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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009425
Receipt No. R000011073
Scientific Title A validity inspection study of the treat-to-target strategy with golimumab for the treatment of rheumatoid arthritis patient
Date of disclosure of the study information 2012/12/01
Last modified on 2014/08/03

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Basic information
Public title A validity inspection study of the treat-to-target strategy with golimumab for the treatment of rheumatoid arthritis patient
Acronym Go-Go trial
Scientific Title A validity inspection study of the treat-to-target strategy with golimumab for the treatment of rheumatoid arthritis patient
Scientific Title:Acronym Go-Go trial
Region
Japan

Condition
Condition Rheumatoid Arthritis
Classification by specialty
Clinical immunology Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To establish a treatment strategy with golimumab for the treatment of rheumatoid arthritis (RA), which is the anti-TNF (tumor necrosis factor) blockade and two doses (50 and 100mg/month) was approved as a medicine for RA only in Japan
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase IV

Assessment
Primary outcomes The rate of RRP (Radiographic rapid progression) at 6 and 12 months
Key secondary outcomes 1.The change of DAS28-ESR, DAS28-CRP, SDAI and remission rate based on these composite measures
2.The change of mTTS
3.The change of CRP, ESR, MMP-3
4.The change of HAQ score
5. Prevalence of adverse events

Base
Study type Interventional

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

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The dose of golimumab should be fixed as 50 mg/month for all period. Treat-to-target strategy might be achieved by MTX or other DMARDs for one year. The goal of treatment is low disease activity.
Interventions/Control_2 Treat-to-target strategy will be started with 50 mg of golimumab for first 3 months and then 100 mg golimumab can be used for tight control of rheumatoid arthritis to achieve low disease activity (LDA). Also MTX or other DMARDs might be used for tight control. If the LDA is achieved, reduction of dose from 100 to 50 mg/month is allowed. Total period is one year.
Interventions/Control_3 Treat-to-target strategy will be started with 100 mg of golimumab for first 3 months. If the LDA is achieved, reduction of dose from 100 to 50 mg/month is performed. If not, physicians should control the disease activity using MTX or other DMARDs. Total period is one year.
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 1. Patients with active rheumatoid arthritis
2. Patients who will receive the treatment by golimumab
3. Patients who is receiving MTX (no matter on dose)
4. Over moderate disease activity score. DAS28>=3.2
5. Glucocorticoid use should be under 7.5 mg/day
Key exclusion criteria 1. Patients who show the allergic reaction for golimumab
2. The use of previous biologics is not included in exclusion criteria
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuya Koike
Organization Osaka City University Medical School
Division name RheumatosurgeryCenter for Senile Degenerative Disorders
Zip code
Address Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan
TEL 06-6645-3984
Email tatsuya@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuya Koike
Organization Osaka City University Medical School
Division name Center for Senile Degenerative Disorders
Zip code
Address Abenoku Asahimachi 1-4-3
TEL 06-6646-6010
Homepage URL
Email tatsuya@med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University Medical School
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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 白浜はまゆう病院(和歌山県)、北出病院(和歌山県)、東住吉森本病院(大阪府)、十三市民病院(大阪府)、藤井寺市民病院(大阪府)、大東中央病院(大阪府)、淀川キリスト教病院(大阪府)、早石病院(大阪府)、東京女子医科大学東医療センター(東京都)、長崎大学附属病院(長崎県)、香芝旭ヶ丘病院(奈良県)、市民の森病院(宮崎県)、兵庫医科大学附属病院(兵庫県)、横浜南共済病院(神奈川県)、片山整形外科リウマチ科クリニック(北海道)、生野リウマチ整形外科クリニック(福岡県)、岡山大学付属病院(岡山県)、静岡リウマチ整形外科リハビリ病院(静岡県)、倉敷スイートホスピタルリウマチセンター(岡山県)、本荘クリニック(富山県)、大阪市立総合医療センター(大阪府)、大阪市立大学医学部付属病院(大阪府)

Other administrative information
Date of disclosure of the study information
2012 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Open public recruiting
Date of protocol fixation
2012 Year 08 Month 29 Day
Date of IRB
Anticipated trial start date
2012 Year 12 Month 06 Day
Last follow-up date
2016 Year 12 Month 31 Day
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
2017 Year 05 Month 31 Day
Date analysis concluded
2017 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2012 Year 11 Month 28 Day
Last modified on
2014 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011073

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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