The Effects of Infliximab Versus Methotrexate in the Treatment of Moderate to Severe Psoriasis (Study P04271AM2)(COMPLETED)
Summary
This is a Phase 3b, randomized, parallel-group, multicenter, active-controlled, open-label study of the efficacy and safety of infliximab compared with methotrexate (MTX) in the treatment of moderate to severe psoriasis in adults who were diagnosed with moderate to severe plaque-type psoriasis for at least 6 months prior to screening (subjects with concurrent psoriatic arthritis may also be enrolled).
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Psoriasis
Intervention
infliximab, methotrexate
Status
Completed
Source
Schering-Plough
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00251641
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Psoriasis
A common genetically determined, chronic, inflammatory skin disease characterized by rounded erythematous, dry, scaling patches. The lesions have a predilection for nails, scalp, genitalia, extensor surfaces, and the lumbosacral region. Accelerated epidermopoiesis is considered to be the fundamental pathologic feature in psoriasis.
Methotrexate
An antineoplastic antimetabolite with immunosuppressant properties. It is an inhibitor of TETRAHYDROFOLATE DEHYDROGENASE and prevents the formation of tetrahydrofolate, necessary for synthesis of thymidylate, an essential component of DNA.
Desoximetasone
A topical anti-inflammatory glucocorticoid used in DERMATOSES, skin allergies, PSORIASIS, etc.
Halcinonide
A glucocorticoid used topically in the treatment of DERMATITIS; ECZEMA; or PSORIASIS. It may cause skin irritation.
Tetrahydrofolate Dehydrogenase
An enzyme of the oxidoreductase class that catalyzes the reaction 7,8-dihyrofolate and NADPH to yield 5,6,7,8-tetrahydrofolate and NADPH+, producing reduced folate for amino acid metabolism, purine ring synthesis, and the formation of deoxythymidine monophosphate. Methotrexate and other folic acid antagonists used as chemotherapeutic drugs act by inhibiting this enzyme. (Dorland, 27th ed) EC 1.5.1.3.
Clinical Trials
Dose Optimization of Infliximab in Moderate to Severe Plaque Psoriasis (Study P05315)
Patients from an ongoing observational study (P05319) who have a limited (adequate but less than optimal) response to infliximab will be randomized to either increase the frequency of infl...
A Study of the Safety and Efficacy of Infliximab in Patients With Psoriasis
The purpose of this study is to determine if infliximab (anti-TNF) is effective in the treatment of plaque psoriasis.
A Study of the Safety and Effectiveness of Infliximab in Patients With Plaque-type Psoriasis
The purpose of the study is to evaluate the safety and effectiveness of scheduled and as needed treatment of psoriasis with infliximab. Infliximab (Remicade) targets specific proteins in...
The purpose of the study is to compare the effects of methotrexate (MTX) alone or in combination with intravenous (IV) methylprednisolone (MP) or infliximab (IFX) on MRI-detected synovitis...
Psoriasis Longitudinal Assessment and Registry (PSOLAR)
The purpose of this study is to further evaluate the safety of infliximab and ustekinumab in patients with plaque psoriasis, and other overlapping forms of psoriasis (such as plaque psoria...
PubMed Articles
Background: The EXPRESS study demonstrated the initial efficacy of infliximab in psoriasis affecting the skin and nails. Objective: To further assess how patients with a positive initial response to i...
Severe infliximab-induced psoriasis treated with adalimumab switching.
Background Antitumor necrosis factor (anti-TNF) agents are a well-established treatment for various medical conditions, including psoriasis and psoriatic arthritis. However, anti-TNF agents may the...
Drug-induced lupus and autoimmune hepatitis secondary to infliximab for psoriasis.
We describe a case of previously unreported autoimmune hepatitis and lupus-like syndrome induced by infliximab treatment for chronic plaque psoriasis. The condition resolved after withdrawal of inflix...
Psoriasis triggered by infliximab in a patient with Behçet's disease.
PURPOSE: To report a case of psoriasis triggered by anti-tumor necrosis factor-alpha (TNF-α) therapy in a uveitis patient with Behçet's disease. CASE REPORT: A 34-year-old man with established Behç...
Treatment of psoriasis by methotrexate in the era of biotherapies: a study in 21 tunisian patients.
Introduction. We present here results of methotrexate, in term of efficacy and tolerance, administrated in 21 Tunisian patients with severe psoriasis. Methods. It was a retrospective study conducted b...
