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/NCT00264550
Registration number
NCT00264550
Ethics application status
Date submitted
11/12/2005
Date registered
13/12/2005
Date last updated
29/04/2014
Titles & IDs
Public title
An Efficacy and Safety Study of Golimumab in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Query!
Scientific title
A Multicenter, Randomized, Double-blind, Placebo-controlledTrial of Golimumab, a Fully Human Anti-TNFa MonoclonalAntibody, Administered Subcutaneously, in Subjects With ActiveRheumatoid Arthritis Despite Methotrexate Therapy
Query!
Secondary ID [1]
0
0
C0524T06
Query!
Secondary ID [2]
0
0
CR006343
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
GO-FORWARD
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis
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 100 mg
Treatment: Drugs - Golimumab 50 mg
Treatment: Drugs - Methotrexate
Treatment: Drugs - Placebo injection
Treatment: Drugs - Placebo capsules
Placebo comparator: Group 1: Placebo + Methotrexate - Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg 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 up to 5 yrs; Placebo - 7-10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; 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 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg 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 - Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; 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: Golimumab 100 mg
Participants will receive subcutaneous (SC) injections of golimumab 100 mg every 4 weeks.
Treatment: Drugs: Golimumab 50 mg
Participants will receive subcutaneous (SC) injections of golimumab 50 mg every 4 weeks.
Treatment: Drugs: Methotrexate
Participants will receive methotrexate capsules weekly.
Treatment: Drugs: Placebo injection
Participants will receive subcutaneous (SC) injections of placebo every 4 weeks.
Treatment: Drugs: Placebo capsules
Participants will receive placebo capsules weekly
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of Participants Who Achieved American College of Rheumatology (ACR) 20 Response at Week 14
Query!
Assessment method [1]
0
0
ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain of pain by the Visual Analogue Scale (VAS) (0-10 cm) b.Patient's Global Assessment of Disease activity VAS (0-10 cm) c. Physician's Global Assessment of Disease Activity VAS (0-10 cm) d. Patient'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!
Primary outcome [2]
0
0
Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 24
Query!
Assessment method [2]
0
0
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). The average score across the functional areas yields an overall HAQ score which ranges from 0 (no disability) to 3 (completely disabled).
Query!
Timepoint [2]
0
0
Baseline (Week 0) and Week 24
Query!
Secondary outcome [1]
0
0
Number of Participants With Disease Activity Index Score 28 (DAS 28) Using C-reactive Protein (CRP) Response at Week 14
Query!
Assessment method [1]
0
0
DAS 28 using CRP is an index to measure the disease activity in participants with rheumatoid arthritis which combines tender joint count (28 joints), swollen joint count (28 joints), CRP value, and participant's global assessment of disease activity (using a Visual Analog Scale of 0 to 100 mm). The DAS 28 score ranges from 0 (best) to 10 (worst). Participants are considered to have a DAS 28 response if they have a score of \<= 3.2 (good response) or \> 3.2 to 5.1 (moderate response).
Query!
Timepoint [1]
0
0
Week 14
Query!
Secondary outcome [2]
0
0
Number of Participants Who Achieved American College of Rheumatology 20 (ACR 20) Response at Week 24
Query!
Assessment method [2]
0
0
An ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain (VAS) (0-10 cm) b.Patient's Global Assessment of Disease activity (VAS) (0-10 cm) c. Physician's Global Assessment of Disease Activity (VAS) (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein (CRP).
Query!
Timepoint [2]
0
0
Week 24
Query!
Secondary outcome [3]
0
0
Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 14
Query!
Assessment method [3]
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). The average score across the functional areas yields an overall HAQ score which ranges from 0 (no disability) to 3 (completely disabled).
Query!
Timepoint [3]
0
0
Baseline (Week 0) and Week 14
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
The vdH-S score is the sum of joint erosion score and joint-space narrowing (JSN) score. The total score ranges from 0 (best) to 448 (worst) with higher scores indicating more joint damage.
