Golimumab in Rheumatoid Arthritis Participants With an Inadequate Response to Etanercept (ENBREL) or Adalimumab (HUMIRA)
A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment With Etanercept (ENBREL) or Adalimumab (HUMIRA)
4 other identifiers
interventional
433
8 countries
117
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of switching rheumatoid arthritis (RA) participants who have an inadequate response to their current treatment with either etanercept + methotrexate or adalimumab + methotrexate to treatment with golimumab 50 milligram (mg) subcutaneous (SC) injection (a needle inserted under the skin in the back of upper arm, upper thigh or stomach area) every 4 weeks + methotrexate. This study is also designed to evaluate the benefit and safety of switching participants from treatment with golimumab 50 mg subcutaneous injection every 4 weeks + methotrexate to golimumab 2 milligram per kilogram (mg/kg) intravenous every 8 weeks + methotrexate, for those who do not achieve a marked improvement of their RA at Week 16.
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 Dec 2009
Typical duration for phase_3
117 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2009
CompletedFirst Posted
Study publicly available on registry
October 30, 2009
CompletedStudy Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedResults Posted
Study results publicly available
May 13, 2014
CompletedApril 30, 2015
April 1, 2015
3.6 years
October 29, 2009
March 13, 2014
April 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving Erythrocyte Sedimentation Rate (ESR)-Based American College of Rheumatology [ACR] 20 Response at Week 14
Erythrocyte Sedimentation Rate (ESR)-based ACR 20 response: greater than or equal to (\>=) 20 percent (%) improvement from Baseline in tender (68 joints assessed) and swollen (66 joints assessed) joint counts and \>=20% improvement from Baseline in 3 of the following 5 assessments: 1- Participant's assessment of pain using Visual Analog Scale (VAS) (0 to 10 centimeters \[cm\]), 2- Participant's global assessment of disease activity using VAS (0 to 10 cm), 3- Physician's global assessment of disease activity using VAS (0 to 10 cm), 4- Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas), 5- ESR.
Week 14
Secondary Outcomes (5)
Percentage of Participants Who Achieved Erythrocyte Sedimentation Rate (ESR)-Based ACR20 Response at Week 2
Within 2 weeks of initiating therapy
Percentage of Participants Who Achieved Erythrocyte Sedimentation Rate (ESR)-Based Disease Activity Score (DAS28) Response at Week 16 and Maintained Response Through Week 52
Week 52
Percentage of Participants Who Achieved Erythrocyte Sedimentation Rate (ESR)-Based ACR20 Response at Week 52 Relative to Week 16
Week 52
Percentage of Participants Who Achieved ESR-based and C-Reactive Protein (CRP)-Based ACR20 Response at Week 76 Relative to Week 16
Week 76
Change in ESR-based DAS28 Score at Week 76 Relative to Week 52
Week 52, 76
Study Arms (5)
Open-label (OL) Overall Group: Golimumab 50 mg SC + MTX
EXPERIMENTALAll enrolled and dosed participants receive golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks + Methotrexate (MTX) from Week 0 to Week 12.
Double blind (DB) Group 2a: Golimumab 50mg SC & Placebo IV+MTX
EXPERIMENTALParticipants, who do not achieve Disease Activity Score in 28 joints (DAS28) good response at Week 16, will be randomly assigned to receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48, along with placebo matched to golimumab intravenous infusion (IV) at Week 16, 20, 28, 36, and 44.
DB Group 2b: Golimumab 2mg/kg IV & Placebo SC + MTX
EXPERIMENTALParticipants, who do not achieve DAS28 good response at Week 16, will be randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
OL Group 1: Golimumab 50 mg SC + MTX
EXPERIMENTALParticipants, who achieve DAS28 good response at Week 16, will receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48.
OL Study Extension Group: Golimumab 50 mg SC + MTX
EXPERIMENTALParticipants who complete the main study (Week 0 to Week 52), do not meet lack of efficacy criteria, and participate in the OL study extension, will receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 52 to Week 72.
Interventions
Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks.
Golimumab 2 milligram per kilogram (mg/kg) intravenous infusion every 8 weeks.
Participants will continue taking their current Methotrexate (MTX) treatment regimen.
Placebo matched to golimumab SC injection every 4 weeks.
Placebo matched to golimumab intravenous infusion every 8 weeks.
