- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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).
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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North Carolina
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Chapel Hill, North Carolina, Forente stater, 27516
- UNC Dermatology Clinical Trials Unit
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage Change in Endothelial Function Compared to Baseline.
Tidsramme: 6 months
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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%).
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6 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Changes in IL-6 Profile Compared to Baseline
Tidsramme: 6 months
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IL6 average concentration in pg/ml at Baseline compared to end of treatment, 6 months.
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6 months
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Changes in Adiponectin Profile Compared to Baseline
Tidsramme: 24 weeks
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Adiponectin concentration in pg/ml measured at Baseline and end of treatment, 6 months.
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24 weeks
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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Aida Lugo-Somolinos, MD, University of North Carolina, Chapel Hill
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ABBO-0001
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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