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| Sponsors and Collaborators: |
Schering-Plough 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 versus methotrexate alone in methotrexate naïve active psoriatic arthritis patients.
| Condition | Intervention | Phase |
|---|---|---|
|
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 |
|---|---|
|
Group 1, Remicade + MTX: Experimental
Remicade 5 mg/kg infusions at Weeks 0, 2, 6, 14 and oral methotrexate 15 mg/week
|
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.
|
|
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.
|
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:
Subjects must confirm that they are practicing adequate contraception: Female subjects of childbearing potential (includes women who are less than
1 year postmenopausal and women who become sexually active during the study) must agree to use a medically accepted method of contraception or be surgically sterilized prior to screening, while receiving protocol-specified medication, and for 6 months after stopping the medication. Acceptable methods of contraception include condoms (male and female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed IUD, oral or injectable hormonal contraceptive, and surgical sterilization (e.g., hysterectomy or tubal ligation).
The screening laboratory tests must beet the following criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| 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 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 Spinal Diseases Immunologic Factors Skin Diseases Arthritis, Psoriatic Infliximab Joint Diseases Spondylarthropathy Folate Folinic Acid Folic Acid Antagonists |
Immunosuppressive Agents Bone Diseases Vitamin B9 Folic Acid Musculoskeletal Diseases Psoriasis Arthritis Methotrexate Antirheumatic Agents Spondylarthritis Skin Diseases, Papulosquamous Spondylarthropathies |
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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 |