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A Study of Certolizumab Pegol as Additional Therapy in Chinese Patients With Active Rheumatoid Arthritis

NCT02151851 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 430

Last updated 2018-06-28

Study results available
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Summary

This study will evaluate the safety \& efficacy of Certolizumab Pegol (CZP) as additional medication to Methotrexate (MTX) in Chinese subjects with Rheumatoid Arthritis. 400 patients will be randomized to receive either CZP + MTX or placebo + MTX. Anticipated time in the study is about 32 weeks.

Conditions

Interventions

BIOLOGICAL

Certolizumab Pegol

* Active substance: Certolizumab Pegol * Pharmaceutical Form: Prefilled syringes * Concentration: 200 mg/ml * Route of administration: Subcutaneous injection

DRUG

Methotrexate

* Active substance: Methotrexate * Pharmaceutical form: Tablet * Concentration: Maximum dose 10 mg per week * Route of administration: Oral

OTHER

Placebo

* Active substance: Placebo * Pharmaceutical form: Prefilled syringes * Concentration: 0.9 % saline * Route of Administration: Subcutaneous injection

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • UCB Pharma SA, Belgium

    lead INDUSTRY

Principal Investigators

  • UCB Cares · UCB Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • China

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 NCT02151851 on ClinicalTrials.gov