A Multi-center, Multinational, Noninterventional Study With Certolizumab Pegol in Comparison to Any Other Subcutaneous TNF Inhibitor in Two Parallel Groups in Biologic Naive Patients With Rheumatoid Arthritis
18 Years
N/A
Both
Rheumatoid Arthritis
Trial Information
A Multi-center, Multinational, Noninterventional Study With Certolizumab Pegol in Comparison to Any Other Subcutaneous TNF Inhibitor in Two Parallel Groups in Biologic Naive Patients With Rheumatoid Arthritis
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) latest at
Visit 1
- Treatment is according to the Summary of Product Characteristics (SmPC) and local
labeling
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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Proportion of patients demonstrating persistence to the initially prescribed Tumor Necrosis Factor (TNF) inhibitor after 24 months of treatment
Outcome Description:
For a patient to be classified as persistent he or she must be classified as an early responder up to Week 12 and be continuously treated up to Week 104 with the initially prescribed Tumor Necrosis Factor (TNF) inhibitor at a dose not greater than that initially prescribed according to the Summary of Product Characteristics (SmPC) or local labeling. For the definition of persistence rate for the primary variable, patients will be classified as early responders if their Disease Activity Score 28 (Erythrocyte Sedimentation Rate) (DAS28 (ESR)) shows a reduction of ≥ 1.2 from Baseline or decreases to ≤ 3.2 (Low Disease Activity (LDA) or remission) up to Week 12. Non responders up to Week 12 will be counted as non persistent to the initially prescribed TNF inhibitor treatment. Patients who stop the initially prescribed TNF inhibitor treatment will not be counted as persistent, except if treatment with TNF inhibitor is stopped because the patient is in clinical remission.
Outcome Time Frame:
up to Week 104
Safety Issue:
No
Principal Investigator
UCB Clinical Trial Call Center
Investigator Role:
Study Director
Investigator Affiliation:
+1 877 822 9493 (UCB)
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
RA0097
NCT ID:
NCT01764321
Start Date:
December 2012
Completion Date:
July 2017
Related Keywords:
- Rheumatoid Arthritis
- Certolizumab Pegol
- Cimzia®
- TNF inhibitor
- DMARD
- Rheumatoid Arthritis
- Arthritis
- Arthritis, Rheumatoid
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