A Study of the Safety and Efficacy of Golimumab (CNTO 148) in Subjects With Active Rheumatoid Arthritis Previously Treated With Biologic Anti-TNFa Agent(s)
A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Subjects With Active Rheumatoid Arthritis and Previously Treated With Biologic Anti- TNFa Agent(s)
2 other identifiers
interventional
461
9 countries
74
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of golimumab (CNTO 148) in subjects who have active rheumatoid arthritis and have been treated previously with at least 1 dose of a biologic anti-TNFa agent (etanercept, adalimumab or infliximab).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2006
Longer than P75 for phase_3
74 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 3, 2006
CompletedFirst Posted
Study publicly available on registry
March 7, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedResults Posted
Study results publicly available
September 28, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedFebruary 27, 2014
January 1, 2014
1.5 years
March 3, 2006
May 21, 2009
January 27, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
American College of Rheumatology (ACR) 20 Response at Week 14.
ACR 20 response is an improvement of \>= 20% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments ( patient's assessment of pain visual analog scale (VAS), patient's global assessment of disease activity VAS scale, Physician's global assessment of disease activity VAS scale, Health Assessment Questionnaire and C-reactive protein)
Week 14
Secondary Outcomes (4)
American College of Rheumatology (ACR) 50 Response at Week 14
Week 14
Disease Activity Index Score 28 (DAS 28) (Using C-reactive Protein) Response at Week 14
Week 14
American College of Rheumatology (ACR) 20 at Week 24
From Baseline to Week 24
Health Assessment Questionnaire (HAQ) Score at Week 24
From Baseline to Week 24
Study Arms (3)
Group 1: Placebo
PLACEBO COMPARATORPlacebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); Golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; Golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); 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-24 database lock.
Group 2: Golimumab 50 mg
EXPERIMENTALGolimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); Golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 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-24 database lock.
Group 3: Golimumab 100 mg
EXPERIMENTALGolimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period will be until the week-24 database lock.
Interventions
Eligibility Criteria
You may qualify if:
- Patients have a diagnosis of rheumatoid arthritis (RA) (according to the revised 1987 criteria of the ACR) for at least 3 months 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
- Must have been previously treated with at least one dose of etanercept, adalimumab, or infliximab
- If currently using methotrexate, sulfasalazine and/or hydroxychloroquine must have tolerated these agents for at least 12 weeks and be on a stable dose for at least 4 weeks prior to the first administration of study agent
- If using NSAIDs or other analgesics must be on a stable dose for at least 2 weeks prior to the first administration of study agent
- 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.
You may not qualify if:
- Patients cannot have other inflammatory diseases other than RA that might interfere with the evaluation of the benefit of golimumab therapy
- No history of treatment with natalizumab, rituximab or cytotoxic agents
- No history of demyelinating diseases such as multiple sclerosis or optic neuritis or of concurrent congestive heart failure (CHF), lymphoproliferative disease, known malignancy or history of malignancy within the previous 5 years (with the exception of a nonmelanoma skin cancer that has been treated with no evidence of recurrence)
- No history of, or ongoing, chronic or recurrent infectious disease
- No serious infection within 2 months prior to first administration of study agent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centocor, Inc.lead
- Schering-Ploughcollaborator
Study Sites (77)
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Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Paradise Valley, Arizona, United States
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La Jolla, California, United States
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Los Angeles, California, United States
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Santa Monica, California, United States
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Torrance, California, United States
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Upland, California, United States
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Trumbull, Connecticut, United States
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Aventura, Florida, United States
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Jacksonville, Florida, United States
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Jupiter, Florida, United States
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Largo, Florida, United States
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Palm Harbor, Florida, United States
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Tamarac, Florida, United States
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Moline, Illinois, United States
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Springfield, Illinois, United States
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Cedar Rapids, Iowa, United States
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Witchita, Kansas, United States
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Louisville, Kentucky, United States
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Wheaton, Maryland, United States
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Boston, Massachusetts, United States
