At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 300 enrolled
Drug / intervention
Methotrexate +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
MIRACLE (Methotrexate Inadequate Response Patient With Rheumatoid Arthritis Treated by Adalimumab in Combination With Low-dose Methotrexate) Study
In Brief
A Phase 4 clinical trial evaluating Methotrexate and Adalimumab for Rheumatoid Arthritis. Completed, enrolled 300 participants across 24 sites in 3 countries.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesJapan, South Korea, Taiwan
CollaboratorsEisai Co., Ltd.
Timeline
Phase 4CompletedFinished
20192020202120222023202420252026
Enrollment StartApr 2018
First PostedApr 2018
Primary CompletionMay 2021
TodayJul 2026
First PostedApr 20, 2018
Enrollment StartApr 18, 2018
Primary CompletionMay 11, 2021
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 8.2 years ago
Interventions
Methotrexatedrug
Route of Administration: Oral
Adalimumabdrug
Route of Administration: Subcutaneous