CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 430 enrolled
Drug / intervention
Certolizumab Pegol +2 morebiological
Likely dose
Certolizumab Pegol 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02151851
NCT02151851Phase 3Completed
CompareCT.gov

A Phase 3, Multi-center, 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 in Chinese Subjects With Active Rheumatoid Arthritis Who Have an Incomplete Response to Methotrexate

UCB Pharma SA, Belgium·interventional·Posted May 30, 2014·Updated Jun 28, 2018

In Brief

A Phase 3 clinical trial evaluating Certolizumab Pegol, Methotrexate, and 1 other intervention for Rheumatoid Arthritis. Completed, enrolled 430 participants across 30 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesChina
CollaboratorsParexel

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 30, 2014
Enrollment StartJul 1, 2014
Primary CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 12.1 years ago

Interventions

Certolizumab Pegolbiological

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

Methotrexatedrug

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

Placeboother

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