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Rochester, Minnesota, United States
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St Louis, Missouri, United States
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Syracuse, New York, United States
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Charlotte, North Carolina, United States
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Wilmington, North Carolina, United States
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Cincinnati, Ohio, United States
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Mayfield, Ohio, United States
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Duncansville, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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West Reading, Pennsylvania, United States
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Knoxville, Tennessee, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Lubbock, Texas, United States
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Arlington, Virginia, United States
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Spokane, Washington, United States
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Brookfield, Wisconsin, United States
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Racine, Wisconsin, United States
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Adelaide, Australia
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Cotton Tree, Australia
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Melbourne, Australia
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Graz, Austria
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Lainz/Wien N/A, Austria
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Vienna, Austria
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Victoria, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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St. John's, Newfoundland and Labrador, Canada
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Kitchener, Ontario, Canada
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Newmarket, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Sainte-Foy, Quebec, Canada
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Claire, Canada
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Helsinki, Finland
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Hyvinkää, Finland
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Jyvalskyla, Finland
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Baden-Baden, Germany
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Berlin, Germany
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Cologne, Germany
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Erlangen, Germany
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Hamburg, Germany
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Herne, Germany
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München, Germany
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Vogelsang-Gommern, Germany
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Würzburg, Germany
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Maastricht, Netherlands
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Auckland, New Zealand
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Rotorua, New Zealand
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Timaru, New Zealand
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Santander, Spain
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Seville, Spain
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Valencia, Spain
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Leeds, United Kingdom
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London, United Kingdom
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Oxford, United Kingdom
Related Publications (4)
Vieira MC, Zwillich SH, Jansen JP, Smiechowski B, Spurden D, Wallenstein GV. Tofacitinib Versus Biologic Treatments in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors: Results From a Network Meta-analysis. Clin Ther. 2016 Dec;38(12):2628-2641.e5. doi: 10.1016/j.clinthera.2016.11.004. Epub 2016 Nov 24.
PMID: 27889300DERIVEDKay 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.
PMID: 27803138DERIVEDSmolen JS, Kay J, Doyle M, Landewe R, Matteson EL, Gaylis N, Wollenhaupt J, Murphy FT, Xu S, Zhou Y, Hsia EC. Golimumab in patients with active rheumatoid arthritis after treatment with tumor necrosis factor alpha inhibitors: findings with up to five years of treatment in the multicenter, randomized, double-blind, placebo-controlled, phase 3 GO-AFTER study. Arthritis Res Ther. 2015 Jan 22;17(1):14. doi: 10.1186/s13075-015-0516-6.
PMID: 25627338DERIVEDSmolen JS, Kay J, Doyle MK, Landewe R, Matteson EL, Wollenhaupt J, Gaylis N, Murphy FT, Neal JS, Zhou Y, Visvanathan S, Hsia EC, Rahman MU; GO-AFTER study investigators. Golimumab in patients with active rheumatoid arthritis after treatment with tumour necrosis factor alpha inhibitors (GO-AFTER study): a multicentre, randomised, double-blind, placebo-controlled, phase III trial. Lancet. 2009 Jul 18;374(9685):210-21. doi: 10.1016/S0140-6736(09)60506-7. Epub 2009 Jun 26.
PMID: 19560810DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The count of patients with any nonserious adverse events (NAE) excludes patients who only had NAE that occurred in \<= 5% of patients. This information may vary from existing approved labeling and publications due to the requirement of this website.
Results Point of Contact
- Title
- Associate Director Clinical Research
- Organization
- Centocor Research & Development, Inc.
Study Officials
- STUDY DIRECTOR
Centocor, Inc. Clinical Trial
Centocor, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2006
First Posted
March 7, 2006
Study Start
February 1, 2006
Primary Completion
August 1, 2007
Study Completion
May 1, 2012
Last Updated
February 27, 2014
Results First Posted
September 28, 2011
Record last verified: 2014-01