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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 12, 2005 | ||||
| Last Updated Date | April 2, 2009 | ||||
| Start Date ICMJE | November 2005 | ||||
| Primary Completion Date | February 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Proportion of patients achieving an ACR 20 response at Week 14, and the change from baseline in total radiographic scores of the hands and feet at Week 24 [ Time Frame: Week 14 and Week 24 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Proportion of subjects achieving an ACR 20 response at Week 14, and the change from baseline in total radiographic scores of the hands and feet at Week 24 | ||||
| Change History | Complete list of historical versions of study NCT00265096 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
ACR 20 response at Week 24; Psoriatic Area and Severity Index (PASI) >= 75% response from baseline to Week 14 in a subset of patients with psoriasis on >= 3% BSA at baseline; HAQ score at Week 24; Physical component summary score of SF-36 at Week 14 [ Time Frame: Week 14 and Week 24 ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
ACR 20 response at Week 24; Psoriatic Area and Severity Index (PASI) >= 75% response from baseline to Week 14 in a subset of subjects with psoriasis on >= 3% BSA at baseline; HAQ score at Week 24; Physical component summary score of SF-36 at Week 14 | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Study of the Safety and Efficacy of Golimumab in Patients With Active Psoriatic Arthritis | ||||
| Official Title ICMJE | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Golimumab, a Fully Human Anti-TNFa MonoclonalAntibody, Administered Subcutaneously in Subjects With Active Psoriatic Arthritis | ||||
| Brief Summary | The purpose of this study is to evaluate the safety and efficacy (improvement of signs and symptoms) of subcutaneous (under the skin) injections of golimumab for the treatment of active psoriatic arthritis (PsA). Efficacy will be measured by reduction in the signs and symptoms of active PsA, including effects on joint pain and swelling, changes on x-ray related to joint damage, psoriasis skin lesions, physical function, and quality of life. |
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| Detailed Description | Anti-tumor necrosis factor (TNF) agents have been shown to be effective in improving arthritis and psoriasis symptoms in patients with active psoriatic arthritis. Golimumab is a new anti-TNFα agent. This is a multicenter, randomized (patients are assigned different treatments based on chance), double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), placebo-controlled, parallel group study comparing safety and efficacy of golimumab 50mg, golimumab 100mg, and placebo subcutaneous injections administered every 4 weeks, in subjects with active PsA. The total duration of treatment is approximately 5 years. In the first portion of the study, some patients will be randomly assigned to receive placebo treatment through the Week 20 injection; others will be assigned to golimumab 50mg or golimumab 100mg groups through the Week 20 injection. There is an "early escape" at Week 16 in the study whereby patients who meet criteria for minimal improvement in their joints will be switched to golimumab if they were on placebo, or have the golimumab dose increased if they were originally assigned to the golimumab 50mg group. At Week 24, the placebo group subjects will switch to golimumab 50mg injections, and all patients will continue receiving in a blinded manner either 50 or 100mg golimumab injections every 4 weeks until the first 52 weeks of data are fully collected on all the subjects (database lock). After this 52-week database lock, everyone will be unblinded to the golimumab dose, and continue to receive golimumab treatment through Week 252 as part of a long-term extension phase of the study, with options for adjusting concomitant PsA medications and/or increasing the dose of golimumab. The study hypothesis is that golimumab will be more effective than placebo both in terms of reducing the signs and symptoms of PsA, as measured by the American College of Rheumatology (ACR) 20 response at Week 14, and inhibiting the amount of damage due to PsA seen on x-rays of the hand and feet at Week 24, while maintaining an acceptable safety profile. Golimumab 50mg, Golimumab 100mg, or placebo injected under the skin every 4 weeks at Weeks 0, 4, 8, 12, 16, and 20, followed by injections of either Golimumab 50mg or Golimumab 100mg every 4 weeks, for approximately 5 years total duration from the time of the first study agent injection. |
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| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Arthritis, Psoriatic | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 405 | ||||
| Estimated Completion Date | January 2012 | ||||
| Primary Completion Date | February 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00265096 | ||||
| Responsible Party | Sr. Director Clinical Research, Centocor Inc. | ||||
| Study ID Numbers ICMJE | CR006340, C0524T08, GO-REVEAL | ||||
| Study Sponsor ICMJE | Centocor, Inc. | ||||
| Collaborators ICMJE | Schering-Plough | ||||
| Investigators ICMJE |
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| Information Provided By | Centocor, Inc. | ||||
| Verification Date | April 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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