UMIN-CTR Clinical Trial

Public title

Relationship between treatment response of initial DMARD and outcome of treat-to-target strategy in patients with early rheumatoid arthritis: Nationwide Inception Cohort of Early Rheumatoid arthritis patients in Japan

Acronym

NICER-J

Scientific Title

Relationship between treatment response of initial DMARD and outcome of treat-to-target strategy in patients with early rheumatoid arthritis: Nationwide Inception Cohort of Early Rheumatoid arthritis patients in Japan

Scientific Title:Acronym

NICER-J

Region

Japan

Condition

Rheumatoid Arthritis

Classification by specialty

Clinical immunology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To set inception cohort of newly diagnosed rheumatoid arthritis patient with no treatment or nearly untreatment and to explore the relationship between the treatment response of csDMARD including MTX and the effect of adapting therapy using bDMARD, tsDMARD or csDMARD .

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

1. To explore relationship between the changes in disease activity by csDMARD treatment and that of disease activity up to 24 weeks for the first adapting therapy (bDMARD / tsDMARD, or csDMARD). Also analyze by each adapting therapy.
2. To identify factors related to achieving remission at week 24. Also analyze by each adapting therapy.

Key secondary outcomes

1) To explore the relationship between the changes in disease activity by initial treatment after registration and the transition of disease activity up to 52 weeks after first adapting therapy, also for each adapting therapy
2) Factors related to achieving remission at 52 weeks after first adapting therapy, also for each adapting therapy
3) In the cases where MTX was started or increased as the initial treatment after registration, the relationship between the changes in disease activity by MTX treatment and that of the disease activity up to the 24 week and the 52 week after first adapting therapy, also for each adapting therapy
4) In case of starting or increasing MTX as the initial treatment after enrollment, analyze also for each factor relating to remission achievement at 24 and 52 weeks after first adapting therapy, also for each adapting therapy
5) Comparison of the changes in disease activity during adapting therapy between the groups which could and could not start treatment with MT
6) Trends of the following factors and relationship among factors in postmenopausal women: disease activity, biomarkers at the start of treatment (anti-CCP antibody, inflammatory cytokine, bone metabolism marker, cartilage metabolism marker), total Sharp score (Limb bone joint destruction), narrowing of knee joint joint space, DEXA
7) Content and outcome of serious adverse events occurring during observation

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

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) 1987 Classification criteria of American College of Rheumatology or 2010 American Rheumatology Association / European Rheumatology Association (ACR / EULAR) classification criteria are met.
2) Patients diagnosed within 6 months of RA who are not undergoing DMARD treatment or within 3 months
3) Patients who are over 20 years of age at the time of consent acquisition
4) Patients who received written explanations about the purpose and contents of this study, and obtained consent form freely by the person himself / herself in writing

Key exclusion criteria

1) Patients who have been treated with MTX exceeding 6 mg or who have been treated
2) Patients who are being treated with biologic drugs or targeted synthetic antirheumatic drugs or who have been treated
3) Patients who can not comply with dosage regimen
4) Patients who are deemed inappropriate for research by the research staff

Target sample size

685

Name of lead principal investigator

1st name
Middle name
Last name	Toshihisa Kojima

Organization

Nagoya University Hospital

Division name

Orthopedic Surgery

Zip code

Address

65 Tsurumai-cho, Showa-ku, Nagoya

TEL

052-744-1908

Email

toshik@med.nagoya-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Shuji Asai

Organization

Nagoya University Hospital

Division name

Center for Advanced Medicine and Clinical Research

Zip code

Address

65 Tsurumai-cho, Showa-ku, Nagoya

TEL

052-744-1908

Homepage URL

Email

asai@med.nagoya-u.ac.jp

Institute

Nagoya University Hospital
Orthopedic Surgery

Institute

Department

Personal name

Organization

Eli Lilly and Company

Organization

Division

Category of Funding Organization

Profit organization

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

Date of disclosure of the study information

2018

Year

04

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

2018

Year

05

Month

01

Day

Date of IRB

Anticipated trial start date

2018

Year

05

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

<Observation items and schedule>
1) Initial patient background: age sex duration of disease Complications
2) Baseline disease activity (swelling, number of tender joints / 28, patient and doctor general assessment VAS, CRP, MMP-3, HAQ-DI)
3) Collect disease-active HAQ-DI every 3 months after treatment start with anti-rheumatic drug. When treatment is strengthened, at the time of strengthening its treatment, disease activity after 1 month, 3 months later, every 3 months thereafter
4) Drug usage (DMARD, steroid) at the time of collection of disease activity data
Anti-CCP antibody inflammatory cytokine (TNF, IL-6) bone metabolism marker (PINP TRACP-5b Sclerostin RANKL) cartilage metabolism marker (TNF, IL-6 bone metabolism marker) three times after the beginning of therapy, (C2K, C2C).
6) Bone mineral density (lumbar femoral bone) At the start of DEXA, 1 year, 2 years
7) At the start of limbs and limbs, one year after two years
8) At the start of knee roentgen, two years after one year
9) Collect on adverse events that ceased or changed therapy.
10) Joint destruction evaluation by hand / foot X-ray: Performed with standard modified total sharp score
11) Knee X-ray evaluation: Measure the joint cleft by image analysis by computer assistance.

Registered date

2018

Year

03

Month

28

Day

Last modified on

2019

Year

02

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035259