Clinical trial NCT00422227: Study Comparing Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis in the Asia Pacific Region
Official title: A Randomized, Open-Label Study in the Asia-Pacific Region Comparing the Safety and Efficacy of Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-01-15
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy of etanercept with usual disease-modifying anti-rheumatic drug (DMARD) therapy in the treatment of moderate to severe rheumatoid arthritis (RA) over 16 weeks in the Asia Pacific region.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of RA
* Currently receiving an adequate dose of methotrexate (MTX) for treatment of RA
* Active RA at time of screening and baseline

Exclusion Criteria:

* Previous or current treatment with etanercept (ETN), other tumor necrosis factor-alpha inhibitors, or other biologic agents
* Concurrent treatment with a DMARD, other than MTX, at screening
* Receipt of any DMARD, other than MTX, within 3 months before screening

Primary outcomes:
measure: Change From Baseline in Adjusted Mean of American College of Rheumatology Response (ACR-N) Area Under Curve (AUC) Over 16 Weeks
timeFrame: 16 weeks
Secondary outcomes:
measure: Percentage of Participants Achieving ACR 20, 50, and 70 Responses
timeFrame: Week 16
measure: Percentage of Participants Achieving DAS28 <3.2 (Low Disease Activity) and <2.6 (Remission)
timeFrame: Week 16
measure: Percent Change From Baseline in DAS28 at Week 16
timeFrame: Week 16
measure: Percentage of Participants Achieving European League Against Rheumatism (EULAR) Moderate or Good Response
timeFrame: Week 16
measure: Percentage of Participants With DAS28 Improvement of ≥0.6 and ≥1.2
timeFrame: Week 16
measure: Percent Change From Baseline in Painful and Swollen Joint Counts
timeFrame: Week 2, 4, 8, 12, 16
measure: Percent Change From Baseline in Physician And Subject Global Assessments
timeFrame: Week 2, 4, 8, 12, 16
measure: Percent Change From Baseline in Duration (Minutes) of Morning Stiffness
timeFrame: Week 2, 4, 8, 12, 16
measure: Percent Change From Baseline in General Health, Pain, and Fatigue, Visual Analog Scales
timeFrame: Week 2, 4, 8, 12, 16
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
city: Bangalore
country: India
city: Bangalore
country: India
city: Hyderabaad
country: India
city: New Delhi
country: India
city: In Cheon
country: Korea, Republic of
state: Korea
city: Seoul
country: Korea, Republic of
state: Korea
city: Seoul
country: Korea, Republic of
state: Korea
city: Seoul
country: Korea, Republic of
state: Korea
city: Seoul
country: Korea, Republic of
state: Korea
city: Seoul
country: Korea, Republic of
state: Korea
city: Ipoh, Perak
country: Malaysia
city: Kuala Lumpur
country: Malaysia
city: Pulau Pinang
country: Malaysia
city: Putrajaya
country: Malaysia
city: Seremban
country: Malaysia
city: Cebu
country: Philippines
city: Makati City
country: Philippines
city: Manila
country: Philippines
city: Manila
country: Philippines
city: Manila
country: Philippines
city: Quezon City
country: Philippines
city: Singapore
country: Singapore
city: Kaohsiung City
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Bangkok
country: Thailand
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For Hong Kong: medinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Taiwan: medinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fleischmann R, Koenig AS, Szumski A, Nab HW, Marshall L, Bananis E. Short-term efficacy of etanercept plus methotrexate vs combinations of disease-modifying anti-rheumatic drugs with methotrexate in established rheumatoid arthritis. Rheumatology (Oxford). 2014 Nov;53(11):1984-93. doi: 10.1093/rheumatology/keu235. Epub 2014 Jun 6.
citation: Bae SC, Gun SC, Mok CC, Khandker R, Nab HW, Koenig AS, Vlahos B, Pedersen R, Singh A. Improved health outcomes with etanercept versus usual DMARD therapy in an Asian population with established rheumatoid arthritis. BMC Musculoskelet Disord. 2013 Jan 8;14:13. doi: 10.1186/1471-2474-14-13.