Efficacy and Safety of CDP870 Versus Placebo in the Treatment of the Signs and Symptoms of Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Efficacy and Safety of CDP870 400 mg Subcutaneously Versus Placebo in the Treatment of the Signs and Symptoms of Patients With Rheumatoid Arthritis Who Have Previously Failed at Least One DMARD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00548834
• Other study ID #: C87011
• Status: Completed
• Phase: Phase 3
• First received: October 15, 2007
• Last updated: September 3, 2013
• Start date: June 2003
• Est. completion date: July 2004

Study information

• Verified date: February 2010
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to confirm and extend the data from previous studies and to demonstrate the efficacy (in terms of signs and symptoms) and safety of monotherapy with CDP870 administered SC every 4 weeks compared to placebo in patients with active RA who had failed at least one DMARD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: July 2004
• Est. primary completion date: July 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis
• Signs and Symptoms

Intervention

Drug:
• CDP870

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

References & Publications (1)

Fleischmann R, Vencovsky J, van Vollenhoven RF, Borenstein D, Box J, Coteur G, Goel N, Brezinschek HP, Innes A, Strand V. Efficacy and safety of certolizumab pegol monotherapy every 4 weeks in patients with rheumatoid arthritis failing previous disease-mo — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	American College of Rheumatology (ACR)-20 responder rate at Week 24		24 weeks
Secondary	safety and tolerability every 4 weeks		Every 4 weeks
Secondary	effect of CDP870 on health outcomes measures		24 weeks
Secondary	systemic exposures and immunogenic profile of CDP870		24 weeks

External Links

•   Clinical Study Summary on UCB.com