Clinical trial NCT00913458: Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis
Official title: A 3-Phase Study to Evaluate Sustained Remission and Productivity Outcomes in Subjects With Early Rheumatoid Arthritis Initiated on Treatment With Etanercept Plus Methotrexate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Active Rheumatoid Arthritis
Arthritis, Rheumatoid
Rheumatoid Arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-06-04
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study to evaluate whether there is sustained remission and productivity in subjects with early rheumatoid arthritis started on etanercept plus methotrexate treatment.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of early rheumatoid arthritis.
* Methotrexate (MTX) naive.
* Active early rheumatoid arthritis at the time of enrollment.

Exclusion Criteria:

* Previous or current treatment with etanercept, other tumor necrosis factor-alpha (TNF) inhibitors, or other biologic agents.
* Concurrent treatment with any disease-modifying anti-rheumatoid drugs (DMARD), within 4 weeks before baseline.
* Concurrent treatment with more than 1 non-steroidal anti-inflammatory drug (NSAID) at baseline.

Primary outcomes:
measure: Number of Participants That Met Sustained Remission at Week 76 and Week 91 Based on DAS28 Score
timeFrame: 76 and 91 weeks
Secondary outcomes:
measure: Number of Participants Achieving Complete Response (Using Disease Activity Score Based on 28-joint Count, Modified Total Sharp Score, Health Assessment Questionnaire)
timeFrame: End of Phase 1
measure: Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52 and Final on Therapy
timeFrame: 52 week and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)
measure: Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Overall Work Impairment Due to Problem
timeFrame: 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)
measure: Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Impairment While Working Due to Problem
timeFrame: 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)
measure: Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Work Time Missed Due to Problem
timeFrame: 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)
measure: Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Activity Impairment Due to Problem
timeFrame: 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)
measure: Number of Participants Achieving American College of Rhematology 20% (ACR 20) Response
timeFrame: 2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)
measure: Number of Participants Achieving American College of Rhematology 50% (ACR 50) Response
timeFrame: 2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)
measure: Number of Participants Achieving American College of Rhematology 70% (ACR 70) Response
timeFrame: 2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)
measure: Number of Participants Achieving American College of Rhematology 90% (ACR 90) Response
timeFrame: 2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)
measure: Change From Baseline in Physician's Global Assessment of Disease Activity
timeFrame: 2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)
measure: Change From Baseline in Participant's Global Assessment of Disease Activity
timeFrame: 2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)
measure: Change From Baseline in DAS44 Score at All Visits
timeFrame: 2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)
measure: Number of Participants With Disease Activity Score Based on 44-joints Count (DAS44)-Remission
timeFrame: 2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)
measure: Number of Participants With Disease Activity Score Based on 44-joints Count (DAS44) - Low Disease Activity
timeFrame: 2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)
measure: Proportion of Subjects Achieving a Patient Acceptable Symptom State (PASS) at Each Visit
timeFrame: 2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)
measure: Number of Participants With an American College of Rheumatology 20% (ACR20) Response
timeFrame: 52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)
measure: Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response
timeFrame: 52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)
measure: Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response
timeFrame: 52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)
measure: Number of Participants Achieving American College of Rheumatology 90% (ACR90) Response
timeFrame: 52, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)
measure: Number of Participants With Disease Activity Score Based on 44-joints Count (DAS44) Remission
timeFrame: 52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)
measure: Number of Participants With Disease Activity Score Based on 44-joints Count (DAS44) - Low Disease Activity
timeFrame: 52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)
measure: Number of Participants Achieving Complete Response (Using Disease Activity Score Based on a 28-joint Count, Modified Total Sharp Score, Health Assessment Questionnaire)
timeFrame: 52 and 91 weeks
measure: Physician's Global Assessment of Disease Activity
timeFrame: 52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)
measure: Participant's Global Assessment of Disease Activity
timeFrame: 52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)
measure: Participant's Global Assessment of Pain (Visual Analogue Scale) (VAS)
timeFrame: 52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)
measure: Number of Participants Achieving Patient Acceptable Symptom State (PASS)
timeFrame: 52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)
measure: Modified Total Sharp Score (mTSS) at Week 52
timeFrame: 52 weeks
measure: Change From Baseline mTSS at Week 91 and Final on Therapy
timeFrame: 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)
measure: Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Work Time Missed in the Past 7 Days Due to Problem
timeFrame: 52 weeks
measure: Change From Baseline in WPAI Questionnaire: Percent Work Time Missed in the Past 7 Days Due to Problem
timeFrame: 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant upto Week 91 or the visit they discontinued at)
measure: WPAI Questionnaire: Percent Impairment While Working in the Past 7 Days Due to Problem
timeFrame: 52 Weeks
measure: Change From Baseline in WPAI Questionnaire: Percent Impairment While Working in the Past 7 Days Due to Problem
