To evaluate the safety profile, the effectiveness and the economic impact of adalimumab when
used for the treatment of subjects with active plaque psoriasis who have not adequately
responded to prior psoriasis therapy.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Inclusion Criteria:
- Subject has a clinical diagnosis of psoriasis for at least 6 months prior to the
Screening, as determined by subject interview of his/her medical history and
confirmation of diagnosis through physical examination by the investigator
- Subject must have stable plaque psoriasis for at least 2 months prior to the
Screening, as determined by subject interview of his/her medical history
- Subject has moderate to severely active plaque psoriasis at Baseline defined as: BSA
(Body Surface Area) > 10% and a Psoriasis Area and Severity Index (PASI) > 12
- Subject has active psoriasis despite treatment with topical agents
- Subject has failed to respond to, is intolerant to or unable to access phototherapy
- Subject has failed to respond to, is intolerant to or has contraindication for at
least two of the following therapies:
- CyA (Cyclosporine A)
- MTX (Methotrexate)
- Oral retinoid
- If female, subject is either not of childbearing potential, defined as postmenopausal
for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral
oophorectomy or hysterectomy), or is of childbearing potential and practicing one of
the following methods of birth control:
- Condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD)
- Contraceptives (oral or parenteral) for three months (90 days) prior to study
drug administration
- A vasectomized partner
- Total abstinence from sexual intercourse
- If female and of childbearing potential, the result of a serum pregnancy test
performed at Screening is negative
- Able and willing to self-administer sc injections or has available qualified
person(s) to administer sc injections
- Able and willing to give written informed consent and comply with the requirements of
the study protocol
Exclusion Criteria:
- Subject has other active skin diseases or skin infections (bacterial, fungal, or
viral) that may interfere with the evaluation of psoriasis or compromise the
subject's safety
- Subject has erythrodermic psoriasis, generalized or localized pustular psoriasis,
medication-induced or medication-exacerbated psoriasis, or new onset guttate
psoriasis as the primary morphology of their psoriasis
- Subject has a history of an allergic reaction or significant sensitivity to
constituents of adalimumab
- Investigational agents not mentioned must be discontinued at least 30 days or 5
half-lives prior to the Baseline visit (whichever is longer)
- Topical therapies:
- Subject started receiving a new topical therapy within the last four weeks prior
to the Baseline visit for areas other than the palms, soles of feet, axilla and
groin.
- Dose(s) and regimen(s) of topical therapy(ies) that the subject is receiving at
the Baseline visit, for areas other than the palms, soles of feet, axilla and
groin, was (were) increased during the four weeks that preceded the Baseline
visit.
- Subject is likely to require the initiation of a new topical therapy for the
treatment of psoriasis such as corticosteroids, vitamin D analogs, or retinoids
during the first 16 weeks that will follow the Baseline visit. (During the first
16 weeks that will follow the Baseline visit, initiation of topical therapies
are allowed for the palms, soles of feet, axilla and groin area only).
- Oral or injectable corticosteroids therapies:
- Subject started receiving oral or injectable doses of corticosteroids within the
last four weeks prior to the Baseline visit.
- Dose(s) and regimen(s) of corticosteroids therapy(ies) that the subject is
receiving at the Baseline visit, was (were) increased during the four weeks that
preceded the Baseline visit.
- Subject is likely to require the initiation of oral or injectable dose of
corticosteroids therapies for the treatment of psoriasis during the first 16
weeks that will follow the Baseline visit.
- Phototherapies
- Subject started being treated with UVB phototherapy, within the last four weeks
prior to the Baseline visit.
- Regimen(s) of concomitant UVB phototherapy that the subject is receiving at the
Baseline visit was (were) increased during the four weeks that preceded the
Baseline visit.
- Subject is likely to require the initiation of UVB therapy during the first 16
weeks that will follow the Baseline visit.
- Subject was treated with psoralen UVA (PUVA) phototherapy within the last four
weeks prior to the Baseline visit.
- Subject is likely to require PUVA phototherapy during the course of the study.
- Subject cannot avoid excessive sun exposure or the use of tanning booths for at
least 2 weeks prior to Baseline and during the first 16 weeks that will follow
the Baseline visit.
- Systemic Therapies:
- Subject has been initiated on a new systemic agent for the treatment of
psoriasis within the last four weeks prior to the Baseline visit.
