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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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
|---|---|
|
Experimental: Infliximab + methotrexate (IFX + MTX)
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.
Other Name: Group 1, Remicade + MTX
|
|
Active Comparator: Methotrexate (MTX)
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.
Other Name: Group 2, MTX
|
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: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00367237 History of Changes |
| Other Study ID Numbers: | P04422, EUDRACT #: 2005-002189-12 |
| Study First Received: | August 18, 2006 |
| Results First Received: | March 19, 2009 |
| Last Updated: | December 14, 2009 |
| 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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Arthritis Arthritis, Psoriatic Joint Diseases Musculoskeletal Diseases Spondylarthropathies Spondylarthritis Spondylitis Spinal Diseases Bone Diseases Psoriasis Skin Diseases, Papulosquamous Skin Diseases Methotrexate Infliximab Abortifacient Agents, Nonsteroidal |
Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents |