Study Comparing Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept

NCT00459706 | Completed Phase 3 Results

• 2 other identifiers: 0881K1-6000B1801017
• Study Type: interventional
• Target: 640
• Locations: 9 countries
• Sites: 113

Brief Summary

The purpose of this study is to explore and compare the perceptions and satisfaction for two different delivery mechanisms for Etanercept (Etanercept Autoinjector and the Etanercept Prefilled Syringe) in patients with rheumatoid arthritis (RA).

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

• Participant Satisfaction on Day 84 for 2 Different Delivery Mechanisms for Etanercept, Modified Intent-to-treat Population

  Participant's response to the question "How satisfied are you with your injection device?" scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher score indicated greater satisfaction with the delivery mechanism.

  Day 84

• Participant Satisfaction on Day 84 for 2 Different Delivery Mechanisms for Etanercept, Per-Protocol Population

  Participant's response to the question "How satisfied are you with your injection device?" scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher score indicated greater satisfaction with the delivery mechanism.

  Day 84

Secondary Outcomes (66)

• Percentage of Participants on Day 28 Satisfied With Either of the Different Delivery Mechanisms for Etanercept

  Day 28

• Percentage of Participants on Day 84 Satisfied With Either of the Delivery Mechanisms for Etanercept

  Day 84

• Participant Satisfaction by Age for 2 Different Delivery Mechanisms for Etanercept

  Day 84

• Participant Satisfaction by Gender for 2 Different Delivery Mechanisms for Etanercept

  Day 84

• Participant Satisfaction by Socio-Educational Level for 2 Different Delivery Mechanisms for Etanercept

  Day 84

Study Arms (2)

Enbrel 50 mg Prefilled Syringe

EXPERIMENTAL

Enbrel 50 mg subcutaneously once weekly for 12 Weeks using Prefilled Syringe

Device: Enbrel 50 mg Prefilled Syringe

Enbrel 50 mg Autoinjector

EXPERIMENTAL

Enbrel 50 mg subcutaneously once weekly for 12 Weeks using Autoinjector

Device: Enbrel 50 mg Autoinjector

Interventions

Enbrel 50 mg Prefilled Syringe DEVICE

Enbrel 50 mg subcutaneously once weekly for 12 Weeks using Prefilled Syringe

Enbrel 50 mg Prefilled Syringe

Enbrel 50 mg Autoinjector DEVICE

Enbrel 50 mg subcutaneously once weekly for 12 Weeks using Autoinjector

Enbrel 50 mg Autoinjector

Eligibility Criteria

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

You may qualify if:

• Diagnosis of RA according to the ACR-Criteria.
• Eligible for treatment with etanercept according to Summary of Product Characteristics (SmPC), and applicable local guidelines.
• Willing and able to self-inject etanercept.

You may not qualify if:

• Prior experience of biologics and anti-TNF treatment for their RA including etanercept.
• Sepsis or risk of sepsis.
• Current or recent infections, including chronic or localized.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (113)

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Frederiksberg, 02000, Denmark

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Hjørring, 09800, Denmark

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Holbæk, 04300, Denmark

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Silkeborg, DK-8600, Denmark

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Helsinki, 00130, Finland

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Hyvinkää, 05800, Finland

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Joensuu, 802 10, Finland

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Lohja, 08200, Finland

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Amiens, 80054, France

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Aulnay-sous-Bois, 93602, France

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Avignon, 84000, France

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Boulogne-Billancourt, 92104, France

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Brest, 29609, France

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Cahors, 49000, France

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Corbeilles-Essonnes, 91100, France

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Grenoble, 38043, France

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Lille, 59037, France

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Lyon, 69091, France

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Marseille, 13008, France

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Montpellier, 34000, France

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Montpellier, 34059, France

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Niort, 79021, France

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Orléans, 45032, France

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Paris, 75013, France

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Paris, 75018, France

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Pierre-Bénite, 69495, France