- Dose(s) and regimen(s) of systemic therapy(ies) that the subject is receiving at
the Baseline visit, was (were) increased during the four weeks that preceded the
Baseline visit.
- Subject is likely to require the initiation of systemic therapy, other than
adalimumab, for the treatment of psoriasis during the first 16 weeks that will
follow the Baseline visit.
- Subject has been treated with systemic calcineurin inhibitors (cyclosporin,
FK506 and others) within the last four weeks prior to the Baseline visit.
- Subject is likely to receive systemic calcineurin inhibitors during the course
of the study.
- Subject has received Anakinra/Kineret within the last 2 weeks prior to the
Baseline visit and is likely to receive Anakinra/Kineret during the course of
the study.
- Subject cannot discontinue the following systemic psoriasis therapies:
- Alefacept must be discontinued at least 12 weeks prior to the Baseline visit.
- Efalizumab must be discontinued at least 6 weeks prior to the Baseline visit.
- Infliximab must be discontinued at least 8 weeks prior to the Baseline visit.
- Etanercept must be discontinued at least 3 weeks prior to the Baseline visit.
- Subject has a history of cancer or lymphoproliferative disease other than:
- Successfully and completely treated Cervical dysplasia, with no recurrence
within the last five years.
- Has a history of uncontrolled diabetes, unstable ischemic heart disease, congestive
heart failure, New York Heart Association (NYHA) III, IV, recent stroke (within three
months), chronic leg ulcer and any other condition (e. g., indwelling urinary
catheter) which, in the opinion of the Investigator, would put the subject at risk by
participation in the protocol or who would make the subject unsuitable for the study.
- Positive serology for hepatitis B indicating acute or chronic infection.
- Currently taking or likely to begin anti-retroviral therapy at any time during the
course of the study.
- Subject is known to have immune deficiency, history of human immunodeficiency virus
(HIV) or is immunocompromised.
- Persistent or recurrent or severe infections requiring hospitalization or treatment
with intra-venous (IV) antibiotics within 30 days, or oral antibiotics within 14
days, prior to Baseline.
- Female subjects who are pregnant or breastfeeding.
- Has a history of clinically significant drug or alcohol abuse in the last year.
- Previous diagnosis or signs of central nervous system demyelinating diseases (e. g.,
optic neuritis, visual disturbance, gait disorder/ataxia, facial paresis, apraxia).
- History of active tuberculosis (TB), history of histoplasmosis or listeriosis.
- Has latent TB (positive purified protein derivative (PPD) skin test, two-step PPD
when applicable, and chest X-ray indicative of TB) or has other risk factors for the
activation of latent TB, e. g. previous exposure to TB, and has not initiated TB
prophylaxis prior to the first adalimumab treatment. In either case, the Abbott
Medical Advisor must be contacted before initiating the study treatment.
- Subjects will be excluded if the CXR is found to have changes suggestive of old
healed tuberculous lesion (e. g. calcified nodule, fibrotic scar, apical or basilar
pleural thickening etc.).
Quebec G1J 1X7, Canada
Calgary, Alberta T2S 3B3, Canada
Calgary, Alberta T3A 2N1, Canada
Edmonton, Alberta T5K 1X3, Canada
Surrey, British Columbia V3R 6A7, Canada
Vancouver, British Columbia V5Z 4E8, Canada
Winnipeg, Manitoba R3C 0N2, Canada
Winnipeg, Manitoba R3C 1R4, Canada
Moncton, New Brunswick E1C 8X3, Canada
St. John's, Newfoundland and Labrador A1B 3E1, Canada
St. John's, Newfoundland and Labrador A1C 2H5, Canada
Halifax, Nova Scotia B3H 1Z4, Canada
Barrie, Ontario L4M 6L2, Canada
Fenwick, Ontario L0S 1C0, Canada
Hamilton, Ontario L8N 1V6, Canada
London, Ontario N5X 2P1, Canada
London, Ontario N6A 3H7, Canada
Markham, Ontario L3P 1A8, Canada
Nepean, Ontario K2G 6E2, Canada
North Bay, Ontario P1B 3Z7, Canada
Oakville, Ontario L6K 1E1, Canada
Oakville, Ontario L6J 7W5, Canada
Toronto, Ontario M4V 1R1, Canada
Waterloo, Ontario N2J 1C4, Canada
Montreal, Quebec H3Z 2S6, Canada
Sherbrooke, Quebec J1H 1Z1, Canada
Ste-Foy, Quebec G1V 4X7, Canada