CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 127 enrolled
Drug / intervention
Placebo of CDP870 +2 moredrug
Likely dose
CDP870 200mgfrom 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/NCT00993317
NCT00993317Phase 3Completed
CompareCT.gov

A Phase III Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, 24-week Study to Assess the Efficacy and Safety of Certolizumab Pegol as Additional Medication to MTX in Patients With Active Rheumatoid Arthritis Who Have an Incomplete Response to Methotrexate

Korea Otsuka Pharmaceutical Co., Ltd.·interventional·Posted Oct 12, 2009·Updated Sep 27, 2012

In Brief

A Phase 3 clinical trial evaluating Placebo of CDP870, CDP870 200mg, and 1 other intervention for Rheumatoid Arthritis. Completed, enrolled 127 participants across 15 sites.

Detailed Summary

The objective of this trial is to compare the efficacy of Certolizumab (CZP) (CDP870) in combination with Methotrexate (MTX) to MTX alone in the treatment of signs and symptoms in patients with active rheumatoid arthritis (RA) who are incomplete responders to MTX.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesSouth Korea
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 12, 2009
Enrollment StartOct 1, 2009
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.7 years ago

Interventions

Placebo of CDP870drug

Given every 2 weeks until Week22 (SC)

CDP870 200mgdrug

400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks until Week 22(SC)

Methotrexatedrug

Received treatment with Methotrexate(MTX)for at least 24 weeks prior to the Baseline Visit. The dose and route of administration of MTX had to have been stable for at least 8 weeks prior to the Baseline Visit. The minimum stable dose of MTX allowed is 10mg weekly.