Query!
Timepoint [4]
0
0
Baseline (Week 0) and Week 24
Query!
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 screening
* Must 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 a MTX dose of >=15 mg/week and <=25 mg/week and stable for at least 4 weeks prior to screening
* 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 magnetic resonance imaging (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
* Are considered eligible according to specified tuberculosis (TB) screening criteria
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
* Have inflammatory diseases other than RA that might confound the evaluation of the benefit of golimumab therapy
* Have had treatment with disease-modifying anti-rheumatic drugs (DMARDs)/systemic immunosuppressives other than MTX, during the 4 weeks prior to the first administration of study agent
* Have had prior treatment with biologic anti-tumor necrosis factor (TNF) drugs (infliximab, etanercept, adalimumab)
* Have had history of, or ongoing, chronic or recurrent infectious disease.
* Have serious infection within 2 months prior to first administration of study agent
* Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to screening
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
1/12/2005
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/05/2012
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
444
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
- Clayton
Query!
Recruitment hospital [2]
0
0
- Maroochydore
Query!
Recruitment hospital [3]
0
0
- Melbourne
Query!
Recruitment postcode(s) [1]
0
0
- Clayton
Query!
Recruitment postcode(s) [2]
0
0
- Maroochydore
Query!
Recruitment postcode(s) [3]
0
0
- Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Illinois
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Missouri
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Nebraska
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Pennsylvania
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Virginia
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
S.M. De Tucuman
Query!
Country [13]
0
0
Argentina
Query!
State/province [13]
0
0
San Miguel De Tucuman
Query!
Country [14]
0
0
Canada
Query!
State/province [14]
0
0
British Columbia
Query!
Country [15]
0
0
Canada
Query!
State/province [15]
0
0
Newfoundland and Labrador
Query!
Country [16]
0
0
Canada
Query!
State/province [16]
0
0
Ontario
Query!
Country [17]
0
0
Canada
Query!
State/province [17]
0
0
Quebec
Query!
Country [18]
0
0
Canada
Query!
State/province [18]
0
0
Hamilton Ontario
Query!
Country [19]
0
0
Chile
Query!
State/province [19]
0
0
Rancagua
Query!
Country [20]
0
0
Chile
Query!
State/province [20]
0
0
Santiago De Chile
Query!
Country [21]
0
0
Chile
Query!
State/province [21]
0
0
Santiago
Query!
Country [22]
0
0
Chile
Query!
State/province [22]
0
0
Temuco Ix
Query!
Country [23]
0
0
Germany
Query!
State/province [23]
0
0
Berlin
Query!
Country [24]
0
0
Germany
Query!
State/province [24]
0
0
Hamburg
Query!
Country [25]
0
0
Germany
Query!
State/province [25]
0
0
Hannover
Query!
Country [26]
0
0
Germany
Query!
State/province [26]
0
0
Köln
Query!
Country [27]
0
0
Germany
Query!
State/province [27]
0
0
Leipzig
Query!
Country [28]
0
0
Germany
Query!
State/province [28]
0
0
Rostock
Query!
Country [29]
0
0
Hungary
Query!
State/province [29]
0
0
Budepest
Query!
Country [30]
0
0
Korea, Republic of
Query!
State/province [30]
0
0
Anyang
Query!
Country [31]
0
0
Korea, Republic of
Query!
State/province [31]
0
0
Daegu
Query!
Country [32]
0
0
Korea, Republic of
Query!
State/province [32]
0
0
Pusan
Query!
Country [33]
0
0
Korea, Republic of
Query!
State/province [33]
0
0
Seoul
Query!
Country [34]
0
0
Mexico
Query!
State/province [34]
0
0
Monterrey
Query!
Country [35]
0
0
New Zealand
Query!
State/province [35]
0
0
Auckland
Query!
Country [36]
0
0
New Zealand
Query!
State/province [36]
0
0
Rotorua
Query!
Country [37]
0
0
New Zealand
Query!
