An Effectiveness and Safety Study of Intravenous Golimumab in Patients With Active Rheumatoid Arthritis Despite Treatment With Methotrexate Therapy
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
3 other identifiers
interventional
592
13 countries
88
Brief Summary
The purpose of this study is to evaluate clinical effectiveness and safety of golimumab with methotrexate (MTX) in the treatment of rheumatoid arthritis (RA) when compared to MTX alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2009
Typical duration for phase_3
88 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
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 4, 2009
CompletedFirst Posted
Study publicly available on registry
September 9, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedResults Posted
Study results publicly available
October 14, 2013
CompletedDecember 25, 2013
November 1, 2013
1.5 years
September 4, 2009
August 8, 2013
November 29, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Participants With an American College of Rheumatology (ACR) 20 Response at Week 14
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.
Week 14
Secondary Outcomes (4)
Proportion of Participants With Moderate or Good Response in Disease Activity Index Score 28 (DAS28) Using C-reactive Protein (CRP) at Week 14
Week 14
Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 14
Week 14
Proportion of Participants Who Achieved American College of Rheumatology (ACR) 50 Response at Week 24
Week 24
Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 24.
Week 24
Study Arms (2)
Group I: Placebo + Methotrexate (MTX)
EXPERIMENTALParticipants 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.
Group II: Golimumab + Methotrexate (MTX)
PLACEBO COMPARATORParticipants 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.
Interventions
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).
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.
Participants will be maintained on their stable dose of commercial MTX (between 15 to 25 mg/week) throughout the study.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centocor, Inc.lead
- Schering-Ploughcollaborator
Study Sites (88)
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Daytona Beach, Florida, United States
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Miami, Florida, United States
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Palm Harbor, Florida, United States
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Moline, Illinois, United States
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Wheaton, Maryland, United States
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Worcester, Massachusetts, United States
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Lincoln, Nebraska, United States
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Cincinnati, Ohio, United States
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Lubbock, Texas, United States
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Buenos Aires, Argentina
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Córdoba, Argentina
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Rosario, Argentina
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San Juan, Argentina
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San Miguel de Tucumán, Argentina
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Santa Fe, Argentina
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Cairns, Australia
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Maroochydore, Australia
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Melbourne, Australia
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Woodville, Australia
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Woolloongabba, Australia
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Antioquia, Colombia
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Barranquilla, Colombia
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Bogotá, Colombia
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Cali Valley Del Cauca, Colombia
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Medellín, Colombia
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Budapest, Hungary
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Debrecen, Hungary
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Eger, Hungary
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Győr, Hungary
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Gyula, Hungary
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Szombathely, Hungary
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Veszprém, Hungary
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Alytus, Lithuania
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Kaunas, Lithuania
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Klaipėda, Lithuania
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Šiauliai, Lithuania
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Vilnius, Lithuania
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George Town, Malaysia
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Ipoh, Malaysia
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Johor Bahru, Malaysia
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Kota Kinabalu, Malaysia
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Kuantan, Malaysia
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Kuching, Malaysia
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Precinct 7, Malaysia
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Selangor Darul Ehasan, Malaysia
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Seremban, Malaysia
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Guadalajara, Mexico
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León, Mexico
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Mexico City, Mexico
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México, Mexico
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Monterrey, Mexico
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Auckland, New Zealand
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Takapuna Auckland, New Zealand
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Timaru, New Zealand
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Bialystok, Poland
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Bydgoszcz, Poland
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Działdowo, Poland
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Elblag, Poland
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Katowice, Poland
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Lublin, Poland
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Poznan, Poland
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Sopot, Poland
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Szczecin, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Włoszczowa, Poland
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Chelyabinsk, Russia
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Krasnoyarsk, Russia
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Moscow, Russia
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Petrozavodsk, Russia
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Saint Petersburg, Russia
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Saratov, Russia
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Yekaterinburg, Russia
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Anyang, South Korea
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Daegu, South Korea
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Daejeon, South Korea
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Incheon, South Korea
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Pusan, South Korea
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Seoul, South Korea
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Donetsk, Ukraine
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Ivano-Frankivsk, Ukraine
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Kharkiv, Ukraine
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Kyiv, Ukraine
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Odesa, Ukraine
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Simferopol, Ukraine
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Ternopil, Ukraine
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Vinnitsa, Ukraine
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Zaporizhzhya, Ukraine
Related Publications (7)
Husni ME, Deodhar A, Schwartzman S, Chakravarty SD, Hsia EC, Leu JH, Zhou Y, Lo KH, Kavanaugh A. Pooled safety results across phase 3 randomized trials of intravenous golimumab in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Arthritis Res Ther. 2022 Mar 21;24(1):73. doi: 10.1186/s13075-022-02753-6.
