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Open Label Study to Assess the Predictability of Early Response to Certolizumab Pegol in Patients With Rheumatoid Arthritis

NCT01443364 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2017-08-15

Study results available
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Summary

The study aims to evaluate the predictability of early response to Certolizumab pegol in combination with Methotrexate at one year in patients with moderate to severe rheumatoid arthritis.

Conditions

Interventions

BIOLOGICAL

Certolizumab pegol

Prefilled syringes containing an injectable volume of 1ml of liquid Certolizumab Pegol (CZP) for single use at a dosage strength of 200 mg/ml. Injections will be given subcutaneously. CZP 400 mg at Week 0, 2 and 4, then continued as maintenance dose of 200 mg every 2 weeks until Week 50.

Sponsors & Collaborators

  • UCB Italy s.p.a.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • Italy

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 NCT01443364 on ClinicalTrials.gov