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Efficacy Confirmation Study of CDP870 in Early Rheumatoid Arthritis

NCT01451203 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 319

Last updated 2024-12-09

Study results available
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Summary

The objective of this study is to assess the efficacy of certolizumab pegol (CZP) with methotrexate (MTX) compared with MTX-alone in patients with early-stage rheumatoid arthritis (RA) who are naive to MTX and have with poor prognostic factors, using inhibition of radiographically confirmed joint damage progression over a one-year period as a primary endpoint. Following a year of treatment with CZP plus MTX treatment, CZP will be discontinued, and the subjects will be monitored for one more year (the follow-up period) to investigate the sustainability of efficacy of CZP during the MTX monotherapy for exploratory purposes.

Conditions

Interventions

DRUG

Placebo

Subcutaneous (SC)

DRUG

CZP

SC

DRUG

methotrexate (MTX)

oral

Sponsors & Collaborators

  • UCB Japan Co. Ltd.

    collaborator INDUSTRY

  • Astellas Pharma Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-11
Primary Completion
2013-08-28
Completion
2014-10-20

Countries

  • Japan

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Drugs
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 NCT01451203 on ClinicalTrials.gov