Noninterventional Examination of Subcutaneous (sc) Tumor Necrosis Factor (TNF) Inhibitors (NexT)

UCB

Status: Completed

Conditions: Rheumatoid Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT01764321

RA0097

Details and patient eligibility

About

This prospective, post marketing, observational, Noninterventional Study (NIS) is designed to compare drug persistence in patients treated with Certolizumab Pegol (CZP) and patients treated with any other subcutaneously (sc) administered Tumor Necrosis Factor (TNF) inhibitor.

Enrollment: 1,723 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of Rheumatoid Arthritis (RA)
• Moderate to severe disease activity of RA
• The patient receives Tumor Necrosis Factor (TNF) inhibitor in combination with at least 1 synthetic Disease Modifying Antirheumatic Drug (DMARD)
• The decision to prescribe a TNF inhibitor in combination with DMARD is made by the treating physician, prior to and independently from the decision to include the patient in this Non-Interventional Study (NIS)
• Male or female patients ≥ 18 years of age, considered by the treating physician to be reliable and capable of adhering to the observational plan (eg, able to understand and complete questionnaires)
• The patient personally signed and dated Patient Data Consent Form (PDCF) prior to Visit 2
• Treatment is according to the Summary of Product Characteristics (SmPC)

Exclusion criteria

• Known contraindications to Tumor Necrosis Factor (TNF) inhibitors
• Prior use of any TNF inhibitors (including Adalimumab, Etanercept, Infliximab, Certolizumab, or Golimumab), or other biologic DMARDs (including Abatacept, Rituximab, Tocilizumab, or Anakinra)
• Participation in an investigational study

Trial design

1,723 participants in 2 patient groups

Certolizumab Pegol treatment

Description:

Certolizumab Pegol in combination with at least one Disease Modifying Antirheumatic Drug (DMARD)

Other Tumor Necrosis Factor TNF inhibitor treatment

Description:

Other subcutaneous (sc) Tumor Necrosis Factor (TNF) inhibitor (Adalimumab, Golimumab, Etanercept) in combination with at least one Disease Modifying Antirheumatic Drug (DMARD)