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Reims, 51092, France

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Rouen, 76031, France

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Toulouse, 31054, France

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Vandœuvre-lès-Nancy, 54511, France

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Erlangen, Bay, 91054, Germany

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Frankfurt am Main, Hesse, 60590, Germany

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Pirna, Saxony, 01796, Germany

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Bad Abbach, 93077, Germany

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Bad Nauheim, 61231, Germany

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Berlin, 10777, Germany

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Berlin, 13125, Germany

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Cologne, 50924, Germany

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Düsseldorf, 40211, Germany

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Erlangen, 91056, Germany

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Essen, 45326, Germany

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Göttingen, 37075, Germany

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Hanover, 30159, Germany

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Hanover, 30161, Germany

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Hofheim/Taunus, 65719, Germany

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Leipzig, 04103, Germany

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München, 80336, Germany

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Nienburg, 31582, Germany

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Oberammergau, 82487, Germany

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Osnabrück, 49074, Germany

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Tübingen, 72076, Germany

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Villingen-Schwenningen, 78034, Germany

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Würzburg, 97080, Germany

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Zeven, 27404, Germany

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Ariano Irpino, Avellino, 83031, Italy

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S. Pietro Vernotico, Brescia, 72027, Italy

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San Cesario di Lecce, Lecce, 73016, Italy

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Alessandria, 15100, Italy

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Bologna, 40133, Italy

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Cagliari, 09042, Italy

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Cinisello Balsamo, 20099, Italy

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Como, 22100, Italy

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Coppito, 67010, Italy

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Fano, 61032, Italy

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Ferrara, 44100, Italy

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Foggia, 71100, Italy

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Massa, 54100, Italy

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Milan, 20124, Italy

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Napoli, 80137, Italy

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Napoli, 80144, Italy

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Padua, 35128, Italy

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Palermo, 90100, Italy

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Parma, 43100, Italy

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Reggio Calabria, 89133, Italy

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Rieti, 02100, Italy

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Roma, 00165, Italy

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Roma, 00189, Italy

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S. Dona Di Piave, 30027, Italy

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Terni, 05100, Italy

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Torino, 10128, Italy

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Torrette Di Ancona, 60020, Italy

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Verona, 37134, Italy

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Vimercate, 20059, Italy

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Arnhem, 6815 AD, Netherlands

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Eindhoven, 5631 BM, Netherlands

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Rotterdam, 3078 HT, Netherlands

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Gjettum, 01346, Norway

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Harstad, 09480, Norway

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Kristiansand, 04615, Norway

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Lillehammer, 02609, Norway

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Skien, 03722, Norway

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Trondheim, NO-7030, Norway

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Tønsberg, 03118, Norway

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Danderyd, 182 88, Sweden

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Malmo, SE-205 02, Sweden

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Stockholm, 11152, Sweden

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Sundsvall, 851 86, Sweden

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Uppsala, 75185, Sweden

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Vasterås, 721 89, Sweden

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Västerås, 72189, Sweden

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Ashford, TW15 3AA, United Kingdom

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Basingstoke, RG24 9NA, United Kingdom

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Cambridge, CB2 2QQ, United Kingdom

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Chertsey, KT16 0PZ, United Kingdom

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London, E1 4DG, United Kingdom

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London, SE1 9RT, United Kingdom

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Manchester, M13 9WL, United Kingdom

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Portsmouth, PO6 3LY, United Kingdom

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Southampton, SO16 6YD, United Kingdom

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Stoke-on-Trent, United Kingdom

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Truro, TR1 3LJ, United Kingdom

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Westcliff-on-Sea, SS0 0RY, United Kingdom

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Wigan, WN6 9EP, United Kingdom

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MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System 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: April 11, 2007
• First Posted: April 12, 2007
• Study Start: September 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: September 1, 2009
• Last Updated: March 28, 2013
• Results First Posted: March 28, 2013

Record last verified: 2013-02

Locations

DK (4); FI (4); DE (24); NO (7); NL (3); IT (29); GB (13); FR (22); SE (7)