State/province [37]
0
0
Timaru
Query!
Country [38]
0
0
Poland
Query!
State/province [38]
0
0
Elblag
Query!
Country [39]
0
0
Poland
Query!
State/province [39]
0
0
Kalisz
Query!
Country [40]
0
0
Poland
Query!
State/province [40]
0
0
Szczecin
Query!
Country [41]
0
0
Poland
Query!
State/province [41]
0
0
Warsaw
Query!
Country [42]
0
0
Poland
Query!
State/province [42]
0
0
Warszawa N/A
Query!
Country [43]
0
0
Taiwan
Query!
State/province [43]
0
0
Kaohsiung County
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 the efficacy and safety of golimumab, alone or in combination with methotrexate (MTX), as compared to methotrexate alone in rheumatoid arthritis (RA) patients who have active rheumatoid arthritis despite treatment with MTX.
Query!
Trial website
https://clinicaltrials.gov/study/NCT00264550
Query!
Trial related presentations / publications
Leu JH, Adedokun OJ, Gargano C, Hsia EC, Xu Z, Shankar G. Immunogenicity of golimumab and its clinical relevance in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. Rheumatology (Oxford). 2019 Mar 1;58(3):441-446. doi: 10.1093/rheumatology/key309. George MD, Ostergaard M, Conaghan PG, Emery P, Baker DG, Baker JF. Obesity and rates of clinical remission and low MRI inflammation in rheumatoid arthritis. Ann Rheum Dis. 2017 Oct;76(10):1743-1746. doi: 10.1136/annrheumdis-2017-211569. Epub 2017 Jun 12. Kay J, Fleischmann R, Keystone E, Hsia EC, Hsu B, Zhou Y, Goldstein N, Braun J. Five-year Safety Data from 5 Clinical Trials of Subcutaneous Golimumab in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis. J Rheumatol. 2016 Dec;43(12):2120-2130. doi: 10.3899/jrheum.160420. Epub 2016 Nov 1. Mack ME, Hsia E, Aletaha D. Comparative Assessment of the Different American College of Rheumatology/European League Against Rheumatism Remission Definitions for Rheumatoid Arthritis for Their Use as Clinical Trial End Points. Arthritis Rheumatol. 2017 Mar;69(3):518-528. doi: 10.1002/art.39945. Baker JF, Conaghan PG, Smolen JS, Aletaha D, Shults J, Emery P, Baker DG, Ostergaard M. Development and validation of modified disease activity scores in rheumatoid arthritis: superior correlation with magnetic resonance imaging-detected synovitis and radiographic progression. Arthritis Rheumatol. 2014 Apr;66(4):794-802. doi: 10.1002/art.38304. Keystone EC, Genovese MC, Hall S, Miranda PC, Bae SC, Palmer W, Wu Z, Xu S, Hsia EC. Golimumab in patients with active rheumatoid arthritis despite methotrexate therapy: results through 2 years of the GO-FORWARD study extension. J Rheumatol. 2013 Jul;40(7):1097-103. doi: 10.3899/jrheum.120584. Epub 2013 May 15. Genovese MC, Han C, Keystone EC, Hsia EC, Buchanan J, Gathany T, Murphy FT, Wu Z, Parasuraman S, Rahman MU. Effect of golimumab on patient-reported outcomes in rheumatoid arthritis: results from the GO-FORWARD study. J Rheumatol. 2012 Jun;39(6):1185-91. doi: 10.3899/jrheum.111195. Epub 2012 Apr 15. Visvanathan S, Rahman MU, Keystone E, Genovese M, Klareskog L, Hsia E, Mack M, Buchanan J, Elashoff M, Wagner C. Association of serum markers with improvement in clinical response measures after treatment with golimumab in patients with active rheumatoid arthritis despite receiving methotrexate: results from the GO-FORWARD study. Arthritis Res Ther. 2010;12(6):R211. doi: 10.1186/ar3188. Epub 2010 Nov 17.
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/NCT00264550
Download to PDF