Eligibility Criteria
You may qualify if:
- Have inadequate RA disease control prior to the first administration of study agent despite treatment with etanercept (Enbrel) + methotrexate or adalimumab (Humira) + methotrexate (MTX)
- Must have received a stable dose of MTX greater than or equal to (\>=) 7.5 milligram (mg) per week to less than or equal to (\<=) 25 mg per week for at least 4 consecutive weeks prior to the first screening visit and must plan to maintain that dose throughout the study
- Participants must have received etanercept or adalimumab in combination with MTX for a minimum of 3 months prior to the first visit
- Negative tuberculosis (TB) test
- Are capable of providing informed consent, which must be obtained prior to any study-related procedures
You may not qualify if:
- Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, or are frequently in contact with individuals who carry active TB infection
- Have inflammatory diseases other than RA, including but not limited to psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, primary Sjogren's or Lyme disease
- Have demonstrated a discernible improvement in disease activity between screening and prior to the first golimumab injection at Week 0
- Have any known malignancy or have a 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)
- Have a history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease such as lymphadenopathy of unusual size or location
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Janssen Biotech, Inc.lead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (117)
Unknown Facility
Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Tuscaloosa, Alabama, United States
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Mesa, Arizona, United States
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Phoenix, Arizona, United States
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Hot Springs, Arkansas, United States
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Little Rock, Arkansas, United States
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Covina, California, United States
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Hemet, California, United States
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Loma Linda, California, United States
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Long Beach, California, United States
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Murrieta, California, United States
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Santa Maria, California, United States
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Santa Monica, California, United States
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Torrance, California, United States
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Van Nuys, California, United States
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Victorville, California, United States
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Whittier, California, United States
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Bridgeport, Connecticut, United States
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Hamden, Connecticut, United States
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Trumbull, Connecticut, United States
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Aventura, Florida, United States
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Fort Lauderdale, Florida, United States
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Jacksonville, Florida, United States
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Naples, Florida, United States
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Orange Park, Florida, United States
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Orlando, Florida, United States
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Palm Harbor, Florida, United States
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Plantation, Florida, United States
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Sarasota, Florida, United States
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Tampa, Florida, United States
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Duluth, Georgia, United States
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Coeur d'Alene, Idaho, United States
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Idaho Falls, Idaho, United States
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Rockford, Illinois, United States
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South Bend, Indiana, United States
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Bettendorf, Iowa, United States
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Kansas City, Kansas, United States
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Bowling Green, Kentucky, United States
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Monroe, Louisiana, United States
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New Orleans, Louisiana, United States
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Wheaton, Maryland, United States
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Rochester, Minnesota, United States
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Flowood, Mississippi, United States
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Tupelo, Mississippi, United States
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Clayton, Missouri, United States
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Florissant, Missouri, United States
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Lincoln, Nebraska, United States
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Freehold, New Jersey, United States
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Brooklyn, New York, United States
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Mineola, New York, United States
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Plainview, New York, United States
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Rochester, New York, United States
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Smithtown, New York, United States
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Charlotte, North Carolina, United States
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Greenville, North Carolina, United States
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Hickory, North Carolina, United States
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Wilmington, North Carolina, United States
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Akron, Ohio, United States
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Columbus, Ohio, United States
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Mayfield, Ohio, United States
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Middleburg Heights, Ohio, United States
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Edmond, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Lake Oswego, Oregon, United States
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Bethlehem, Pennsylvania, United States
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Duncansville, Pennsylvania, United States
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West Reading, Pennsylvania, United States
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Wexford, Pennsylvania, United States
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Charleston, South Carolina, United States
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Columbia, South Carolina, United States
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Myrtle Beach, South Carolina, United States
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Hixson, Tennessee, United States
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Jackson, Tennessee, United States
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Kingsport, Tennessee, United States
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Knoxville, Tennessee, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Carrollton, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Arlington, Virginia, United States
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Chesapeake, Virginia, United States
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Seattle, Washington, United States
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Spokane, Washington, United States
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Beckley, West Virginia, United States
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Clarksburg, West Virginia, United States
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Glendale, Wisconsin, United States
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Vienna, Austria
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Brussels, Belgium
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Genk, Belgium
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Ghent, Belgium
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Liège, Belgium
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Merksem, Belgium
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Edmonton, Alberta, Canada
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Kelowna, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Hamilton, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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St. Johns, Canada
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Hamburg, Germany
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Herne, Germany
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München, Germany
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Ratingen, Germany
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Heraklion- Crete, Greece
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Thessalonikis, Greece
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Stockholm, Sweden
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Cannock, United Kingdom
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Leeds, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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Merseyside, United Kingdom
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Newcastle upon Tyne, United Kingdom
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Wigan, United Kingdom
Related Publications (2)
Dehoratius RJ, Brent LH, Curtis JR, Ellis LA, Tang KL. Satisfaction with Subcutaneous Golimumab and its Auto-Injector among Rheumatoid Arthritis Patients with Inadequate Response to Adalimumab or Etanercept. Patient. 2018 Jun;11(3):361-369. doi: 10.1007/s40271-018-0297-5.
PMID: 29427176DERIVEDHuffstutter JE, Kafka S, Brent LH, Matucci-Cerinic M, Tang KL, Chevrier M, Sprabery T, DeHoratius RJ. Clinical response to golimumab in rheumatoid arthritis patients who were receiving etanercept or adalimumab: results of a multicenter active treatment study. Curr Med Res Opin. 2017 Apr;33(4):657-666. doi: 10.1080/03007995.2016.1277195. Epub 2017 Jan 25.
PMID: 28035867DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Since participants assigned to the double blind groups were non-responders to at least 2 anti-Tumor Necrosis Factors (TNF), thus comprising a very difficult group to treat.
Results Point of Contact
- Title
- Study Director
- Organization
- Janssen Scientific Affairs, LLC
Study Officials
- STUDY DIRECTOR
Janssen Biotech, Inc. Clinical Trial
Janssen Biotech, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- 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
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2009
First Posted
October 30, 2009
Study Start
December 1, 2009
Primary Completion
July 1, 2013
Study Completion
October 1, 2013
Last Updated
April 30, 2015
Results First Posted
May 13, 2014
Record last verified: 2015-04