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

NCT00927069 | Completed Phase 3 Results

• 1 other identifier: Inno-6002
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 12

Brief Summary

This study will provide data on additional therapeutic benefits in administering Adalimumab in patients with plaque psoriasis that showed an unsatisfactory response after at least 3 months of treatment with etanercept.

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

Patients in group A who - after 12 weeks of adalimimab 40 mg every other week in this study - failed to reach a physician's global assessment (PGA) of clear or almost clear and had a dose increase to 40 mg adalimimab every week for another 12 weeks.

Drug: Adalimumab Every Week

Group B dose increase at Week 12

EXPERIMENTAL

Patients in group B who - after 12 weeks of adalimimab 40 mg every other week in this study - failed to reach a physician's global assessment (PGA) of clear or almost clear and had a dose increase to 40 mg adalimimab every week for another 12 weeks.

Drug: Adalimumab Every Week

Interventions

Adalimumab every other week DRUG

Adalimumab 40mg injection every other week for 24 weeks

Also known as: HUMIRA

Group A; Group B

Adalimumab Every Week DRUG

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

Also known as: HUMIRA

Group A dose increase at Week 12; Group B dose increase at Week 12

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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;
• Failure to present a PGA of clear or almost clear after at least 3 months of etanercept at 50 mg twice a week followed by a dose reduction to 50 mg once a week. To be eligible these patients must have reached a PGA of clear or almost clear after at least 3 months of etanercept at 50 mg twice a week followed by a loss of PGA of clear or almost clear at anytime after a dose reduction to 50 mg of etanercept once a week.
• Subject presents a PGA of 3 or more at baseline visit.
• Subject with plaque psoriasis at screening that is severe enough to be candidate for systemic therapy.
• Subject is 18 to 80 years of age .
• 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 throughout the study and for 150 days after study completion:
• condoms, sponge, foams, jellies, diaphragm or IUD;
• contraceptives (oral or parenteral) for three months prior to study drug administration;
• a vasectomized partner;
• Female subjects of childbearing potential must have a negative serum pregnancy test at the Screening visit.
• Subject is judged to be in good general health as determined by the principal investigator based upon the results of medical history, laboratory profile, physical examination, and CXR performed at Screening.
• Subjects will be evaluated for latent TB infection with a PPD test and CHX. Subjects who demonstrate evidence of latent TB infection (either PPD more than or equal to 5 mm of induration, irrespective of BCG vaccination status and negative CXR findings for active TB, and/or suspicious CXR findings will not be allowed to participate in the study.
• Subjects must be able and willing to provide written informed consent and comply with the requirements of this study protocol.
• Subjects must be able and willing to self-administer SC injections or have a qualified person available to administer SC injections.

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.

Sponsors & Collaborators

• Innovaderm Research Inc.: lead
• Abbott: collaborator

Study Sites (12)

Winnipeg Clinic

Winnipeg, Manitoba, R3C 0N2, Canada

Location

NewLab Clinical Research

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

Location

Mediprobe Research

London, Ontario, N5X 2P1, Canada

Location

The Guenther Dermatology Research center

London, Ontario, N6A 3H7, Canada

Location

Lynderm Research

Markham, Ontario, L3P 1A8, Canada

Location

Entralogix Inc.

Oakville, Ontario, L6K 1E1, Canada

Location

Entralogix Clinical Group Inc.

Toronto, Ontario, M4V 1R1, Canada

Location

Windsor Clinical Research Inc.

Windsor, Ontario, N8W 5L7, Canada

Location

Innovaderm Research Laval Inc.

Laval, Quebec, H7S 2C6, Canada

Location

Innovaderm Research Inc

Montreal, Quebec, H2K 4L5, Canada

Location

Centre de Recherche Clinique Martin Gilbert inc et Centre Dermatologie Maizerets

Québec, Quebec, G1J 1X7, Canada

Location

Centre de Recherches Dermatologiques du Quebec Metropolitain

Ste-Foy, Quebec, G1V 4X7, Canada

Location

MeSH Terms

Interventions

Adalimumab

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

This was an open label uncontrolled study.

Results Point of Contact

• Title: Annie Levesque
• Organization: Innovaderm Research, Inc.

alevesque@innovaderm.ca

514 521 4285

Study Officials

• Robert Bissonnette, MD

  Innovaderm Research Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

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 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: December 1, 2008
• Last Updated: September 9, 2011
• Results First Posted: August 24, 2010

Record last verified: 2011-09

Locations

CA (12)