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Sponsors and Collaborators: |
Schering-Plough Integrated Therapeutics Group |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00367237 |
This study is undertaken to compare the efficacy and onset of action of infliximab plus methotrexate versus methotrexate alone in methotrexate naïve active psoriatic arthritis patients.
Condition | Intervention | Phase |
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Arthritis, Psoriatic |
Drug: Infliximab + methotrexate Drug: Methotrexate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Multicenter, International, Open-Label Study of Infliximab Plus Methotrexate Versus Methotrexate (MTX) Alone for the Treatment of MTX naïve Subjects With Active Psoriatic Arthritis |
Estimated Enrollment: | 243 |
Study Start Date: | May 2006 |
Study Completion Date: | March 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group 1, Remicade + MTX: Experimental
Remicade 5 mg/kg infusions at Weeks 0, 2, 6, 14 and oral methotrexate 15 mg/week
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Drug: Infliximab + methotrexate
Infliximab 5 mg/kg infusion at Weeks 0, 2, 6, 14 and oral methotrexate 15 mg/week for 16 weeks. Methotrexate dose can be increased to 20 mg/week at week 6.
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Group 2, MTX: Active Comparator
Oral methotrexate 15 mg/week
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Drug: Methotrexate
Oral methotrexate 15 mg/week for 15 weeks. Dose can be increased to 20 mg/week at Week 6.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Diagnosis of Psoriatic Arthritis with peripheral polyarticular involvement. Patients will have at least one of the following:
Active disease at the time of screening and prior to receiving the baseline study medication(s) as defined by:
and one out of the following three categories:
The screening laboratory tests must beet the following criteria:
Exclusion Criteria:
Responsible Party: | Schering-Plough ( Maarten Kraan, PhD - Senior Global Medical Director, Global Medical Affairs ) |
Study ID Numbers: | P04422, EUDRACT #: 2005-002189-12 |
Study First Received: | August 18, 2006 |
Last Updated: | May 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00367237 |
Health Authority: | Russia: Pharmacological Committee, Ministry of Health; Estonia: The State Agency of Medicine; Lithuania: State Medicine Control Agency - Ministry of Health; Egypt: Ministry of Health and Population; Israel: Israeli Health Ministry Pharmaceutical Administration; Poland: Ministry of Health; Slovakia: State Institute for Drug Control; Hungary: National Institute of Pharmacy; Romania: State Institute for Drug Control; Bulgaria: Ministry of Health; Croatia: Ministry of Health and Social Care; Slovenia: Agency for Medicinal Products - Ministry of Health; Turkey: Ministry of Health; South Africa: National Health Research Ethics Council; Qatar: Hamad Medical Corporation, Rheumatology Divison-Doha |
Spinal Diseases Skin Diseases Arthritis, Psoriatic Infliximab Joint Diseases Spondylarthropathy Bone Diseases Folic Acid |
Musculoskeletal Diseases Psoriasis Arthritis Methotrexate Spondylarthritis Skin Diseases, Papulosquamous Spondylarthropathies |
Anti-Inflammatory Agents Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Gastrointestinal Agents Enzyme Inhibitors Reproductive Control Agents |
Abortifacient Agents, Nonsteroidal Folic Acid Antagonists Immunosuppressive Agents Pharmacologic Actions Therapeutic Uses Abortifacient Agents Antirheumatic Agents Dermatologic Agents Nucleic Acid Synthesis Inhibitors |