PsoriasisPhase 4NCT01181570
Efficacy and Safety of Adalimumab in Patients With Psoriasis and Obstructive Sleep Apnea
A Phase 4 study testing Adalimumab in people with Psoriasis and Sleep Apnea, Obstructive, run by Innovaderm Research Inc. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Psoriasis, Sleep Apnea, Obstructive
- What is being tested?
- Adalimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2010to Sep 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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.
Who cannot join
- 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.
Show all 21Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Adalimumab, Placebo
- Keywords
- psoriasis, adalimumab, obstructive sleep apnea, obesity
- Medical subject headings
- Psoriasis, Sleep Apnea, Obstructive, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabDrug
Also called Humira, mannitol, citric acid monohydrate, sodium citrate
Patients receive adalimumab 80 mg followed by 40 mg at week 1 and 40 mg every other week (EOW) thereafter.
PlaceboDrug
Also called mannitol, citric acid monohydrate, sodium citrate, disodium phosphate dihydrate
Patients will receive 2 injections of placebo at week 0, one injection at week 1 and one injection every other week (EOW) thereafter.
| Study group | Role | What they receive |
|---|---|---|
| Adalimumab | Experimental | Not described Receives: Drug: Adalimumab |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 56 Days
Secondary outcomes (20)
Sleep maintenance efficiency
Changes from baseline in sleep maintenance efficiency for patients with psoriasis randomized to adalimumab as compared to patients randomized to placebo.
Measured: 56 days
Total wake time
Changes from baseline in total wake time for patients with psoriasis randomized to adalimumab as compared to patients randomized to placebo
Measured: 56 days
Percentage of sleep time
Changes from baseline in percentage of sleep time for patients with psoriasis randomized to adalimumab as compared to patients randomized to placebo.
Measured: 56 days
Time spent in REM (rapid eye movement) stage.
Changes from baseline in time spent in REM (rapid eye movement) stage for patients with psoriasis randomized to adalimumab as compared to patients randomized to placebo.
Measured: 56 days
Time spent in sleep stage N1
Changes from baseline in time spent in sleep stages N1 for patients with psoriasis randomized to adalimumab as compared to patients randomized to placebo.
Measured: 56 days
Time spent in sleep stage N3
Changes from baseline in time spent in sleep stage N3 for patients with psoriasis randomized to adalimumab as compared to patients randomized to placebo.
Measured: 56 days
REM (rapid eye movement) latency time
Changes from baseline in REM (rapid eye movement) latency time for patients with psoriasis randomized to adalimumab as compared to patients randomized to placebo.
Measured: 56 days
Minimum overnight oxygen saturation index
Changes from baseline in minimum overnight oxygen saturation index for patients with psoriasis randomized to adalimumab as compared to patients randomized to placebo.
Measured: 56 days
Oxygen desaturation index
Changes from baseline in oxygen desaturation index for patients with psoriasis randomized to adalimumab as compared to patients randomized to placebo.
Measured: 56 days
Sleep related quality of life questionnaire (FOSQ)
Changes from baseline in the sleep related quality of life questionnaire (FOSQ - functional outcome of sleep questionnaire) for patients with psoriasis randomized to adalimumab as compared to patients randomized to placebo.
Measured: 56 days
Epworth sleepiness scale
Changes from baseline in patient's perception of daytime sleepiness as measured by the Epworth sleepiness scale for patients with psoriasis randomized to adalimumab as compared to patients randomized to placebo.
Measured: 56 days
Daytime sleep latency
Changes from baseline in daytime sleep latency time for patients with psoriasis randomized to adalimumab as compared to patients randomized to placebo
Measured: 56 days
Safety of adalimumab
Evaluate the safety of adalimumab in patients with psoriasis randomized to adalimumab as compared to patients randomized to placebo.
Measured: 56 weeks
Body surface area (BSA)
Tertiary - Changes from baseline in Body Surface Area (BSA) for patients with psoriasis randomized to adalimumab as compared to patients randomized to placebo.
Measured: 56 days
Physician's Global Assessment (PGA)
Tertiary - Changes from baseline in Physician's Global Assessment (PGA) for patients with psoriasis randomized to adalimumab as compared to patients randomized to placebo.
Measured: 56 days
Psoriatic Area and Severity Index (PASI)
Tertiary - Changes from baseline in Psoriatic Area and Severity Index (PASI) for patients with psoriasis randomized to adalimumab as compared to patients randomized to placebo.
