A Study Comparing Biologics + Methotrexate With Biologics + Tacrolimus in Patients With Rheumatoid Arthritis (RA)

Sponsor
Astellas Pharma Korea, Inc.
Study ID
NCT03737708
Phase
PHASE4
Status
Completed

Conditions

  • Rheumatoid Arthritis (RA)

Eligibility Criteria

Sex
ALL
Age
19 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • tacrolimus — DRUG
    Administered orally
  • methotrexate — DRUG
    Administered orally
  • adalimumab — BIOLOGICAL
    Administered as subcutaneous injection
  • tocilizumab — BIOLOGICAL
    Administered by intravenous injection
  • abatacept — BIOLOGICAL
    Administered by intravenous injection

Study Details

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.

Key Dates

Start date
Feb 13, 2019
Status verified
Oct 2024
Primary completion
Jun 16, 2020
Completion
Jun 16, 2020

Study Design

Enrollment
21 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: tacrolimus + biologics
    Participants will receive tacrolimus daily for 12 weeks. In addition, each participant will be administered one of adalimumab, tocilizumab, or abatacept for 12 weeks.
  • Active Comparator: methotrexate + biologics
    Participants will receive methotrexate weekly for 12 weeks. In addition, each participant will be administered one of adalimumab, tocilizumab, or abatacept for 12 weeks.

Primary Outcome Measure

Change in disease activity score 28 (DAS28) erythrocyte sedimentation rate score (ESR) score at 12 weeks [ Time Frame: From baseline (week 1) to week 12 ]

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