Back to Clinical Trials

P021

Peptide 021, GLXC-21260

Quick Stats

Studies 37

Trials 57

Overview Studies Clinical Trials

Completed PHASE3 INTERVENTIONAL NCT02319642

An Open-label Extension Study of Certolizumab Pegol in Chinese Patients With Rheumatoid Arthritis Who Enrolled in RA0044

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

This study will continue to evaluate the safety \& efficacy of Certolizumab Pegol (CZP) for 6 months in Chinese subjects with active Rheumatoid Arthritis who participated in RA0044.

Detailed Description

This study (RA0078) will continue to assess the safety, tolerability, and efficacy of Certolizumab Pegol (CZP) for 6 months as additional medication to methotrexate (MTX) with or without folic acid in Chinese subjects with active Rheumatoid Arthritis (RA) who participated in the main feeder study, RA0044. All subjects will continue to receive their established treatment with MTX with or without folic acid. The dose of MTX may be decreased by the Investigator due to toxicity, but should not be discontinued completely. Concomitant nonsteroidal anti-inflammatory drugs and oral corticosteroids will be permitted. For each subject, the study duration will last a maximum of approximately 32 weeks.

Interventions

Name: Certolizumab Pegol

Type: DRUG

Description: Active Substance: Certolizumab Pegol Pharmaceutical form: Prefilled syringes Concentration: 200 mg/ ml Route of Administration: Subcutaneous injection

Primary Outcomes

Measure: Percentage of Subjects That Withdrew Due to a Treatment-emergent Adverse Event (TEAE)

TimeFrame: Baseline to the end of observation period (32 weeks)

Description: TEAEs are defined as Advere Events (AEs) starting on or after the date of first study medication administration in this Open-label Extension (OLE) study up to 70 days post-last dose.

Measure: Percentage of Subjects With at Least One Treatment-emergent Adverse Event (TEAE)

TimeFrame: Baseline to the end of observation period (32 weeks)

Description: TEAEs are defined as Adverse Events (AEs) starting on or after the date of first study medication administration in this Open-label Extension (OLE) study up to 70 days post-last dose.

Measure: Percentage of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE)

TimeFrame: Baseline to the end of observation period (32 weeks)

Description: Treatment emergent SAEs are defined as SAEs starting on or after the date of first study medication administration in this OLE study up to 70 days post-last dose.

Trial Information

NCT ID

NCT02319642

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE3

Sponsor

UCB Pharma SA

Last Updated

December 15, 2025