Long-Term Effects of Infliximab in the Treatment of Moderate to Severe Psoriasis [Extension of Study P04271] (P04563)

21:17 EST 20th November 2014 | BioPortfolio

Summary

This is a long-term, randomized, multi-center, open-label study of infliximab treatment in adults with moderate to severe plaque-type psoriasis. This study is the long-term extension of Study P04271; Study P04271 is a Phase 3b, randomized, parallel-group, multicenter, open-label, 26-week study comparing the efficacy and safety of infliximab versus methotrexate in the treatment of adult subjects with moderate to severe plaque-type psoriasis. The objectives of this study are to assess the efficacy and safety of long-term maintenance therapy versus intermittent therapy with 5 mg/kg infliximab in a moderate to severe plaque-type psoriasis population.

During an interim safety evaluation of the trial, a higher incidence of serious and severe infusion reactions was observed in the intermittent treatment arm, consisting of a re-induction cycle (maximum of 4 infusions at 0, 2, 6 and 14 weeks) after a period of no treatment compared with the maintenance arm (infusions every 8 weeks without an interruption of treatment). Consequently, the sponsor has terminated the trial. The label will be updated to reflect this new information relating to the use of a re-induction regimen with infliximab.

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, infliximab

Status

Terminated

Source

Schering-Plough

Results (where available)

View Results

Links

Clinical Trials [406 Associated Clinical Trials listed on BioPortfolio]

Dose Optimization of Infliximab in Moderate to Severe Plaque Psoriasis (Study P05315)

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A Study of the Safety and Efficacy of Infliximab in Patients With Psoriasis

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A Study of the Safety and Effectiveness of Infliximab in Patients With Plaque-type Psoriasis

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This is a prospective Phase 4, open-label, non-randomized, observational, multi-center study of infliximab in participants with plaque-type psoriasis to assess the clinical response in rea...

A Study to Evaluate Infliximab in Subjects With Moderate-to-Severe Psoriasis Not Responding to Standard or Biologic Therapy (Study P04612AM4)(COMPLETED)

Subjects with moderate-to-severe chronic psoriasis not responding to standard or biologic therapy will be eligible to enroll in this study. Subjects will receive infliximab infusions (5 m...

PubMed Articles [344 Associated PubMed Articles listed on BioPortfolio]

A5: detectable anti-infliximab antibodies in children treated with infliximab for rheumatic diseases.

Infliximab (IFX) is a monoclonal TNF-alpha inhibiting antibody which is frequently used to treat children with refractory arthritis and uveitis. The most frequent and limiting adverse events are infus...

Ulcerative colitis worsened after Clostridium difficile infection: Efficacy of infliximab.

The incidence of Clostridium difficile (C. difficile) infection (CDI) is 1.8%-5.7% in admitted patients with ulcerative colitis (UC). CDI can worsen UC and increase the risk for colectomy or even deat...

Mucosal Healing Did Not Predict Sustained Clinical Remission in Patients with IBD after Discontinuation of One-Year Infliximab Therapy.

To assess the endoscopic activity and Clinical activity after a one-year period of infliximab therapy and to evaluate the association between mucosal healing and need for retreatment after stopping in...

Infliximab Reverses Suppression of Cholesterol Efflux Proteins by TNF- α : A Possible Mechanism for Modulation of Atherogenesis.

Tumor necrosis factor- (TNF-) α is a proinflammatory proatherogenic cytokine. Infliximab, an anti-TNF- α monoclonal antibody, is effective in treating rheumatoid arthritis. However, its impact on ca...

Tumor Necrosis Factor Inhibitors in Psoriasis: An Update.

Three inhibitors of tumor necrosis factor (TNF) currently are approved for the treatment of psoriasis: etanercept, infliximab, and adalimumab. The other two TNF inhibitors, golimumab and certolizumab ...

Medical and Biotech [MESH] Definitions

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.

A glucocorticoid used topically in the treatment of DERMATITIS; ECZEMA; or PSORIASIS. It may cause skin irritation.

A topical anti-inflammatory glucocorticoid used in DERMATOSES, skin allergies, PSORIASIS, etc.

An anthracene derivative that disrupts MITOCHONDRIA function and structure and is used for the treatment of DERMATOSES, especially PSORIASIS. It may cause FOLLICULITIS.

An oral retinoid used in the treatment of keratotic genodermatosis, lichen planus, and psoriasis. Beneficial effects have also been claimed in the prophylaxis of epithelial neoplasia. The compound may be teratogenic.

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