- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00265096
A Study of the Safety and Efficacy of Golimumab in Patients With Active Psoriatic Arthritis (GO-REVEAL)
A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFa MonoclonalAntibody, Administered Subcutaneously in Subjects With Active Psoriatic Arthritis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Brussel, Belgium
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Gent, Belgium
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Leuven, Belgium
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Liege, Belgium
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Merksem, Belgium
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Claire, Canada
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Hamilton Ontario, Canada
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Newmarket, Canada
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Saskatoon, Canada
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Vancouver, Canada
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British Columbia
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Victoria, British Columbia, Canada
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Manitoba
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Winnipeg, Manitoba, Canada
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Newfoundland and Labrador
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St. John'S, Newfoundland and Labrador, Canada
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Ontario
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North Bay, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Waterloo, Ontario, Canada
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Quebec
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Montreal, Quebec, Canada
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Sainte Foy, Quebec, Canada
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Sante Foy, Quebec, Canada
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Bialystok, Poland
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Elblag, Poland
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Kalisz, Poland
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Poznan N/A, Poland
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Szczecin, Poland
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Torun, Poland
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Warsaw, Poland
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Warszawa N/A, Poland
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Santiago De Compostela, Spain
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Valencia, Spain
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Glasgow, United Kingdom
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London, United Kingdom
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Middlesbrough, United Kingdom
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Wigan, United Kingdom
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Alabama
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Huntsville, Alabama, United States
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California
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La Jolla, California, United States
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Upland, California, United States
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Florida
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Aventura, Florida, United States
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Idaho
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Coeur D'Alene, Idaho, United States
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Kansas
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Kansas City, Kansas, United States
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Maryland
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Wheaton, Maryland, United States
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Massachusetts
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Worcester, Massachusetts, United States
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Nebraska
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Omaha, Nebraska, United States
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Ohio
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Cincinnati, Ohio, United States
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Mayfield, Ohio, United States
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Oregon
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Lake Oswego, Oregon, United States
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Portland, Oregon, United States
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Pennsylvania
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Duncansville, Pennsylvania, United States
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West Reading, Pennsylvania, United States
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Texas
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Houston, Texas, United States
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Washington
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Edmonds, Washington, United States
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Seattle, 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:
- Psoriatic arthritis (PsA) diagnosed > 6months prior
- Active PsA at the time of screening and at baseline visits, with >= 3 swollen joints and >= 3 tender joints
- Have at least 1 of the PsA subsets (DIP joint arthritis, polyarticular arthritis without rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis)
- Active plaque psoriasis with a lesion >= 2cm in diameter
- Active arthritis despite current disease modifying anti-rheumatic drug (DMARD) or nonsteroidal anti-inflammatory drug (NSAID) therapy
- Stable doses of methotrexate, low-dose corticosteroids, and NSAIDs are permitted.
Exclusion Criteria:
- No prior treatment with biologic anti-TNF agents (infliximab, etanercept, adalimumab)
- No treatment with alefacept or efalizumab within 3 months prior to the first study drug injection
- No DMARDs other than methotrexate, or immunosuppressive drugs within 4 weeks prior to the first study drug injection.
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: 002
golimumab 50 mg sc injs every 4 wks from wk 0 thru 5 yrs (unless early escape at wk 16); golimumab - if early escape, 100mg sc injection every 4 wks beginning wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100mg
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50 mg sc injs every 4 wks from wk 0 thru 5 yrs (unless early escape at wk 16); golimumab - if early escape, 100mg sc injection every 4 wks beginning wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100mg
100 mg sc injections every 4 wks from wk 0 up to 5 yrs
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Experimental: 001
Placebo; golimumab SC injections ever 4 wks thru Wk 20 (unless early escape at wk 16); golimumab - if early escape, 50mg sc injection from wk 16 up to 5 yrs; golimumab -50mg sc injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg
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SC injections ever 4 wks thru Wk 20 (unless early escape at wk 16); golimumab - if early escape, 50mg sc injection from wk 16 up to 5 yrs; golimumab -50mg sc injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg
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Experimental: 003
golimumab 100 mg sc injections every 4 wks from wk 0 up to 5 yrs
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50 mg sc injs every 4 wks from wk 0 thru 5 yrs (unless early escape at wk 16); golimumab - if early escape, 100mg sc injection every 4 wks beginning wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100mg
100 mg sc injections every 4 wks from wk 0 up to 5 yrs
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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American College of Rheumatology (ACR) 20 Response at Week 14
Time Frame: Baseline (Week 0), Week 4, Week 8 and Week 14
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ACR 20 response is an improvement of >= 20% from baseline (baseline measurement is defined as the closest measurement taken prior to or at the time of the initiation of study medication administration) 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 assessment of disease activity, Physician's global assessment of disease activity Visual Analogue Scale [VAS], Health Assessment Questionnaire [HAQ] and C-reactive protein [CRP])
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Baseline (Week 0), Week 4, Week 8 and Week 14
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Change From Baseline in Total Radiographic Scores of the Hands and Feet at Week 24
Time Frame: Baseline and Week 24
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Summary of change from baseline in total van der Heijde-Sharp (vdH-S) score of the hands and feet, as modified for psoriatic arthritis, at Week 24.
The vdH-S score is the sum of joint erosion score and joint-space narrowing (JSN) score.
The total score ranges from 0 to 528 with higher scores indicating more joint damage.
For the change from baseline, positive values show an increase in damage.
