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

UCB

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: CDP870

Study type: Interventional

Funder types: Industry

Identifiers

NCT00548834

C87011

Details and patient eligibility

About

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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind