NCT00993668

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

A Phase 4, Randomized, Single-blind, Placebo-controlled, Multicenter Study to Evaluate the Immunogenicity of Pneumococcal and Influenza Vaccines in Adult Subjects With Rheumatoid Arthritis Receiving Certolizumab Pegol or Placebo

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 224 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Rheumatoid Arthritis

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-06-01
• Completion: 2011-02-01
• First posted: 2009-10-12
• Last updated: 2018-08-01
• Results posted: 2011-06-20

Locations

41 sites across 1 country: United States