EUCTR2014-004798-17-DE
Active, not recruiting
Phase 1
Evaluation of inflammatory and structural joint damage in patients with psoriasis and psoriatic arthritis treated with secukinumab: A phase 2, single arm, single centre mode of action study (Psoriasis-Arthritis & Bone Program) - PSARTROS
niversitätsklinikum Erlangen0 sites40 target enrollmentMarch 11, 2015
ConditionsPsoriasis or prosiatric arthritisMedDRA version: 18.1Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersMedDRA version: 18.1Level: LLTClassification code 10037154Term: Psoriasis aggravatedSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
DrugsConsentyx
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Psoriasis or prosiatric arthritis
- Sponsor
- niversitätsklinikum Erlangen
- Enrollment
- 40
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Men and women aged 18 years and older
- •Negative urine pregnancy test in females of child\-bearing potential
- •Adequate wash\-out period for subjects previously treated with TNF\-alpha inhibitors or ustekinumab
- •Moderate to severe psoriatric arthritis with symptoms for at least 6 months or moderate to severe psoriasis with inflammatory and/or structural lesions and/or erosions in the MRI/HR\-qCT scan
- •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 30
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 10
Exclusion Criteria
- •Radiological evidence of ongoing infectious or malignant process
- •Intake of high potency opioids
- •Previous exposure to secukinumab or other biological drugs directly targeting the IL\-17 axis
- •Previous cell\-depleting therapies
- •History of any condition which poses an unacceptable risk for receiving an immunomodulatory therapy
- •History of alcohol or drug abuse within the last six months before randomization
Outcomes
Primary Outcomes
Not specified
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