Compare Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept

NCT00482170 | Completed Phase 3 Results

• 1 other identifier: 0881A6-3326
• Study Type: interventional
• Target: 421
• Locations: 12 countries
• Sites: 78

Brief Summary

Primary objective of this study is to compare patient satisfaction with the prefilled syringe (PFS) and the auto-injector (AI), two different delivery devices for etanercept after 12 weeks of use, using a 10 point scale form totally dissatisfied to totally satisfied.Secondary evaluation focus on the identification of patient and device attributes associated with patient satisfaction.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (2)

• Participant Satisfaction With Injection Device Evaluated at Week 12 for Modified Intent-to-treat (mITT) Population

  Participant satisfaction was assessed by asking the question, "How satisfied are you with your injection device?" using a 0-10 point scale, where 0= totally dissatisfied and 10= totally satisfied.

  Week 12

• Participant Satisfaction With Injection Device at Week 12 for Per-protocol (PP) Population

  Participant satisfaction was assessed by asking the question, "How satisfied are you with your injection device?" using a 0-10 point scale, where 0= totally dissatisfied and 10= totally satisfied.

  Week 12

Secondary Outcomes (55)

• Percentage of Participants Satisfied With Injection Device

  Baseline, Week 4 and Week 12

• Influence of Age on Participant Satisfaction With Injection Device

  Week 12

• Influence of Gender on Participant Satisfaction With Injection Device

  Week 12

• Influence of Socio-educational Status on Participant Satisfaction With Injection Device

  Week 12

• Influence of Psychological Status as Assessed by Hospital Anxiety Depression (HAD) Score on Participant Satisfaction With Injection Device

  Week 12

Study Arms (2)

1

EXPERIMENTAL

Arm 1: Enbrel 50 mg Prefilled Syringe

Device: Enbrel (etanercept)

2

ACTIVE COMPARATOR

Arm 2 Enbrel 50 mg Autoinjector

Device: Etanercept

Interventions

Enbrel (etanercept) DEVICE

Arm 1 = Enbrel 50 mg Prefilled Syringe twice weekly

1

Etanercept DEVICE

Arm 2 = Enbrel 50 mg Autoinjector twice weekly

2

Eligibility Criteria

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

You may qualify if:

• Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA
• Eligible for treatment with etanercept according to Summary of Product Characteristics (SmPC), and applicable local guidelines.
• Aged 18 years or more
• Willing and able to self-inject etanercept.
• Able to store test drug at 2-8oC.
• Negative serum ß-human chorionic gonadotropin (ß-HCG) pregnancy test at baseline (week 0) for all women of childbearing potential. Sexually active women of childbearing potential must use a medically acceptable form of contraception. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception. Sexually active men must agree to use a reliable form of contraception during the study.
• Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol-specific procedures are performed.

You may not qualify if:

• Prior experience of biologics and anti-TNF treatment for their Psoriasis including etanercept.
• Sepsis or risk of sepsis.
• Current or recent infections, including chronic or localized.
• Latex sensitivity.
• Vaccination with live vaccine in last 4 weeks, or expected to require such vaccination during the course of the study.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (78)

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Bruges, 08000, Belgium

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Brussels, 01070, Belgium

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Brussels, 01200, Belgium

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Edegem, B-2650, Belgium

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Ghent, 09000, Belgium

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Hasselt, 03500, Belgium

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Kapellen, 02950, Belgium

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Liège, B-4000, Belgium

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Hellerup, 02900, Denmark

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Hørsholm, 02970, Denmark

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Roskilde, 04000, Denmark

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Helsinki, 00029 HUS, Finland

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Helsinki, 00250, Finland

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Joensuu, 802 10, Finland

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Tampere, FIN-33521, Finland

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Le Mans, Cedex, 72037, France

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Limoges, 87042, France

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Montpellier, 34000, France

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Nancy, 54000, France

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Nantes, 44093, France

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Paris, 75010, France

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Pessac, 33600, France

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Pierre-Bénite, 69495, France

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Reims, 51092, France

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Toulouse, 31059, France

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Augsburg, 86179, Germany

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Berlin, 10435, Germany

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Berlin, 10827, Germany

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Bonn, 53105, Germany

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Cologne, 50931, Germany

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Dresden, 01307, Germany

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Dülmen, 48249, Germany

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Erlangen, 91052, Germany

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Freiburg im Breisgau, 79106, Germany

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Göttingen, 37099, Germany

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Greifswald, 17475, Germany

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Hamburg, 20246, Germany

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Lübeck, 23538, Germany

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Mainz, 55101, Germany

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Mannheim, 68135, Germany

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München, 80802, Germany

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Münster, 48149, Germany

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Tübingen, 72076, Germany

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Wiesbaden, 65199, Germany

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Würzburg, 97070, Germany

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Würzburg, D-97080, Germany

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Athens, 54644, Greece

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Athens, Greece

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Ioannina, 45332, Greece

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Thessaloniki, 54644, Greece

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Szeged, 06720, Hungary

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S. Giovanni Rotondo, Foggia, 71013, Italy

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Terracina, Latina, ITALY 04019, Italy

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Gallarate, Varese, 21013, Italy

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Capranica, Viterbo, 01012, Italy

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Bologna, 40128, Italy

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Como, 22100, Italy

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Milan, 20122, Italy

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Napoli, 80131, Italy

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Napoli, 80132, Italy

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Padua, Italy

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Pisa, 56126, Italy

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Breda, 4818 CK, Netherlands

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Flushing, 4382 EE, Netherlands

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Nijmegen, 06525, Netherlands

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Bergen, 05021, Norway

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Stavanger, 04068, Norway

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Tromsø, N-9038, Norway

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Elche, Alicante, 03203, Spain

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Santander, Cantabria, 39008, Spain

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Córdoba, 14004, Spain

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Granada, 18012, Spain

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Madrid, SPAIN 28046, Spain

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Valencia, 46015, Spain

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Danderyd, 182 88, Sweden

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Gothenburg, 41459, Sweden

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Linköping, SE-581 85, Sweden

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Malmo, SE-205 02, Sweden

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MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: June 1, 2007
• First Posted: June 4, 2007
• Study Start: September 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: September 1, 2009
• Last Updated: March 30, 2012
• Results First Posted: March 30, 2012

Record last verified: 2012-03

Locations

DK (3); BE (8); FI (4); FR (10); IT (11); NO (3); ES (6); DE (21); GR (4); NL (3); SE (4); HU (1)