Clinical Trials Logo
  1. Home
  2. Chronic Plaque Psoriasis
  3. NCT00794807

Safety and Tolerability of Repeat Courses of IM Alefacept

Chronic Plaque Psoriasis Clinical Trial

Official title:
A 12-Week Open-Label Followed by 4-Week Double-Blind Study to Determine the Safety and Efficacy of an Extended Course of Alefacept (LFA-3/IgG1 Fusion Protein) in Subjects With Chronic Plaque Psoriasis

Clinical Trial Summary

Previous Biogen studies have provided experience with the tolerability, immunogenicity, and efficacy of a single and multiple 12-week courses of therapy of alefacept. At this stage, experience in larger studies, as well as the FDA-approved labeling, is confined to treatment courses of 12 weeks. The purpose of the present study is to offer an extended course of therapy with alefacept.

Clinical Trial Description

Twenty statistically matched patients (15 males, 5 females, aged between 28 and 70 years, median 50 years) with moderate to severe psoriasis (PASI: 7-36) were included in this study. They were treated with 15 mg alefacept i.m. weekly. Peripheral blood was taken prior to first alefacept application and then weekly until week five and thereafter every second week, until the end of treatment at week 13. At the same time points severity of disease and thereby possible reduction of symptoms was evaluated applying the PASI. Investigators analysing the samples were blinded to the outcome of the study. The protocol concerning human subjects was approved by the ethics commission of the Charité University Medicine Berlin Campus Mitte, Germany . ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00794807
Study type Interventional
Source Charite University, Berlin, Germany
Contact
Status Completed
Phase Phase 4
Start date February 2004
Completion date December 2005
View Details
See also
  Status Clinical Trial Phase
Completed NCT03598790 - A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis Phase 3
Completed NCT00799877 - Chronic Plaque Psoriasis (Ps) Registry
Completed NCT02581345 - Phase 3 Study of M923 and Humira® in Subjects With Chronic Plaque-type Psoriasis Phase 3
Withdrawn NCT01200264 - Apremilast for Chronic Plaque Psoriasis (CPP) Patients Who Have Failed One Course of Biologic Therapy Phase 2
Terminated NCT00972543 - Raptiva in Palm and Sole Psoriasis Phase 4
Not yet recruiting NCT00707070 - Combining Acitretin and Efalizumab in the Therapy of Chronic Plaque Psoriasis Phase 4
Completed NCT00539929 - Paired-Comparison Study Evaluating the Efficacy and Safety of E6201 Versus Vehicle for the Treatment of Plaque-Type Psoriasis Phase 2
Completed NCT02852967 - A Phase 2, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Belumosudil in Subjects With Moderate/Severe Chronic Plaque Psoriasis Phase 2
Completed NCT00770965 - Phase II Efficacy Study Looking at a Single-dose of One of Three Dose Levels of AIN457 in Patients With Chronic Plaque-type Psoriasis Phase 2
Active, not recruiting NCT06011733 - A Study to Evaluate the Efficacy and Safety of Bimekizumab in Chinese Adult Study Participants With Moderate to Severe Plaque Psoriasis Phase 3
Completed NCT00245765 - Efficacy Study of CDP870 in Subjects With Chronic Plaque Psoriasis Who Are Candidate for Systemic Therapy and/or Phototherapy/Photochemotherapy Phase 2
Completed NCT00673556 - A Study to Assess the Efficacy and Safety of Alefacept in Psoriasis Patients for Whom Conventional Treatment is Ineffective or Inappropriate Phase 3
Terminated NCT00844363 - Narrowband UVB Phototherapy in the Treatment of Psoriasis Vulgaris N/A
Completed NCT00574249 - Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment Phase 3
Completed NCT00512187 - Moderate Weight Loss Makes Obese Patients With Severe Chronic Plaque Psoriasis Responsive to Sub-Optimal Dose of Cyclosporine: an Investigator Blinded, Controlled, Randomized Clinical Trial Phase 4
Completed NCT02570750 - The Effect Of Smoking Status Of The Patient On The Success Of Etanercept Therapy In Psoriasis
Completed NCT00438360 - Efficacy and Safety of Cyclosporine A Microemulsion in Maintenance Patients With Chronic Plaque Psoriasis Phase 3
Active, not recruiting NCT03897075 - Efficacy and Safety Study of Tildrakizumab in the Treatment of Nail Psoriasis Phase 3
Completed NCT01358578 - Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe, Chronic Plaque-Type Psoriasis Phase 3
Completed NCT03536884 - A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis Phase 3