CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 230 enrolled
Drug / intervention
CDP870 +1 moredrug
Likely dose
CDP870 400mgfrom 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/NCT00791921
NCT00791921Phase 3Completed
CompareCT.gov

A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Trial to Assess the Efficacy, Pharmacokinetics, and Safety of CDP870 Without Coadministration of MTX in Japanese Active RA Patients in Whom MTX Cannot be Administrated.

Otsuka Pharmaceutical Co., Ltd.·interventional·Posted Nov 17, 2008·Updated Aug 7, 2012

In Brief

A Phase 3 clinical trial evaluating CDP870 and Placebo of CDP870 for Rheumatoid Arthritis. Completed, enrolled 230 participants across 7 sites.

Detailed Summary

The objectives of this study are to verify the superiority in efficacy (American College of Rheumatology 20%: ACR20) and investigate the pharmacokinetics and safety of CDP870 versus placebo without coadministration of MTX in active RA patients in whom MTX cannot be administrated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesJapan
CollaboratorsUCB Japan Co. Ltd.

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 17, 2008
Enrollment StartNov 1, 2008
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 17.6 years ago

Interventions

CDP870drug

400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks until Week22 subcutaneously(SC)

Placebo of CDP870drug

Placebo given every 2 weeks until Week22 (SC)