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Study to Evaluate Maintenance of Sustained Remission of axSpA With CZP Compared to Placebo

NCT02505542 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 736

Last updated 2020-12-17

Study results available
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Summary

Patients receive study drug for one year (Part A). If, after the initial run-in phase, a sustained remission is reached they will be randomly split into one of three dose groups for another year (Part B). The maintenance of the sustained remission will be analyzed.

Conditions

Interventions

BIOLOGICAL

Certolizumab Pegol

* Active substance: Certolizumab Pegol * Pharmaceutical form: Prefilled syringe * Concentration: 200 mg / ml * Route of Administration: Subcutaneous injection

OTHER

Placebo

* Active substance: Placebo * Pharmaceutical form: Prefilled syringe * Concentration: 0.9 % Saline * Route of Administration: Subcutaneous injection

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • UCB BIOSCIENCES GmbH

    lead INDUSTRY

Principal Investigators

  • UCB Cares · +1 844 599 2273(UCB)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2019-02-28
Completion
2019-04-30

Countries

  • United States
  • Belgium
  • Bulgaria
  • Czechia
  • France
  • Germany
  • Hungary
  • Netherlands
  • Poland
  • Romania
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02505542 on ClinicalTrials.gov