A Study Comparing Biologics + Methotrexate With Biologics + Tacrolimus in Patients With Rheumatoid Arthritis (RA)
NCT03737708 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 21
Last updated 2024-10-31
Summary
The purpose of this study is to compare the efficacy of Biologics + Methotrexate with Biologics + Tacrolimus measured by the disease activity score 28 (DAS28) erythrocyte sedimentation rate (ESR) and the American College of Rheumatology (ACR) scores. The study will also assess the safety of the combinations.
Conditions
- Rheumatoid Arthritis (RA)
Interventions
- DRUG
-
Administered orally
- DRUG
-
methotrexate
Administered orally
- BIOLOGICAL
-
Administered as subcutaneous injection
- BIOLOGICAL
-
Administered by intravenous injection
- BIOLOGICAL
-
Administered by intravenous injection
Sponsors & Collaborators
-
Astellas Pharma Korea, Inc.
lead INDUSTRY
Principal Investigators
-
Medical Monitor · Astellas Pharma Korea, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-02-13
- Primary Completion
- 2020-06-16
- Completion
- 2020-06-16
Countries
- South Korea
Study Locations
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