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A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP5094 Following Multiple Intravenous Doses in Subjects With Rheumatoid Arthritis on Methotrexate

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.
NCT02698657

Astellas Study ID

The unique identification code given by the study sponsor.

5094-CL-0102

EudraCT ID

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

2015-004562-28

Follow Trial

Condition

Rheumatoid Arthritis

Phase

These clinical trials are usually the first time an experimental treatment is studied in a small group of people.

Phase 1

Age

18 years - 65 years

Sex

Female & Male

Product

N/A

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 2016 - Sep 2017

Masking

Double (Participant, Investigator)

Enrollment number

30

A Phase 1, Randomized, Placebo-controlled, Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP5094 Following Multiple Intravenous Doses in Subjects With Rheumatoid Arthritis on Methotrexate

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 PL48004

Nowa Sol, Poland, 67-100

Site US10008

Debary, United States, 32713-1818

Site US10002

Anniston, United States, 36207

Site US10004

Jacksonville, United States, 32216

Site US10010

Memphis, United States, 38119

Site PL48003

Warszawa, Poland, 00-660

Site PL48007

Stalowa Wola, Poland

Site PL48006

Lodz, Poland, 91-347

Site PL48011

Krakow, Poland, 31-637

Site PL48001

Lublin, Poland, 20-582

Site US10001

Dallas, United States, 75231

Site US10003

Duncansville, United States, 16635

Site PL48009

Elblag, Poland, 82-300

Site PL48008

Wroclaw, Poland, 50-556

Site US10009

Miami Lakes, United States, 33014

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