Measured: 56 days
PASI 75 (75% reduction in Psoriatic Area and Severity Index)
Tertiary - Proportion of patients who achieve PASI 75 (75% reduction in Psoriatic Area and Severity Index) at Day 56 for patients with psoriasis randomized to adalimumab as compared to patients randomized to placebo.
Measured: 56 days
Proportion with PGA (Physician's Global Assessment) of 0 or 1
Tertiary - Proportion of patients who achieve a PGA (Physician's Global Assessment) of 0 or 1 at Day 56 for patients with psoriasis randomized to adalimumab as compared to patients randomized to placebo.
Measured: 56 days
Time to sleep induction
Changes from baseline in time to sleep induction for patients with psoriasis randomized to adalimumab as compared to patients randomized to placebo
Measured: 56 days
Time spent in sleep stages N2
Changes from baseline in time spent in sleep stages N2 for patients with psoriasis randomized to adalimumab as compared to patients randomized to placebo.
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionAug 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovaderm Research Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor
- Investigators
- Robert Bissonnette, MD, FRCPC, Principal investigator, Innovaderm Research Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01181570
- Sponsor's protocol ID
- Inno-6016
- Other IDs
- IMM 10-0005
- Status last verified
- Oct 2011
- First submitted
- 11 Aug 2010
- Last updated
- 28 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Adalimumab in Patients With Psoriasis and Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT01181570
- Acronym / sponsor ID
- Inno-6016
- Conditions
- Psoriasis, Sleep Apnea, Obstructive
- Keywords
- psoriasis, adalimumab, obstructive sleep apnea, obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Innovaderm Research Inc.University, hospital or other
- Collaborators
- Abbott
- Study start
- Sep 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 13 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adalimumab | Experimental | Drug: Adalimumab |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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:
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdalimumabAlso: Humira, mannitol, citric acid monohydrate, sodium citratePatients receive adalimumab 80 mg followed by 40 mg at week 1 and 40 mg every other week (EOW) thereafter. | Drug | Adalimumab |
| PlaceboAlso: mannitol, citric acid monohydrate, sodium citrate, disodium phosphate dihydratePatients will receive 2 injections of placebo at week 0, one injection at week 1 and one injection every other week (EOW) thereafter. | Drug | Placebo |
Primary outcome
Number of sleep apnea per hour.
Time frame: 56 Days
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.
20 secondary outcomes
Sleep maintenance efficiency
Time frame: 56 days
Total wake time
Time frame: 56 days
Percentage of sleep time
Time frame: 56 days
Time spent in REM (rapid eye movement) stage.
Time frame: 56 days
Time spent in sleep stage N1
Time frame: 56 days
Time spent in sleep stage N3
Time frame: 56 days
REM (rapid eye movement) latency time
Time frame: 56 days
Minimum overnight oxygen saturation index
Time frame: 56 days
Oxygen desaturation index
Time frame: 56 days
Sleep related quality of life questionnaire (FOSQ)
Time frame: 56 days
Epworth sleepiness scale
Time frame: 56 days
Daytime sleep latency
Time frame: 56 days
Safety of adalimumab
Time frame: 56 weeks
Body surface area (BSA)
Time frame: 56 days
Physician's Global Assessment (PGA)
Time frame: 56 days
Psoriatic Area and Severity Index (PASI)
Time frame: 56 days
PASI 75 (75% reduction in Psoriatic Area and Severity Index)
Time frame: 56 days
Proportion with PGA (Physician's Global Assessment) of 0 or 1
Time frame: 56 days
Time to sleep induction
Time frame: 56 days
Time spent in sleep stages N2
Time frame: 56 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2011.
Related trials for Psoriasis
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
Not yet recruiting
Assessing Psoriasis Treatment Outcomes
Psoriasis
Not yet recruiting
Cosmetic Efficacy Evaluation of Hydraporin AI Cream in Individuals With Atopic Dermatitis and Psoriasis
Atopic Dermatitis, Psoriasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Bissonnette, MD, FRCPC principal investigator
Innovaderm Research Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adalimumab in people with Psoriasis and Sleep Apnea, Obstructive, run by Innovaderm Research Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of sleep apnea per hour. (time frame: 56 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2011; AzTrials last refreshed its copy on 8 Nov 2026.