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

NCT00513370 | Completed Phase 3 Results

• 1 other identifier: W10-151
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 27

Brief 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.

Conditions

Psoriasis

Keywords

Psoriasis; adalimumab

Outcome Measures

Primary Outcomes (1)

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

  PASI 75 is a 75% or greater improvement on the Psoriasis Area and Severity Index (PASI). The PASI scale runs from 0-72, where 0 = no psoriasis and 72 = complete erythroderma of the severest possible degree

  16 weeks

Secondary Outcomes (15)

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

  16 and 24 weeks

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

  16 and 24 weeks

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

  16 and 24 weeks

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

  16 and 24 weeks

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

  16 and 24 weeks

Study Arms (1)

1

EXPERIMENTAL

Biological: Humira (adalimumab)

Interventions

Humira (adalimumab) BIOLOGICAL

Study drug will be provided as a sterile, preservative-free solution for subcutaneous injection, contained in a pre-filled syringe housed in a pen device (pre-filled pen). Loading dose of 80 mg of adalimumab subcutaneously (sc) at Baseline, and 40 mg of adalimumab sc at Week 1, followed by 40 mg of adalimumab sc every other week (eow) for 24 weeks.

Also known as: ABT-D2E7, adalimumab, Humira

1

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott: lead

Study Sites (27)

Unknown Facility

Calgary, Alberta, T2S 3B3, Canada

Location

Unknown Facility

Calgary, Alberta, T3A 2N1, Canada

Location

Unknown Facility

Edmonton, Alberta, T5K 1X3, Canada

Location

Unknown Facility

Surrey, British Columbia, V3R 6A7, Canada

Location

Unknown Facility

Vancouver, British Columbia, V5Z 4E8, Canada

Location

Unknown Facility

Winnipeg, Manitoba, R3C 0N2, Canada

Location

Unknown Facility

Winnipeg, Manitoba, R3C 1R4, Canada

Location

Unknown Facility

Moncton, New Brunswick, E1C 8X3, Canada

Location

Unknown Facility

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

Location

Unknown Facility

St. John's, Newfoundland and Labrador, A1C 2H5, Canada

Location

Unknown Facility

Halifax, Nova Scotia, B3H 1Z4, Canada

Location

Unknown Facility

Barrie, Ontario, L4M 6L2, Canada

Location

Unknown Facility

Fenwick, Ontario, L0S 1C0, Canada

Location

Unknown Facility

Hamilton, Ontario, L8N 1V6, Canada

Location

Unknown Facility

London, Ontario, N5X 2P1, Canada

Location

Unknown Facility

London, Ontario, N6A 3H7, Canada

Location

Unknown Facility

Markham, Ontario, L3P 1A8, Canada

Location

Unknown Facility

Nepean, Ontario, K2G 6E2, Canada

Location

Unknown Facility

North Bay, Ontario, P1B 3Z7, Canada

Location

Unknown Facility

Oakville, Ontario, L6J 7W5, Canada

Location

Unknown Facility

Oakville, Ontario, L6K 1E1, Canada

Location

Unknown Facility

Toronto, Ontario, M4V 1R1, Canada

Location

Unknown Facility

Waterloo, Ontario, N2J 1C4, Canada

Location

Unknown Facility

Montreal, Quebec, H3Z 2S6, Canada

Location

Unknown Facility

Québec, Quebec, G1J 1X7, Canada

Location

Unknown Facility

Sherbrooke, Quebec, J1H 1Z1, Canada

Location

Unknown Facility

Ste-Foy, Quebec, G1V 4X7, Canada

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Medical Information Specialist
• Organization: Abbott

1-800-633-9110

Study Officials

• Kim Papp, MD PhD FRCPC

  K. Papp Clinical Research Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 6, 2007
• First Posted: August 8, 2007
• Study Start: September 1, 2007
• Primary Completion: September 1, 2008
• Last Updated: April 11, 2011
• Results First Posted: November 20, 2009

Record last verified: 2011-04

Locations

CA (27)