Clinical trial NCT01004432: Golimumab in Rheumatoid Arthritis Participants With an Inadequate Response to Etanercept (ENBREL) or Adalimumab (HUMIRA)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Keywords: humira, remicade
rheumatoid arthritis
enbrel failure
humira failure
arthritis
enbrel
Lead sponsor: Janssen Biotech, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2009-10-30
Enrollment: 433
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Detailed description: The study consists of a main study and a voluntary, open-label (participants and researchers are aware about the treatment participants are receiving), 24-week study extension. The main study includes a Screening Run-in Period (Week -6 to Week 0), an Open-label Treatment Period (Week 0 to Week 16), an Open-label or Double-blind Treatment Period (Week 16 to Week 52). The main study also includes a Follow-up Period from Week 52 through Week 64 for those participants who will not participate in the 24-week study extension. Participants, participating in 24-week extension (at Week 52), will receive open-label golimumab SC injections every 4 weeks from Week 52 up to Week 72 and will be followed-up up to Week 88. All eligible participants will initiate the treatment with open-label golimumab SC injection every 4 weeks up to Week 12. At Week 16, depending upon the treatment response either participants will continue to receive open-label golimumab SC injection every 4 weeks up to Week 48 or participants will be randomly assigned to receive following 2 treatments: 1- golimumab 50mg SC injection every 4 weeks along with placebo intravenous infusion every 8 weeks through Week 48; 2- Placebo SC injection every 4 weeks along with golimumab 2mg/kg intravenous infusion every 8 weeks through Week 48. At Week 52, participants who choose to participate in the 24-week study extension will receive open-label golimumab 50 mg SC injections every 4 weeks through Week 72. Participants' safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of Participants Achieving Erythrocyte Sedimentation Rate (ESR)-Based American College of Rheumatology [ACR] 20 Response at Week 14
timeFrame: Week 14
Secondary outcomes:
measure: Percentage of Participants Who Achieved Erythrocyte Sedimentation Rate (ESR)-Based ACR20 Response at Week 2
timeFrame: Within 2 weeks of initiating therapy
measure: Percentage of Participants Who Achieved Erythrocyte Sedimentation Rate (ESR)-Based Disease Activity Score (DAS28) Response at Week 16 and Maintained Response Through Week 52
timeFrame: Week 52
measure: Percentage of Participants Who Achieved Erythrocyte Sedimentation Rate (ESR)-Based ACR20 Response at Week 52 Relative to Week 16
timeFrame: Week 52
measure: Percentage of Participants Who Achieved ESR-based and C-Reactive Protein (CRP)-Based ACR20 Response at Week 76 Relative to Week 16
timeFrame: Week 76
measure: Change in ESR-based DAS28 Score at Week 76 Relative to Week 52
timeFrame: Week 52, 76
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Tuscaloosa
country: United States
state: Alabama
city: Mesa
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Hot Springs
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: Covina
country: United States
state: California
city: Hemet
country: United States
state: California
city: Loma Linda
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Murrieta
country: United States
state: California
city: Santa Maria
country: United States
state: California
city: Santa Monica
country: United States
state: California
city: Torrance
country: United States
state: California
city: Van Nuys
country: United States
state: California
city: Victorville
country: United States
state: California
city: Whittier
country: United States
state: California
city: Bridgeport
country: United States
state: Connecticut
city: Hamden
country: United States
state: Connecticut
city: Trumbull
country: United States
state: Connecticut
city: Aventura
country: United States
state: Florida
city: Fort Lauderdale
country: United States
state: Florida
city: Jacksonville
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state: Florida
city: Naples
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state: Florida
city: Orange Park
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Palm Harbor
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state: Florida
city: Plantation
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state: Florida
city: Sarasota
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state: Florida
city: Tampa
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state: Florida
city: Duluth
country: United States
state: Georgia
city: Coeur D'Alene
country: United States
state: Idaho
city: Idaho Falls
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state: Idaho
city: Rockford
country: United States
state: Illinois
city: South Bend
country: United States
state: Indiana
city: Bettendorf
country: United States
state: Iowa
city: Kansas City
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state: Kansas
city: Bowling Green
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state: Kentucky
city: Monroe
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state: Louisiana
city: New Orleans
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state: Louisiana
city: Wheaton
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state: Maryland
city: Rochester
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state: Minnesota
city: Flowood
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state: Mississippi
city: Tupelo
country: United States
state: Mississippi
city: Clayton
country: United States
state: Missouri
city: Florissant
country: United States
state: Missouri
city: Lincoln
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state: Nebraska
city: Freehold
country: United States
state: New Jersey
city: Brooklyn
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state: New York
city: Mineola
country: United States
state: New York
city: Plainview
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Smithtown
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Greenville
country: United States
state: North Carolina
city: Hickory
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Akron
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Mayfield
country: United States
state: Ohio
city: Middleburg Heights
country: United States
state: Ohio
city: Edmond
country: United States
state: Oklahoma
city: Oklahoma City
country: United States
state: Oklahoma
city: Lake Oswego
country: United States
state: Oregon
city: Bethlehem
country: United States
state: Pennsylvania
city: Duncansville
country: United States
state: Pennsylvania
city: West Reading
country: United States
state: Pennsylvania
city: Wexford
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Columbia
country: United States
state: South Carolina
city: Myrtle Beach
country: United States
state: South Carolina
city: Hixson
country: United States
state: Tennessee
city: Jackson
country: United States
state: Tennessee
city: Kingsport
country: United States
state: Tennessee
city: Knoxville
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Carrollton
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Arlington
country: United States
state: Virginia
city: Chesapeake
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Beckley
country: United States
state: West Virginia
city: Clarksburg
country: United States
state: West Virginia
city: Glendale
country: United States
state: Wisconsin
city: Vienna
country: Austria
city: Brussel
country: Belgium
city: Genk
country: Belgium
city: Gent
country: Belgium
city: Liège
country: Belgium
city: Merksem
country: Belgium
city: Edmonton
country: Canada
state: Alberta
city: Kelowna
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: Hamilton
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Quebec
country: Canada
city: St Johns
country: Canada
city: Hamburg
country: Germany
city: Herne
country: Germany
city: München
country: Germany
city: Ratingen
country: Germany
city: Heraklion- Crete
country: Greece
city: Thessalonikis
country: Greece
city: Stockholm
country: Sweden
city: Cannock
country: United Kingdom
city: Leeds
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Merseyside
country: United Kingdom
city: Newcastle Upon Tyne
country: United Kingdom
city: Wigan
country: United Kingdom
Study officials:
affiliation: Janssen Biotech, Inc.
name: Janssen Biotech, Inc. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Huffstutter 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.