Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
Query!
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
Query!
Secondary ID [1]
0
0
CNTO148ART3001
Query!
Secondary ID [2]
0
0
CR015784
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Arthritis, Rheumatoid
0
0
Query!
Condition category
Condition code
Musculoskeletal
0
0
0
0
Query!
Osteoarthritis
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Rheumatoid arthritis
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Intervention code [2]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Proportion of Participants With an American College of Rheumatology (ACR) 20 Response at Week 14
Query!
Assessment method [1]
0
0
An ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in: 1. Swollen (66 joints) and tender (68 joints) joint counts; 2. greater than or equal to 20 percentage improvement in at least 3 of the following 5 assessments: a. Participant's assessment of pain by Visual Analog Scale (VAS), (0 \[no pain\] to 10 \[worst pain\]) b. Participant's global assessment of disease activity by VAS c. Physician's global assessment of disease activity by VAS d. Participant's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C-reactive protein.
Query!
Timepoint [1]
0
0
Week 14
Query!
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
Query!
Assessment method [1]
0
0
DAS28 using CRP is an index to measure the disease activity in participants with rheumatoid arthritis combining tender joints (28 joints), swollen joints (28 joints), CRP, and participant's global assessment of disease activity. The DAS28 score ranges from 0 (best) to 10 (worst). DAS28 score above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Higher scores indicate worsening. A decrease in DAS28 score \>1.2 is being referred to as a "good response" and a decrease of 0.6-1.2 as a "moderate response".
Query!
Timepoint [1]
0
0
Week 14
Query!
Secondary outcome [2]
0
0
Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 14
Query!
Assessment method [2]
0
0
The HAQ is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). HAQscore on a scale ranges from 0 (no disability) to 3 (completely disabled). Higher scores indicate worsening.
Query!
Timepoint [2]
0
0
Week 14
Query!
Secondary outcome [3]
0
0
Proportion of Participants Who Achieved American College of Rheumatology (ACR) 50 Response at Week 24
Query!
Assessment method [3]
0
0
An ACR 50 response is defined as a greater than or equal to 50 percent improvement from baseline in: 1. Swollen (66 joints) and tender (68 joints) joint counts; 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm) b. Participant's global assessment of disease activity by VAS (0-10 cm) c. Physician's global assessment of disease activity by VAS (0-10 cm) d. Participant's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein.
Query!
Timepoint [3]
0
0
Week 24
Query!
Secondary outcome [4]
0
0
Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 24.
Query!
Assessment method [4]
0
0
Total vdH-S score is sum of joint erosion score and joint-space narrowing (JSN) score. Joint erosion score summarizes erosion severity in 32 joints of hands and 12 joints of feet. Each joint scored from 0 (no erosion) to 5 (extensive loss of bone from more than one half of the articulating bone). Maximal erosion score is 280. JSN score summarizes severity of JSN in 30 joints of hands and 12 joints of feet. Assessment of JSN, including subluxation, is scored from 0 (normal) to 4 (bony ankylosis or complete luxation). Maximal JSN score is 168. Thus, the worst possible vdH-S score is 448.
Query!
Timepoint [4]
0
0
Week 24
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/09/2009
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/02/2013
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
592
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
- Cairns
Query!
Recruitment hospital [2]
0
0
- Maroochydore
Query!
Recruitment hospital [3]
0
0
- Melbourne
Query!
Recruitment hospital [4]
0
0
- Woodville
Query!
Recruitment hospital [5]
0
0
- Woolloongabba
Query!
Recruitment postcode(s) [1]
0
0
- Cairns
Query!
Recruitment postcode(s) [2]
0
0
- Maroochydore
Query!
Recruitment postcode(s) [3]
0
0
- Melbourne
Query!
Recruitment postcode(s) [4]
0
0
- Woodville
Query!
