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

Not Applicable

• Conditions: Rheumatoid Arthritis

• Registration Number: JPRN-UMIN000030584
• Lead Sponsor: Keio University School of Medicine Division of Rheumatology, Department of Internal Medicine

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.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-27
• Study Completion: 2021-06-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified