Efficacy and Safety of Etanercept in Active RA Despite Methotrexate Therapy in Japan

Rheumatoid Arthritis Clinical Trial

— JESMR  

Official title:

Efficacy and Safety of Etanercept in Active Rheumatoid Arthritis Despite Methotrexate Therapy in Japan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00688103
• Other study ID #: Etanercept-01
• Status: Completed
• Phase: Phase 4
• First received: May 25, 2008
• Last updated: September 1, 2015
• Start date: June 2005
• Est. completion date: October 2010

Study information

• Verified date: September 2015
• Source: Japan Biological Agent Study Integrated Consortium
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Multi-center, parallel-group, randomized, open control study. All patients will be selected to two treatment groups.

1. Etanercept alone treatment group (25mg, twice/week, s.c.)

2. Etanercept combined with MTX group (25mg, twice/week, s.c.+MTX 6-8mg/week)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: October 2010
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients had to be at least 18 years of age

• fulfilled the 1987 revised classification criteria for RA by in American College of Rheumatology (ACR)

• met the guidelines for the proper use of ETN in Japan (having at least 6 tender joints and 6 swollen joints

• either serum C-reactive protein more than 2 mg/dl or ESR no less than 28 mm at 1 hour, with adequate safety profiles)

• be ACR functional class I-III

• have been receiving MTX 6 mg/week for a minimum of 3 months at a stable dose for at least 4 weeks at the time of study enrollment

Exclusion Criteria:

• Patients who required concurrent use of prednisone (PSL) >10 mg/day, or its equivalent, were excluded from study entry

• the start of dose increment of PSL equivalents within 3 months of the study enrollment

• experience of antirheumatic therapy except for MTX and PSL equivalents

• previous treatment with ETN or any other biological treatment

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• ETN Alone
etanercept (25 mg, twice/week, s.c.)
• ETN+MTX
etanercept (25 mg, twice/week, s.c.) combined with methotrexate (6-8 mg/week)

Locations

Country	Name	City	State
Japan	Keio University	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Japan Biological Agent Study Integrated Consortium

Country where clinical trial is conducted

Japan, 

References & Publications (3)

Kameda H, Kanbe K, Sato E, Ueki Y, Saito K, Nagaoka S, Hidaka T, Atsumi T, Tsukano M, Kasama T, Shiozawa S, Tanaka Y, Yamanaka H, Takeuchi T. Continuation of methotrexate resulted in better clinical and radiographic outcomes than discontinuation upon star — View Citation

Kameda H, Kanbe K, Sato E, Ueki Y, Saito K, Nagaoka S, Hidaka T, Atsumi T, Tsukano M, Kasama T, Shiozawa S, Tanaka Y, Yamanaka H, Takeuchi T; Japan Biological Agent Integrated Consortium (JBASIC). A merged presentation of clinical and radiographic data us — View Citation

Kameda H, Ueki Y, Saito K, Nagaoka S, Hidaka T, Atsumi T, Tsukano M, Kasama T, Shiozawa S, Tanaka Y, Takeuchi T; Japan Biological Agent Study Integrated Consortium. Etanercept (ETN) with methotrexate (MTX) is better than ETN monotherapy in patients with a — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EULAR Good Response	EULAR good response was defined as reaching, at least, low decease activity by the disease activity score of 28 joints (DAS28) and its improvement by > 1.2. DAS28 is a quantitative composite measure of disease activity for rheumatoid arthritis, and DAS28 < 3.2 is regarded as low disease activity.	at 24 weeks	No
Primary	ACR50 Response Rate	ACR (American College of Rheumatology) 50 response is defined by the following definition of improvement: at least 50% improvement in tender and swollen joint counts and at least 50% improvement in 3 of the 5 remaining ACR-core set measures; patient and physician global assessments, pain, disability, and an acute phase reactant (erythrocyte sedimentation rate or C-reactive protein).	at 24 weeks	No
Primary	Radiographic Progression Defined by Change in Van Der Heijde-modified Total Sharp Score	The van der Heijde-modifiedtotal Sharp score is the sum of scores for erosions and joint space narrowing. The minimum and maximum total scores are 0 and 448, respectively. The maximum number of erosions is 160 in the hands and 120 in the feet; and the maximum scores for joint space narrowing are 120 and 48, respectively.; Erosions are scored 1 for a discrete interruption of the cortical surface, and scored 2-5 for a larger defect according to the surface area of the joint involved. Notably, the maximum erosion score in each joint in hands is 5, while it is 10 in the feet.; For joint space narrowing, 0=normal; 1=focal or doubtful; 2=general, <50% of the original joint space; 3=general, >50% of the original joint space or subluxation; 4=ankylosis.	at 52 weeks	No

External Links

•   website for J-BASIC