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| Sponsor: | Schering-Plough |
|---|---|
| Collaborator: |
Integrated Therapeutics Group |
| Information provided by: | Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00367237 |
Purpose
This study is undertaken to compare the efficacy and onset of action of infliximab plus methotrexate (IFX + MTX) versus methotrexate alone (MTX) in methotrexate naïve active psoriatic arthritis patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Arthritis, Psoriatic |
Drug: Infliximab + methotrexate (IFX + MTX) Drug: Methotrexate (MTX) |
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 |
| Enrollment: | 115 |
| 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 |
|---|---|
|
Infliximab + methotrexate (IFX + MTX): Experimental
Remicade (infliximab [IFX]) 5 mg/kg infusions at Weeks 0, 2, 6, 14 and oral methotrexate (MTX) 15 mg/week
|
Drug: Infliximab + methotrexate (IFX + MTX)
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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Methotrexate (MTX): Active Comparator
Oral methotrexate (MTX) 15 mg/week
|
Drug: Methotrexate (MTX)
Oral methotrexate 15 mg/week for 15 weeks. Dose can be increased to 20 mg/week at Week 6.
|
Eligibility| 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:
Contacts and Locations
More Information
| Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
| Study ID Numbers: | P04422, EUDRACT #: 2005-002189-12 |
| Study First Received: | August 18, 2006 |
| Results First Received: | March 19, 2009 |
| Last Updated: | May 21, 2009 |
| ClinicalTrials.gov Identifier: | NCT00367237 History of Changes |
| 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 |
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Anti-Inflammatory Agents Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Infliximab Antineoplastic Agents Physiological Effects of Drugs Reproductive Control Agents Bone Diseases Musculoskeletal Diseases Psoriasis Arthritis Therapeutic Uses Abortifacient Agents |
Methotrexate Spondylarthritis Dermatologic Agents Nucleic Acid Synthesis Inhibitors Spondylarthropathies Spinal Diseases Skin Diseases Arthritis, Psoriatic Joint Diseases Gastrointestinal Agents Enzyme Inhibitors Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Pharmacologic Actions |