PMID: 35313978DERIVEDLee JB, Broadwell A, Fan Y, Hu C, Adedokun OJ, Chakravarty SD, Zhou H, Xu Z, Leu JH. Population Pharmacokinetic and Exposure-Response Model Simulations: Predicted Exposure and Efficacy for Maintenance Doses of Intravenous Golimumab Every 6 or 8 Weeks in Patients With Moderately to Severely Active Rheumatoid Arthritis. Clin Ther. 2022 Mar;44(3):457-464.e2. doi: 10.1016/j.clinthera.2022.01.015. Epub 2022 Feb 17.
PMID: 35183373DERIVEDTesser J, Kafka S, DeHoratius RJ, Xu S, Hsia EC, Turkiewicz A. Efficacy and safety of intravenous golimumab plus methotrexate in patients with rheumatoid arthritis aged < 65 years and those >/= 65 years of age. Arthritis Res Ther. 2019 Aug 20;21(1):190. doi: 10.1186/s13075-019-1968-x.
PMID: 31429794DERIVEDStandish KA, Huang CC, Curran ME, Schork NJ. Comprehensive analysis of treatment response phenotypes in rheumatoid arthritis for pharmacogenetic studies. Arthritis Res Ther. 2017 May 12;19(1):90. doi: 10.1186/s13075-017-1299-8.
PMID: 28494788DERIVEDBingham CO 3rd, Mendelsohn AM, Kim L, Xu Z, Leu J, Han C, Lo KH, Westhovens R, Weinblatt ME; GO-FURTHER Investigators. Maintenance of Clinical and Radiographic Benefit With Intravenous Golimumab Therapy in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy: Week-112 Efficacy and Safety Results of the Open-Label Long-Term Extension of a Phase III, Double-Blind, Randomized, Placebo-Controlled Trial. Arthritis Care Res (Hoboken). 2015 Dec;67(12):1627-36. doi: 10.1002/acr.22556.
PMID: 25623393DERIVEDBingham CO 3rd, Weinblatt M, Han C, Gathany TA, Kim L, Lo KH, Baker D, Mendelsohn A, Westhovens R. The effect of intravenous golimumab on health-related quality of life in rheumatoid arthritis: 24-week results of the phase III GO-FURTHER trial. J Rheumatol. 2014 Jun;41(6):1067-76. doi: 10.3899/jrheum.130864. Epub 2014 May 1.
PMID: 24786931DERIVEDWeinblatt ME, Westhovens R, Mendelsohn AM, Kim L, Lo KH, Sheng S, Noonan L, Lu J, Xu Z, Leu J, Baker D, Bingham CO; GO-FURTHER investigators. Radiographic benefit and maintenance of clinical benefit with intravenous golimumab therapy in patients with active rheumatoid arthritis despite methotrexate therapy: results up to 1 year of the phase 3, randomised, multicentre, double blind, placebo controlled GO-FURTHER trial. Ann Rheum Dis. 2014 Dec;73(12):2152-9. doi: 10.1136/annrheumdis-2013-203742. Epub 2013 Sep 3.
PMID: 24001888DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director Clinical Research
- Organization
- Centocor, Inc.
Study Officials
- STUDY DIRECTOR
Centocor, Inc. Clinical Trial
Centocor, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- 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
September 4, 2009
First Posted
September 9, 2009
Study Start
September 1, 2009
Primary Completion
March 1, 2011
Study Completion
February 1, 2013
Last Updated
December 25, 2013
Results First Posted
October 14, 2013
Record last verified: 2013-11