Clinical trial · Observational
Noninterventional Examination of Subcutaneous (sc) Tumor Necrosis Factor (TNF) Inhibitors
A Multi-center, Noninterventional Study With Certolizumab Pegol in Comparison With Any Other Subcutaneous TNF Inhibitor in Two Parallel Groups in Biologic Naive Patients With Rheumatoid Arthritis
NCT01764321CI-TRIAL-00049077NexTcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rheumatoid Arthritis | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Certolizumab Pegol treatment
- description
- Certolizumab Pegol in combination with at least one Disease Modifying Antirheumatic Drug (DMARD)
- label
- 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)
Primary outcomes (1)
- measure
- Proportion of patients demonstrating persistence to the initially prescribed Tumor Necrosis Factor (TNF) inhibitor after 24 months of treatment
- timeFrame
- up to Week 104
- 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). For the definition of persistence rate for the primary variable, patients will be classified as early responders if their Disease Activity Score 28 (DAS28) 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.