- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00361335
A Study of Safety and Effectiveness of Golimumab in Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy
A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Buenos Aires, Argentina
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Cordoba, Argentina
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Rosario, Argentina
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San Juan, Argentina
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San Miguel De Tucuman, Argentina
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Santa Fe, Argentina
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Fitzroy, Australia
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Heidelberg, Australia
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Maroochydore, Australia
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Melbourne, Australia
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Perth, Australia
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Woodville, Australia
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Barranquilla, Colombia
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Bogota, Colombia
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Bucaramanga, Colombia
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Floridablanca, Colombia
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Erlangen, Germany
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Hamburg, Germany
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Magdeburg, Germany
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München, Germany
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Budapest, Hungary
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Szolnok, Hungary
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Daugavpils, Latvia
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Riga, Latvia
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Kaunas, Lithuania
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Klaipeda, Lithuania
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Siauliai, Lithuania
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Vilnius, Lithuania
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Ipoh, 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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Msd06 Gwardiamangia, Malta
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Col. Del Valle, Mexico
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Guadalajara Jalisco, Mexico
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Guadalajara N/A, Mexico
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Monterrey, Mexico
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Christchurch, New Zealand
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Dunedin, New Zealand
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Rotorua, New Zealand
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Takapuna Auckland, New Zealand
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Timaru, New Zealand
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Lima, Peru
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Bialystok, Poland
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Elblag, Poland
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Krakow, Poland
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Warszawa, Poland
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Wloszczowa, Poland
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Kiev, Ukraine
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Kyiv, Ukraine
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Symferpol, Ukraine
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Zhaporizhzhya, Ukraine
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Arizona
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Peoria, Arizona, United States
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Florida
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Aventura, Florida, United States
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Orlando, Florida, United States
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Tampa, Florida, United States
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Georgia
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Atlanta, Georgia, United States
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Nebraska
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Lincoln, Nebraska, United States
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Omaha, Nebraska, United States
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New Jersey
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Voorhees, New Jersey, United States
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New York
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Albany, New York, United States
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Roslyn, New York, United States
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North Carolina
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Charlotte, North Carolina, United States
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Oklahoma
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Oklahoma City, Oklahoma, United States
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Pennsylvania
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Duncansville, Pennsylvania, United States
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Norristown, Pennsylvania, United States
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West Reading, Pennsylvania, United States
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Willow Grove, Pennsylvania, United States
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Texas
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Amarillo, Texas, United States
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Fort Worth, Texas, United States
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Lubbock, Texas, United States
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Washington
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Spokane, Washington, United States
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Must have a diagnosis of active rheumatoid arthritis (RA) (according to the revised 1987 criteria of the ARA (American Rheumatism Association) with at least 4 swollen and 4 tender joints for at least 3 months prior to screening - Have been treated with and tolerated methotrexate (MTX) at a dose of at least 15 mg per week for at least 3 months prior to screening - Have been on a stable MTX dose of greater than or equal to 15 mg per week and less than or eual to 25 mg per week for at least 4 weeks prior to screening - If using non steroidal anti-inflammatory agents (such as naproxen) or other pain relievers for RA, must be on a stable dose for at least 2 weeks prior to the first administration of study agent
Exclusion Criteria:
- Participants having known hypersensitivity (severe allergy) to human immunoglobulin proteins or other components of golimumab - Having known clinically serious adverse reaction to a biologic anti-TNF agent - Have had history of latent or active granulomatous infection, including tuberculosis, histoplasmosis, or coccidioidomycosis, prior to screening
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Group I: 2mg/kg Golimumab + MTX
Intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter with early escape (an additional 2mg/kg IV infusion of golimumab) and dose regimen adjustment (switch to 4mg/kg IV golimumab), depending on joint assessment results, at Week 16 and 24, respectively.
The duration of the combined IV treatment period (initial treatment plus early escape and/or dose regimen adjustment) will be a minimum of 48 weeks.
The IV treatment period will be followed by the option of subcutaneous (SC) injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study).
In addition, patients will receive methotrexate (MTX) at the same dose as that before study entry
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2mg/kg or 4mg/kg will be administered as an IV infusion over 30 minutes
Active MTX capsules, filled with microcrystalline cellulose (Avicel PH 102) and a 2.5 mg MTX tablet, will be administered at the same dose as before the study entry.
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Experimental: Group II: 2mg/kg Golimumab only
IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter with early escape (addition of MTX) and dose regimen adjustment (addition of MTX or switch to 4mg/kg IV golimumab), depending on joint assessment results, at Week 16 and 24, respectively.
The duration of the combined IV treatment period (initial treatment plus early escape and/or dose regimen adjustment) will be a minimum of 48 weeks.
The IV treatment period will be followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study).
In addition, patients will receive placebo (sham MTX) capsules
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2mg/kg or 4mg/kg will be administered as an IV infusion over 30 minutes
Placebo solution will be administered through IV infusion in Group V and oral placebo capsules (sham MTX) filled with microcrystalline cellulose (Avicel PH 102) will be administered in Group II and IV.
Other Names:
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Experimental: Group III: 4mg/kg Golimumab + MTX
IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study).
In addition, patients will receive MTX at the same dose as that before study entry.
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2mg/kg or 4mg/kg will be administered as an IV infusion over 30 minutes
Active MTX capsules, filled with microcrystalline cellulose (Avicel PH 102) and a 2.5 mg MTX tablet, will be administered at the same dose as before the study entry.
