Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/JPRN-jRCT1031180088
JPRN-jRCT1031180088CompletedPhase 4

MIRACLE (Methotrexate inadequate response patient with Rheumatoid Arthritis treated by Adalimumab in combination with Low-dose Methotrexate) Study - MIRACLE Study

Kaneko Yuko0 sites300 target enrollmentStarted: January 18, 2019Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
300
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This study demonstrated that in patients with rheumatoid arthritis with inadequate response to methotrexate, the efficacy of adalimumab with reduced dose of concomitant methotrexate was not inferior to that with maximum tolerable dose of methotrexate. There was no significant difference about HAQ remission rate and structural remission rate between the two groups. The incidence of AEs was numerically lower in reduced dose group than in maximum tolerable dose group.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
>= 18age old to ot applicable (—)
Sex
All

Inclusion Criteria

  • •1)Patients aged >=18 years (>=20 years in Taiwan) at the time of informed consent
  • •2)Patients who meet the 1987 revised ACR criteria or 2010 ACR/EULAR criteria
  • •3)Patients who have RA within 2 years from initial diagnosis to informed consent
  • •4)Patients who were previously untreated with MTX, JAK inhibitor, or bDMARDs
  • •5)Patients who have disease activity of SDAI >11 at screening
  • •6)Patients who are no need for concomitant use of DMARDs other than hydroxychloroquine (only in South Korea and Taiwan) and study drug during the study as judged by principal investigator/sub-investigator at screening
  • •7)Patients who are no need for concomitant use of corticoid steroid equivalent to >10 mg/day prednisolone during the study as judged by principal investigator/sub- investigator at screening.
  • •8)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.)
  • •9)Virile male who can use appropriate contraceptive during the study
  • •10)Patients who can adequately understand this study procedures, and voluntarily consent in writing to take part in this study (consent of a legally-acceptable representative is also required for patients aged <20 years in Japan and aged <19 years in South Korea)

Exclusion Criteria

  • •1)Patients who currently have a malignant tumor, except for non-melanoma forms of skin cancer limited within epidermis, and uterine cervix cancer limited within epidermis
  • •2)Patients who have serious infections such as sepsis
  • •3)Patients who have active tuberculosis
  • •4)Patients who have a history or current complication of demyelinating disease such as multiple sclerosis
  • •5)Patients who have congestive heart failure
  • •6)Pregnant female, or female who intend to conceive during the study period
  • •7)Patients who have bone marrow depression and whom investigator considered ineligible
  • •8)Patients who have chronic liver disease and whom investigator considered ineligible, and who is positive for HBs antigen
  • •9)Patients who have nephropathy and whom investigator considered ineligible
  • •10)Lactating female
  • •11)Patients who have pleural effusion or ascites
  • •12)Patients with a known hypersensitivity to MTX or ADA
  • •13)Patients otherwise whom principal investigator/sub- investigator considered medically ineligible to participate in the study

Investigators

Sponsor
Kaneko Yuko

Similar Trials

Completed
Not Applicable
MIRACLE (Methotrexate inadequate response patient with Rheumatoid Arthritis treated by Adalimumab in combination with Low-dose Methotrexate) StudyRheumatoid Arthritis
JPRN-UMIN000030584Keio University School of Medicine Division of Rheumatology, Department of Internal Medicine300
Completed
Phase 2
Brodalumab (AMG 827) in Rheumatoid Arthritis (RA) Participants With Inadequate Response to MethotrexateRheumatoid Arthritis
NCT00950989Amgen252
Completed
Phase 2
Dose-finding Study of GLPG0634 as Monotherapy in Active Rheumatoid Arthritis (RA) Participants (DARWIN2)Rheumatoid Arthritis
NCT01894516Galapagos NV287
Completed
Phase 3
A Phase IIIb Study of BMS-188667 in Subjects With Active Rheumatoid Arthritis and Inadequate Response to MethotrexateActive Rheumatoid Arthritis
NCT00420199Bristol-Myers Squibb50
Completed
Phase 4
In methotrexate resistant rheumatoid arthritis, switching methotrexate to tofacitinib versus adding tofacitinib to methotrexate, open labeled, multicenter randomized non-inferiority study.Rheumatoid arthritis
JPRN-UMIN000017440Graduate School of Medicine and School of Medicine, Chiba University the department of allergy and clinical immunology134