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NCT02052375 · ClinicalTrials.gov registry record · Phase 1

A Study To Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of ASP2408 After Multiple Dose Subcutaneous Injections in Patients With Rheumatoid Arthritis on Methotrexate

A Phase 1 study of Rheumatoid Arthritis and Pharmacokinetics of ASP2408, sponsored by Astellas Pharma Global Development.

Completed
Registry status
Phase 1
Development phase
24
Enrollment target
3
Study locations

NCT02052375 is a Phase 1 study of Rheumatoid Arthritis and Pharmacokinetics of ASP2408 that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 24 participants, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (99% lower). The trial reports 3 study locations across 3 states.

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The verdict

NCT02052375, a Phase 1 study of Rheumatoid Arthritis and Pharmacokinetics of ASP2408, has completed, sponsored by Astellas Pharma Global Development.

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target
3
Study locations

Study Summary

The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of two dosing regimens of multiple, subcutaneous (sc) injections of ASP2408 in patients with Rheumatoid Arthritis (RA) on Methotrexate (MTX) and to evaluate the pharmacodynamics (PD) of ASP2408.

Interventions

  • DRUG Placebo
  • DRUG ASP2408

Study Locations (3)

Alabama

  • Pinnacle Research Group, LLC - Anniston

Pennsylvania

  • Altoona Center for Clinical Research - Duncansville

Texas

  • Metroplex Clinical Research Center, LLC - Dallas

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2012-06
Est. Completion 2013-12
Phase Phase 1

Sponsor

Astellas Pharma Global Development

168 total trials

What the Registry Record Tells You About NCT02052375

The ClinicalTrials.gov registry entry for NCT02052375 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (99% lower). The listed sponsor is Astellas Pharma Global Development, which has 168 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT02052375 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Alabama, Pennsylvania, Texas.

Frequently Asked Questions

What is clinical trial NCT02052375 about?

NCT02052375 is a clinical study titled "A Study To Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of ASP2408 After Multiple Dose Subcutaneous Injections in Patients With Rheumatoid Arthritis on Methotrexate". The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of two dosing regimens of multiple, subcutaneous (sc) injections of ASP2408 in patients with Rheumatoid Arthritis (RA) on Methotrexate (MTX) and to evaluate the pharmacodynamics (PD) of ASP2408.

What is the current status of trial NCT02052375?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2012-06. Estimated completion is 2013-12.

What conditions does trial NCT02052375 study?

This clinical trial studies the following conditions: Rheumatoid Arthritis, Pharmacokinetics of ASP2408.

What interventions are being tested in trial NCT02052375?

The interventions under investigation include: Placebo (DRUG), ASP2408 (DRUG).

Who is sponsoring clinical trial NCT02052375?

This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02052375 being conducted?

This trial has 3 study locations across Alabama, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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