Trial Review

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.


With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

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
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
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
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.
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
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".
Timepoint [1] 0 0
Week 14
Secondary outcome [2] 0 0
Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 14
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.
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
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.
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.
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.
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
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Nebraska
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
Argentina
State/province [8] 0 0
Buenos Aires N/A
Country [9] 0 0
Argentina
State/province [9] 0 0
Buenos Aires
Country [10] 0 0
Argentina
State/province [10] 0 0
Cordoba
Country [11] 0 0
Argentina
State/province [11] 0 0
Rosario
Country [12] 0 0
Argentina
State/province [12] 0 0
San Juan
Country [13] 0 0
Argentina
State/province [13] 0 0
San Miguel De Tucuman
Country [14] 0 0
Argentina
State/province [14] 0 0
Santa Fe
Country [15] 0 0
Colombia
State/province [15] 0 0
Antioquia
Country [16] 0 0
Colombia
State/province [16] 0 0
Barranquilla
Country [17] 0 0
Colombia
State/province [17] 0 0
Bogota
Country [18] 0 0
Colombia
State/province [18] 0 0
Cali Valley Del Cauca
Country [19] 0 0
Colombia
State/province [19] 0 0
Medellin
Country [20] 0 0
Hungary
State/province [20] 0 0
Budapest
Country [21] 0 0
Hungary
State/province [21] 0 0
Debrecen
Country [22] 0 0
Hungary
State/province [22] 0 0
Eger
Country [23] 0 0
Hungary
State/province [23] 0 0
Gyor
Country [24] 0 0
Hungary
State/province [24] 0 0
Gyula
Country [25] 0 0
Hungary
State/province [25] 0 0
Szombathely
Country [26] 0 0
Hungary
State/province [26] 0 0
Veszprem
Country [27] 0 0
Korea, Republic of
State/province [27] 0 0
Anyang
Country [28] 0 0
Korea, Republic of
State/province [28] 0 0
Dae-Gu
Country [29] 0 0
Korea, Republic of
State/province [29] 0 0
Daejeon
Country [30] 0 0
Korea, Republic of
State/province [30] 0 0
Incheon
Country [31] 0 0
Korea, Republic of
State/province [31] 0 0
Pusan
Country [32] 0 0
Korea, Republic of
State/province [32] 0 0
Seoul
Country [33] 0 0
Lithuania
State/province [33] 0 0
Alytus
Country [34] 0 0
Lithuania
State/province [34] 0 0
Kaunas
Country [35] 0 0
Lithuania
State/province [35] 0 0
Klaipeda
Country [36] 0 0
Lithuania
State/province [36] 0 0
Siauliai
Country [37] 0 0
Lithuania
State/province [37] 0 0
Vilnius
Country [38] 0 0
Malaysia
State/province [38] 0 0
Georgetown
Country [39] 0 0
Malaysia
State/province [39] 0 0
Ipoh
Country [40] 0 0
Malaysia
State/province [40] 0 0
Johor Bahru
Country [41] 0 0
Malaysia
State/province [41] 0 0
Kota Kinabalu
Country [42] 0 0
Malaysia
State/province [42] 0 0
Kuantan
Country [43] 0 0
Malaysia
State/province [43] 0 0
Kuching
Country [44] 0 0
Malaysia
State/province [44] 0 0
Precinct 7
Country [45] 0 0
Malaysia
State/province [45] 0 0
Selangor Darul Ehasan
Country [46] 0 0
Malaysia
State/province [46] 0 0
Seremban
Country [47] 0 0
Mexico
State/province [47] 0 0
Guadalajara
Country [48] 0 0
Mexico
State/province [48] 0 0
Leon
Country [49] 0 0
Mexico
State/province [49] 0 0
Mexico
Country [50] 0 0
Mexico
State/province [50] 0 0
Mex
Country [51] 0 0
Mexico
State/province [51] 0 0
Monterrey
Country [52] 0 0
New Zealand
State/province [52] 0 0
Auckland
Country [53] 0 0
New Zealand
State/province [53] 0 0
Takapuna Auckland
Country [54] 0 0
New Zealand
State/province [54] 0 0
Timaru
Country [55] 0 0
Poland
State/province [55] 0 0
Bialystok
Country [56] 0 0
Poland
State/province [56] 0 0
Bydgoszcz
Country [57] 0 0
Poland
State/province [57] 0 0
Dzialdowo
Country [58] 0 0
Poland
State/province [58] 0 0
Elblag
Country [59] 0 0
Poland
State/province [59] 0 0
Katowice
Country [60] 0 0
Poland
State/province [60] 0 0
Lublin
Country [61] 0 0
Poland
State/province [61] 0 0
Poznan
Country [62] 0 0
Poland
State/province [62] 0 0
Sopot
Country [63] 0 0
Poland
State/province [63] 0 0
Szczecin
Country [64] 0 0
Poland
State/province [64] 0 0
Warszawa
Country [65] 0 0
Poland
State/province [65] 0 0
Wloszczowa
Country [66] 0 0
Poland
State/province [66] 0 0
Wroclaw
Country [67] 0 0
Russian Federation
State/province [67] 0 0
Chelyabinsk
Country [68] 0 0
Russian Federation
State/province [68] 0 0
Ekaterinburg
Country [69] 0 0
Russian Federation
State/province [69] 0 0
Krasnoyarsk
Country [70] 0 0
Russian Federation
State/province [70] 0 0
Moscow N/A
Country [71] 0 0
Russian Federation
State/province [71] 0 0
Moscow
Country [72] 0 0
Russian Federation
State/province [72] 0 0
Petrozavodsk
Country [73] 0 0
Russian Federation
State/province [73] 0 0
Saint Petersburg
Country [74] 0 0
Russian Federation
State/province [74] 0 0
Saratov
Country [75] 0 0
Russian Federation
State/province [75] 0 0
St.Petersburg
Country [76] 0 0
Ukraine
State/province [76] 0 0
Donetsk
Country [77] 0 0
Ukraine
State/province [77] 0 0
Ivano-Frankovsk
Country [78] 0 0
Ukraine
State/province [78] 0 0
Kharkiv
Country [79] 0 0
Ukraine
State/province [79] 0 0
Kyiv
Country [80] 0 0
Ukraine
State/province [80] 0 0
Odessa
Country [81] 0 0
Ukraine
State/province [81] 0 0
Simferopol
Country [82] 0 0
Ukraine
State/province [82] 0 0
Ternopil
Country [83] 0 0
Ukraine
State/province [83] 0 0
Vinnitsa
Country [84] 0 0
Ukraine
State/province [84] 0 0
Zaporizhzhya

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Centocor, Inc.
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Schering-Plough
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
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 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/NCT00973479