UMIN-CTR Clinical Trial

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

Rheumatoid Arthritis

Classification by specialty

Clinical immunology

Orthopedics

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Osaka City University Medical School

Institute

Department

Personal name

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2012

Year

12

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2012

Year

11

Month

28

Day

Last modified on

2014

Year

08

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011073