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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000006702
Receipt No. R000007922
Scientific Title A parallel group, randomized clinical trial on the efficacy and safety of intensive treatment strategy with MTX as the anchor-drug in patients with active early rheumatoid Arthritis
Date of disclosure of the study information 2011/11/11
Last modified on 2014/05/12

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Basic information
Public title A parallel group, randomized clinical trial on the efficacy and safety of intensive treatment strategy with MTX as the anchor-drug in patients with active early rheumatoid Arthritis
Acronym An intensive treatment strategy in patients with active early RA
Scientific Title A parallel group, randomized clinical trial on the efficacy and safety of intensive treatment strategy with MTX as the anchor-drug in patients with active early rheumatoid Arthritis
Scientific Title:Acronym An intensive treatment strategy in patients with active early RA
Region
Japan

Condition
Condition rheumatoid arthritis
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In this study, we have co-primary endpoints. First, we compare the efficacy and safety between the intensive treatment strategy aiming at achieving and maintaining remission and the conventional treatment strategy in Japanese patients with active early RA. Second, we identify factors that contribute to achieving clinical remission and improvement of physical function. Secondary endpoint is to provide data and evidence when reviewing Japanese guideline for RA in future.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Remission rates at week 24 by SDAI or Boolean index
Key secondary outcomes 1.Remission rates at week 48 and 72 by SDAI and Boolean index
2.Achievement rates for low disease activity status by SDAI and CDAI at weeks 24, 48 and 72
3.Changes of ACR20,50,70 over time
4.Changes of ACR-hybrid, SDAI, CDAI, and DAS28 over time
5.Changes of sigmaSDAI, sigmaCDAI, sigmaDAS28, vdH-modified TSS score, JSN score and erosion score from baseline and achievement rate of structural remission at weeks 24, 48 and72
6.Changes of physical function (EQ-5D, full HAQ) over time and functional remission rates at weeks 24, 48 and 72
7.Safety (incidence and types of adverse events, severe adverse events, adverse drug reactions, and serious adverse drug reactions)
8.Identification of prognostic factor for clinical remission, functional remission, and normalization of physical function

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Intensive treatment group
Period: 24 weeks
In the intensive treatment group, a patient starts treatment with MTX at 8mg/week. Dosage is increased to 0.25mg/kg/week by week 8 and is further increased to his or her maximum tolerable dosage by week 12. The maximum tolerable dosage is maintained until week 24. If a patient shows inadequate response to MTX and does not achieve SDAI(simplified disease activity index)emission or CDAI (linical disease activity index)remission by week 16, additional treatment with tacrolimus, bucillamine, sarazosulfapyridine, or biologics will be started as scheduled in the protocol.
After week 24, both groups receive treatments by attending rheumatologists'discretion and are followed until week 72.
Interventions/Control_2 Conventional treatment group
Period: 24 weeks
In the control group, a patient starts treatment with MTX, tacrolimus, bucillamine, sarazosulfapyridine, or biologics by attending rheumatologists' discretion by week 24. Biologics are allowed on and after week 12. After week 24, both groups receive treatments by attending rheumatologists'discretion and are followed until week 72.
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
70 years-old >=
Gender Male and Female
Key inclusion criteria A Patient of rheumatoid arthritis (RA) who meets all of the following will be eligible to the study.
1.A patient who develops arthritis within 2 years before the enrollment and who fulfills the 2010 ACR/EULAR classification criteria for RA
2.A patient who has SDAI>11
3.A patient who is 20 to 70 years old and gives written informed consent
4.A patient who has never received MTX, tacrolimus, and biologics.
5.A patient who can use MTX
6.A patient who has not started any DMARDs within the last 4weeks.
7.A patient who has not received intravenous or intra-articular injection of corticosteroid within the last 4weeks.
8.A patient who has equal or more than 4 swollen joints and equal or more than 4 tender joints (using 66- or 68-joint count, respectively)
9.Patients who meets any of the following criteria 1) positive serology (rheumatoid factor or anti-CCP antibody), 2) typical bone erosion for RA by X-ray, 3) CRP equal or more than 0.8mg/dL
Key exclusion criteria A patient who has any of the following will be excluded from the study.
1.When a patient refuses to give or withdraws his or her consent.
2.A patient who with concurrent other inflammatory joint diseases (ankylosing spondylitis, psoriatic arthritis, reactive arthritis, SLE, systemic sclerosis and mixed connective tissue disease), or history of these diseases. Sjogren syndrome is not included in these diseases.
3.When a patient has contraindications for MTX or tacrolimus.
4.When a patient has an active infectious disease.
5.A patient who is positive for HBs antigen or HBV DNA is excluded unless he/she receive nucleotide analogue and becomes negative for HBV DNA.
6.When a patient has severe hepatic disease, which is contraindication for MTX.
7.When a patient has severe renal disease, which is contraindication for MTX
8.When a patient has concurrent malignancy, lymphoma, leukemia or lymphproliferative disorder except for skin cancer (basal cell carcinoma or epithelial cell carcinoma) and cervical cancer of uterus which were completely resected and has not recurred for more than 5 years,
9.When a patient has uncontrollable comorbidities (i.e., severe diabetes, unstable ischemic heart disease, stroke within the last 1 year).
10.A patient with latent tuberculosis unless he/she receives proper chemoprophylaxis according to the Japan College of Rheumatology guideline.
11.When a patient received investigational drug within the last month or within the five times of half-life, whichever is longer.
12.When a patient's body weight less than 40kg.
13.When a patient is under breastfeeding or pregnant, or has plan to be pregnant in 24 weeks.
14.When a doctor judges a patient cannot to visit outpatient clinic regularly for 24 weeks.
15.When a doctor judges a patient not appropriate to participate in the study.
Target sample size 290

