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Efficacy Confirmation Trial of CDP870 as add-on Medication to Methotrexate (MTX) in Japanese Rheumatoid Arthritis (RA)

NCT00791999 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 316

Last updated 2012-08-10

Study results available
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Summary

The objective of this trial is to investigate the efficacy (American College of Rheumatology 20% : ACR20) superiority of two dose regiments of CDP870 versus placebo in combination with MTX in active RA patients who have an incomplete response to MTX. The pharmacokinetics and immunogenicity profile of CDP870 will also be investigated to assess the extrapolability of foreign data to the Japanese population.

Conditions

Interventions

DRUG

CDP870 400mg

400mg CDP870 given every 2 weeks until Week22 (SC)

DRUG

CDP870 200mg

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

DRUG

CDP870 100mg

200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks until Week22 subcutaneously(SC)

DRUG

Placebo of CDP870

given every 2 weeks until Week22 (SC)

Sponsors & Collaborators

  • UCB Japan Co. Ltd.

    collaborator INDUSTRY

  • Otsuka Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Katsuhisa Saito · OPCJ

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2010-01-31
Completion
2011-01-31

Countries

  • Japan

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00791999 on ClinicalTrials.gov