timeFrame: 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant upto Week 91 or the visit they discontinued at)
measure: WPAI Questionnaire: Percent Overall Work Impairment in the Past 7 Days Due to Problem
timeFrame: 52 weeks
measure: Change From Baseline in WPAI Questionnaire: Percent Overall Work Impairment in the Past 7 Days Due to Problem
timeFrame: 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant upto Week 91 or the visit they discontinued at)
measure: WPAI Questionnaire: Percent Activity Impairment in the Past 7 Days Due to Problem
timeFrame: 52 weeks
measure: Change From Baseline in WPAI Questionnaire: Percent Activity Impairment in the Past 7 Days Due to Problem
timeFrame: 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant upto Week 91 or the visit they discontinued at)
Other outcomes:
Locations:
city: Lyon
country: France
facility: Pfizer Investigational Site
city: Montpellier Cedex 05
country: France
facility: Pfizer Investigational Site
city: Paris Cedex 13
country: France
facility: Pfizer Investigational Site
city: Paris Cedex 14
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Strasbourg Cedex
country: France
facility: Pfizer Investigational Site
city: Toulouse Cedex 9
country: France
facility: Pfizer Investigational Site
city: Vogelsang
country: Germany
facility: Pfizer Investigational Site
state: Gommern
city: Elmshorn
country: Germany
facility: Pfizer Investigational Site
city: Halle
country: Germany
facility: Pfizer Investigational Site
city: Halle
country: Germany
facility: Pfizer Investigational Site
city: Hamburg-Altona
country: Germany
facility: Pfizer Investigational Site
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Ludwigsfelde
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Osnabrueck
country: Germany
facility: Pfizer Investigational Site
city: Rostock
country: Germany
facility: Pfizer Investigational Site
city: Wuerzburg
country: Germany
facility: Pfizer Investigational Site
city: Zerbst
country: Germany
facility: Pfizer Investigational Site
city: Dublin
country: Ireland
facility: Pfizer Investigational Site
city: Pavia
country: Italy
facility: Pfizer Investigational Site
city: Pisa
country: Italy
facility: Pfizer Investigational Site
city: Monaco
country: Monaco
facility: Pfizer Investigational Site
city: Amsterdam
country: Netherlands
facility: Pfizer Investigational Site
state: Noord Holland
city: Haarlem
country: Netherlands
facility: Pfizer Investigational Site
city: Heerlen
country: Netherlands
facility: Pfizer Investigational Site
city: Bydgoszczy
country: Poland
facility: Pfizer Investigational Site
city: Poznan
country: Poland
facility: Pfizer Investigational Site
city: Torun
country: Poland
facility: Pfizer Investigational Site
city: Ustron
country: Poland
facility: Pfizer Investigational Site
city: Warsawa
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Wroclaw
country: Poland
facility: Pfizer Investigational Site
city: Zyrardow
country: Poland
facility: Pfizer Investigational Site
city: Doha
country: Qatar
facility: Pfizer Investigational Site
city: Bucharest
country: Romania
facility: Pfizer Investigational Site
city: Bucuresti
country: Romania
facility: Pfizer Investigational Site
city: Bucuresti
country: Romania
facility: Pfizer Investigational Site
city: Bucuresti
country: Romania
facility: Pfizer Investigational Site
city: Bucuresti
country: Romania
facility: Pfizer Investigational Site
city: Targu Mures
country: Romania
facility: Pfizer Investigational Site
city: Yaroslavl
country: Russian Federation
facility: Pfizer Investigational Site
city: Oviedo
country: Spain
facility: Pfizer Investigational Site
state: Asturias
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: La Coruna
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
city: St. Gallen
country: Switzerland
facility: Pfizer Investigational Site
state: SG
city: Chur
country: Switzerland
facility: Pfizer Investigational Site
city: Lausanne
country: Switzerland
facility: Pfizer Investigational Site
city: Wigan
country: United Kingdom
facility: Pfizer Investigational Site
state: Lancaster
city: Harrogate
country: United Kingdom
facility: Pfizer Investigational Site
state: North Yorkshire
city: Dudley
country: United Kingdom
facility: Pfizer Investigational Site
state: West Midlands
city: Leeds
country: United Kingdom
facility: Pfizer Investigational Site
state: West Yorkshire
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: Manchester
country: United Kingdom
facility: Pfizer Investigational Site
city: Newcastle Upon Tyne
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Tanaka Y, Smolen JS, Jones H, Szumski A, Marshall L, Emery P. The effect of deep or sustained remission on maintenance of remission after dose reduction or withdrawal of etanercept in patients with rheumatoid arthritis. Arthritis Res Ther. 2019 Jul 5;21(1):164. doi: 10.1186/s13075-019-1937-4.
citation: Fleischmann RM, van der Heijde D, Gardiner PV, Szumski A, Marshall L, Bananis E. DAS28-CRP and DAS28-ESR cut-offs for high disease activity in rheumatoid arthritis are not interchangeable. RMD Open. 2017 Jan 30;3(1):e000382. doi: 10.1136/rmdopen-2016-000382. eCollection 2017.
citation: Zhang W, Bansback N, Sun H, Pedersen R, Kotak S, Anis AH. Impact of etanercept tapering on work productivity in patients with early rheumatoid arthritis: results from the PRIZE study. RMD Open. 2016 Jul 7;2(2):e000222. doi: 10.1136/rmdopen-2015-000222. eCollection 2016.
citation: Wiland P, Dudler J, Veale D, Tahir H, Pedersen R, Bukowski J, Vlahos B, Williams T, Gaylord S, Kotak S. The Effect of Reduced or Withdrawn Etanercept-methotrexate Therapy on Patient-reported Outcomes in Patients with Early Rheumatoid Arthritis. J Rheumatol. 2016 Jul;43(7):1268-77. doi: 10.3899/jrheum.151179. Epub 2016 Jun 1.
citation: Zhang W, Bansback N, Sun H, Pedersen R, Kotak S, Anis AH. Estimating the monetary value of the annual productivity gained in patients with early rheumatoid arthritis receiving etanercept plus methotrexate: interim results from the PRIZE study. RMD Open. 2015 Apr 8;1(1):e000042. doi: 10.1136/rmdopen-2014-000042. eCollection 2015.
citation: Emery P, Hammoudeh M, FitzGerald O, Combe B, Martin-Mola E, Buch MH, Krogulec M, Williams T, Gaylord S, Pedersen R, Bukowski J, Vlahos B. Sustained remission with etanercept tapering in early rheumatoid arthritis. N Engl J Med. 2014 Nov 6;371(19):1781-92. doi: 10.1056/NEJMoa1316133.