Safety and Efficacy of Combining nbUVB to Etanercept in P... | NCT00640393

NCT00640393

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Sponsor/Collaborators Module

Name	Class
Amgen	INDUSTRY

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Part 1 - Etanercept	Active Comparator	All participants received etanercept 50 mg twice a week for 12 weeks.	Drug: Etanercept
Part 2 - Etanercept and nbUVB	Active Comparator	Participants who did not reach a 90 percent reduction in psoriasis area and severity index (PASI-90) after 12 weeks and were randomized to the narrow band ultra violet B (nbUVB) group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.	Drug: Etanercept Device: nbUVB
Part 2 - Etanercept	Active Comparator	Participants who did not reach PASI-90 after 12 weeks and were randomized to the Etanercept group. They received 50 mg Etanercept once per a week.	Drug: Etanercept

Name	Type	Description	Arm Group Labels	Other Names
Etanercept	Drug	Etanercept 50 mg, subcutaneous (SC) injection.	Part 1 - Etanercept Part 2 - Etanercept Part 2 - Etanercept and nbUVB

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI 90) - ITT	Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale: 0 = No symptoms 1 = Slight 2 = Moderate 3 = Marked 4 = Very marked The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6. Total scale 0 = best and 72 = worst	112 and 140 days

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants Attaining a 75 Percent Reduction in PASI From Baseline (PASI 75) - ITT	Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale: 0 = No symptoms 1 = Slight 2 = Moderate 3 = Marked 4 = Very marked The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6. Total scale 0 = best and 72 = worst

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 or older;
Patient with moderate to severe plaque psoriasis for whom a decision to use etanercept has been made;
At the investigator discretion, patient who would benefit from systemic therapy;
PASI (psoriasis area and severity index) ≥ 10 and BSA (body surface area affected by psoriasis) ≥ 10 at day 0;
Unless surgically sterile (or at least 1 year post-menopausal for women), abstinent or homosexual, patient (men and women) willing to use adequate contraceptive method for at least 30 days before Day 0 and until one month after the last drug administration;
Patient capable of giving informed consent;
Patient with normal or non clinically significant chest X ray within six months of screening;
Patient with negative purified protein derivative (PPD) within 3 months of Day 0;
Negative urine pregnancy test for women of childbearing potential

Exclusion Criteria:

Patient used topical steroid, topical tar preparations, or other anti-psoriatic preparations except tar or salicylic acid shampoo or hydrocortisone for the face, scalp, genital and inframammary areas within two weeks of Day 0;
Patient with presence of erythrodermic, pustular or a predominantly guttate psoriasis;
At the investigator's discretion, patient with any significant infection within 30 days of screening or a patient at risk of septicemia;
Patient with evidence of any skin condition that would interfere with the evaluation of psoriasis;
Patient used investigational drugs within 12 weeks or three half-life of Day 0 whichever is longer;
Patient used systemic anti-psoriatic drugs such as steroids, retinoids, methotrexate, cyclosporine within four weeks of Day 0;
Patient used any biologic such as alefacept, etanercept, efalizumab, infliximab and adalimumab within 12 weeks of Day 0;
Patient used ultraviolet light therapy (UVB or nbUVB) within four weeks of Day 0 or PUVA (psoralen ultra violet A) within eight weeks of Day 0;
Patient with prior or concurrent use of cyclophosphamide;
Patient with concurrent sulfasalazine therapy or concurrent use of anakinra;
Patient with an unstable or serious medical condition as defined by the investigator or presence of any significant medical condition that might cause this study to be detrimental to the patient.
Uncontrolled or severe comorbidities such as diabetes mellitus requiring insulin; congestive heart failure (NYHA (New York Heart Association) class III or IV) or history of myocardial infarction or cerebrovascular accident or transient ischemic attack within three months of screening visit; unstable angina pectoris; uncontrolled hypertension, oxygen-dependent severe pulmonary disease;
Patient with a known sero-positivity for HIV (human immunodeficiency virus) or history of any other immunosuppressing disease;
Patient with active or chronic hepatitis B or C;
Patient with any active or chronic infection within four weeks before screening or between the screening and baseline visits;
Patient with any mycobacterial disease, patient with a positive PPD, a chest X-Ray suggestive of tuberculosis or patient taking anti-tuberculosis medication;
Patient with a known hypersensitivity to etanercept or one of its components or known to have antibodies to etanercept;
Patient who received a live attenuated vaccines within 12 weeks of Day 0 or plan to receive one during the study;
Current pregnancy or lactation;
At the investigator's discretion, patient with current or history of alcohol or drug abuse that would interfere with the ability of the patient to comply with the study protocol;
Patient with systemic lupus erythematosus or demyelinating disorder (optic neuritis, multiple sclerosis or other);
Patient with a history of cancer within five years of Day 0 or presence of cancer except for treated basal or squamous cell carcinoma and in situ cervix carcinoma;
Patient who failed to respond to nbUVB in the past;
Patient who have a contra-indication to nbUVB;
Patient with latex sensitivity (applicable only if they are using prefilled syringe or prefilled SureClickTM autoinjector presentations);
Patient with a history of non-compliance with other therapies.

