One year follow-up of patients treated in Study 1206.5, a 12 week double-blind, randomised, placebo-controlled, modified dose-escalation trial to investigate safety, efficacy, and pharmacokinetics of BIRT 2584XX tablets at doses of 100,300 and 500 mg administered once daily in patients with moderate to severe psoriasis with a 12 week treatment extension for PASI 50 responders.
- Conditions
- The original trial was for psoriasis. The proposed trial is a follow up to patients who received study treatment in that trial which consists only of a physical examination and does not seek to investigate any conditionMedDRA version: 9.1Level: LLTClassification code 10050576Term: Psoriasis vulgaris
- Registration Number
- EUCTR2007-004328-18-GB
- Lead Sponsor
- Boehringer Ingelheim Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
1.Patients who received at least 1 dose of study medication in BI study 1206.5
2. The patient or the patient's legally acceptable representative must be able to give informed consent in accordance with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and local legislation
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Not applicable. All patients who satisfy the Inclusion Criteria are eligible for inclusion into this study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method