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Evaluation of the Optimal MTX Dose as an Add-on Therapy to Adalimumab for RA Patients in Japan, South Korea and Taiwan

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ClinicalTrials.gov Identifier: NCT03505008
Recruitment Status : Not yet recruiting
First Posted : April 20, 2018
Last Update Posted : April 20, 2018
Sponsor:
Collaborator:
Eisai Co., Ltd.
Information provided by (Responsible Party):
Yuko Kaneko, Keio University

April 16, 2018
April 20, 2018
April 20, 2018
April 2018
February 2021   (Final data collection date for primary outcome measure)
Simple Disease Activity Index (SDAI) Remission Rate [ Time Frame: Week 48 ]
SDAI Remission Rate at Week 48 in ADA/MTX-Maximum Tolerated Dose Group and ADA/MTX-Reduced Dose Group
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Evaluation of the Optimal MTX Dose as an Add-on Therapy to Adalimumab for RA Patients in Japan, South Korea and Taiwan
MIRACLE (Methotrexate Inadequate Response Patient With Rheumatoid Arthritis Treated by Adalimumab in Combination With Low-dose Methotrexate) Study
This study will be conducted in Japan, South Korea and Taiwan to evaluate the optimal dosage of methotrexate (MTX) as an add-on therapy to adalimumab (ADA) in participants with rheumatoid arthritis (RA) who have not achieved remission by MTX monotherapy.
The erythrocyte MTX-polyglutamates (MTX-PG) concentration will be measured to evaluate its relationship to the efficacy and safety of MTX therapy.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: Methotrexate
    Route of Administration: Oral
    Other Name: MTX
  • Drug: Adalimumab
    Route of Administration: Subcutaneous
    Other Name: ADA
  • Experimental: MTX-Monotherapy Group
    Participants will receive Methotrexate (MTX) at a starting dose of 6 to 8 mg/week, which will be promptly escalated to the maximum tolerated dose (MTD) of ≤25 mg/week up to Week 12, and maintained until Week 24. If the dosage of MTX is maintained ≥ 10 mg/week and simple disease activity index (SDAI) remission is achieved at Week 24, the MTX therapy will continue until Week 48.
    Intervention: Drug: Methotrexate
  • Experimental: ADA/MTX-Maximum Tolerated Dose Group
    Participants will receive Methotrexate (MTX) at a starting dose of 6 to 8 mg/week, which will be promptly escalated to the MTD of ≤25 mg/week up to Week 12, and maintained until Week 24. If the dosage of MTX is maintained ≥ 10 mg/week and SDAI remission is not achieved at Week 24, Adalimumab (ADA) 40 mg will be administered subcutaneously every other week in addition to the MTX therapy until Week 48.
    Interventions:
    • Drug: Methotrexate
    • Drug: Adalimumab
  • Experimental: ADA/MTX-Reduced Dose Group
    Participants will receive Methotrexate (MTX) at a starting dose of 6 to 8 mg/week, which will be promptly escalated to the MTD of ≤25 mg/week up to Week 12, and maintained until Week 24. If the dosage of MTX is maintained ≥ 10 mg/week and SDAI remission is not achieved at Week 24, Adalimumab (ADA) 40 mg will be administered subcutaneously every other week in addition to low-dose MTX (6 to 8 mg/week) treatment until Week 48.
    Interventions:
    • Drug: Methotrexate
    • Drug: Adalimumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
300
Same as current
February 2022
February 2021   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Participants aged ≥18 years at the time of informed consent
  • Participants who meet the 1987 revised American College of Rheumatology (ACR) criteria or 2010 ACR/European League Against Rheumatism (EULAR) criteria
  • Duration of RA less than 2 years from diagnosis to informed consent
  • Previously untreated with methotrexate (MTX), Janus kinase (JAK) inhibitor, or biological disease-modifying antirheumatic drugs (bDMARDs)
  • SDAI >11 at screening
  • No need for concomitant use of DMARDs other than MTX during the study as judged by principal investigator/sub-investigator at screening
  • Female of child-bearing potential who can use appropriate contraceptive during the study, female in whom time from menopause to informed consent is ≥1 year, or female of no child-bearing potential through sterilization (bilateral tubal ligation, bilateral ovariectomy or hysterectomy, etc.)
  • Virile male who can use appropriate contraceptive during the study
  • Participants who can adequately understand this protocol, and voluntarily consent in writing to take part in this study (in Japan, consent of a legally-acceptable representative is also required for participants aged <20 years)

Exclusion Criteria:

  • Current complication of malignant tumor, except for non-melanoma forms of skin cancer limited within epidermis, and uterine cervix cancer limited within epidermis
  • Serious infections such as sepsis
  • Active tuberculosis
  • History or current complication of demyelinating disease such as multiple sclerosis
  • Congestive heart failure
  • Pregnant female, or female who intend to conceive during the study period
  • Bone marrow depression
  • Chronic liver disease
  • Nephropathy
  • Lactating female
  • Pleural effusion or ascites
  • Participants with a known hypersensitivity to MTX or ADA
  • Ineligible to participate in the study in the opinion of principal investigator/sub-investigator
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Hiroya Tamai, MD +81-3-5363-3786 h.tamai@keio.jp
Japan
 
 
NCT03505008
D2E7-C000-401
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Yuko Kaneko, Keio University
Keio University
Eisai Co., Ltd.
Principal Investigator: Yuko Kaneko, MD, PhD Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine
Keio University
April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP