leflunomide, azathioprine, cyclosporine, mycophenolate
mofetil) during the 4 weeks prior to first administration of study agent

- Received intra-articular (in the joint), intramuscular (in the muscle), or intravenous
corticosteroids, including adrenocorticotropic hormone, during the 4 weeks prior to
first administration of study agent

- Known allergy to human immunoglobulin proteins or other components of golimumab

- Received any commercial or investigational anti-tumor necrosis factor alpha therapy
such as but not exclusively infliximab, golimumab, adalimumab or etanercept

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
1/09/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2013
Sample size
Target
Accrual to date
Final
592
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Cairns
Recruitment hospital [2] 0 0
- Maroochydore
Recruitment hospital [3] 0 0
- Melbourne
Recruitment hospital [4] 0 0
- Woodville
Recruitment hospital [5] 0 0
- Woolloongabba
Recruitment postcode(s) [1] 0 0
- Cairns
Recruitment postcode(s) [2] 0 0
- Maroochydore
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment postcode(s) [4] 0 0
- Woodville
Recruitment postcode(s) [5] 0 0
- Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
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Florida
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Illinois
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Maryland
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Massachusetts
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Nebraska
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Ohio
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United States of America
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Texas
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Argentina
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Buenos Aires N/A
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Argentina
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Buenos Aires
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Argentina
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Cordoba
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Rosario
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Argentina
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San Juan
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Argentina
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San Miguel De Tucuman
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Argentina
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Santa Fe
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Colombia
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Antioquia
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Colombia
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Barranquilla
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Colombia
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Bogota
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Colombia
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Cali Valley Del Cauca
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Colombia
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Medellin
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Hungary
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Budapest
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Hungary
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Debrecen
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Eger
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Gyor
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Gyula
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Szombathely
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Hungary
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Veszprem
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Korea, Republic of
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Anyang
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Dae-Gu
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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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Pusan
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Korea, Republic of
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Seoul
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Lithuania
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Alytus
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Lithuania
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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
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Malaysia
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Georgetown
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Ipoh
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Johor Bahru
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Kota Kinabalu
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Malaysia
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Kuantan
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Malaysia
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Kuching
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Malaysia
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Precinct 7
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Malaysia
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Selangor Darul Ehasan
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Malaysia
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Seremban
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Guadalajara
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Leon
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Mex
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Auckland
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Takapuna Auckland
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New Zealand
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Timaru
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Poland
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Bialystok
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Bydgoszcz
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Dzialdowo
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Elblag
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Katowice
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Lublin
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Poznan
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Sopot
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Szczecin
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Warszawa
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Wloszczowa
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Wroclaw
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Russian Federation
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Chelyabinsk
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Russian Federation
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Ekaterinburg
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Russian Federation
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Krasnoyarsk
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Russian Federation
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Moscow N/A
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Russian Federation
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Moscow
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Russian Federation
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Petrozavodsk
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Russian Federation
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Saint Petersburg
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Russian Federation
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Saratov
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Russian Federation
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St.Petersburg
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Ukraine
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Donetsk
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Ivano-Frankovsk
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Kharkiv
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Ukraine
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Kyiv
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Odessa
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Ukraine
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Simferopol
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Ukraine
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Ternopil
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Ukraine
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Vinnitsa
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Ukraine
State/province [84] 0 0
Zaporizhzhya

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 clinical effectiveness and safety of golimumab with
methotrexate (MTX) in the treatment of rheumatoid arthritis (RA) when compared to MTX alone.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00973479
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