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Baseline and Week 24
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Psoriasis Area and Severity Index (PASI) 75 Response at Week 14 in a Subset of Patients With ≥ 3 Percent Body Surface Area (BSA) Psoriasis Skin Involvement at Baseline
Time Frame: Baseline, Week 4, Week 8 and Week 14
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Number of patients (randomized patients with >= 3 percent Body Surface Area [BSA] psoriasis skin involvement at baseline) with Psoriasis Area and Severity Index (PASI) 75 response at Week 14. PASI is the widely used tool for the measurement of severity of psoriasis.
PASI combines the assessment of the severity of lesions and the area affected into a single score in the range of 0 to 72.
Zero (0) means no disease and 72 means maximal disease.
PASI 75 Response at Week 14 means reduction in PASI score by 75 percent at Week 14.
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Baseline, Week 4, Week 8 and Week 14
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Improvement From Baseline in Health Assessment Questionnaire Scores at Week 24
Time Frame: Baseline, Week 4, Week 8, Week 14, Week 16, Week 20 and Week 24
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Summary of improvement from baseline in Health Assessment Questionnaire (HAQ) score at Week (Wk) 24.
This 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living).
Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area based on the worst score from the questions that pertain to that task.
The HAQ score is determined by the average of the 8 scores.
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Baseline, Week 4, Week 8, Week 14, Week 16, Week 20 and Week 24
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Change From Baseline in the Physical Component Summary Score of the 36-item Short Form Health Survey at Week 14
Time Frame: Baseline and Week 14
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The short form health survey (SF-36) is a well-validated and widely used quality-of-life instrument employed in numerous disease states.
It is a self-administered survey that measures eight domains of health including: physical functioning, role limitations due to physical health (role-physical), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems (role-emotional) and general mental health.
Scoring of the SF-36 was based on the SF-36 Manual and Interpretation Guide.
Worst value is 0 and best value is 100.
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Baseline and Week 14
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American College of Rheumatology 20 at Week 24
Time Frame: Baseline, Week 4, Week 8, Week 14, Week 16, Week 20 and Week 24
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Number of Patients who achieved an American College of Rheumatology (ACR) 20 response at Week (Wk) 24. 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, Patient's global assessment of disease activity, Physician's global assessment of disease activity Visual Analogue Scale [VAS], Health Assessment Questionnaire [HAQ] and C-reactive protein [CRP]) |
Baseline, Week 4, Week 8, Week 14, Week 16, Week 20 and Week 24
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Leu JH, Adedokun OJ, Gargano C, Hsia EC, Xu Z, Shankar G. Immunogenicity of golimumab and its clinical relevance in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. Rheumatology (Oxford). 2019 Mar 1;58(3):441-446. doi: 10.1093/rheumatology/key309.
- Kay 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.
- Aletaha D, Alasti F, Smolen JS. Disease activity states of the DAPSA, a psoriatic arthritis specific instrument, are valid against functional status and structural progression. Ann Rheum Dis. 2017 Feb;76(2):418-421. doi: 10.1136/annrheumdis-2016-209511. Epub 2016 Jul 25.
- Kavanaugh A, van der Heijde D, Beutler A, Gladman D, Mease P, Krueger GG, McInnes IB, Helliwell P, Coates LC, Xu S. Radiographic Progression of Patients With Psoriatic Arthritis Who Achieve Minimal Disease Activity in Response to Golimumab Therapy: Results Through 5 Years of a Randomized, Placebo-Controlled Study. Arthritis Care Res (Hoboken). 2016 Feb;68(2):267-74. doi: 10.1002/acr.22576.
- Kavanaugh A, McInnes IB, Mease P, Krueger GG, Gladman D, van der Heijde D, Zhou Y, Lu J, Leu JH, Goldstein N, Beutler A. Clinical efficacy, radiographic and safety findings through 5 years of subcutaneous golimumab treatment in patients with active psoriatic arthritis: results from a long-term extension of a randomised, placebo-controlled trial (the GO-REVEAL study). Ann Rheum Dis. 2014 Sep;73(9):1689-94. doi: 10.1136/annrheumdis-2013-204902. Epub 2014 Apr 19.
- Helliwell PS, Kavanaugh A. Comparison of composite measures of disease activity in psoriatic arthritis using data from an interventional study with golimumab. Arthritis Care Res (Hoboken). 2014 May;66(5):749-56. doi: 10.1002/acr.22204.
- Kavanaugh A, McInnes IB, Krueger GG, Gladman D, Beutler A, Gathany T, Mack M, Tandon N, Han C, Mease P. Patient-reported outcomes and the association with clinical response in patients with active psoriatic arthritis treated with golimumab: findings through 2 years of a phase III, multicenter, randomized, double-blind, placebo-controlled trial. Arthritis Care Res (Hoboken). 2013 Oct;65(10):1666-73. doi: 10.1002/acr.22044.
- Kavanaugh A, van der Heijde D, McInnes IB, Mease P, Krueger GG, Gladman DD, Gomez-Reino J, Papp K, Baratelle A, Xu W, Mudivarthy S, Mack M, Rahman MU, Xu Z, Zrubek J, Beutler A. Golimumab in psoriatic arthritis: one-year clinical efficacy, radiographic, and safety results from a phase III, randomized, placebo-controlled trial. Arthritis Rheum. 2012 Aug;64(8):2504-17. doi: 10.1002/art.34436.
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
- Skin Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Skin Diseases, Papulosquamous
- Spinal Diseases
- Bone Diseases
- Spondylarthropathies
- Spondylarthritis
- Spondylitis
- Psoriasis
- Arthritis
- Arthritis, Psoriatic
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tumor Necrosis Factor Inhibitors
- Antibodies, Monoclonal
- Golimumab
Other Study ID Numbers
- CR006340
- C0524T08 (Other Identifier: Centocor)
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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