UMIN-CTR Clinical Trial

Public title

Adherence to Treatment with Methotrexate in Rheumatoid Arthritis: Cross-sectional study

Acronym

Adherence to Treatment with Methotrexate in Rheumatoid Arthritis

Scientific Title

Adherence to Treatment with Methotrexate in Rheumatoid Arthritis: Cross-sectional study

Scientific Title:Acronym

Adherence to Treatment with Methotrexate in Rheumatoid Arthritis

Region

Japan

Condition

Rheumatoid Arthritis

Classification by specialty

Clinical immunology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim of this study is to assess the levels of adherence of methotrexate in patients with rheumatoid arthritis.

Basic objectives2

Others

Basic objectives -Others

Relationship between the level of adherence and the clinical anchors.

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Level of adherence of methotrexate measured by the MMAS-8

Key secondary outcomes

Relationship between the level of adherence and the clinical anchor.
The clinical anchors are followed; Disease Activity Score (DAS) - 28 as the disease activity, SF-8 as QOL measurement, modified Health Assessment Questionnaire as ADL measurement, Beliefs about Medicines Questionnaire as the patients' beliefs measurement, CES-D as depression assessment, Brief Pain inventory item 2 to 5 as pain intensity assessment, and Common Terminology Criteria for Adverse Events version 4.0 as adverse events assessment.
Relationship between the adherence and patients' demographics.
Discriminant validity of MMAS-8 by assessing social desirability.

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. 20 years and older
2. Outpatients diagnosed with rheumatoid arthritis
3. Currently taking methotrexate for at least 3 months

Key exclusion criteria

1. Cognitive disorder, agitation or delirium
2. Severe psychiatric disorder
3. Patients judged inappropriate for this study by the health care provider

Target sample size

176

Name of lead principal investigator

1st name
Middle name
Last name	Nobuyuki Yajima

Organization

Department of Medicine, Showa University

Division name

Division of Rheumatology

Zip code

Address

1-5-8 Hatanodai, Shinagawa-ku, Tokyo, 142-8666, Japan.

TEL

03-3784-8942

Email

n.yajima@med.showa-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Takashi Kawaguchi

Organization

Tokyo University of Pharmacy and Life Sciences

Division name

Department of Practical Pharmacy

Zip code

Address

192-0392, 1432-1 Horinouchi, Hachioji, Tokyo, Japan

TEL

042-676-1521

Homepage URL

Email

tkawa@toyaku.ac.jp

Institute

Division of Rheumatology, Department of Medicine, Showa University

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Tokyo University of Pharmacy and Life Sciences
Tohoku University
University of California, Los Angeles

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

昭和大学藤が丘病院（神奈川県）、昭和大学横浜市北部病院（神奈川県）、関東労災病院（神奈川県）

Date of disclosure of the study information

2013

Year

12

Month

25

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

Completed

Date of protocol fixation

2013

Year

08

Month

01

Day

Date of IRB

2013

Year

08

Month

01

Day

Anticipated trial start date

2014

Year

01

Month

09

Day

Last follow-up date

2014

Year

08

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

To assess the level of adherence of methotrexate and to investigate the relationship between the level of adherence and the clinical anchor.
The clinical anchors are followed; Disease Activity Score (DAS) - 28 as the disease activity, SF-8 as QOL measurement, modified Health Assessment Questionnaire as ADL measurement, Beliefs about Medicines Questionnaire as the patients' beliefs measurement, CES-D as depression assessment, Brief Pain inventory item 2 to 5 as pain intensity assessment, and Common Terminology Criteria for Adverse Events version 4.0 as adverse events assessment.

Registered date

2013

Year

12

Month

25

Day

Last modified on

2023

Year

07

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014560