Contacts/Locations Module

Name	Affiliation	Role
Robert Bissonnette, MD	Innovaderm Research Inc.	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Winnipeg Clinic		Winnipeg	Manitoba	R3C 0N2	Canada
Sudbury Skin Clinic

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21797805	Derived	Lynde CW, Gupta AK, Guenther L, Poulin Y, Levesque A, Bissonnette R. A randomized study comparing the combination of nbUVB and etanercept to etanercept monotherapy in patients with psoriasis who do not exhibit an excellent response after 12 weeks of etanercept. J Dermatolog Treat. 2012 Aug;23(4):261-7. doi: 10.3109/09546634.2011.607795. Epub 2011 Aug 10.

IPD Sharing Statement Module

No data available

No data is available for this block.

Arm/Group Information

ID	Title	Description
FG000	Part 1 - Etanercept	All participants received etanercept 50 mg twice a week for 12 weeks.
FG001	Part 2 - Etanercept and nbUVB	Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
FG002	Part 2 - Etanercept	Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.

Periods

Title

Milestones

Reasons Not Completed

Part 1

Type	Comment	Milestone Data
STARTED		FG00099 subjects FG0010 subjects FG0020 subjects
COMPLETED		FG00094 subjects FG0010 subjects FG0020 subjects
NOT COMPLETED		FG0005 subjects FG0010 subjects FG0020 subjects

Type	Comment	Reasons
Lost to Follow-up		FG0002 subjects FG0010 subjects FG0020 subjects
Withdrawal by Subject		FG000

Randomization

Type	Comment	Milestone Data
STARTED		FG00094 subjects FG0010 subjects FG0020 subjects
COMPLETED		FG000

Part 2

Type	Comment	Milestone Data
STARTED		FG0000 subjects FG00137 subjects FG00238 subjects
COMPLETED		FG000

Baseline Characteristics Module

ID	Title	Description
BG000	Part 1 - Etanercept	All participants received etanercept 50 mg twice a week for 12 weeks.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI 90) - ITT

Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:

0 = No symptoms
1 = Slight
2 = Moderate
3 = Marked
4 = Very marked

The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.

Total scale 0 = best and 72 = worst

The analysis was intention to treat (ITT) and the imputation technique was Non-Responder(NRI).

Posted

Number

Participants

112 and 140 days

ID	Title	Description
OG000	Part 1 - Etanercept	All participants received etanercept 50 mg twice a week for 12 weeks.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Part 1 - Etanercept	All participants received etanercept 50 mg twice a week for 12 weeks.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Presyncope	Nervous system disorders		Non-systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Common cold	Infections and infestations		Non-systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Annie Levesque	Innovaderm Research Inc	514-521-4285	222	alevesque@innovaderm.ca

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

ID	Term
D011565	Psoriasis

ID	Term
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Intervention Browse Module

ID	Term
D000068800	Etanercept

ID	Term
D007141	Immunoglobulin Fc Fragments
D007128	Immunoglobulin Fragments
D010446	Peptide Fragments
D010455	Peptides

Masking Info

FG00127 subjectsPer Protocol analysis is of 7 participants that were compliant to protocol

FG00235 subjectsPer protocol analysis of 27 to 29 participants that were compliant depending on evaluation or visit

EG0000 events0 affected99 at risk

EG0010 events0 affected37 at risk

EG0021 events1 affected38 at risk

EG0009 events9 affected99 at risk

EG0012 events2 affected37 at risk

EG0025 events5 affected38 at risk