Recruitment postcode(s) [5]
0
0
- Woolloongabba
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Florida
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Illinois
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Maryland
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Massachusetts
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Nebraska
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Ohio
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Texas
Query!
Country [8]
0
0
Argentina
Query!
State/province [8]
0
0
Buenos Aires N/A
Query!
Country [9]
0
0
Argentina
Query!
State/province [9]
0
0
Buenos Aires
Query!
Country [10]
0
0
Argentina
Query!
State/province [10]
0
0
Cordoba
Query!
Country [11]
0
0
Argentina
Query!
State/province [11]
0
0
Rosario
Query!
Country [12]
0
0
Argentina
Query!
State/province [12]
0
0
San Juan
Query!
Country [13]
0
0
Argentina
Query!
State/province [13]
0
0
San Miguel De Tucuman
Query!
Country [14]
0
0
Argentina
Query!
State/province [14]
0
0
Santa Fe
Query!
Country [15]
0
0
Colombia
Query!
State/province [15]
0
0
Antioquia
Query!
Country [16]
0
0
Colombia
Query!
State/province [16]
0
0
Barranquilla
Query!
Country [17]
0
0
Colombia
Query!
State/province [17]
0
0
Bogota
Query!
Country [18]
0
0
Colombia
Query!
State/province [18]
0
0
Cali Valley Del Cauca
Query!
Country [19]
0
0
Colombia
Query!
State/province [19]
0
0
Medellin
Query!
Country [20]
0
0
Hungary
Query!
State/province [20]
0
0
Budapest
Query!
Country [21]
0
0
Hungary
Query!
State/province [21]
0
0
Debrecen
Query!
Country [22]
0
0
Hungary
Query!
State/province [22]
0
0
Eger
Query!
Country [23]
0
0
Hungary
Query!
State/province [23]
0
0
Gyor
Query!
Country [24]
0
0
Hungary
Query!
State/province [24]
0
0
Gyula
Query!
Country [25]
0
0
Hungary
Query!
State/province [25]
0
0
Szombathely
Query!
Country [26]
0
0
Hungary
Query!
State/province [26]
0
0
Veszprem
Query!
Country [27]
0
0
Korea, Republic of
Query!
State/province [27]
0
0
Anyang
Query!
Country [28]
0
0
Korea, Republic of
Query!
State/province [28]
0
0
Dae-Gu
Query!
Country [29]
0
0
Korea, Republic of
Query!
State/province [29]
0
0
Daejeon
Query!
Country [30]
0
0
Korea, Republic of
Query!
State/province [30]
0
0
Incheon
Query!
Country [31]
0
0
Korea, Republic of
Query!
State/province [31]
0
0
Pusan
Query!
Country [32]
0
0
Korea, Republic of
Query!
State/province [32]
0
0
Seoul
Query!
Country [33]
0
0
Lithuania
Query!
State/province [33]
0
0
Alytus
Query!
Country [34]
0
0
Lithuania
Query!
State/province [34]
0
0
Kaunas
Query!
Country [35]
0
0
Lithuania
Query!
State/province [35]
0
0
Klaipeda
Query!
Country [36]
0
0
Lithuania
Query!
State/province [36]
0
0
Siauliai
Query!
Country [37]
0
0
Lithuania
Query!
State/province [37]
0
0
Vilnius
Query!
Country [38]
0
0
Malaysia
Query!
State/province [38]
0
0
Georgetown
Query!
Country [39]
0
0
Malaysia
Query!
State/province [39]
0
0
Ipoh
Query!
Country [40]
0
0
Malaysia
Query!
State/province [40]
0
0
Johor Bahru
Query!
Country [41]
0
0
Malaysia
Query!
State/province [41]
0
0
Kota Kinabalu
Query!
Country [42]
0
0
Malaysia
Query!
State/province [42]
0
0
Kuantan
Query!
Country [43]
0
0
Malaysia
Query!
State/province [43]
0
0
Kuching
Query!
