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Dosing Flexibility Study in Patients With Rheumatoid Arthritis

NCT00580840 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 333

Last updated 2018-08-02

Study results available
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Summary

During the run-in period, CZP will be administered at 400 mg (2 injections) at Wks 0, 2, and 4 and 200 mg with placebo (1 injection placebo, 1 injection CZP) at Wks 6, 8, 10, 12, 14 and 16. At Wk 18 patients will be grouped as responders or non-responders based on results of the ACR20 at Week 16.

Conditions

Interventions

DRUG

Certolizumab pegol

400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks)

DRUG

Certolizumab pegol

200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each)

OTHER

Placebo

placebo (saline) administered as two injections every 2 weeks

Sponsors & Collaborators

  • UCB Pharma

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2010-12-31
Completion
2011-03-31

Countries

  • United States
  • Canada
  • France

Study Locations

More Related Trials

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 NCT00580840 on ClinicalTrials.gov