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NCT01521923 · ClinicalTrials.gov registry record · Phase 3

A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate in the Treatment of Disease Modifying Antirheumatic Drugs (DMARD)-naïve Adults With Early Active Rheumatoid Arthritis

A Phase 3 study, sponsored by UCB Pharma.

Completed
Registry status
Phase 3
Development phase
359
Enrollment target

NCT01521923 is a Phase 3 study that has completed, run by UCB Pharma. The registered enrollment target is 359 participants.

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The verdict

NCT01521923, a Phase 3 study, has completed, sponsored by UCB Pharma.

COMPLETED
Registry status
Phase 3
Development phase
359 participants
Enrollment target

Study Summary

This study is intended to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in combination with Methotrexate (MTX) for sustaining clinical response achieved in study RA0055 Period 1 \[NCT01519791\]. Subjects entering this study RA0055 Period 2 achieved sustained Low Disease Activity at Week 52 in study RA0055 Period 1.

Interventions

  • BIOLOGICAL Certolizumab Pegol + Methotrexate (MTX)
  • BIOLOGICAL Placebo + Methotrexate (MTX)

Trial Details

FieldValue
Enrollment Target 359 participants
Start Date 2012-01
Est. Completion 2015-09
Phase Phase 3

Sponsor

UCB Pharma

100 total trials

What the Registry Record Tells You About NCT01521923

The ClinicalTrials.gov registry entry for NCT01521923 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 359 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UCB Pharma, which has 100 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Certolizumab Pegol + Methotrexate (MTX) is the first listed.

NCT01521923 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01521923 about?

NCT01521923 is a clinical study titled "A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate in the Treatment of Disease Modifying Antirheumatic Drugs (DMARD)-naïve Adults With Early Active Rheumatoid Arthritis". This study is intended to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in combination with Methotrexate (MTX) for sustaining clinical response achieved in study RA0055 Period 1 \[NCT01519791\]. Subjects entering this study RA0055 Period 2 achieved sustained Low Disease Activity at We...

What is the current status of trial NCT01521923?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 359 participants. The study started on 2012-01. Estimated completion is 2015-09.

What interventions are being tested in trial NCT01521923?

The interventions under investigation include: Certolizumab Pegol + Methotrexate (MTX) (BIOLOGICAL), Placebo + Methotrexate (MTX) (BIOLOGICAL).

Who is sponsoring clinical trial NCT01521923?

This trial is sponsored by UCB Pharma, which has 100 total clinical trials registered on ClinicalTrials.gov.

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.