DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



A Canadian Open-Label Access Program to Evaluate Adalimumab When Added to Inadequate Therapy for the Treatment of Psoriasis

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

Condition(s) targeted: Psoriasis

Intervention: Humira (adalimumab) (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Kim Papp, MD PhD FRCPC, Principal Investigator, Affiliation: K. Papp Clinical Research Inc.

Summary

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.

Clinical Details

Official title: A Canadian Open-Label Access Program to Evaluate the Safety and the Effectiveness of Adalimumab When Added to Inadequate Therapy for the Treatment of Psoriasis

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of Subjects With Psoriasis Area and Severity Index (PASI) 75 Response at 16 Weeks

Secondary outcome:

Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at 16 and 24 Weeks

Mean Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at 16 and 24 Weeks

Number of Subjects With Improvement in Physician's Global Assessment for Psoriasis (PGA)

Number of Subjects Achieving a Clinical Response Defined as a Physician's Global Assessment for Psoriasis (PGA) of "Clear" or "Clear or Minimal"

Mean Change From Baseline in Physician Global Assessment of Arthritic Disease Activity at 16 and 24 Weeks

Number of Subjects With Psoriasis Area and Severity Index (PASI) 50/75/90/100 Response

Mean Change From Baseline in Tender Joint Count at 16 and 24 Weeks

Mean Change From Baseline in Swollen Joint Count at 16 and 24 Weeks

Mean Change From Baseline in Patient's Global Assessment of Joint Pain at 16 and 24 Weeks

Mean Change From Baseline in the Dermatology Life Quality Index (DLQI) at 16 and 24 Weeks

Number of Subjects Achieving a Dermatology Life Quality Index (DLQI) = 0

Mean Change From Baseline in Beck Depression Inventory (BDI-II) at 16 and 24 Weeks

Change From Baseline on the EuroQol (EQ-5D) Quality of Life Questionnaire

Change in Productivity Outcomes and Costs From Baseline as Measured by the Health and Labour Questionnaire (HLQ)

Change in Resource Utilization Outcomes and Costs From Baseline as Measured by the Health Care Resource (HCR) Questionnaire

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.).

Locations and Contacts

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

Additional Information

Starting date: September 2007
Last updated: April 7, 2011

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2015