Clinical trial · Observational
Observation of Treatment With Certolizumab Pegol in Daily Practice
A Multicenter, Observational, Non-interventional Study to Evaluate the Safety and Efficacy of Anti-TNF (Anti-Tumor Necrosis Factor) Alpha Therapy With Certolizumab Pegol Observed in Daily Practice in Adult Rheumatoid Arthritis (RA) Patients
NCT01069419CI-TRIAL-00019644FasTcompletedResults postedClinicalTrials.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 is an observational, non-interventional, non-comparative, post-authorization safety study to evaluate efficacy and long-term safety of Cimzia in adult patients with RA in need of treatment with a biological product.
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 (1)
- label
- Cimzia
- description
- All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC
Primary outcomes (1)
- measure
- Clinical Remission at Visit 9 (Around Week 104) Measured by Achieving a Disease Activity Score 28 (DAS28) of < 2.6
- timeFrame
- From Baseline to Visit 9 (around Week 104)
- description
- The DAS28 was calculated using the tender and swollen joint counts, c-reactive Protein (CRP), or erythrocyte sedimentation rate (ESR), and the Patient's Global Assessment of Disease Activity (PtGADA). The joint assessment was carried out on 28 joints. For the analysis, DAS28 values were categorized into the following groups: * DAS28 \< 2.6: clinical remission * DAS28 from 2.6 to ≤ 3.2: low disease activity * DAS28 from \> 3.2 to 5.1: moderate disease activity * DAS28 \> 5.1: high disease activity
Secondary outcomes (3)
- measure
- Change From Baseline to Visit 9 (Around Week 104) in Patients's Arthritis Pain as Measured by Patient's Assessment of Arthritis Pain (PAAP) Visual Analog Scale (VAS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients eligible for treatment with Cimzia as defined in EU approved SmPC Exclusion Criteria: * Patient previously treated with Cimzia. Patient with known hypersensitivity to any component of Cimzia
References
Publications (0)
Data not yet available
No reference posted for this study.