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

UCB Pharma247 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

247

Conditions

Arthritis, Rheumatoid

Interventions

CDP870DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

American college of Rheumatolofy (ACR)-20 responder rate at Week 24

Secondary Outcomes

Safety and tolerability

health outcomes measures

immunogenic profile of CDP870 plus methotrexate

systemic exposure of CDP870

Data from ClinicalTrials.gov

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