Trials Sponsors Conditions Drugs Pricing

Conditions

Plaque Psoriasis

Keywords

Adalimumab

Outcome Measures

Primary Outcomes (1)

Number of Patients From Group B Who Achieve a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 12.
Efficacy of adalimumab 40 mg every other week in patients in Group B by calculating the number of patients who achieve a PGA of clear or almost clear at Week 12. Clear is defined by no plaque elevation above normal skin. There is no scale. Erythema is perceptible as hyperpigmentation, pigmented macules, diffuse faint pink or red coloration. Almost Clear is defined as follows: It is possible but difficult to ascertain whether there is a slight elevation above normal skin. There is scaling in the form of surface dryness with some white coloration. Erythema is up to a difinite red coloration.
12 weeks

Secondary Outcomes (4)

Number of Patients From Group A Who Achieve a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 12.
12 weeks
Number of Patients From Group B Who Achieve a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 24 After a Dose Increase to 40mg Adalimumab Every Week.
24 weeks
Number of Patients From Group A Who Achieve a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 24 After a Dose Increase to 40mg Adalimumab Every Week.
24 weeks
Total Number of Adverse Events for All Patients in the Study.
24 weeks

Study Arms (4)

Group A

EXPERIMENTAL

Patients who have shown an unsatisfactory response to 3 months of etanercept 50 mg twice a week without dose reduction prior to screening.

Drug: Adalimumab every other week

Group B

EXPERIMENTAL

Patients who showed a satisfactory response to 3 months or more of etanercept 50 mg twice a week followed by a loss of response after dose reduction to 50 mg etanercept once a week prior to screening.

Drug: Adalimumab every other week

Group A dose increase at Week 12

EXPERIMENTAL

Interventions

Adalimumab every other weekDrug

Adalimumab 40mg injection every other week for 24 weeks

Also known as: HUMIRA

Group AGroup B

Adalimumab Every WeekDrug

Adalimumab 40mg injection every week for the last 12 weeks of study.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Administration procedure
Adalimumab every other week
The registry describes an administration procedure or treatment schedule. Actual exposure and doses are not established by this entry.
View registry record
Administration procedure
Adalimumab Every Week
The registry describes an administration procedure or treatment schedule. Actual exposure and doses are not established by this entry.
View registry record

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Subject with plaque psoriasis with documentation of an unsatisfactory response to etanercept as defined by either:
Failure to present a PGA of clear or almost clear after at least 3 months of etanercept at 50 mg twice a week OR;

Sponsors & Collaborators

Innovaderm Research Inc.
Otherlead
Abbott
Industrycollaborator

Study Sites (12)

Winnipeg Clinic

Winnipeg, Manitoba, R3C 0N2, Canada

NewLab Clinical Research

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

Mediprobe Research

London, Ontario, N5X 2P1, Canada

The Guenther Dermatology Research center

London, Ontario, N6A 3H7, Canada

Lynderm Research

Markham, Ontario, L3P 1A8, Canada

Entralogix Inc.

Oakville, Ontario, L6K 1E1, Canada

Entralogix Clinical Group Inc.

Toronto, Ontario, M4V 1R1, Canada

MeSH Terms

Interventions

Adalimumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Limitations and Caveats

This was an open label uncontrolled study.

Results Point of Contact

Title: Annie Levesque
Organization: Innovaderm Research, Inc.

Study Officials

Robert Bissonnette, MD
Innovaderm Research Inc.
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes
Restriction Type: LTE60
Restrictive Agreement: Yes

Enrollment

85 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 22, 2009

First Posted

June 24, 2009

Study Start

March 2007

Date type not reported

This date has not been verified as actual or estimated.

You may not qualify if:

Subject has other active skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with evaluation of psoriasis or with subject's safety.
Subject has a history of an allergic reaction or significant sensitivity to constituents of study drug, including latex (a component of the pre-filled syringe).
Subject who has used topical treatments in the last 4 weeks of the etanercept treatment period when the response to etanercept was evaluated as unsatisfactory must use the same topical therapy with the same agents applied in the same manner and with the same application frequency for two weeks prior to the baseline visit as well as during the entire trial. The use of any other topical treatment for psoriasis is prohibited except for allowed treatments.
Subject who has used UVB phototherapy, excessive sun exposure, phototherapy or any non-biological systemic therapy for the treatment of psoriasis less than 30 days before day 0. Investigational chemical agents must be discontinued at least 30 days or 5 half-lives prior to the Baseline visit (whichever is longer).
Subject who has used any biological therapy (apart from etanercept) for the treatment of psoriasis less than 3 months (90 days) before day 0. Etanercept must be discontinued before baseline but a washout period is not required.
Subject is taking or requires oral or injectable corticosteroids during the study. Inhaled corticosteroids for stable medical conditions are allowed.
Subjects for whom documentation of unsatisfactory response to etanercept was obtained while the subject was under combination treatment with any of the following: UVB phototherapy, PUVA therapy, prednisone, methotrexate, acitretin, cyclosporine or any other systemic or biologic drug (apart from etanercept).
Subject has a poorly controlled medical condition, such as uncontrolled diabetes with documented history of recurrent infections, unstable ischemic heart disease, congestive heart failure, recent stroke and any other condition which, in the opinion of the investigator, would put the subject at risk if participating in the study.
Subject has history of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease.
Subject has 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.
Subject 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 the Baseline visit.
Subject who has received any live attenuated vaccine 28 days or less before baseline.
Subject with hepatitis B or hepatitis C viral infection.
Subject with any of the following: hemoglobin ≤ 10 g/L, white blood cells ≤ 3.0 X 109/L, platelet counts ≤130 X 109/L, ALT ≥ 2 times the upper limit of normal, AST ≥ 2 times the upper normal limit, total bilirubin ≥ 2 times the upper normal limit or creatinine ≥ 150 mmol/L.
Subject currently uses or plans to use anti-retroviral therapy at any time during the study.
+5 more criteria

Safety and Efficacy of Adalimumab in Patients Who Showed an Unsatisfactory Response to Etanercept

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (4)

Group A

Group B

Group A dose increase at Week 12

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (12)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Group B dose increase at Week 12

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (4)

Group A

Group B

Group A dose increase at Week 12

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (12)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Group B dose increase at Week 12

You may not qualify if:

Source record

Locations