Open Label Study to Assess the Predictability of Early Response to Certolizumab Pegol in Patients With Rheumatoid Arthritis (SPEED)

UCB

Status and phase: Completed; Phase 4

Conditions: Rheumatoid Arthritis

Treatments: Biological: Certolizumab pegol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01443364

2011-000385-35 (EudraCT Number)

RA0069

Details and patient eligibility

About

The study aims to evaluate the predictability of early response to Certolizumab pegol in combination with Methotrexate at one year in patients with moderate to severe rheumatoid arthritis.

Enrollment: 132 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of adult-onset Rheumatoid Arthritis (RA) for a duration of at least 6 months but not longer than 5 years
• positive Rheumatoid Factor (RF) and/or positive anti Cyclic Citrullinated Peptide (anti-CCP)
• active RA disease
• subjects must have failed at least one traditional Disease Modifying Anti-Rheumatic Drug (DMARD).
• subject is naïve to RA related biologics

Exclusion criteria

• a diagnosis of any other inflammatory arthritis
• history of infected joint prosthesis, or other significant infection
• known Tuberculosis (TB) disease or high risk of acquiring TB infection

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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132 participants in 1 patient group

Certolizumab pegol

Experimental group

Treatment:

Biological: Certolizumab pegol