Study Details

A Study comparing Biologics + Methotrexate with Biologics + Tacrolimus in patients with Rheumatoid Arthritis (RA)

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT03737708

Astellas Study ID

The unique identification code given by the study sponsor.

506-MA-3187

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

N/A

Condition

Rheumatoid Arthritis

Phase

These clinical trials happen after a drug or treatment has been approved for patients to take. Clinical trials in phase 4 usually take place over many years because researchers want to learn about long term use and safety of a drug or treatment.

Phase 4

Age

19 years - 75 years

Sex

Female & Male

Product

tacrolimus extended-release

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Feb 2019 - Jun 2020

Masking

None (Open Label)

Enrollment number

21

Compare efficacy and safety between Biologics + Methotrexate (MTX) vs Biologics + Tacrolimus (TAC) (Switched from Biologics + Methotrexate (MTX)) in the patients with rheumatoid arthritis (RA): Randomized, interventional, open, active controlled, parallel group, multicenter-designed, phase 4 clinical trial

Study summary

Study documents

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

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Locations

Site KR82009

Seongnam, Republic of Korea

Site KR82011

Gwangju, Republic of Korea

Site KR82008

Seoul, Republic of Korea

Site KR82007

Daegu, Republic of Korea

Site KR82014

Jeonju, Republic of Korea

Site KR82012

Seoul, Republic of Korea

Site KR82015

Busan, Republic of Korea

Site KR82003

Daegu, Republic of Korea

Site KR82001

Seoul, Republic of Korea

Site KR82002

Incheon, Republic of Korea

Site KR82004

Busan, Republic of Korea

Site KR82006

Daejeon, Republic of Korea

Site KR82005

Seoul, Republic of Korea

Site KR82010

Seoul, Republic of Korea

Site KR82013

Suwon, Republic of Korea