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The Influence of Adalimumab on Cardiovascular and Metabolic Risk in Psoriasis (CASTIP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Gregor Holzer, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01088165
First received: March 16, 2010
Last updated: January 18, 2012
Last verified: January 2012
  Purpose

Psoriasis vulgaris is no longer considered as a chronic inflammatory disease restricted to the skin. Evidence has accumulated in the past that psoriasis is a chronic inflammatory systemic disease. As in rheumatoid arthritis, the chronic inflammatory process plays a central role in the pathogenesis of associated comorbidities such as diabetes and cardiovascular disease. Since several years the armamentarium of psoriasis treatment has been broadened by the availability of TNF alpha blockers. These neutralize systemic TNF alpha which not only plays a central role in the pathogenesis of psoriasis but has also been linked to inflammatory pathways in diabetes and cardiovascular disease. While a few studies have investigated the positive effects of TNF alpha blockers on associated cardiovascular disease in rheumatoid arthritis patients, no research data exist on the effects of these therapeutic agents in patients with moderate to severe chronic plaque psoriasis.

The present study aims at determining the effects of adalimumab, a potent and frequently prescribed TNF alpha blocker for the treatment of psoriasis, on different diabetic and cardiovascular risk factors in patients receiving this treatment as a remedy for moderate to severe plaque type psoriasis. The study is designed to explore whether adalimumab is capable to prevent or modulate psoriasis-associated comorbidities by blocking systemic inflammation. The effects of adalimumab will be compared with those of fumaric acids, which represent an established traditional systemic treatment option for moderate to severe psoriasis.

Study hypothesis:

Therapy with adalimumab will lead to an improvement of several parameters that reflect the risk for diabetes and cardiovascular disease in patients with chronic plaque psoriasis due to chronic inflammation. Endothelial dysfunction, as assessed by ultrasound flow mediated dilatation, will serve as primary outcome measure. Other risk factors such as blood lipids, hsCRP, IL-6, endothelial adhesion molecules, parameters of glucose metabolism and carotid intima-media thickness will be secondary outcomes.

Aim:

If adalimumab and/or fumaric acids will show a significant impact on the above mentioned parameters, these findings would offer a new perspective for the long term management of psoriatic patients and their comorbidities.

Study design: Randomized, prospective, controlled, parallel group study

Study population: 66 patients


Condition Intervention Phase
Psoriasis
Cardiovascular Diseases
Diabetes Mellitus, Type 2
Drug: Adalimumab treatment arm
Drug: Fumaric acid esters treatment group
Other: Narrow band UVB radiation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Influence of Adalimumab vs. Fumaric Acid Esters on Cardiovascular and Metabolic Risk Factors in the Therapy of Patients With Moderate to Severe Psoriasis Vulgaris

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • The influence of adalimumab treatment in comparison to treatment with fumaric acid esters on the functional integrity of the endothelium will be monitored by flow mediated dilatation (FMD) [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The measurement of carotid artery intima-media thickness (IMT) by ultrasound will serve as a morphological substrate for evaluating the potential effect of adalimumab on signs of atherosclerosis within the vessel wall [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • Influence of adalimumab in comparison to fumaric acid esters on biochemical cardiovascular and metabolic risk factors [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 66
Study Start Date: May 2010
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adalimumab treatment group Drug: Adalimumab treatment arm
Adalimumab: day 1: 2x40 mg s.c., day 8: 40 mg s.c., thereafter 40 mg s.c. in biweekly intervals
Other Name: Humira, Adalimumab
Other: Narrow band UVB radiation

No reduction of 50% minimum of baseline psoriasis severity index by week 12: additional narrow band UVB radiation, 3x/week until the patients achieve PASI reduction of 75% or greater or over a maximum period of another 12 weeks.

Initial dosage: Fitzpatrick skin phototype I and II: 0,4 J/cm2, III and IV: 0,6), 10% Increments after each radiation

Active Comparator: Fumaric acid esters treatment group Drug: Fumaric acid esters treatment group

First week:FAE mite (DIMETHYL FUMARATE 30mg, ETHYL FUMARATE CALCIUM 87mg, ETHYL FUMARATE ZINC 3mg, ETHYL FUMARATE MAGNESIUM 5mg):day 1 and 2: 0-0-1, day 3 and 4: 1-0-1, day 5-7: 1-1-1).

Week 2: FAE forte (DIMETHYL FUMARATE 120mg ETHYL, FUMARATE CALCIUM 87mg, ETHYL FUMARATE ZINC 3mg, ETHYL FUMARATE MAGNESIUM 5mg)starting with 0-0-1 capsule daily, thereafter weekly increases by on capsule until maximum daily dose 2-2-2. In the event of side effects (in particular, gastrointestinal disturbances or flushing) adaption of the dose (reduction or no increase) depending on the type and severity of the side effect will be performed. If remission occurs at a lower than the maximum dose that dose will be maintained throughout the rest of the study period.

Other Name: Fumaderm
Other: Narrow band UVB radiation

No reduction of 50% minimum of baseline psoriasis severity index by week 12: additional narrow band UVB radiation, 3x/week until the patients achieve PASI reduction of 75% or greater or over a maximum period of another 12 weeks.

Initial dosage: Fitzpatrick skin phototype I and II: 0,4 J/cm2, III and IV: 0,6), 10% Increments after each radiation


  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic severe plaque type psoriasis (PASI <10) requiring systemic treatment. Non-response or contraindication to previous systemic and/or light treatment
  • PASI ≥ 10, BSA ≥ 10
  • Age 18 - 80 years

Exclusion Criteria:

  • Women of childbearing potential not taking contraceptive measures
  • Pregnant or breastfeeding women
  • Patients with a history or ongoing malignancy, chronic infections or autoimmune disease
  • Patients with severe impairment of their general health
  • Patients who are unable to understand or comply with the study protocol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01088165

Contacts
Contact: Gregor Holzer, MD 40400 ext 7701 gregor.holzer@meduniwien.ac.at
Contact: Adrian Tanew, MD 40400 ext 7701 adrian.tanew@meduniwien.ac.at

Locations
Austria
Medical University Vienna Dpt. of Dermatology Recruiting
Vienna, Austria, 1090
Contact: Gregor Holzer, Dr    40400 7702    gregor.holzer@meduniwien.ac.at   
Contact: Adrian Tanew, ao Univ. Prof.    40400 7701    adrian.tanew@meduniwien.ac.at   
Principal Investigator: Gregor Holzer, Dr         
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Adrian Tanew, MD Medical University of Vienna Department of Dermatology
  More Information

No publications provided

Responsible Party: Gregor Holzer, Dr, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01088165     History of Changes
Other Study ID Numbers: CASTIP1
Study First Received: March 16, 2010
Last Updated: January 18, 2012
Health Authority: Austria : Federal Ministry for Labour, Health, and Social Affairs
Austria: Agency for Health and Food Safety
Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
Psoriasis
Cardiovascular Diseases
Diabetes Mellitus, Type 2
Adalimumab
Fumaric acid esters

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Psoriasis
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Skin Diseases
Skin Diseases, Papulosquamous
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014