- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01320293
Cardiovascular Effects in Psoriasis Patients Treated With Adalimumab.
Effect of Immunomodulatory Therapy With Adalimumab on Endothelial Function in Patients With Moderate to Severe Psoriasis
Severe psoriasis has been demonstrated to be associated with decreased endothelial function and an increase risk of future coronary events. Although systemic therapy with immunomodulatory agents has been shown to improve psoriatic symptoms, its effects on systemic inflammation and endothelial function are unknown.
In this study we want to assess the cardiovascular risks factors, endothelial dysfunction and inflammatory markers before and after treatment of moderate to severe psoriasis with an FDA-approved biologic agent, adalimumab (Humira).
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
North Carolina
-
Chapel Hill, North Carolina, Förenta staterna, 27516
- UNC Dermatology Clinical Trials Unit
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Must understand and voluntarily sign an informed consent form.
- Must be male or female and age 18-55 years at time of consent.
- Must be able to adhere to the study visit schedule and other protocol requirements
- Have chronic plaque psoriasis for more than 6 months with a PASI score of 12 or greater at Baseline.
- Females of childbearing potential (FCBP)‡ must have a negative urine pregnancy test at screening (Visit 1).
- Negative PPD at Screening or 3 months earlier.
- Have not used any biologic treatment for psoriasis in the past 12 months.
Exclusion Criteria:
- Inability to provide voluntary consent
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
- Pregnant, trying to become pregnant or breastfeeding
- Prior diagnosis of coronary artery disease (CAD) or heart disease.
- Systemic fungal infection
- History of past or active mycobacterial infection with any species (including Mycobacterium tuberculosis). Latent Mycobacterium tuberculosis infection as indicated by a positive (more than 15mm induration)Purified Protein Derivative [PPD] skin test. Subjects with a positive PPD skin test and documented completion of treatment for latent TB are eligible. Subjects with a positive PPD skin test and not treated or no documentation of completion of treatment are ineligible.
- History of recurrent bacterial infection (at least 3 major infections resulting in hospitalization and/or requiring intravenous antibiotic treatment within the past 2 years)
- Clinically significant abnormality on the chest x-ray (CXR) at screening. Chest x-rays performed within 3 months prior to start of study drug are acceptable.
- Use of any investigational medication within 4 weeks prior to start of study drug or 5 pharmacokinetic/pharmacodynamic half-lives (whichever is longer)
- History of Human Immunodeficiency Virus (HIV) infection or Hepatitis C
- Positive Hepatitis B Surface antigen at screening
- Malignancy or history of malignancy (except for treated [ie, cured] basal-cell skin carcinomas > 3 years prior to screening)
- History of any demyelinating disorder such as multiple sclerosis.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Adalimumab 40mg
Adalimumab 40 MG/0.8
ML Subcutaneous Solution [HUMIRA] Dose administered every other week for 6 months
|
40mg subcutaneously, every other week for 6 months
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage Change in Endothelial Function Compared to Baseline.
Tidsram: 6 months
|
Percentage change in endothelial function between baseline visit and end of treatment, 6 months.
Endothelial function was measured by percent change in brachial artery diameter after flow mediated dilation (FMD%).
|
6 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Changes in IL-6 Profile Compared to Baseline
Tidsram: 6 months
|
IL6 average concentration in pg/ml at Baseline compared to end of treatment, 6 months.
|
6 months
|
|
Changes in Adiponectin Profile Compared to Baseline
Tidsram: 24 weeks
|
Adiponectin concentration in pg/ml measured at Baseline and end of treatment, 6 months.
|
24 weeks
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Aida Lugo-Somolinos, MD, University of North Carolina, Chapel Hill
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ABBO-0001
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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