Country [44]
0
0
Malaysia
Query!
State/province [44]
0
0
Precinct 7
Query!
Country [45]
0
0
Malaysia
Query!
State/province [45]
0
0
Selangor Darul Ehasan
Query!
Country [46]
0
0
Malaysia
Query!
State/province [46]
0
0
Seremban
Query!
Country [47]
0
0
Mexico
Query!
State/province [47]
0
0
Guadalajara
Query!
Country [48]
0
0
Mexico
Query!
State/province [48]
0
0
Leon
Query!
Country [49]
0
0
Mexico
Query!
State/province [49]
0
0
Mexico
Query!
Country [50]
0
0
Mexico
Query!
State/province [50]
0
0
Mex
Query!
Country [51]
0
0
Mexico
Query!
State/province [51]
0
0
Monterrey
Query!
Country [52]
0
0
New Zealand
Query!
State/province [52]
0
0
Auckland
Query!
Country [53]
0
0
New Zealand
Query!
State/province [53]
0
0
Takapuna Auckland
Query!
Country [54]
0
0
New Zealand
Query!
State/province [54]
0
0
Timaru
Query!
Country [55]
0
0
Poland
Query!
State/province [55]
0
0
Bialystok
Query!
Country [56]
0
0
Poland
Query!
State/province [56]
0
0
Bydgoszcz
Query!
Country [57]
0
0
Poland
Query!
State/province [57]
0
0
Dzialdowo
Query!
Country [58]
0
0
Poland
Query!
State/province [58]
0
0
Elblag
Query!
Country [59]
0
0
Poland
Query!
State/province [59]
0
0
Katowice
Query!
Country [60]
0
0
Poland
Query!
State/province [60]
0
0
Lublin
Query!
Country [61]
0
0
Poland
Query!
State/province [61]
0
0
Poznan
Query!
Country [62]
0
0
Poland
Query!
State/province [62]
0
0
Sopot
Query!
Country [63]
0
0
Poland
Query!
State/province [63]
0
0
Szczecin
Query!
Country [64]
0
0
Poland
Query!
State/province [64]
0
0
Warszawa
Query!
Country [65]
0
0
Poland
Query!
State/province [65]
0
0
Wloszczowa
Query!
Country [66]
0
0
Poland
Query!
State/province [66]
0
0
Wroclaw
Query!
Country [67]
0
0
Russian Federation
Query!
State/province [67]
0
0
Chelyabinsk
Query!
Country [68]
0
0
Russian Federation
Query!
State/province [68]
0
0
Ekaterinburg
Query!
Country [69]
0
0
Russian Federation
Query!
State/province [69]
0
0
Krasnoyarsk
Query!
Country [70]
0
0
Russian Federation
Query!
State/province [70]
0
0
Moscow N/A
Query!
Country [71]
0
0
Russian Federation
Query!
State/province [71]
0
0
Moscow
Query!
Country [72]
0
0
Russian Federation
Query!
State/province [72]
0
0
Petrozavodsk
Query!
Country [73]
0
0
Russian Federation
Query!
State/province [73]
0
0
Saint Petersburg
Query!
Country [74]
0
0
Russian Federation
Query!
State/province [74]
0
0
Saratov
Query!
Country [75]
0
0
Russian Federation
Query!
State/province [75]
0
0
St.Petersburg
Query!
Country [76]
0
0
Ukraine
Query!
State/province [76]
0
0
Donetsk
Query!
Country [77]
0
0
Ukraine
Query!
State/province [77]
0
0
Ivano-Frankovsk
Query!
Country [78]
0
0
Ukraine
Query!
State/province [78]
0
0
Kharkiv
Query!
Country [79]
0
0
Ukraine
Query!
State/province [79]
0
0
Kyiv
Query!
Country [80]
0
0
Ukraine
Query!
State/province [80]
0
0
Odessa
Query!
Country [81]
0
0
Ukraine
Query!
