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Assessing the Use of Certolizumab Pegol in Adult Subjects With Rheumatoid Arthritis on the Antibody Response When Receiving Influenza Virus and Pneumococcal Vaccines

NCT00993668 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2018-08-01

Study results available
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Summary

The purpose of this trial is to assess the affect of Certolizumab Pegol (CZP) treatment on antibody response to T cell-independent and T cell-dependent immunizations using pneumococcal and influenza vaccines, respectively.

Conditions

Interventions

OTHER

Placebo

Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).

BIOLOGICAL

Certolizumab pegol

Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).

Sponsors & Collaborators

  • UCB Pharma

    lead INDUSTRY

Principal Investigators

  • UCB Clinical Trial Call Center · +1-877-822-9493 (UCB)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-06-30
Completion
2011-02-28

Countries

  • United States

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 NCT00993668 on ClinicalTrials.gov