UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002687 |
|---|---|
| Receipt number | 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 20:55:16 |
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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
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
seto@ior.twmu.ac.jp
Sponsor or person
Institute
TAP Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002976
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| Registered date | File name |
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