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Efficacy and Safety of Adalimumab in Patients With Psoriasis and Obstructive Sleep Apnea

Information source: Innovaderm Research Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Psoriasis; Sleep Apnea, Obstructive

Intervention: Adalimumab (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Innovaderm Research Inc.

Official(s) and/or principal investigator(s):
Robert Bissonnette, MD, FRCPC, Principal Investigator, Affiliation: Innovaderm Research Inc.

Summary

This study will evaluate the effect and safety of adalimumab in approximately 20 subjects with mild to moderate psoriasis and sleep apnea and will be conducted in one treatment center located in Montreal. Patients with psoriasis often have additional disorders such as obesity. Obese patients are more at risk of developing obstructive sleep apnea. This is believed to be caused by both the collapse of upper airways and inflammation (swelling). Adalimumab, a drug currently approved by Health Canada for the treatment of psoriasis, blocks tumor necrosis factor-alpha (TNF-alpha). This chemical is present at higher levels in patients with sleep apnea. It is believed that adalimumab could improve obstructive sleep apnea by lowering the levels of TNF-alpha.

Clinical Details

Official title: Efficacy and Safety of Adalimumab in Patients With Psoriasis and Obstructive Sleep Apnea

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Number of sleep apnea per hour.

Secondary outcome:

Sleep maintenance efficiency

Total wake time

Percentage of sleep time

Time spent in REM (rapid eye movement) stage.

Time spent in sleep stage N1

Time spent in sleep stage N3

REM (rapid eye movement) latency time

Minimum overnight oxygen saturation index

Oxygen desaturation index

Sleep related quality of life questionnaire (FOSQ)

Epworth sleepiness scale

Daytime sleep latency

Safety of adalimumab

Body surface area (BSA)

Physician's Global Assessment (PGA)

Psoriatic Area and Severity Index (PASI)

PASI 75 (75% reduction in Psoriatic Area and Severity Index)

Proportion with PGA (Physician's Global Assessment) of 0 or 1

Time to sleep induction

Time spent in sleep stages N2

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Men or women are 18 to 80 years of age at time of consent.

- Has at least a 6-month history of chronic moderate to severe psoriasis and is a

candidate for systemic therapy.

- Has a body surface area (BSA) covered with psoriasis of at least 5% or more at Day 0.

- Has a diagnosis of obstructive sleep apnea confirmed by at least 15 episodes/hour of

apnea/hypopnea at the polysomnographic testing on Day - 2.

- Unless surgically sterile (or at least 1 year post-menopausal), or abstinent, patient

(female) is willing to use an effective method of contraception for at least 30 (90 for "c") days before Day 0 and until at least 6 months after the last drug administration. Effective method of contraception are:

- Condom with spermicidal foam, cream or gel, sponge with spermicidal foam, cream

or gel, diaphragm with spermicidal foam, cream or gel

- Intra uterine device (IUD)

- Contraceptives (oral or parenteral)

- Nuvaring

- Vasectomised partner

- Same-sex partner

- Negative serum pregnancy test at the screening visit for female patient of

childbearing potential only.

- Patient is judged not to have contraindications to adalimumab as determined by the

principal investigator based upon the results of medical history, laboratory profile, physical examination and chest X-ray performed at screening.

- Patient will be evaluated for latent tuberculosis (TB) infection with a purified

protein derivative (PPD) or a QuantiFERON-TB Gold test and Chest X-Ray (CXR). All patients who previously received TB immunization (BCG vaccination) will have the QuantiFERON-TB Gold test performed. Patient who demonstrates evidence of latent TB infection (either PPD more than or equal to 5 mm of induration or positive QuantiFERON-TB Gold) or suspicious CXR will not be allowed to participate.

- Capable of giving informed consent and the consent must be obtained prior to any

study related procedures.

- Patient must be able and willing to self-administer subcutaneous (SC) injections or

have a qualified person available to administer SC injections. Exclusion Criteria:

- Has received medical treatment for sleep apnea in the 6 months preceding Day 0.

- Presence of other skin diseases or skin infections (bacterial, fungal or viral) that

may interfere with evaluation of psoriasis or with patient's safety.

- Has a history of an allergic reaction or significant sensitivity to constituents of

study drug, including latex (a component of the pre-filled syringe).

- Use of any non-biological systemic therapy for the treatment of psoriasis (including

PUVA (psoralen and ultraviolet A)) less than 30 days before Day 0.

- Use of investigational chemical agents within 30 days or five half-lives prior to Day

0, whichever is longer.

- Use of any biological therapy for the treatment of psoriasis less than 90 days before

Day 0.

- Current use of oral or injectable corticosteroids or during the study. Inhaled

corticosteroids for stable medical conditions are allowed.

- Use of any topical treatments for psoriasis or phototherapy within two weeks prior to

Day 0, at the exception of low strength (hydrocortisone and desonide) topical corticosteroid for the face, groin (including genitals) and inframammary areas.

- Has received Anakinra/Kineret within the last 2 weeks prior to Day 0 or is likely to

receive Anakinra/Kinaret during the course of the study.

- Has a poorly controlled medical condition, such as uncontrolled diabetes, documented

history of recurrent infections, unstable ischemic heart disease, congestive heart failure, recent stroke (within the past 90 days), chronic leg ulcer or any other condition which, in the opinion of the investigator, would put the patient at risk if participating in the study.

- Has a history of neurologic symptoms suggestive of central nervous system (CNS)

demyelinating disease (e. g. optic neuritis, visual disturbance, gait disorder/ataxia, facial paresis, apraxia).

- Has a history of cancer or lymphoproliferative disease other than a successfully

treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix.

- Has a history of listeriosis, treated or untreated TB, persistent chronic infections,

or recent active infections requiring hospitalization or treatment with intravenous anti-infectives within 30 days or oral anti-infectives within 14 days prior to Day 0.

- Has received any live attenuated vaccine 28 days or less before Day 0 or plans to

receive one during the study.

- Has hepatitis B or hepatitis C viral infection.

- Has any of the following: hemoglobin ≤ 10 g/L, white blood cell count ≤ 3. 0 X 10^9/L,

platelet count ≤130 X 10^9/L, ALT ≥ 3 times the upper limit of normal, AST ≥ 3 times the upper normal limit, total bilirubin ≥ 2 times the upper normal limit or creatinine ≥ 150 µmol/L.

- Current use or plan to use anti-retroviral therapy at any time during the study.

- Is known to have immune deficiency or is immunocompromised.

- Current pregnancy or lactation or considering becoming pregnant during the study or

for 150 days after the last dose of study medication.

- Has a history of clinically significant drug or alcohol abuse in the last year.

- Is considered by the investigator, for any reason, to be an unsuitable candidate for

the study.

Locations and Contacts

Innovaderm Research Inc., Montreal, Quebec H2K 4L5, Canada
Additional Information

Starting date: September 2010
Last updated: October 27, 2011

Page last updated: August 23, 2015

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