Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT02154425 · ClinicalTrials.gov registry record · Phase 1

A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers

A Phase 1 study of Rheumatoid Arthritis and Crohn's Disease, sponsored by UCB Biosciences.

Completed
Registry status
Phase 1
Development phase
17
Enrollment target
6
Study locations

NCT02154425 is a Phase 1 study of Rheumatoid Arthritis and Crohn's Disease that has completed, run by UCB Biosciences. The registered enrollment target is 17 participants, below the 4,691-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (100% lower). The trial reports 6 study locations across 3 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT02154425, a Phase 1 study of Rheumatoid Arthritis and Crohn's Disease, has completed, sponsored by UCB Biosciences.

COMPLETED
Registry status
Phase 1
Development phase
17 participants
Enrollment target
6
Study locations

Study Summary

The primary objectives of this study are to assess whether there is transfer of Certolizumab Pegol (CZP) into breast milk of lactating mothers who are receiving an established dosing regimen of CZP by evaluating the concentration of CZP in mature breast milk, and to calculate the daily infant dose of maternal CZP.

Conditions Studied

Rheumatoid Arthritis Crohn's Disease Psoriatic Arthritis Ankylosing Spondylitis Axial Spondyloarthritis (AxSpA) Non-radiographic Evidence-AxSpA

Interventions

  • PROCEDURE Breast milk sampling
  • BIOLOGICAL Certolizumab Pegol

Study Locations (6)

Other

  • 500 - Maastricht
  • 501 - Rotterdam
  • 20 - Bern

North Carolina

  • 1 - Chapel Hill
  • 3 - Durham

California

  • 7 - Los Angeles

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2014-09
Est. Completion 2016-01
Phase Phase 1

Sponsor

UCB Biosciences

39 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02154425

The ClinicalTrials.gov registry entry for NCT02154425 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,691-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (100% lower). The listed sponsor is UCB Biosciences, which has 39 total studies on file at ClinicalTrials.gov.

The record links to 6 conditions, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 2 interventions - of which Breast milk sampling is the first listed.

NCT02154425 reports 6 study locations spanning 3 distinct geographic areas - top geographies include Other, North Carolina, California.

Frequently Asked Questions

What is clinical trial NCT02154425 about?

NCT02154425 is a clinical study titled "A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers". The primary objectives of this study are to assess whether there is transfer of Certolizumab Pegol (CZP) into breast milk of lactating mothers who are receiving an established dosing regimen of CZP by evaluating the concentration of CZP in mature breast milk, and to calculate the daily infant dose o...

What is the current status of trial NCT02154425?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2014-09. Estimated completion is 2016-01.

What conditions does trial NCT02154425 study?

This clinical trial studies the following conditions: Rheumatoid Arthritis, Crohn's Disease, Psoriatic Arthritis, Ankylosing Spondylitis, Axial Spondyloarthritis (AxSpA).

What interventions are being tested in trial NCT02154425?

The interventions under investigation include: Breast milk sampling (PROCEDURE), Certolizumab Pegol (BIOLOGICAL).

Who is sponsoring clinical trial NCT02154425?

This trial is sponsored by UCB Biosciences, which has 39 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02154425 being conducted?

This trial has 6 study locations across California, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Rheumatoid Arthritis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Rheumatoid Arthritis

All registered trials for this condition

Crohn's Disease

All registered trials for this condition

California

All trials with a study site in California

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.