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

NCT01181570 | Completed Phase 4

• 2 other identifiers: Inno-6016IMM 10-0005
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psoriasis; Sleep Apnea, Obstructive

Keywords

psoriasis; adalimumab; obstructive sleep apnea; obesity

Outcome Measures

Primary Outcomes (1)

• Number of sleep apnea per hour.

  Changes from baseline in number of apnea/hypopnea per hour for patients with psoriasis randomized to adalimumab as compared to patients randomized to topical therapy.

  56 Days

Secondary Outcomes (20)

• Sleep maintenance efficiency

  56 days

• Total wake time

  56 days

• Percentage of sleep time

  56 days

• Time spent in REM (rapid eye movement) stage.

  56 days

• Time spent in sleep stage N1

  56 days

Study Arms (2)

Adalimumab

EXPERIMENTAL

Drug: Adalimumab

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Adalimumab DRUG

Patients receive adalimumab 80 mg followed by 40 mg at week 1 and 40 mg every other week (EOW) thereafter.

Also known as: Humira, mannitol, citric acid monohydrate, sodium citrate, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, polysorbate 80, water for injection, sodium hydroxide.

Adalimumab

Placebo DRUG

Patients will receive 2 injections of placebo at week 0, one injection at week 1 and one injection every other week (EOW) thereafter.

Also known as: mannitol, citric acid monohydrate, sodium citrate, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, polysorbate 80, water for injection, sodium hydroxide

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Innovaderm Research Inc.: lead
• Abbott: collaborator

Study Sites (1)

Innovaderm Research Inc.

Montreal, Quebec, H2K 4L5, Canada

Location

MeSH Terms

Conditions

Psoriasis; Sleep Apnea, Obstructive; Obesity

Interventions

Adalimumab; Mannitol; Citric Acid; Sodium Citrate; 3-lauroyl-glycero-1-phosphate; Sodium Chloride; Polysorbates; Water; Injections; Sodium Hydroxide

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Polyethylene Glycols; Ethylene Glycols; Glycols; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Hydroxides; Alkalies; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Robert Bissonnette, MD, FRCPC

  Innovaderm Research Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2010
• First Posted: August 13, 2010
• Study Start: September 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: September 1, 2011
• Last Updated: October 28, 2011

Record last verified: 2011-10

Locations

CA (1)