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P021

Peptide 021, GLXC-21260

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Studies 37
Trials 57
Completed PHASE3 INTERVENTIONAL NCT02151851

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

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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.

Detailed Description

This is a phase 3, multicenter, double-blind, placebo-controlled, parallel group, randomized, 24-week study to evaluate the safety and efficacy of Certolizumab Pegol (CZP) as additional medication to Methotrexate (MTX) in Chinese subjects with active Rheumatoid Arthritis (RA) who have an incomplete response to Methotrexate. This study is designed to determine whether CZP 400 mg at Weeks 0, 2, and 4 followed by CZP 200 mg every 2 weeks (Q2W) in combination with MTX demonstrates superiority, in terms of greater improvement in relief of the signs and symptoms of RA, compared with MTX alone. Approximately 535 subjects will be screened to randomize 400 subjects into this study, at approximately 25 centers in the People's Republic of China. There will be 2 treatment groups, with 300 subjects in the CZP+MTX group and 100 subjects in the PBO+MTX group. For each subject, the study duration will last a maximum of approximately 38 weeks. Subjects who complete study RA0044 and subjects who fail to achieve an American College of Rheumatology 20 % Response Criteria (ACR20) response at Week 12 that is confirmed at Week 14 and thus are withdrawn from this study at Week 16, are permitted to receive treatment with CZP in the open-label extension study, RA0078. The secondary objectives are to assess the dose regimen of CZP in combination with MTX compared with MTX alone in the safety and tolerability, ability to improve physical function, and health outcomes measures in Chinese subjects with active RA; also to characterize the pharmacokinetic (PK) profile and immunogenicity of CZP in combination with MTX.

Interventions

Name: Certolizumab Pegol
Type: BIOLOGICAL
Description: * Active substance: Certolizumab Pegol * Pharmaceutical Form: Prefilled syringes * Concentration: 200 mg/ml * Route of administration: Subcutaneous injection
Name: Methotrexate
Type: DRUG
Description: * Active substance: Methotrexate * Pharmaceutical form: Tablet * Concentration: Maximum dose 10 mg per week * Route of administration: Oral
Name: Placebo
Type: OTHER
Description: * Active substance: Placebo * Pharmaceutical form: Prefilled syringes * Concentration: 0.9 % saline * Route of Administration: Subcutaneous injection

Primary Outcomes

Measure: Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 24
TimeFrame: Week 24
Description: The assessments are based on a 20 % or greater improvement from Baseline to Week 24 in the number of tender joints, in the number of swollen joints, and a 20 % or greater improvement in at least 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).

Trial Information

NCT ID

NCT02151851

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE3

Sponsor

UCB Pharma SA, Belgium

Last Updated

December 15, 2025