State/province [81]
0
0
Simferopol
Query!
Country [82]
0
0
Ukraine
Query!
State/province [82]
0
0
Ternopil
Query!
Country [83]
0
0
Ukraine
Query!
State/province [83]
0
0
Vinnitsa
Query!
Country [84]
0
0
Ukraine
Query!
State/province [84]
0
0
Zaporizhzhya
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Centocor, Inc.
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/industry
Query!
Name [1]
0
0
Schering-Plough
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT00973479
Query!
Trial related presentations / publications
Husni ME, Deodhar A, Schwartzman S, Chakravarty SD, Hsia EC, Leu JH, Zhou Y, Lo KH, Kavanaugh A. Pooled safety results across phase 3 randomized trials of intravenous golimumab in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Arthritis Res Ther. 2022 Mar 21;24(1):73. doi: 10.1186/s13075-022-02753-6. Lee JB, Broadwell A, Fan Y, Hu C, Adedokun OJ, Chakravarty SD, Zhou H, Xu Z, Leu JH. Population Pharmacokinetic and Exposure-Response Model Simulations: Predicted Exposure and Efficacy for Maintenance Doses of Intravenous Golimumab Every 6 or 8 Weeks in Patients With Moderately to Severely Active Rheumatoid Arthritis. Clin Ther. 2022 Mar;44(3):457-464.e2. doi: 10.1016/j.clinthera.2022.01.015. Epub 2022 Feb 17. Tesser J, Kafka S, DeHoratius RJ, Xu S, Hsia EC, Turkiewicz A. Efficacy and safety of intravenous golimumab plus methotrexate in patients with rheumatoid arthritis aged < 65 years and those >/= 65 years of age. Arthritis Res Ther. 2019 Aug 20;21(1):190. doi: 10.1186/s13075-019-1968-x. Standish KA, Huang CC, Curran ME, Schork NJ. Comprehensive analysis of treatment response phenotypes in rheumatoid arthritis for pharmacogenetic studies. Arthritis Res Ther. 2017 May 12;19(1):90. doi: 10.1186/s13075-017-1299-8. Bingham CO 3rd, Mendelsohn AM, Kim L, Xu Z, Leu J, Han C, Lo KH, Westhovens R, Weinblatt ME; GO-FURTHER Investigators. Maintenance of Clinical and Radiographic Benefit With Intravenous Golimumab Therapy in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy: Week-112 Efficacy and Safety Results of the Open-Label Long-Term Extension of a Phase III, Double-Blind, Randomized, Placebo-Controlled Trial. Arthritis Care Res (Hoboken). 2015 Dec;67(12):1627-36. doi: 10.1002/acr.22556. Bingham CO 3rd, Weinblatt M, Han C, Gathany TA, Kim L, Lo KH, Baker D, Mendelsohn A, Westhovens R. The effect of intravenous golimumab on health-related quality of life in rheumatoid arthritis: 24-week results of the phase III GO-FURTHER trial. J Rheumatol. 2014 Jun;41(6):1067-76. doi: 10.3899/jrheum.130864. Epub 2014 May 1. Weinblatt ME, Westhovens R, Mendelsohn AM, Kim L, Lo KH, Sheng S, Noonan L, Lu J, Xu Z, Leu J, Baker D, Bingham CO; GO-FURTHER investigators. Radiographic benefit and maintenance of clinical benefit with intravenous golimumab therapy in patients with active rheumatoid arthritis despite methotrexate therapy: results up to 1 year of the phase 3, randomised, multicentre, double blind, placebo controlled GO-FURTHER trial. Ann Rheum Dis. 2014 Dec;73(12):2152-9. doi: 10.1136/annrheumdis-2013-203742. Epub 2013 Sep 3.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Centocor, Inc. Clinical Trial
Query!
Address
0
0
Centocor, Inc.
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
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/NCT00973479
Download to PDF