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

Condition(s) targeted: Psoriasis

Intervention: Humira (adalimumab) (Biological)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Abbott

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

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.

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: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Primary outcome: the PASI 75 response rate at the 16-week time point relative to the Baseline (Week 0) PASI score.

Secondary outcome:

Change and percent change from Baseline in PASI score

Proportion of subjects achieving a clinical response defined as a PGA of 'Clear' or "Clear" or "Minimal"

Proportion of subjects with improvement in PGA

Change from Baseline in Physician Global Assessment of Arthritic Disease Activity

Proportion of subjects achieving a clinical response defined as > PASI 50, > PASI 75, > PASI 90, PASI 100

Change from Baseline in Swollen Joint Count and Tender Joint Count

Change from Baseline in patient global assessment of joint pain

Change from Baseline in the DLQI

Proportion of subjects achieving a DLQI=0

Change from Baseline in BDI-II

Change from Baseline in EQ-5D

Change in productivity outcomes and costs from Baseline as measured by the HLQ

Change in resource utilization outcomes and costs from Baseline as measured by the HCR

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 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

- 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.

Quebec G1J 1X7, Canada

Calgary, Alberta T3A 2N1, Canada

Calgary, Alberta T2S 3B3, Canada

Edmonton, Alberta T5K 1X3, Canada

Surrey, British Columbia V3R 6A7, Canada

Vancouver, British Columbia V5Z 4E8, Canada

Winnipeg, Manitoba R3C 1R4, Canada

Winnipeg, Manitoba R3C 0N2, Canada

Moncton, New Brunswick E1C 8X3, Canada

St. John's, Newfoundland and Labrador A1B 4S8, Canada

St. John's, Newfoundland and Labrador A1B 3E1, Canada

Halifax, Nova Scotia B3H 1Z4, Canada

Hamilton, Ontario L8N 1V6, Canada

London, Ontario N5X 2P1, Canada

London, Ontario N6A 3H7, Canada

Oakville, Ontario L6K 1E1, Canada

Markham, Ontario L3P 1A8, Canada

Oakville, Ontario L6J 7W5, Canada

Fenwick, Ontario L0S 1C0, Canada

Barrie, Ontario L4M 6L2, Canada

Nepean, Ontario K2G 6E2, Canada

North Bay, Ontario P1B 3Z7, Canada

Toronto, Ontario M4V 1R1, Canada

Waterloo, Ontario N2J 1C4, Canada

Sherbrooke, Quebec J1H 1Z1, Canada

Ste-Foy, Quebec G1V 4X7, Canada

Montreal, Quebec H3Z 2S6, Canada

Starting date: September 2007
Ending date: December 2008
Last updated: March 20, 2008