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Experimental: Group IV: 4mg/kg Golimumab only
IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter with early escape (addition of MTX) and dose regimen adjustment (addition of MTX), depending on joint assessment results, at Week 16 and 24, respectively.
The duration of the combined IV treatment period (initial treatment plus early escape and/or dose regimen adjustment) will be a minimum of 48 weeks.
The IV treatment period will be followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study).
In addition, patients will receive placebo (sham MTX) capsules.
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2mg/kg or 4mg/kg will be administered as an IV infusion over 30 minutes
Placebo solution will be administered through IV infusion in Group V and oral placebo capsules (sham MTX) filled with microcrystalline cellulose (Avicel PH 102) will be administered in Group II and IV.
Other Names:
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Placebo Comparator: Group V: IV Placebo + MTX
IV infusions of placebo at Week 0 and Week 12 with early escape (switch to 4mg/kg IV golimumab) and dose regimen adjustment (switch to 4mg/kg IV golimumab), depending on joint assessment results, at Week 16 and 24, respectively.
The duration of the combined IV treatment period (placebo plus golimumab) will be a minimum of 48 weeks.
The IV treatment period will be followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study).
In addition patients will receive MTX at the same dose as that before study entry.
Participants still receiving placebo injections at Week 48 are not eligible to enter the Extension Study.
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Active MTX capsules, filled with microcrystalline cellulose (Avicel PH 102) and a 2.5 mg MTX tablet, will be administered at the same dose as before the study entry.
Placebo solution will be administered through IV infusion in Group V and oral placebo capsules (sham MTX) filled with microcrystalline cellulose (Avicel PH 102) will be administered in Group II and IV.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 14
Time Frame: Week 0 to Week 14
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An ACR 50 response is defined as a greater than or equal to 50 percentage 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).
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Week 0 to Week 14
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 24
Time Frame: Week 0 to Week 24
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ACR 50 response is an improvement of greater than or equal to 50 percentage from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain, patient's global assessemnt of disease activity, Physician's global assessment of disease activity (based on a scale of 0=no disease to 10=severe disease), HAQ (20 questions on life activities) and CRP blood test to measure inflammation).
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Week 0 to Week 24
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Number of Participants With an American College of Rheumatology (ACR) 20 Response at Week 14
Time Frame: Week 0 to Week 14
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ACR 20 response is an improvement of greater than or equal to 20 percentage from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain, patient's global assessemnt of disease activity, Physician's global assessment of disease activity [based on a scale of 0=no disease to 10=severe disease), HAQ (20 questions on life activities] and CRP blood test to measure inflammation).
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Week 0 to Week 14
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Number of Participants With a Disease Activity Index Score 28 (Using C-reactive Protein)Moderate or Good Response at Week 14
Time Frame: Week 0 to Week 14
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DAS28 using CRP is a measure of tender and swollen joints (28 joints each) and the patient's assessment of disease activity.
Values range from 0 (best) to 10 (worst).
A score of higher than 5.1 indicates high disease activity, and a score below 3.2 indicates low disease activity.
A "Good" response is defined as a patient with a DAS28 score of <= 3.2 at Week 14 with improvement from Baseline in DAS28 score of > 1.2.
A "Moderate" response is defined as a patient with DAS28 score of >3.2-5.1 at Week 14 with improvement from baseline in DAS28 score of >1.2 or a DAS28 score of <= 5.1 and improvement from baseline in DAS28 score of >0.6 to 1.2
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Week 0 to Week 14
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Physical Component Summary (PCS) Score of the Short Form-36 (SF-36) at Week 14
Time Frame: Weeks 0 to Week 14
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The SF-36 consists of 8 multi-item scales: limitations in physical functioning due to health problems, usual role activities due to physical health problems, bodily pain, usual role activities due to personal or emotional problems, social functioning due to physical or mental health problems, general mental health (psychological distress and well-being), vitality and general health perception.
The values are 100=best to 0=worst.
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Weeks 0 to Week 14
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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.
- 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.
- Baker JF, Baker DG, Toedter G, Shults J, Von Feldt JM, Leonard MB. Associations between vitamin D, disease activity, and clinical response to therapy in rheumatoid arthritis. Clin Exp Rheumatol. 2012 Sep-Oct;30(5):658-64. Epub 2012 Oct 17.
- Taylor PC, Ritchlin C, Mendelsohn A, Baker D, Kim L, Xu Z, Mack M, Kremer J. Maintenance of efficacy and safety with subcutaneous golimumab among patients with active rheumatoid arthritis who previously received intravenous golimumab. J Rheumatol. 2011 Dec;38(12):2572-80. doi: 10.3899/jrheum.110570. Epub 2011 Nov 15.
- Kremer J, Ritchlin C, Mendelsohn A, Baker D, Kim L, Xu Z, Han J, Taylor P. Golimumab, a new human anti-tumor necrosis factor alpha antibody, administered intravenously in patients with active rheumatoid arthritis: Forty-eight-week efficacy and safety results of a phase III randomized, double-blind, placebo-controlled study. Arthritis Rheum. 2010 Apr;62(4):917-28. doi: 10.1002/art.27348. Erratum In: Arthritis Rheum. 2010 Oct;62(10):3130.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Arthritis
- Arthritis, Rheumatoid
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Reproductive Control Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Tumor Necrosis Factor Inhibitors
- Methotrexate
- Golimumab
Other Study ID Numbers
- CR012781
- C0524T12 (Other Identifier: Centocor, Inc.)
- 2005-003232-21 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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