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masayoshi Harigai
Organization Tokyo Medical and Dental University
Division name Department of Pharmacovigilance, Department of Medicine and Rheumatology
Zip code
Address 1-5-45,Yushima 1-chome, Bunkyo-ku, Tokyo
TEL 03-5803-4677
Email mharigai.mpha@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Michi Tanaka
Organization Tokyo Medical and Dental University
Division name Department of Pharmacovigilance
Zip code
Address 1-5-45,Yushima 1-chome, Bunkyo-ku, Tokyo
TEL 03-5803-4677
Homepage URL
Email tanaka.phv@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization ministry of health, labour, and welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Pharmacovigilance
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 東京医科歯科大学・埼玉医科大学総合医療センター・慶應義塾大学・長崎大学・国立病院機構相模原病院・北海道大学・新潟県立リウマチセンター・宇多津浜クリニック・横浜市立大学・東広島記念病院・日立製作所多賀総合病院・道後温泉病院・草加市立病院・産業医科大学・東京都健康長寿医療センター・順天堂大学・香川大学・青梅市立総合病院・国家公務員東京共済病院・横浜市立みなと赤十字病院・筑波大学・宮崎市民の森病院・熊本大学・京都大学
Tokyo medical and dental university, Saitama medical center, Keio university, Nagasaki university, NHO Sagamihara national hospital, Hokkaido university, Niigata rheumatic center, Utazuhama clinic, Yokohama city university, Higashi hiroshima memorial hospital, Taga general hospital, Dohgo spa hospital, Soka municipal hospital, University of occupational and environmental health, Tokyo metropolitan geriatric hospital, Juntendo university, Kagawa university, Ome municipal general hospital, Tokyo kyosai Hospital, Yokohama city minato red cross hospital, Tsukuba university, Shiminnomori hospital, Kumamoto university, Kyoto university.

Other administrative information
Date of disclosure of the study information
2011 Year 11 Month 11 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 No longer recruiting
Date of protocol fixation
2011 Year 09 Month 05 Day
Date of IRB
Anticipated trial start date
2012 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 11 Month 11 Day
Last modified on
2014 Year 05 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007922

Research Plan
Registered date File name

Research case data specifications
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Research case data
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