Clinical trial NCT00706797: Study Evaluating Efficacy / Safety of Etanercept + Methotrexate Compared to Usual Treatment in Moderate RA Subjects
Official title: An Open-Label, Randomized Study to Evaluate the Radiographic Efficacy and Safety of Enbrel™ (Etanercept) Added to Methotrexate in Comparison With Usual Treatment in Subjects With Moderate Rheumatoid Arthritis Disease Activity
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Keywords: Moderate Rheumatoid Arthritis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2008-06-30
Enrollment: 141
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: To assess comparative radiographic efficacy, clinical efficacy and safety of etanercept (ETN) + methotrexate (MTX) with usual disease-modifying anti-rheumatic drug (DMARD) treatment in subjects with moderate RA who were treated with MTX monotherapy, but continue to have moderate disease activity.


Eligibility criteria: Inclusion Criteria:

* Meet the 1987 ACR Revised Criteria for Rheumatoid Arthritis.
* Documented evidence, confirmed by a blinded 3rd party assessor, of at least one erosion observed by X-ray at randomization based on X-ray taken at the screening visit.
* Have received MTX as stable dose for 28 days prior to the screening visit.

Exclusion Criteria:

* Previous treatment with ETN, infliximab, adalimumab, other Tumor necrosis factor (TNF) -a inhibitors, anakinra or other biological agents.
* Receipt of any DMARD, other than MTX, within 28 days before screening.

Primary outcomes:
measure: Change From Baseline in Modified Total Sharp Score (TSS) at Week 52
timeFrame: Baseline, Week 52
Secondary outcomes:
measure: Change From Baseline in Erosions at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in Joint Space Narrowing at Week 52
timeFrame: Baseline, Week 52
measure: Percentage of Participants Showing no Radiographic Progression (TSS Change <0.5) at Week 52
timeFrame: Baseline, Week 52, Last observation carried forward (LOCF)
measure: Percentage of Participants Achieving >1.2 Improvement in Disease Activity Score Based on a 28-joint Count (DAS28)
timeFrame: Baseline, Week 12, Week 24, and Week 52
measure: Percentage of Participants Achieving Remission (DAS28 <2.60)
timeFrame: Week 12, Week 24, and Week 52
measure: Percentage of Participants Achieving Low Disease Activity (DAS28 ≤3.20)
timeFrame: Week 12, Week 24, and Week 52
measure: Percentage of Participants Achieving a >0.6 Disease Activity Score (DAS)28 Response
timeFrame: Week 12, Week 24, and Week 52
measure: Percentage of Participants Achieving Moderate or Good Response on European League Against Rheumatism (EULAR) Response Criteria
timeFrame: Week 12, Week 24, Week 52
measure: Percentage of Participants With American College of Rheumatology 20% (ACR20) Response
timeFrame: Week 12, Week 24, Week 52
measure: Percentage of Participants With American College of Rheumatology 50% (ACR50) Response
timeFrame: Week 12, Week 24, Week 52
measure: Percentage of Participants With American College of Rheumatology 70% (ACR70) Response
timeFrame: Week 12, Week 24, Week 52
measure: Percentage of Participants With American College of Rheumatology 90% (ACR90) Response
timeFrame: Week 12, Week 24, Week 52
measure: Change From Baseline in Mean Daily Dose of Corticosteroids to Manage Flare-ups Across the 52-week Treatment Period
timeFrame: Week 4, Week 12, Week 24, Week 40, Week 52
measure: Percentage of Participants Achieving a Minimal Clinically Important Improvement (MCII)
timeFrame: Week 12, Week 52
measure: Percentage of Participants Achieving a Patient Acceptable Symptom State (PASS)
timeFrame: Week 4, Week 12, Week 24, Week 40, Week 52
measure: Health Related Quality of Life: EuroQol-5D Health Index
timeFrame: Baseline, Week 12, Week 24, and Week 52
measure: Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)
timeFrame: Baseline, Week 12, Week 24, and Week 52
Other outcomes:
Locations:
city: Ostrava
country: Czech Republic
city: Prague
country: Czech Republic
city: Prague
country: Czech Republic
city: Amiens cedex 1
country: France
city: Amiens
country: France
city: Echirolles
country: France
city: Metz
country: France
city: Montpellier
country: France
city: Paris cedex 13
country: France
city: Paris cedex 14
country: France
city: Paris
country: France
city: Paris
country: France
city: Rouen
country: France
city: Tours cedex 9
country: France
city: Tours
country: France
city: Berlin
country: Germany
city: Frankfurt
country: Germany
city: Hamburg-Eilbeck
country: Germany
city: Homburg
country: Germany
city: Koeln
country: Germany
city: Mainz
country: Germany
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Miskolc
country: Hungary
city: Rijeka
country: Hungary
city: Split
country: Hungary
city: Zagreb
country: Hungary
city: Jesi (Ancona)
country: Italy
city: Reggio Calabria
country: Italy
city: Bytom
country: Poland
city: Krakow
country: Poland
city: Ustron
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Santander
country: Spain
state: Cantabria
city: Getafe
country: Spain
state: Madrid
city: Bilbao
country: Spain
state: Vizcaya
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Valencia
country: Spain
city: Izmir
country: Turkey
city: Cambridge
country: United Kingdom
state: Cambs
city: Birmingham
country: United Kingdom
state: West Midlands
city: Aintree
country: United Kingdom
city: Newcastle
country: United Kingdom
city: Wirral
country: United Kingdom
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Mandl P, Balint PV, Brault Y, Backhaus M, D'Agostino MA, Grassi W, van der Heijde D, de Miguel E, Wakefield RJ, Logeart I, Dougados M. Clinical and ultrasound-based composite disease activity indices in rheumatoid arthritis: results from a multicenter, randomized study. Arthritis Care Res (Hoboken). 2013 Jun;65(6):879-87. doi: 10.1002/acr.21913.
citation: Mandl P, Balint PV, Brault Y, Backhaus M, D'Agostino MA, Grassi W, van der Heijde D, de Miguel E, Wakefield RJ, Logeart I, Dougados M. Metrologic properties of ultrasound versus clinical evaluation of synovitis in rheumatoid arthritis: results of a multicenter, randomized study. Arthritis Rheum. 2012 Apr;64(4):1272-82. doi: 10.1002/art.33491. Epub 2011 Nov 30.