Trials / Completed
CompletedNCT03505008
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
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 300 (actual)
- Sponsor
- Keio University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The erythrocyte MTX-polyglutamates (MTX-PG) concentration will be measured to evaluate its relationship to the efficacy and safety of MTX therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Methotrexate | Route of Administration: Oral |
| DRUG | Adalimumab | Route of Administration: Subcutaneous |
Timeline
- Start date
- 2018-04-18
- Primary completion
- 2021-05-11
- Completion
- 2021-05-11
- First posted
- 2018-04-20
- Last updated
- 2025-03-06
- Results posted
- 2025-03-06
Locations
24 sites across 3 countries: Japan, South Korea, Taiwan
Source: ClinicalTrials.gov record NCT03505008. Inclusion in this directory is not an endorsement.