Efficacy and Safety of CDP870 and Methotrexate Compared to Methotrexate Alone in Subjects With Rheumatoid Arthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

247 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2004-01-31

Brief Summary

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The main purpose of the study was to determine the efficacy of CDP870 in treating RA signs/symptoms in patients who were partial responders to MTX. Other purposes were to show additional efficacy without increased toxicity and the immunogenic response to CDP870 during combined CDP870 and MTX therapy.

Detailed Description

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Conditions

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Arthritis, Rheumatoid

Keywords

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CDP870 Certolizumab pegol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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CDP870

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* male/female, 18-75 years old, inclusive
* diagnosis of adult-onset RA
* had active disease
* had received methotrexate
* on a stable dose of folic acid

Exclusion Criteria

* contraindication for methotrexate or anti-TNF

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

UCB Pharma

References

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Choy E, McKenna F, Vencovsky J, Valente R, Goel N, Vanlunen B, Davies O, Stahl HD, Alten R. Certolizumab pegol plus MTX administered every 4 weeks is effective in patients with RA who are partial responders to MTX. Rheumatology (Oxford). 2012 Jul;51(7):1226-34. doi: 10.1093/rheumatology/ker519. Epub 2012 Feb 16.

Reference Type RESULT

PMID: 22344576 (View on PubMed)

Other Identifiers

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C87014

Identifier Type: -

Identifier Source: org_study_id