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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002687
Receipt No. R000002976
Scientific Title ENBREL Clinical Outcome in RA patients for Growing Evidence
Date of disclosure of the study information 2009/11/16
Last modified on 2015/04/30

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Basic information
Public title ENBREL Clinical Outcome in RA patients for Growing Evidence
Acronym ENCOURAGE
Scientific Title ENBREL Clinical Outcome in RA patients for Growing Evidence
Scientific Title:Acronym ENCOURAGE
Region
Japan Asia(except Japan)

Condition
Condition rheumatoid arthritis
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study was designed to compare the progress of joint destruction and disease activity in moderate disease activity RA patients between the following two treatment groups; a group receiving ETN in combination with MTX (ETN + MTX group) and a group receiving MTX alone or in combination with DMARDs (MTX/MTX+DMARDs group) (Step I). Subsequently, patients in the ETN + MTX group who have maintained clinical remission (DAS28<2.6) for a certain period of time will be randomized to either ETN-continuation group or ETN -discontinuation group to compare the progress of joint destruction and disease activity after drug withdrawal between two groups (Step II).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Remission (clinical, structural, functional) rate
Key secondary outcomes -EULAR response rate
-ACR20, 50 and 70 response rates
-J-HAQ (K-HAQ in Korea) improvement rate
-EQ-5D
-Safety
-Treatment continuation rate in the ETN-discontinuation and ETN-continuation groups (only in Step II)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 MTX/MTX+DMARDs group
MTX+ETN group
Interventions/Control_2 ETN continuation group
ETN discontinuation group
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria [Step I]
1. Patient has had a diagnosis of RA for less than five years as defined according to the American College of Rheumatology (ACR) Criteria for RA.
2. RA patient has moderate disease activity, as defined by DAS28 (3.2 =< DAS28 =< 5.1), despite the treatment with MTX.
3. RA patient who has received any biological drug prior to the start of the study must discontinue the prior drug for the following periods of time prior to participation in the study; not less than eight weeks for infliximab, not less than two weeks for adalimumab and not less than four weeks for tocilizumab.
4. Patient is a male or female, aged not younger than 20 years at the time of informed consent.
5. Patient is an inpatient or outpatient.
[Step II]
1. Patient in the ETN + MTX group in Step I has maintained clinical remission (DAS28<2.6) for not less than six months (patient achieved clinical remission as confirmed by evaluation at Months 6 and 12 of study treatment in Step I).
2. Patient has newly provided informed consent.
Key exclusion criteria 1.Patient does not meet the guideline of anti-TNF alpha therapy in RA patients. (According to the applicable guidelines in each country)
2.Patient is septicemic or at risk of sepsis.
3.Patient has serious infection.
4.Patient has active tuberculosis.
5.Patient has a history of hypersensitivity to ingredients of the study drugs (ETN and MTX).
6.Patient has any current or previous demyelinating diseases.
7.Patient has congested heart failure (NYHA 3 or 4).
8.Patient cannot be treated with MTX (=> 6 mg/week).
9.Patient has bone marrow suppression.
10.Patient has chronic hepatic disease.
11.Patient has renal dysfunction.
12.Patient is a nursing woman.
13.Patient is pregnant or possibly pregnant.
14.Patient has pleural effusion or ascites.
15.Patient has received ETN in the past.
16.Patient has received any investigational biological drug that is not approved at the time of starting the study.
17.Patient is on any oral corticosteroid at a dose of => 10mg as prednisolone equivalent.
18.Patient is otherwise ineligible to participate in this study in the investigator's opinion.
Target sample size 330

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisashi Yamanaka
Organization Tokyo Women's Medical University
Division name Institute of Rheumatology
Zip code
Address 10-22 Kawada-cho, Shinjuku-ku, Tokyo
TEL 03-5269-1711
Email yamanaka@twmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yohei Seto
Organization Tokyo Women's Medical University
Division name Institute of Rheumatology
Zip code
Address 10-22 Kawada-cho, Shinjuku-ku, Tokyo
TEL 03-5269-1725
Homepage URL
Email seto@ior.twmu.ac.jp

Sponsor
Institute TAP Corporation
Institute
Department

Funding Source
Organization Specified nonprofit corporation, Advance Clinical Research Organaization
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2009 Year 11 Month 16 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2009 Year 10 Month 05 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2014 Year 04 Month 01 Day
Date of closure to data entry
2014 Year 04 Month 30 Day
Date trial data considered complete
2014 Year 04 Month 30 Day
Date analysis concluded
2014 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date
2009 Year 10 Month 29 Day
Last modified on
2015 Year 04 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002976

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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